The early weeks of the new year are seeing a lot of activity from several U.S. government agencies having oversight over industrial biotechnology, food biotechnology and renewable fuels. Several public comment periods are now underway on proposed regulations, agency initiatives, or requests for information, some of which address potentially important issues for certain applications of advanced biotechnology. These activities include the following:
Biotechnology Coordinated Framework. In what might potentially be a broad, far-reaching inquiry, the Office of Science and Technology Policy (OSTP) announced in December 2022 a Request for Information entitled “Identifying Ambiguities, Gaps, Inefficiencies, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology”. First issued in 1986 and updated in 2017, the “Coordinated Framework” represents the U.S. government’s approach to regulating the diverse products that can be developed using biotechnology, and includes regulations administered by the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA). In a September 2022 Executive Order issued by President Biden, OSTP has been charged with soliciting information from stakeholders on ambiguities and gaps in the framework that might affect the efficient development and regulatory approval for biotech products. A public comment period is open until February 3, 2023. (Another RFI was also issued as a result of this Executive Order, “Request for Information: National Biotechnology and Biomanufacturing Initiative”, but its comment period is expiring on January 20, 2023). The RFI listed 7 specific questions on which comment is solicited, the most important of which are the identification of supposed gaps or ambiguities in the Framework and consideration of their impact, including economic impact, on biotechnology product development.
Animal Feed Ingredients. It is the FDA Center for Veterinary Medicine (CVM) that has regulatory responsibility for animal foods and food ingredients, but as readers of this blog know, FDA CVM also participates in a parallel program for review of feed ingredients maintained by the Association of American Feed Control Officials (AAFCO). The AAFCO program provides an alternative path for review and approval of novel feed ingredients, but CVM staff has conducted the technical reviews of products submitted to AAFCO under this program. In a December 2022 announcement, FDA announced that it will be holding a virtual public hearing on February 9, 2023, to discuss FDA’s role in the AAFCO feed ingredient process. The agency will also entertain public comments on this topic through March 9, 2023. The agency listed the following issues on which comment is solicited:
- What steps can FDA take to improve stakeholder understanding of FDA’s engagement with AAFCO’s feed ingredient definition process and better communicate this information with the public?
- What changes to FDA’s role in AAFCO’s feed ingredient definition process would be helpful to stakeholders and why?
- If FDA made a list of AAFCO feed ingredient definition requests publicly available, where would stakeholders prefer to find such a list and what information would stakeholders like to see with such a list?
- What do stakeholders view as successful or valuable in FDA’s continued participation as the scientific reviewers for new AAFCO feed ingredient definitions?
Renewable Fuel Standard. On December 1, 2022, EPA announced a proposed rule to establish the required Renewable Fuel Standard (RFS) volumes and percentage standards for 2023, 2024, and 2025. The proposed rule also included a series of modifications to strengthen and expand the RFS program. The RFS is the federal government’s major program promoting the use of renewable and low-carbon fuels for automotive and aviation use, by establishing yearly mandated volumes for the amounts of such fuels to be sold in the U.S. A public hearing on the rule was held on January 10-11, 2023, but public comments will be entertained until February 10, 2023.
I don’t expect that anything significant will arise from the review of the Coordinated Framework. The previous review of the Framework that took place in the Obama Administration from 2016-2017 resulted only in some clarifications of agency jurisdictions, and (at least to this longtime observer of the government’s biotech policies) did not break any new ground or result in any new or relaxed regulations (it is not clear to me whether the USDA’s 2020 revised biotechnology rule at 7 CFR 340, the so-called SECURE Rule, which was years in the making, could be directly attributed to the 2017 updating of the Framework).
However, there are certainly some areas of potential overlap which are worth comment. One issue of longstanding concern is the possibility that genetically modified microbial soil inoculant products could be subject both to the USDA biotechnology rule and EPA regulations under the Toxic Substances Control Act. Another topic has to do with the regulation of certain animal feed ingredients that are, or include, inactivated microbial biomass arising from industrial fermentations; a topic that has long been of concern to me (as described in earlier blog posts), and where the cooperation between FDA CVM and AAFCO has contributed to long review times and inefficient reviews of potential products. Another area that may potentially draw some public comment is the emerging oversight regime for cell-based or plant-based meat products, also a topic on which I’ve previously commented in this blog. It’s worth noting that the first successful approval was achieved in November 2022 under FDA’s Pre-Market Consultation program for review of foods made from cultured animal cells.
D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty-five years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and links to some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated.