By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency announced on August 4, 2023, that it is providing resources to help biotechnology developers exercise the full benefits of the exemptions available under the Plant Incorporated Protectants (PIP) exemption rule. These resources are available on EPA’s public website and include the following:

• Fact sheet and background information on PIPs rule;
• Examples of genetic modifications that are exempt under the rule;
• Description of how to submit a self-determination or a request for EPA confirmation of exemption under the rule; and
• Sample documents for submitting a self-determination or request for confirmation.

The PIPs Exemption Final Rule went into effect on July 31, 2023.  More information on the final rule is available in our June 2, 2023, memorandum.

Background

On May 31, 2023, EPA released a final rule exempting two categories of PIPs created using genetic engineering from certain registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. EPA states that the rule ensures that human health and the environment are protected while reducing costs for the regulated community, consistent with the September 2022 Executive Order 14081 on Advancing Biotechnology. According to EPA, the rule may also result in increased research and development activities, commercialization of new pest control options for farmers, and reduced use of conventional pesticides.
 
EPA notes that the final rule reflects the biotechnological advances made since 2001, when it first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements, but did not at that time exempt PIPs created through biotechnology. Specifically, the final rule exempts PIPs derived through genetic engineering from FIFRA registration and FFDCA tolerance requirements in cases where the PIPs are essentially equivalent to those exempted by the 2001 rule.
 
The rule contains conditions for exempting:

• PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption; and 
   
• Loss-of-function (LoF) PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect. EPA states that for this category of PIP, “biotechnology developers can make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.”

EPA notes that it indicated in the preamble to the final rule that it would consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements and expanding the categories of PIPs that are allowed the option to self-determine and do not require EPA confirmation of eligibility for the exemption.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. National Science Foundation (NSF), on behalf of the federal agencies and departments participating on the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity (the Subcommittee), is organizing two virtual listening sessions to hear from members of the public about recommendations, issues, and concerns related to federal department and agency implementation of the NSTC Framework for Federal Scientific Integrity Policy and Practice (the Framework). 88 Fed. Reg. 60713. The Subcommittee is supporting the development of scientific integrity policies at federal departments and agencies and seeks public input on the development and implementation of these policies and associated procedures and practices. According to the notice, perspectives gathered during the virtual listening sessions will inform: (1) federal agencies’ finalization of Scientific Integrity Policies, in response to the Framework and its implementation memorandum from the White House Office of Science and Technology Policy (OSTP); (2) federal agency processes, procedures, and practices related to scientific integrity; and (3) other elements of federal implementation of the Framework. The listening sessions will be held September 15, 2023, 1 p.m. - 3 p.m. (EDT) and September 20, 2023, 5 p.m. - 7 p.m. (EDT). Registration is now open. More information on the Framework is available in our January 19, 2023, blog item.

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By Lynn L. Bergeson and Carla N. Hutton
 
The Independent Commodity Intelligence Services (ICIS) search for the very best in innovation in the chemical industry. The ICIS Innovation Awards are intended to recognize and reward companies paving the way in product, process, and digital innovations that demonstrate a commitment to sustainability. The awards were open to any company in the chemical industry that successfully executed innovative projects that solve problems and provide solutions for companies, their customers, and society, as well as benefiting the environment and progressing sustainability. ICIS will recognize the 2023 winners on October 17, 2023. The 2023 winners include:

Best Digital Innovation from a Large Company

• Joint Winners:
  • Evonik Operations GmbH: COATINO^® Defect Detection -- Quantifying coating defects by using advanced image recognition methods; and
  • Dow: Dow^™ Paint Vision: Shaping the modern digital lab for paint formulation.
• Finalists:
  • Sewage and recycled water networks, Dubai municipality: Development of Fog Watch -- A digital platform to manage fat, oil, and grease waste;
  • Fatima Fertilizer Company: Sarsabz Pakistan (Fatima Fertilizers Farmer Application); and
  • Fatima Fertilizer Company: Sarsabz Asaan (Fatima Fertilizers Dealers Application).

Best Process Innovation from a Large Company

• Winner:
  • UPM Biochemicals, part of UPM -- The Biofore Company: UPM Biochemicals: Future beyond fossils.
• Finalists:
  • Nouri Petrochemical Company, PGPIC: Diagnosis, optimization, and compromising the bottlenecks of the benzene extraction process by designing an innovative tower’s internal;
  • Wanhua Chemical Group Co., Ltd.: Methylene diphenyl diisocyanate (MDI) byproduct amine-containing waste brine recycling technology;
  • Wanhua Chemical Group Co., Ltd.: Automatic continuous formaldehyde-free adhesive spray plywood panel process;
  • PPG: PPG Zero Discharge Project; and
  • Indorama Ventures: Optimization of cycle reaction propoxylation process time.

Best Product Innovation from a Large Company

• Winner:
  • Arkema: Recycling of monomaterial shoe.
• Finalists:
  • Dow: DEXCARE^™ CD-1 Polymer: Boost your shampoo’s conditioning effectiveness with Dow’s renewable, bioderived deposition aid;
  • Dow Chemical: EcoSense^™ GL-60 HA/HL Surfactants: Novel sustainable biosurfactants for personal care rinse-off and leave-on applications;
  • Celanese International Corp: Achieve even lower carbon footprint with Santoprene^® ECO-R Series thermoplastic vulcanizate (TPV) products; and
  • Corteva Agriscience: A modern nematicide with soil health benefits: Salibro^™ nematicide with Reklemel^™ Active from Corteva Agriscience.

Best Process Innovation from Small and Medium Enterprises (SME)

• Winner:
  • Botanical Solution Inc: Growing and extracting from plants in the lab to produce new fungicides for agriculture and QS-21 vaccine adjuvants for human health.
• Finalists:
  • LanzaTech: Pollution to products;
  • AmSty: Innovative PolyRenew^® circularity solution for accelerating plastics recycling;
  • Origin Materials: Origin materials; and
  • GDB Paint & Coatings: Making every drop count: GDB’s commitment toward a net-zero waste paint industry.

Best Product Innovation from an SME

• Winner:
  • Viridis Chemical Company: Commercial scale biobased ethyl acetate with lower greenhouse gas (GHG) emissions.
• Finalists:
  • ECO GLAS Environmental Limited: Septic Tank Smart Box;
  • Locus Ingredients: Leading the charge: Optimizing sophorolipids for real-world applications;
  • LanzaTech: CarbonSmart ethylene from carbon dioxide (CO₂); and
  • Oberon Fuels: Decarbonizing the global liquefied petroleum gas (LPG) industry, with new, negative-carbon intensity (CI) ingredient.

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By Lynn L. Bergeson and Carla N. Hutton
 
The July 2023 issue of the Organization for Economic Cooperation and Development’s (OECD) Chemical Safety and Biosafety Progress Report includes a summary of the April 2023 meeting of the Party on the Harmonization of Regulatory Oversight in Biotechnology (WP-HROB). During the meeting, WP-HROB agreed on next steps for preparing several consensus documents: “Environmental Considerations for Risk/Safety Assessment for the Release of Transgenic Plants” (led by the WP-HROB Bureau); “Revised Biology of Wheat” (led by Australia and the United States), both expected for publication in 2023; “Biology of the Mosquito Anopheles gambiae” (led by Australia, the African Union Development Agency -- New Partnership for Africa’s Development (AUDA-NEPAD), and the Agriculture & Food Systems Institute (AFSI)); and “Photoautotrophic Micro-algae for Biomass Production” (led by Canada and the United States). In addition, WP-HROB agreed on two proposals for new projects on the biology of mosquitoes, Anopheles albimanus and Anopheles stephensi (led by the United Kingdom, Brazil, and AUDA-NEPAD).
 
Three projects jointly developed by WP-HROB and the Working Party for the Safety of Novel Foods and Feeds (WP-SNFF) were reviewed at a joint session in April 2023:

• Revision of the OECD Council Recommendation on the safety of recombinant DNA organisms (2006), for which a revised draft was provisionally agreed for most provisions. A progress report will be delivered at the Chemicals and Biotechnology Committee (CBC) meeting in July 2023;
• Enhanced information exchange on new breeding techniques, for which a first set of information has been collected from delegations through a questionnaire; and
• The proposal on the “Safer-Innovation-Approach” in biotechnology, which was formally approved by WP-HROB in follow-up to a two-year pilot project.

The OECD Product Database, containing information on genetically engineered plant varieties approved for cultivation or use in foods and feeds, continues to be updated. A total of 393 entries of 26 crops, flowers, and trees are now available in the system, keeping pace with new information provided by OECD member countries, as well as a number of non-members.

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By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S.

On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. According to EPA’s May 25, 2023, press release, this rule will reduce costs for the regulated community and result in increased research and development activities, consistent with Executive Order 14081 on advancing biotechnology. EPA states that the rule also may result in the commercialization of new pest control options and reduced use of conventional pesticides. The final rule will be effective on July 31, 2023.

EPA states the final rule will allow PIPs to be exempt from FIFRA registration and FFDCA tolerance requirements in cases where they both pose no greater risk than PIPs that EPA has already concluded meet safety requirements, and when they could have otherwise been created through conventional breeding. The final rule reflects the biotechnological advances made since 2001, when EPA first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements but did not at that time exempt PIPs created through biotechnology.

In the rule, EPA provides criteria and definitions that identify two categories of PIPs that are exempted through this action from FIFRA registration and FFDCA tolerance requirements:

• “PIPs created through genetic engineering from a sexually compatible plant” in which genetic engineering has been used to insert or modify a gene to match a gene found in a sexually compatible plant (to be codified at 40 C.F.R. Section 174.26); and
• “Loss-of-function PIPs” in which the genetically engineered modification reduces or eliminates the activity of a gene, which then helps make the plant resistant to pests (to be codified at 40 C.F.R. Section 174.27).

For the first exempted category, EPA will require a notification process for EPA to confirm that the PIP is eligible for the exemption. For the second exempted category (loss-of-function PIPs), developers of PIPs can submit to EPA a self-determination letter that the exemption applies. EPA also is establishing recordkeeping requirements for these exempted PIPs, clarifying general qualifications for exemption at 40 C.F.R. Section 174.21; clarifying the relationship between the existing exemptions for PIPs from sexually compatible plants (40 C.F.R. Section 174.25) and the newly issued exemption for “PIPs created through genetic engineering from a sexually compatible plant” (40 C.F.R. Section 174.26); and allowing the existing inert ingredient exemption at 40 C.F.R. Section 174.705 to include genetic engineering.

EPA notes that in the future, as biotechnology advances further, it intends to consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements as well as adding categories of exempted PIPs to the list of categories that do not require EPA confirmation of eligibility.

Additional information, including the response to comment document, is available in docket EPA-HQ-OPP-2019-0508.

Commentary

This final rule is the next step for EPA’s Office of Pesticide Programs (OPP) on the path of EPA’s regulation of biotechnology pesticide products. It sets forth how OPP will handle products created by “Clustered Regularly Interspaced Short Palindromic Repeats” (CRISPR). In more general terms, CRISPR refers to manipulating plant genes with a method that was not available at the time the first biotechnology regulations were developed by EPA in the mid-1990s. This is why EPA needs to “update” its regulations, which is the purpose of the final rule.

Proponents of biotechnology methods argue that CRISPR allows the genes of plants to be manipulated more precisely and can be used to “simply” drop out a gene or add one from the same -- sexually compatible -- genome of the target plant. It follows that this is much like “traditional plant breeding” only done more precisely and more rapidly. Critics will likely raise questions about whether any product using this method, and not using traditional methods, might have some kind of unexpected result or unintended eventual effect. One can expect some adverse comments regarding these products even though EPA (among many others) lays out a rationale that this is an extension of its current regulations exempting products of traditional plant breeding from regulation under FIFRA/FFDCA (and not exempting such products from other regulatory authorities).

There also were concerns raised in comments submitted in response to the October 9, 2020, proposed rule. In particular, some in industry remain concerned that the final rule creates differential treatment for products due solely to the methods of development (i.e., biotechnology vs. conventional), thus subjecting products created using biotechnology to additional regulatory and recordkeeping requirements, even in cases when those products could have been created using older research and development approaches.

EPA’s basic requirements for biotechnology products that regulate inter-species gene manipulation would not change. Also worth noting is that the rule also would allow a developer to submit the product for EPA review to affirm that it qualifies for the exemption (i.e., a M009 Pesticide Registration Improvement Act (PRIA) action, which can lead to EPA delays in processing). The EPA docket includes a slide deck with a helpful summary of the final rule and its rationale.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on May 30, 2023, that the Chemical Catalysis for Bioenergy Consortium (ChemCatBio) will hold a webinar on June 14, 2023, on “Perspectives on Engineered Catalyst Design and Forming.” ChemCatBio is a consortium of eight DOE national laboratories overseen by BETO. According to BETO, the performance evaluation, and ultimate commercial adoption, of next-generation catalyst materials requires the development of strategies to prepare complex engineered catalysts suitable for operation in commercially relevant reactor configurations and scales. To leverage the fundamental advancements ChemCatBio has made in catalyst technology, BETO states that the consortium recently implemented a new vision to address risks by focusing on process integration and fuel production with engineered catalysts.
 
In the webinar, Bruce Adkins (Oak Ridge National Laboratory), Frederick Baddour (National Renewable Energy Laboratory), and Matthew Greaney (Clariant) will present critical considerations for the “engineered” catalyst; an industrial perspective on catalyst design and forming; and ChemCatBio’s industry-informed capabilities that support the transition to more commercially relevant catalyst forms. The webinar will end with a question and answer session.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on May 15, 2023, that a new workflow developed by researchers at the Agile BioFoundry (ABF), a BETO-funded consortium of national laboratories and Agilent Research Laboratories (Agilent) addresses the need for faster analytical tools. According to BETO, the workflow “combines state-of-the-art analytical technologies with a machine learning-based algorithm, providing a faster and more powerful way to process data that could accelerate the Design-Build-Test-Learn framework, a bio-engineering cycle used to improve biomanufacturing research and processes.”
 
BETO notes that speeding up the bio-engineering cycle could ultimately speed up biomanufacturing research. According to BETO, one of the biggest barriers to accomplishing this is the ability to improve the Learn step of the cycle, which involves using data to improve future cycles. Improvements to the Learn step can happen only if large amounts of high-quality data are gathered in the Test step of the cycle, however.
 
BETO states that the consortium teams set out to create a workflow that could generate high-quality analytical Test data that could feed into the Learn step. The workflow they developed includes several components:

• A high-throughput analytical method developed in collaboration with Agilent that enables a threefold reduction in sample analysis time (compared to previous conventional approaches) by using optimized liquid chromatography conditions;
• The Automated Method Selection Software tool, which predicts the best liquid chromatography method to use for analyzing new molecules of interest; and
• PeakDecoder, a novel algorithm that processes multi-dimensional metabolite data and automatically calculates errors in metabolite identification.

To test the workflow’s effectiveness, the researchers used it to study metabolites of various strains of microorganisms engineered by ABF. The microorganisms they tested all have the capacity to make various bioproducts, such as polymer and diesel fuel precursors. According to BETO, using their workflow, the researchers were able to interpret 2,683 metabolite features across 116 microbial samples.
 
BETO states that the researchers see PeakDecoder “as a stepping stone towards creating an automated data-gathering pipeline.” According to BETO, the team is already working on leveraging state-of-the-art artificial intelligence methods like computer vision used in other fields. The next version of PeakDecoder is expected to have improved automation and identification performance and to be more applicable to other types of molecular profiling, including proteomics workflows.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) published a “Science & Tech Spotlight” on synthetic biology on April 17, 2023. GAO defines synthetic biology as “a multidisciplinary field of biotechnology that involves engineering the genetic material of organisms -- such as viruses, bacteria, yeast, plants, or animals -- to have new characteristics.” According to GAO, scientists are currently exploring the use of synthetic biology to address environmental challenges by engineering organisms to use carbon dioxide, produce biofuels for vehicles, and transform methane into biodegradable plastics. GAO notes that the synthetic biology market could grow from about $10 billion in 2021 to between $37 billion and $100 billion dollars by 2030. Opportunities include:

• Widely adaptable. Synthetic biology holds the potential to help diagnose and treat diseases, improve industrial processes, and address some environmental challenges;
• More equitable access to biotechnology. Some of the tools needed for synthetic biology are low-cost and widely available, which could make access to beneficial applications more equitable; and
• Conservation efforts. Synthetic biology could support endangered species conservation, for example, by altering the genes of endangered plants to make them resilient to diseases.

GAO notes the following challenges:

• Safety and security concerns. Synthetic biology could pose a significant threat to national security if it were used for nefarious purposes, such as developing new biological or chemical weapons. Additionally, the computational tools used for synthetic biology could be vulnerable to cyberthreats such as automation hacking. For example, a bad actor could manipulate or steal information and use it to create drugs, weapons, or other harmful products.
• Environmental effects. Organisms made using synthetic biology and released into the environment could have unknown, unintended, and potentially irreversible effects on ecosystems. Such effects could be widespread if, for example, these organisms negatively affected food or water systems.
• Public acceptance and access. The public may hesitate to accept certain applications of synthetic biology due to concerns about interfering with nature and about unintended effects. In addition, some medical applications could be inaccessible for some patients due to cost or location of treatment centers.

GAO concludes the “Science & Tech Spotlight” with the following policy context and questions:

• Do policymakers have adequate access to expertise and resources to evaluate the societal effects and public policy implications of synthetic biology research and development?
• How effective is the coordination among 1) domestic and 2) global stakeholders for monitoring and assessing the risks associated with advances in synthetic biology research and applications?
• Is the current regulatory framework sufficient to address ongoing and future applications and their effects without unnecessarily hindering U.S. competitiveness in synthetic biology?

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By Lynn L. Bergeson and Carla N. Hutton
 
To celebrate its 125th anniversary, ASTM International invited case study submissions from committee members to highlight standards that have made a significant impact in society. One of the winning entries is on a set of standards for biodegradable plastic from Committee D20 on Plastics. According to ASTM International’s article, standard test methods for determining the biobased content of solid, liquid, and gaseous samples using radiocarbon analysis (D6866) allows industry, regulators, and government to determine experimentally the percent biobased carbon present in a product or fuel. The article notes that the U.S. Department of Agriculture’s (USDA) BioPreferred^® program, mandated by Congress in the 2018 Farm Bill, authorizes the procurement of biobased products by the federal government. The article states that this standard is required to be used to report the percent biobased content of product for federal procurement, as well as for labeling a product with the BioPreferred logo showing biobased content.
 
The article states that there are two companion specification standards for compostable plastics and paper coatings, “redesigning plastic polymers for biodegradability in industrial composting for an environmentally responsible, managed end-of-life”:

• Standard specification for labeling of plastics designed to be aerobically composted in municipal or industrial facilities (D6400); and
• Standard specification for labeling of end items that incorporate plastics and polymers as coatings or additives with paper and other substrates designed to be aerobically composted in municipal or industrial facilities (D6868).

The standard specifications, which are “grounded in strong science and driven by consensus, provided much-needed clarity and credibility for acceptance in the marketplace and by regulatory bodies in states like California, Washington, Minnesota, Rhode Island, and Connecticut.” The article states that the BioPreferred program mandates D6866 as the only accepted standard for determining and reporting biobased content of products, and that the U.S. Environmental Protection Agency (EPA) requires the standard for reporting on biobased content in fuels. According to the article, industry uses D6400 and D6868 exclusively for making claims of biodegradability under industrial composting conditions. These standards are also the basis of certifications issued by U.S. and European organizations. The article notes that many stakeholders require that compostable products meet D6400 for plastics and D6868 for coatings on paper, and that industrial composters also require certification that the compostable products are certified to these standards.

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 By Lynn L. Bergeson and Carla N. Hutton
 
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 Symbiont^TM 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 on advancing biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy.

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