Abstract
2021 brought a new Administration to Washington, D.C., with punditry abounding, including prognostications about the nation's recovery from COVID-19 and an effort in Washington to reestablish bipartisanship with a generally more cooperative tone on Capitol Hill. With the acknowledgment of the immediate need to address climate issues, the importance of science, and the trifecta of partisan control of the White House and both the House and the Senate, significant consensus to address the nation's needs and environmental concerns will be attainable, right? Not long after the New Year began, the attack on the Capitol on January 6, 2021, and the continued stirrings about the 2020 election results, 2021 got off to a rocky start and closes with renewed concerns about whether Washington can again “get things done.”
In last year's Forecast, we posed the following questions that remain resonant: Will the Biden Administration be torn apart from internal battles within the Democratic Party (progressives vs. centrists)? Will majority control of the Senate make governing easier or harder for the new Administration? Will the Senate remain a Dead Sea of deadlock or provide hope for bipartisan cooperation?
Although these rhetorical questions remain relevant, fortunately this Forecast is limited in scope and ambition, with a narrower focus on the range of issues surrounding biobased chemistry and biotechnology (the full report, covering the regulatory forecast for the broader industrial chemicals and pesticides, was published January 3, 2022 and can be found online at
The effects of the ongoing COVID-19 pandemic continue to affect the economy and have more local impacts of whether the U.S. Environmental Protection Agency (EPA), or any other organization, actually has staff located in a central office setting. Hearings in Congress are still a hybrid of in-person and remote attendance. Large gatherings and public meetings that were slowly beginning again seem now to be returning to being only on Zoom or Teams meeting platforms in light of the onset of the Omicron strain surge. Perhaps budget fights, threats of government debt default, and rancorous partisan bickering are a sign of “normalcy,” that might be welcome in an odd way if COVID-19 and its impact eventually fade as the dominant issue confronting the Administration.
The larger dynamic of underlying tension between partisan jockeying and prospects for bipartisan cooperation will nonetheless affect greatly what may happen to EPA Administration or any other Agency initiatives. Notwithstanding the “all-of-government” priority given to climate issues and environmental justice (EJ), the Administration will continue to address many other competing issues of significance. These include the ongoing pandemic, budget and spending priorities, foreign policy, cyber security, and a long list of other priorities needing attention by the Administration. And do not forget that 2022 will see off-year elections where current projections indicate that the Democrats may no longer control both sides of Capitol Hill—but the impact of what that might mean for EPA and chemical and pesticide issues will have to wait for the 2023 Forecast document.
Biobased and Renewable Chemistry
The biobased chemicals and renewable products industry plays a critical role in building a resilient, dependable, and sustainable system that fosters innovation to develop a circular economy. A circular economy requires new thinking about what we make, what we make it from, and where it goes at the end of its useful life. An important but often overlooked aspect of new product development is an understanding of the regulatory framework and landscape that will govern the commercialization of the new product.
Progress in this industrial sector is key to achieving energy efficiency and the conservation of non-renewable resources. To achieve the larger sustainability and circular economy promise, biobased chemicals must progress quickly from R&D platforms into the market. Therefore, it is essential to eliminate or alleviate the regulatory landscape and its challenges to chemical innovation globally. The next generation of biobased and renewable products may be on the line if a modernized and more efficient regulatory system is not developed.
Global and national policy reforms continue to focus increasingly on a circular economy as a critical part of addressing climate change. In 2021, for example, the U.S. Department of Energy (DOE) continued to concentrate on incentivizing biotechnology and energy efficiency through renewable and sustainable sources. In 2022, industry stakeholders can expect similar DOE funding and activities that incentivize a circular economy. DOE has already announced several funding opportunities in 2022 for efforts focused on the development of novel biobased chemistry.
Internationally, in May 2021, the European Parliament (EP) created a Just Transition Fund (JTF) to assist European Union (EU) countries to address climate neutrality through its 2021-2027 Multiannual Financial Framework (MFF) and NextGenerationEU funding projects focused on the transition into a sustainable and circular European economy. JTF is part of the European Green Deal's Just Transition Mechanism (JTM) initiative, which provides targeted support to regions and sectors in the EU that are most affected by the transition into a circular economy. Similarly, in an effort to develop a circular economy, the European Agency for Safety and Health at Work (EU-OSHA) created the High-Level Roundtable on Implementation of the Chemicals Strategy for Sustainability expert group. The expert group's specific tasks include identifying and addressing social, economic, and cultural barriers to the transition toward safe and sustainable chemicals.
These efforts are mere examples of the global effort to develop a green economy by revitalizing the biobased and renewable chemicals industry through new initiatives and smart policy reforms. B&C expects that such efforts will only continue to grow in 2022.
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 (NDAA) for FY 2021. Subtitle E established an interagency working group (IWG) to coordinate federal programs and activities in the creation of a roadmap for sustainable chemistry in the United States. The Act states that the IWG will be co-chaired by the Director of Office of Science and Technology Policy (OSTP) and a representative from EPA, the National Institute of Standards and Technology (NIST), the National Science Foundation (NSF), or DOE, as selected by the Director of OSTP.
As of November 2021, there is no evidence that the IWG has been formed or, if formed, is meeting. This is why it will be important in 2022 to monitor developments under this initiative for opportunities to engage with policymakers and stakeholders. More information about the Act is available in B&C's January 19, 2021, memorandum, Sustainable Chemistry Research and Development Act Passed as Part of National Defense Authorization Act.
These types of government coordination, policy reform, and dialogue with industry stakeholders will continue to be vital to move the biobased chemicals and renewable products markets forward in 2022.
Biotechnology
The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) are working together to create a clear regulatory pathway for foods made from cultured cells from animals. Under a 2019 formal agreement, FDA oversees cell collection, growth, and differentiation of cells. With the exception of Siluriformes fish, seafood falls under FDA's jurisdiction, while meat, including Siluriformes fish and poultry, are under the jurisdiction of USDA's Food Safety and Inspection Service (FSIS). While FDA was expected to announce in 2021 how it will proceed regarding the labeling of foods comprised of or containing cultured seafood cells, FDA has not yet done so. FDA requested information on October 7, 2020, pertaining to the labeling of these foods (85 Fed. Reg. 63277).
FDA invited comment on names or statements of identity for foods comprised of or containing cultured seafood cells; consumer understanding of terms that have been suggested for the names or statements of identity of foods comprised of or containing cultured seafood cells; and how to assess material differences between the foods that are the subject of the notice and conventionally produced foods. FDA has not publicly indicated what type(s) of action, if any, it will take to ensure that these foods are labeled properly.
On March 8, 2021, the Animal and Plant Health Inspection Service (APHIS) reopened the comment period on a December 28, 2020, Advance Notice of Proposed Rulemaking (ANPRM) soliciting public comment on a contemplated regulatory framework that would transition portions of FDA's pre-existing animal biotechnology regulatory oversight to USDA (86 Fed. Reg. 13221). Under the regulatory framework being contemplated, USDA would promulgate regulations using the authorities granted to it through the Animal Health Protection Act, the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA). Pursuant to these authorities, APHIS would conduct a safety assessment of animals subject to the FMIA or PPIA that have been modified or developed using genetic engineering that may increase the animals' susceptibility to pests or diseases of livestock, including zoonotic diseases, or ability to transmit the same.
FSIS would conduct a pre-slaughter food safety assessment to ensure that the slaughter and processing of certain animals modified or developed using genetic engineering would not result in a product that is adulterated or misbranded. According to the online docket for Docket ID APHIS-2020-0079, more than 51,000 comments were submitted, although many are identical, or nearly so, opposing the transfer of authority from FDA to USDA. APHIS has not yet stated its timeline for next steps.
USDA's FSIS published an ANPRM on September 3, 2021, to request comments pertaining to the labeling of meat and poultry products comprised of or containing cultured cells derived from animals subject to FMIA or PPIA (86 Fed. Reg. 49491). Issues raised in the comments submitted in response to the ANPRM will inform future rulemaking to establish labeling requirements for these products. The ANPRM also discusses how FSIS will generally evaluate labels for these products if they are submitted before FSIS completes the rulemaking.
APHIS could issue a final rule in 2022 to exempt plants with additional modifications that could otherwise be achieved through conventional breeding from the regulations that govern the introduction (importation, interstate movement, or release into the environment) of certain organisms modified or produced through genetic engineering. APHIS published a proposed rule on July 19, 2021 (86 Fed. Reg. 37988). According to APHIS, the exempt plants would have distinct modifications on the paternal and maternal alleles of a single gene resulting from repair of a targeted DNA break; deletions generated using an externally provided repair template; or deletions resulting from repair of two targeted double strand breaks on a chromosome.
Although APHIS was scheduled to complete implementation of its 2020 final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule in 2021, it has not yet issued a final guide detailing the information requirements and process for submitting a Regulatory Status Review (RSR) request. APHIS accepted comments until October 25, 2021, on a draft guide. Developers of certain genetically modified organisms (GMO) may use the RSR process to determine the regulatory status of the organisms.
APHIS is authorized by the Plant Protection Act to evaluate potential plant pest risks resulting from certain organisms developed using genetic engineering techniques. Prior to the SECURE rule, developers of genetically modified plants could petition APHIS to seek a determination that a modified plant is unlikely to pose a plant pest risk and therefore is no longer subject to APHIS' biotechnology regulations. With the SECURE rule, APHIS made several changes to its procedures, including introduction of the RSR process. The RSR process was implemented for select crops on April 5, 2021, and was fully implemented for all crops on October 1, 2021. More information on the draft guide is available in our August 31, 2021, blog item.
In 2022, EPA will continue to implement its mature regulatory systems for managing review of biotechnology innovations for pesticides and industrial chemicals. EPA promulgated several temporary or permanent tolerance exemptions for plant-incorporated protectants (PIP) in 2021, for example.
On October 9, 2020, EPA proposed an exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) for certain PIPs that are created in plants using biotechnology (85 Fed. Reg. 64308). EPA proposed exempt status for select PIPs created through biotechnology if those PIPs could otherwise have been created through conventional breeding and pose no greater risk than PIPs that EPA already had concluded meet the applicable safety standard. Comments were due by December 8, 2020. More than 8,000 comments were received, although only 28 are available in the docket (EPA-HQ-OPP-2019-0508). EPA has not stated its timeline for issuing the proposed rule in final.
In 2021, EPA continued to work with Oxitec Ltd. and its novel approach to mosquito control. In 2020, EPA approved a 24-month experimental use permit (EUP) to allow Oxitec to field test the use of genetically modified Aedes aegypti mosquitoes in Florida as a way to reduce mosquito populations. Oxitec releases genetically modified male mosquitoes that have a gene that makes a specific protein. This protein, as produced in female mosquitoes, prevents female offspring of the modified males from surviving. The absence of female mosquito emergence in the release area results in mosquito population decline and, with it, an expected reduction in the transmission of mosquito-borne disease-causing pathogens.
On May 5, 2021, EPA hosted a webinar to educate the public about this technology and EPA's approval of the EUP; the recorded webinar is available at
EPA continues to review Microbial Commercial Activity Notices (MCAN) under TSCA. EPA received a total of 22 MCANs during FY 2021. Two were submitted in late September, and determinations are not yet complete. Unlike premanufacture notices (PMN), MCANs were reviewed timely (either within 90 days or close to it), and all determinations were “not likely to present an unreasonable risk.” EPA also reviewed two TSCA Environmental Release Applications (TERA) and completed (and granted) both in under 60 days. EPA's biotechnology reviews are a bright spot in EPA's new chemicals review program.
Editor's Note
The preceding was excerpted from “Forecast for U.S. Federal and International Chemical Regulatory Policy 2022” from Bergeson & Campbell, P.C. (B&C®), its consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM). Prepared by the legal, scientific, and regulatory professionals of B&C, Acta, and BCCM, the full report (
B&C's core business focuses on the law, science, regulation, and policy of chemicals of all varieties—industrial, agricultural, intermediate, specialty, and biocidal, whether manufactured at the bulk or nano scale, or using conventional or innovative technologies, including nanotechnology, biotechnology, synthetic biology, or biobased technology. B&C's team includes lawyers; scientists (eight Ph.D.s), including toxicologists, chemists, exposure experts, and geneticists; and regulatory and policy experts deeply versed in chemical law, science, and policy.