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.
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) announced on January 26, 2023, $118 million in funding for 17 projects to accelerate the production of sustainable biofuels for America’s transportation and manufacturing needs. According to DOE, the selected projects, located at universities and private companies, “will drive the domestic production of biofuels and bioproducts by advancing biorefinery development, from pre-pilot to demonstration, to create sustainable fuels that reduce emissions associated with fossil fuels.” Projects selected will contribute to meeting DOE’s goal to achieve cost-competitive biofuels and at least a 70 percent reduction in greenhouse gas (GHG) emissions by 2030.
 
According to DOE, “[m]ade from widely available domestic feedstocks and advanced refining technologies, energy-dense biofuels provide a pathway for low-carbon fuels that can lower greenhouse gas emissions throughout the transportation sector and accelerate the bioeconomy.” DOE notes that financing for novel biorefinery process systems can be a barrier to commercializing advanced biofuels, and states that its funding will reduce technological uncertainties and enable industry deployment. The selected projects include pre-pilot, pilot, and demonstration projects that will scale-up existing biomass to fuel technologies that will eventually create millions of gallons of low-carbon fuel annually.

Tags: DOE, Biofuel, GHG

 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
The Federal Trade Commission (FTC) announced on January 31, 2023, that it has extended the deadline for public comment on its Guides for the Use of Environmental Marketing Claims (Green Guides) to April 24, 2023. 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.” FTC 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.


 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has opened registration for the second ECOTOXicology Knowledgebase (ECOTOX) virtual training on February 7, 2023. ECOTOX is a comprehensive, publicly available tool providing environmental toxicity data on aquatic life, terrestrial plants, and wildlife.  EPA states that the virtual training, which is specifically targeted for decision-makers, will provide:

  • An overview of the database content and function;
     
  • Application-oriented use case demonstrations; and
     
  • Opportunities for participatory learning and engagement.

According to EPA, the virtual training will be a live encore of the training offered in May 2022, presenting the same material and featuring expanded opportunity for live interaction in Session 2. Participants may register for one or both sessions; registration is free but required to attend each session.
 
Session 1 (Presentation and Questions and Answers (Q&A))
11:00 a.m.-12:30 p.m. (EST)
This session will provide an overview of the knowledgebase content and function with opportunities for participation and Q&A.
 
Session 2 (Breakout Sessions)
12:30-1:30 p.m. (EST)
This session will break participants into breakout groups to work on case study exercises in small groups, aided by facilitators.


 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) recently published its new Strategy for Plastics Innovation (SPI), which will guide DOE’s collaborative research and development (R&D) on plastic waste reduction. Four strategic goals focus the scope of the SPI:

  • Deconstruction: Create new chemical, thermal, and biological/hybrid pathways to deconstruct plastics efficiently into useful chemical intermediates;
     
  • Upcycling: Advance the scientific and technological foundations that will underpin new technologies for upcycling chemical intermediates from plastic waste into high-value products;
     
  • Recyclable by Design: Design new and renewable plastics and bioplastics that have the properties of today’s plastics, are easily upcycled, and can be manufactured at scale domestically; and
     
  • Scale and Deploy: Support an energy- and material-efficient domestic plastics supply chain by helping companies scale and deploy new technologies in domestic and global markets, while improving existing recycling technologies such as collection, sorting, and mechanical recycling.

According to the SPI, a lack of robust chemical and biological mechanisms limits the deconstruction of existing plastics. This is further complicated by the need for more robust processes that can convert diverse and contaminated plastic waste streams into useful chemical intermediates that can be upcycled into high-value products. The SPI states that “even when robust processes are developed to deconstruct existing plastics, the demand for plastics remains, leading to a critical need for new plastic materials that have the same advantages as current plastics but can be economically recycled or biodegraded safely in the environment.” The SPI notes that underscoring these goals “is the need to approach this problem in a manner informed by life cycle and techno-economic assessment, ensuring solutions are cost-competitive and environmentally benign.” The SPI identifies key research needs and opportunities for DOE-sponsored R&D and catalogs challenges and opportunities facing SPI efforts. DOE intends the SPI to transform its approach to plastic waste and develop new classes of plastic that are recyclable and upgradable by design.


 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s Bioenergy Technologies Office (BETO) announced on January 23, 2023, that researchers at the National Renewable Energy Laboratory (NREL) examined the benefits and trade-offs of current and emerging technologies for recycling certain types of plastics to determine the optimal options. According to BETO, the researchers provided a comparison of various closed-loop recycling technologies, which allow for the reuse of plastic through mechanical and chemical reprocessing, eliminating the need for fossil-fuel-derived virgin materials. They considered technical metrics, such as the quality and retention of recycled plastics, as well as environmental metrics, including energy use and greenhouse gas (GHG) emissions. BETO and the Advanced Materials and Manufacturing Technologies Office provided funding for the research as part of the BOTTLE™ Consortium (Bio-Optimized Technologies to keep Thermoplastics out of Landfills and the Environment). The Consortium is a collaborative effort among industry, academia, national labs, and the government to change the way we recycle. More information is available in the January 2023 article “Technical, Economic, and Environmental Comparison of Closed-Loop Recycling Technologies for Common Plastics,” published in ACS Sustainable Chemistry & Engineering.


 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s Bioenergy Technologies Office (BETO) announced on January 20, 2023, that a collaborative team of BETO-funded scientists from Argonne National Laboratory (ANL) and National Renewable Energy Laboratory (NREL) are searching for carbon utilization technologies that can make better use of the carbon dioxide generated by industry, transportation, and agriculture by transforming it into sustainable aviation fuel and other useful products. According to BETO, the goal is to identify catalysts that can make beneficial products, such as sustainable aviation fuel, efficiently and selectively. BETO states that methanol has “rich potential for uses that contribute to lower greenhouse gas emissions and help in the fight against climate change.” It can generate electricity when used for fuel cells, serve as a heating fuel for boilers, or be used as a sustainable or blended fuel for road, marine, or (potentially) aviation. Additionally, methanol is used as a chemical industry feedstock for the synthesis of formaldehyde, acetic acid, and other health and life sciences products. BETO notes that the long-term challenge of the research will be scaling up scientific findings into commercial applications. With atmospheric carbon dioxide levels on the rise, “innovative research that finds ways to transform CO2 in the atmosphere into something positive is more important than ever.”


 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
On January 12, 2023, the White House Office of Science and Technology Policy (OSTP) announced the release of A Framework for Federal Scientific Integrity Policy and Practice, “a roadmap that will help strengthen scientific integrity policies and practices across the federal government.” The framework builds on the assessment of federal scientific integrity policies and practices described in the January 2022 report, Protecting the Integrity of Government Science, and draws from extensive input from federal agencies, as well as from across sectors, including academia, the scientific community, public interest groups, and industry. According to OSTP, the framework has several key components that federal departments and agencies will use to improve scientific integrity policies and practices, including:

  • A consistent definition of scientific integrity for all federal agencies;
  • A model scientific integrity policy to guide agencies as they build and update their policies; and
  • A set of tools to help agencies regularly assess and improve their policies and practices.

The framework requires all agencies to designate a Scientific Integrity Official (SIO) and agencies that fund, conduct, or oversee research to designate a Chief Science Officer (CSO), and it establishes the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity to oversee implementation of the framework and evaluate agency progress. Agencies are directed to adopt the following timeline:

  • Within 60 days from public posting of the framework: Agencies should submit new or updated agency and department draft scientific integrity policies for review by OSTP and the Subcommittee via the mailbox .(JavaScript must be enabled to view this email address);
  • Within 120 days from public posting of the framework: OSTP and the Subcommittee will complete the reviews using the framework’s critical policy features for assessment;
  • Within 180 days after public posting of the framework: Each agency should provide an opportunity for public input on its scientific integrity policies and practices, such as through a listening session or request for comment on its draft policy;
  • Within 270 days from public posting of the framework: Final policies are due to OSTP. OSTP will compile and make public all agency policies, as well as all agencies’ designated CSOs and SIOs on a federal web page;
  • Within 360 days from public posting of the framework and every two years thereafter: All agencies report to OSTP on their progress toward implementing the Framework; and
  • For calendar year 2023 and annually thereafter: Each agency should publish, consistent with any requirements related to national security and privacy as well as any other applicable law, an annual report on the agency’s website.

 
  • Email This
  • Print
  • Share Link

 By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 12, 2023, that it is updating the Safer Chemical Ingredients List (SCIL), “a living list of chemicals organized by functional-use class that EPA’s Safer Choice program has evaluated and determined meet Safer Choice criteria.” EPA is adding nine chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”
 
EPA changed the status for one chemical (1-octanesulfonic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-) that has recently been identified on the SCIL as a per- or polyfluoroalkyl substance (PFAS). According to EPA, the chemical is not used in any Safer Choice-certified products. It was added to the SCIL in 2012 based on the data available and the state of EPA’s knowledge at the time. EPA has now updated the SCIL listing for this chemical to a grey square because of a growing understanding of the toxicological profiles for certain PFAS and incomplete information on the potential health and environmental effects of these substances. A grey square notation means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list this chemical on the SCIL. EPA will determine the data required on a case-by-case basis. According to EPA, in general, data useful for making such a determination would provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA will remove the chemical from the SCIL 12 months after the grey square designation.
 
EPA states that after this update, there are 1,064 chemicals listed on the SCIL. The SCIL is a resource that can help many different stakeholders:

  • Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
  • Chemical manufacturers use this list to promote the safer chemicals they manufacture;
  • Retailers use the list to help shape their sustainability programs; and
  • Environmental and health advocates use the list to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.


 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced on December 15, 2022, that it intends to issue two funding opportunity announcements (FOA) in early 2023. According to BETO, these potential FOAs, “Reducing Agricultural Carbon Intensity and Protecting Algal Crops” (RACIPAC) and the “2023 Conversion R&D,” will enable the sustainable use of domestic biomass and waste resources to produce biofuels and bioproducts, and to advance the Biden Administration’s goal of delivering an equitable, clean energy future that puts the United States on a path to achieve net-zero emissions, economy-wide, no later than 2050. The prospective RACIPAC FOA would support high-impact research and development (R&D), focusing on reducing the carbon intensity of agricultural feedstocks, improving soil carbon levels, and protecting cultivated algae from pests under two areas of interest:

  • Climate-smart agricultural practices for low carbon intensity feedstocks; and
  • Algae crop protection.

The prospective 2023 Conversion R&D FOA would support the development of technologies that convert domestic lignocellulosic biomass and waste resources, including industrial syngas, into affordable biofuels and bioproducts that significantly reduce carbon emissions under two main areas of interest:

  • Overcoming barriers to syngas conversion; and
  • Strategic opportunities for decarbonization of the chemicals industry through biocatalysts.

According to BETO, both potential FOAs will help to meet the goals of the Sustainable Aviation Fuel Grand Challenge, which are to reduce aviation emissions by 20 percent by 2030 and produce sufficient sustainable aviation fuel to meet 100 percent of domestic aviation demand by 2050.


 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information requirements and process for submitting an RSR request under the revised biotechnology regulations at 7 C.F.R. Part 340. Under the revised regulations, developers may request a permit and/or an RSR of a plant developed using genetic engineering that APHIS has not previously reviewed. Developers may submit a request for an RSR when they believe a modified plant is not subject to regulation. APHIS will review the modified plant and consider 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 will post the request, its response letter, the plant, trait, and a general description of the Mechanism of Action (MOA) on its website. The posting of plant, trait, and MOA combinations provides a growing range of modifications that are eligible for exemption from regulation. Alternatively, if APHIS is unable to make such a finding, the modified plant is subject to regulation.

Tags: APHIS, GE, USDA

 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
On December 2, 2022, the U.S. Environmental Protection Agency (EPA) published a final rule determining that renewable diesel, jet fuel, heating oil, naphtha, and liquefied petroleum gas (LPG) produced from canola/rapeseed oil via a hydrotreating process all meet the lifecycle greenhouse gas (GHG) emissions reduction threshold of 50 percent required for advanced biofuels and biomass-based diesel (BBD) under the Renewable Fuel Standard (RFS) program. 87 Fed. Reg. 73956. EPA states that based on the analyses described in the earlier notice of proposed rulemaking associated with this action, it is adding these pathways to the list of approved pathways in the RFS regulations, making them eligible to generate Renewable Identification Numbers (RIN), provided they satisfy the other definitional and RIN generation criteria for renewable fuel specified in the RFS regulations. EPA also amended the RFS regulations by adding a new definition of “canola/rapeseed oil.” The final rule was effective on January 3, 2023.

Tags: RFS, GHG, Biofuel, BBD

 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
On January 3, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a draft document entitled Biofuels and the Environment: Third Triennial Report to Congress (External Review Draft) for public comment. 88 Fed. Reg. 72. EPA’s Office of Research and Development (ORD) and Office of Air and Radiation (OAR), in consultation with the U.S. Departments of Agriculture (USDA) and Energy (DOE), prepared the document. The draft report is responsive to Section 204 of the 2007 Energy Independence and Security Act (EISA). The purpose of the report is to examine the effects of the Renewable Fuel Standard (RFS) Program on the environment, including the impacts to date and likely future impacts to the nation’s air, land, and water resources. It focuses on the dominant biofuel sources in the United States: (1) domestic corn ethanol from corn starch; (2) domestic biodiesel from soybean oil; (3) domestic biodiesel from fats, oils, and greases (FOG); and (4) imported ethanol from Brazilian sugarcane. The draft report concludes that the RFS Program likely played a relatively minor role (0-0.4 billion gallons per year) in the growth of corn ethanol in the United States from 2002-2012 and may have played a more important role (0-2.1 billion gallons per year) since 2013. According to the draft report, the more prominent role of the RFS Program on corn ethanol production in the United States in more recent years is consistent with the methyl-tert-butyl-ether (MTBE) phaseout by 2006, expiration of the Volumetric Ethanol Excise Tax Credit (VEETC) at the end of 2010, and lower oil prices after 2015. For biodiesel and renewable diesel, which may be produced from a variety of feedstocks (e.g., soybean, FOGs), the draft report states that the conclusion on the attributional effect of the RFS Program is different. There is evidence that the RFS Program has driven a significant portion of the use of these biofuels since 2010; there is insufficient information available to quantify the attributional effect of the RFS Program, however. The draft report notes that despite the finding of relatively modest effects of the RFS Program nationally for the environmental impacts assessed, these may have important cumulative impacts on the environment. The draft report states that international effects associated with imported biofuels are even more uncertain than national effects but are likely modest as well given the relatively small quantity of imports relative to domestic biofuel production since the RFS Program went into effect.
 
The draft report reinforces the broad conclusions from the first and second Reports to Congress on biofuels in general and further evaluates attribution of those effects to the RFS Program more specifically. According to the draft report, biofuels continue to have the potential for both positive and negative environmental effects, depending on the many factors identified in the report. The draft report notes that at the time of writing, the likely future effects of the RFS Program are highly uncertain. The first and second Reports to Congress “had the benefit of statutory biofuel volumes established by EISA as a guideline for the likely future,” but these statutory volumes ended in 2022. EPA continues to work on issuing final annual biofuel standards under the RFS Program for future years. These standards are critical to estimating accurately the likely future effects of the RFS Program. Since these final standards for future years are not yet available, they are not included in this report. The draft report notes that several other factors contribute to additional uncertainty, including ongoing recovery from the global COVID-19 pandemic, uncertainty in the penetration of E15 in the marketplace, competition with other technologies such as electric vehicles, and continued but slow growth of cellulosic ethanol production from agricultural or marginal lands. As policy and market conditions change, so may the factors to consider and the estimate of the likely future effects of the RFS Program.
 
EPA states that it is releasing the draft document to seek review by a contractor-led peer review panel. EPA will post the external peer review panel, peer review meeting dates, and registration information on its website. Comments on the draft report are due March 6, 2023.

Tags: Biofuel, RFS

 
  • Email This
  • Print
  • Share Link

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.


 
  • Email This
  • Print
  • Share Link

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.


 
  • Email This
  • Print
  • Share Link

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two requests for information (RFI) related to the NBBI. In the first one, OSTP, on behalf of the primary agencies that regulate the products of biotechnology -- the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) -- requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900. According to the RFI, the information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products. The RFI includes the following questions:

  1. Describe any ambiguities, gaps, inefficiencies, or uncertainties regarding statutory authorities and/or agency roles, responsibilities, or processes for different biotechnology product types, particularly for product types within the responsibility of multiple agencies.
     
    1. Describe the impact, including economic impact, of these ambiguities, gaps, inefficiencies, or uncertainties.
       
  2. Provide any relevant data or information, including case studies, that could inform improvement in the clarity or efficiency (including the predictability, transparency, and coordination) of the regulatory system and processes for biotechnology products.
     
  3. Describe any specific topics the agencies should address in plain language on the regulatory roles, responsibilities, and processes of the agencies.
     
  4. Describe any specific issues the agencies should consider in developing a plan to implement regulatory reform, including any updated or new regulations or guidance documents.
  5. Describe any new or emerging biotechnology products (e.g., microbial amendments to promote plant growth; food plants expressing non-food substances or allergens from non-plant sources) that, based on lessons learned from past experiences or other information, the agencies should pay particular attention to in their evaluation of ambiguities, gaps, or uncertainties regarding statutory authorities and/or agency roles or processes.

  6. Describe any new or emerging categories of biotechnology products on the horizon that the regulatory system and processes for biotechnology products should be preparing to address. Describe any specific recommendations for regulating these new or emerging categories of biotechnology products to guide agency preparations.

  7. What is the highest priority issue for the agencies to address in the short term (i.e., within the next year) and in the long term.

OSTP, EPA, FDA, and USDA will host a virtual public listening session on January 12, 2023. The virtual listening session will allow OSTP, EPA, FDA, and USDA to hear, firsthand, from stakeholders who wish to provide feedback on any of the seven questions outlined in the RFI. Comments are due on or before 5 p.m. (EST) February 3, 2023. More information on the Coordinated Framework for the Regulation of Biotechnology is available in our January 9, 2017, memorandum.
 
The second RFI seeks public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to provide the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. 87 Fed. Reg. 77901. OSTP invites input from interested stakeholders, including industry and industry association groups; academic researchers and policy analysts; civil society and advocacy groups; individuals and organizations that work on biotechnology, biomanufacturing, or related topics; and members of the public. OSTP seeks responses to one, some, or all of the following questions:

Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals

  1. For any of the four categories outlined above (health, climate and energy, food and agriculture, and supply chain resilience):
     
    1. What specific bold goals can be achieved through advances in biotechnology and biomanufacturing in the short term (five years) and long term (20 years)? In your answers, please suggest quantitative goals, along with a description of the potential impact of achieving a goal. Listed below are illustrative examples of quantitative goals:
       
      1. Develop domestic bio-based routes of production, including the entire supply chain, for X percent of active pharmaceutical ingredients.
         
      2. Utilize X tons of sustainable biomass annually as input to biomanufacturing processes to displace Y percent of U.S. petroleum consumption.
    2. What R&D is needed to achieve the bold goals outlined in (a), with a focus on cross-cutting or innovative advances? How would the government support this R&D, including through existing federal programs, creation of new areas of R&D, and/or development of new mechanisms?
       
    3. How else can the government engage with and incentivize the private sector and other organizations to achieve the goals outlined in (a)?
       
  2. Public engagement and acceptance are of critical importance for successful implementation of biotechnology solutions for societal challenges. How might social, behavioral, and economic sciences contribute to understanding possible paths to success and any hurdles? What public engagement and participatory models have shown promise for increasing trust and understanding of biotechnology?

Data for the Bioeconomy

  1. What data types and sources, to include genomic and multiomic information, are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D? What data gaps currently exist?

  2. How can the federal government, in partnership with private, academic, and non-profit sectors, support a data ecosystem to drive breakthroughs for the U.S. bioeconomy? This may include technologies, software, and policies needed for data to remain high-quality, interoperable, accessible, secure, and understandable across multiple stakeholder groups.

Building a Vibrant Domestic Biomanufacturing Ecosystem

  1. What is the current state of U.S. and global biomanufacturing capacity for health and industrial sectors, and what are the limits of current practice?

  2. What can the federal government do to expand and scale domestic biomanufacturing capacity and infrastructure? What level of investment would be meaningful, and what incentive structures could be employed?

  3. What are barriers that must be addressed to enable better domestic supply chains for biomanufacturing (e.g., feedstocks, reagents, consumables)?

  4. How can the federal government partner with state and local governments to expand domestic biomanufacturing capacity, with a particular focus on underserved communities?

Biobased Products Procurement

  1. What are new, environmentally sustainable biobased products that the federal government could purchase through its BioPreferred Program? How can the federal government incentivize development of new categories of sustainable biobased products?

    Biotechnology and Biomanufacturing Workforce

  2. How can the U.S. strengthen and expand the biotechnology and biomanufacturing workforce to meet the needs of industry today and in the future? What role can government play at the local, state, and/or federal level?

  3. What strategies and program models have shown promise for successfully diversifying access to biomanufacturing and biotechnology jobs -- including those involving Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities, and other Minority Serving Institutions? What factors have stymied progress in broadening participation in this workforce?

Reducing Risk by Advancing Biosafety and Biosecurity

  1. What can the federal government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing life cycles?
     
  2. How can federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?

 Measuring the Bioeconomy

  1. What quantitative indicators, economic or otherwise, are currently used to measure the contributions of the U.S. bioeconomy? Are there new indicators that should be developed?

  2. How should the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) be revised to enable characterization of the economic value of the U.S. bioeconomy? Specifically, which codes or categories do not distinguish between functionally identical biobased and fossil fuel-based commodities?

International Engagement

  1. What are opportunities for the U.S. government to advance R&D, a skilled workforce, regulatory cooperation, and data sharing for the bioeconomy through international cooperation? Which partnerships and fora are likely keys to advance these priority areas?
     
  2. What risks are associated with international biotechnology development and use, and how can the U.S. government work with allies and partners to mitigate these risks?

Comments are due on or before 5:00 p.m. (EST) on January 20, 2023.


 
 1 2 3 >  Last ›