On December 20, 2022, the Office of Science and Technology Policy (OSTP) issued a notice of request for information (RFI) on the regulation of biotechnology on behalf of the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA). The RFI seeks to identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology (the Coordinated Framework), with a particular focus on new and emerging biotechnology products. The term “biotechnology,” as used in the RFI means “technology that applies to and/or is enabled by life sciences innovation or product development,” and includes, for example, “organisms (including plants, animals, and microbes) developed through genetic engineering or the targeted or in vitro manipulation of genetic information, some products derived from such organisms, as well as products produced via cell-free synthesis, as determined by existing statutes and regulations.”[1]
Established in 1986 and subsequently updated in 1992 and 2017, the Coordinated Framework outlines a comprehensive federal regulatory policy for oversight of biotechnology products under existing statutes implemented by FDA, EPA, and USDA. To facilitate coordinated oversight, the Framework describes the roles and responsibilities of the agencies in regulating biotechnology products based upon a product’s particular use, and sets forth key principles for regulatory oversight.[2] A primary goal of the Coordinated Framework is to ensure the protection of the public health and the environment while maintaining regulatory flexibility to avoid impeding innovation.
As outlined in the Coordinated Framework, including as updated in 1992 and 2017, FDA regulates, among other things, foods developed using biotechnology to “[e]nsure human and animal food is safe” and “properly labeled” pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA).[3] Currently, FDA also regulates animals developed using biotechnology under the new animal drug provisions of the FDCA and FDA’s implementing regulations.[4] USDA’s Animal and Plant Health Inspection Service (APHIS) regulates, among other things, products of biotechnology that may pose a risk to agricultural plant health pursuant to the Plant Protection Act and USDA’s implementing regulations.[5] EPA generally regulates the sale, distribution, and use of pesticides, including those produced using biotechnology under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).[6] Pesticides can include genetically-engineered plant proteins and genomes themselves, if the plant has been engineered to produce substances to protect themselves from pests (referred to as “plant incorporated protectants”). In addition, EPA regulates “new chemical substances” produced using biotechnology for use in certain commercial, industrial, and consumer applications pursuant to the Toxic Substances Control Act (TSCA).[7]
Recent proposals by FDA, EPA, and USDA, prompted by advances in technology and increased scientific understanding, continue to underscore the breadth of policy objectives shaped by the Coordinated Framework. For example, in October 2018, FDA announced its intention to issue guidance for industry explaining how its current policy for foods derived from new plant varieties, which focuses on recombinant DNA technology, applies to foods produced using genome editing.[8] In addition, FDA stated that it would update its existing procedures for voluntary premarket consultations with industry, which date back to 1996, to reflect FDA’s experience with foods derived from biotechnology plants over the last 25 years and to consider any additional issues regarding genome editing of food crops.[9] FDA also noted that it would clarify its approach on the regulation of intentional genomic alterations in animals, including through genome editing “to advance an efficient, science-based pathway to market for safe animal biotechnology-derived products.”[10] Notably, however, in December 2020, USDA issued an Advance Notice of Proposed Rulemaking (ANPR) describing a “contemplated regulatory framework” under which USDA, rather than FDA, would regulate animals modified or developed using biotechnology intended for use as human food that are subject to the Federal Meat Inspection Act (FMIA) or the Poultry Product Inspection Act (PPIA) (e.g., cattle, sheep, goats, swine, domesticated chicken).[11] USDA later reopened the comment period for the ANPR in March 2021.[12] In October 2020, EPA proposed to exempt under FIFRA and the FDCA “certain [plant-incorporated protectants]” derived from sexually-compatible plants using biotechnology.[13] While these proposals signal a willingness to clarify and streamline certain regulatory requirements, to date, none has been finalized.
On September 12, 2022, President Biden issued Executive Order (E.O.) 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” with the goal of accelerating biotechnology innovation across multiple sectors, including health, agriculture, and energy. Among other objectives, E.O. 14081 strives to support such innovation “by clarifying and streamlining regulations in service of a science- and risk-based, predictable, efficient, and transparent regulatory system to support the safe use of products of biotechnology.”[14] Against this backdrop, E.O. 14081 tasked FDA, USDA, and EPA to identify areas of ambiguity, gaps, or uncertainties in the Coordinated Framework, through engaging with developers and stakeholders and through horizon scanning for novel biotechnology products.
Pursuant to E.O. 14081, OSTP issued the instant RFI to engage external stakeholders on seven key questions to help clarify and streamline biotechnology regulations:
- 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.
a. Describe the impact, including economic impact, of these ambiguities, gaps, inefficiencies or uncertainties.
- 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.
- Describe any specific topics the agencies should address in plain language on the regulatory roles, responsibilities, and processes of the agencies.
- 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.
- 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.
- 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.
- 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?
What Can You Do?
Stakeholders may submit comments on or before 5pm ET on February 3, 2023, regarding the regulation of biotechnology products, such as the FDA, UDSA, and EPA proposals described above. Interested stakeholders should submit comments through the Federal eRulemaking Portal by searching “APHIS-2022-0076.”
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If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
[1] 87 Fed. Reg. 77900 (Dec. 20, 2022).
[2] The key principles set forth in the Coordinated Framework serve as guidance for FDA, USDA, and EPA. These principles provide, in relevant part, that: (1) each agency should apply its existing authorities “to ensure the safety of [] biotechnology products for their intended applications;” (2) “[u]nderlying statutes define the boundaries of the scope of oversight;” (3) the agencies should apply their authorities to “regulate products based upon specific uses” to assure that “products with the same use are subject to the same types of [regulatory] oversight;” (4) “[i]t is the characteristics of the biotechnology product, the environment into which it will be introduced, and the application of the product that determine its risk (or lack thereof);” (5) “[e]xercise of agency oversight within the scope afforded by statutes should be commensurate with the risk posed” by the biotechnology product “and should not turn on the fact that it was created or has been altered by a particular process or technique;” (6) the regulatory system should be “risk-based;” (7) the agencies should “endeavor to operate their programs in an integrated and coordinated” manner; and (8) future scientific developments should “lead to further refinements of the Coordinated Framework . . . to reflect a more complete understanding of the potential risks involved.” See Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology at 7-8, https://usbiotechnologyregulation.mrp.usda.gov/2017_coordinated_framework_update.pdf.
[11] 85 Fed. Reg. 84269 (Dec. 28, 2020).
[12] 86 Fed. Reg. 13221 (Mar. 8, 2021).
[13] 85 Fed. Reg. 64308 (Oct. 9, 2020).
[14] 87 Fed. Reg. 77900 (Dec. 20, 2022); see also 87 Fed. Reg. 56849 (Sept. 15, 2022).
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