- OSTP Requests Information on Biotechnology Regulatory Framework
- EPA Renews Biotechnology Innovation Efforts under New Executive Order
- EPA Proposes to Allow Certain Uses of Biotechnology in Development of Plant-Incorporated Protectants
- USDA Issues Guidance to Facilitate Compliance with Bioengineered Food Disclosure Standard
- U.S. Government Accountability Office Issues Recommendations to Clarify Joint Framework for Regulating Cell-Cultured Meat Products
- Federal Agencies Launch New Unified Website for Biotechnology Regulation
- Senate Introduces Bill to Formalize Joint Framework for Regulating Cell-Cultured Meat Products
- Mississippi Joins States Enacting Stricter Labeling Requirements for Food Products Developed from Animal Cell Cultures
- White House Issues Executive Order to Modernize Regulatory Framework for Agricultural Biotechnology
- Regulatory Agencies Issue Joint Agreement to Regulate Laboratory-Grown Human Food
- A Burger By Any Other Name: Regulatory Challenges and Opportunities for Cell-Cultured Meat
- National Academies of Sciences, Engineering, and Medicine Issues Report on Future Biotechnology Products
- Federal Agencies Issue Final Update to Biotechnology Regulatory Framework
OSTP Requests Information on Biotechnology Regulatory Framework
On December 19, 2022, the White House Office of Science and Technology Policy (OSTP) announced an information request to help identify regulatory ambiguities and gaps in the Coordinated Framework for Regulation of Biotechnology. Issued on behalf of the U.S. Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA), the request seeks case studies and other data from the general public, particularly pertaining to new and emerging biotechnology products.
According to the request, additional information is needed to help the agencies improve the clarity and efficiency of the regulatory processes for biotechnology products as described in President Biden’s September 12, 2022 Executive Order (EO) 14081, “Advancing Biomanufacturing and Biotechnology Innovation for a Sustainable, Safe, and Secure Bioeconomy.” Issued in September 2022, EO 14081 sought to renew efforts to improve the clarity and efficiency of regulatory processes for biotechnology products and launched a new “National Biotechnology and Biomanufacturing Initiative to promote innovative biotechnology and biomanufacturing solutions in “health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”
Upon publication in the Federal Register, public comments will be accepted for 45 days in docket APHIS-2022-0076 at www.regulations.gov. EPA, FDA and USDA will review and consider all comments received on the request.
In addition, OSTP, EPA, FDA and USDA will also hold a virtual listening session on Thursday, Jan. 12, from 1 p.m. to 6 p.m. EST. To register, use the Webinar Registration form.
EPA Renews Biotechnology Innovation Efforts under New Executive Order
On September 12, 2022, President Biden issued an Executive Order (EO) calling on his Administration to renew efforts to improve the clarity and efficiency of regulatory processes for biotechnology products. Launching a new “National Biotechnology and Biomanufacturing Initiative,” the EO is intended to advance policies that promote innovative biotechnology and biomanufacturing solutions in “health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”
For the full news alert, click here.
EPA Proposes to Allow Certain Uses of Biotechnology in Development of Plant-Incorporated Protectants
In a new rule proposed September 1, the U.S. Environmental Protection Agency (EPA) announced its intent to streamline the regulatory requirements for certain “plant-incorporated protectants” (PIPs)—regulated pesticidal substances produced by plants, as well as the genetic material necessary for the plant to produce those substances. Currently, only PIPs developed through conventional breeding are exempt from EPA’s pesticide registration requirements. All other PIPs, including those developed using biotechnology, must be registered by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and must obtain a tolerance or exemption from tolerance for pesticide food residues under the Federal Food, Drug, and Cosmetic Act (FFDCA) prior to their distribution or sale.
For the full news alert, click here.
USDA Issues Guidance to Facilitate Compliance with Bioengineered Food Disclosure Standard
In December 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) promulgated a new National Bioengineered Food Disclosure Standard (NBFD Standard or the Standard) to require food manufacturers, importers, and other entities that label foods for retail sale to disclose information about bioengineered food and bioengineered food ingredients. While compliance with all of the Standard’s requirements will not be mandatory until January 1, 2022, a “voluntary compliance period” began on January 1, 2020, during which time regulated entities (above $10 million in gross receipts) must identify covered products and may (but are not required to) disclose bioengineered foods and ingredients.
For a complete overview of these developments, see the news alert here.
U.S. Government Accountability Office Issues Recommendations to Clarify Joint Framework for Regulating Cell-Cultured Meat Products
The U.S. Government Accountability Office (GAO) is recommending that the U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA) strengthen existing efforts to prepare for oversight of “cell-cultured” meat. In a report published on April 7, 2020 and released to the public in early May, GAO analyzed the joint USDA-FDA regulatory framework for overseeing the production of cell-cultured meat and has recommended that the two agencies more fully incorporate leading practices for effective collaboration in their 2019 interagency agreement.
For the full news alert, click here.
Federal Agencies Launch New Unified Website for Biotechnology Regulation
On January 9, 2020, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) launched a new “Unified Website for Biotechnology Regulation” that provides a compilation of links to informational resources about biotechnology on each agency’s website as well as associated laws, regulations, and policies.
The website follows President Trump’s June 11, 2019 Executive Order, which directed his administration to modernize the regulatory framework for agricultural biotechnology products. In addition to providing an overview of each agency’s responsibility under the U.S. Coordinated Framework for the Regulation of Biotechnology, the website also includes a list of Frequently Asked Questions and allows users to submit specific questions or comments to one or more agencies.
According to EPA, the goals of the website including providing enhanced customer service to innovators and developers, while offering the public an opportunity to “learn more about the safe use of biotechnology products.”
Senate Introduces Bill to Formalize Joint Framework for Regulating Cell-Cultured Meat Products
Producers of cell-cultured meat – synthetic meat products derived from animal cell cultures that are intended to simulate the taste, appearance, and texture of traditional animal products – may soon receive regulatory direction from Congress. On December 16, 2019, Senators Mike Enzi (WY) and Jon Tester (MT) introduced legislation to codify a joint agreement between the U.S. Food & Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) regulating the development and sale of cell-cultured meat products. The legislation aims to address ongoing uncertainty over which federal agency should regulate the cell culture development process, and would assign authority to USDA to establish appropriate label terms for cell-cultured meat products. The bill arrives even as a number of states have recently acted to prohibit cell-cultured meat products from being labeled as “meat” – and are now facing lawsuits in federal court.
For the full news alert, click here.
Mississippi Joins States Enacting Stricter Labeling Requirements for Food Products Developed from Animal Cell Cultures
On July 1, Mississippi legislators passed a bi-partisan bill to prohibit certain animal-derived food products from being labeled as “meat” or a “meat food product.” While Senate Bill 2922 also imposes the same new restriction on plant-based and insect-based food products, its passage was driven at least in part to address recent developments in biotechnology that allow the growth of animal-derived food products in laboratories, rather than from livestock raised on farms and ranches. Specifically, SB 2922 amends Mississippi state law to prohibit meat labeling for any “plant-based” or “insect-based” food products, together with food products containing “cultured animal tissue produced from animal cell cultures outside the organism from which it is derived.” Its passage in Mississippi follows similar regulatory action in other states over the last year, including Arkansas, Missouri, Louisiana, and Wyoming.
For the full news alert, click here.
White House Issues Executive Order to Modernize Regulatory Framework for Agricultural Biotechnology
On June 11, 2019, President Trump issued an Executive Order (EO) calling on his administration to “modernize” the regulatory framework for agricultural biotechnology products. Citing the importance of biotechnology to U.S. food production and agricultural productivity, the EO calls on federal agencies to ensure the “transparency, predictability, and consistency” of applicable federal regulatory processes while basing regulatory decisions on scientific and technical evidence, and taking economic factors into account “as appropriate and consistent with applicable law.”
Specifically, the EO directs the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) to each identify relevant regulations and guidance that can be streamlined, along with any opportunities to exempt low-risk products from “undue regulation.” The EO also directs the three agencies to design a web-based “Unified Biotechnology” platform to allow technology developers to submit inquiries about particular products and receive a “single, coordinated response” with informal guidance on the applicable regulatory process.
In addition, the EO calls on EPA, USDA, and FDA to review their respective regulations and guidance applicable to “genome-edited specialty-crop-plant products designed to have significant health, agricultural, or environmental benefits, in particular those that are likely to benefit rural communities significantly,” with an eye toward updating and removing “undue barriers” that may impede commercialization. This effort is consistent with earlier steps taken by the administration, including USDA’s March 2018 clarification that it does not regulate plants produced through genome-editing and other innovative breeding techniques.
Finally, the EO directs USDA to take the lead on development of a consumer engagement action plan to build public confidence in the safe use of biotechnology in agriculture, and also requires the U.S. Department of State and U.S. Trade Representative to focus on international outreach and trade strategy to open and maintain markets for U.S. agricultural exports abroad.
Regulatory Agencies Issue Joint Agreement to Regulate Laboratory-Grown Human Food
On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Food and Safety and Inspection Service (USDA-FSIS) entered into a formal agreement to cooperatively regulate human food created from animal cell culture technology. Consistent with the agencies’ original announcement on November 16, 2018, the agreement establishes a roadmap for each agency to oversee various aspects of the growth and production process, from cell collection and development to labeling harvested products for grocery store shelves.
“Lab-grown” or “cell-cultured” human food is derived from animal cells drawn from either a live biopsy from a living animal, or from an embryo. Scientists grow the food in a sterile laboratory by differentiating cells and allowing them to mature in a nutrient broth. The food mimics products that are traditionally derived from butchered livestock, poultry, or fish. Advocates claim that its commercialization can help reduce emissions from raising livestock and eliminate ethical concerns associated with animal slaughter, among other benefits. Click here for more information about the regulatory challenges and opportunities associated with cell-cultured meat.
Under the formal agreement, FDA is charged with overseeing developers’ initial cell collection, proliferation, and differentiation activities; FDA will also evaluate facility conditions for compliance with FDA regulations. Regulatory oversight will shift to USDA-FSIS at the time of cell harvest, and USDA-FSIS will conduct inspections of facilities where cells cultured from livestock and poultry are harvested, processed, packaged, or labeled. USDA-FSIS will also determine whether harvested cells are eligible to be processed into meat or poultry products that bear the USDA mark of inspection and ensure that products derived from livestock and poultry are labeled accurately.
The agreement also lays the foundation for the agencies to develop a more detailed standard operating procedure to facilitate their coordination of shared regulatory oversight going forward. In addition, the agencies intend to develop joint principles for product labeling and claims to ensure that products are labeled consistently.
A Burger By Any Other Name: Regulatory Challenges and Opportunities for Cell-Cultured Meat
A hamburger produced with zero waste and without slaughtering a single animal. A tuna sandwich prepared with no impacts on marine ecosystems. These are among the many environmental benefits touted by advocates of innovative cellular agriculture products that may begin reaching neighborhood grocery store shelves in the next few years. “Cell-cultured” meat -- alternatively described as “cell-based,” “clean,” “synthetic,” or “lab-grown” meat – is now under development by an expanding cadre of biotechnology companies around the globe. These companies are using cutting-edge laboratory science to create a new and sustainable source of meat that promises consumers the full taste, appearance, and texture of animal products while reducing reliance on, and in some cases replacing, modern animal agriculture and industrial production practices.
For the full text of this article, click here.
National Academies of Sciences, Engineering, and Medicine Issues Report on Future Biotechnology Products
On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine released its report on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System”. Commissioned in connection with the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology, the new report provides an overview of developing plant, animal, and microbial technologies and recommends that federal agencies expand their scientific capabilities and levels of expertise in order to prepare for significant biotechnology product innovations anticipated over the next decade.
For the full report, visit the National Acadamies' website.
Federal Agencies Issue Final Update to Biotechnology Regulatory Framework
On January 4, 2017, the U.S. Environmental Protection Agency, U.S. Department of Agriculture, and U.S. Food and Drug Administration released their final version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.