FDA, EPA, USDA Carve Out Biotech Rules

OMAHA (DTN) -- The trifecta of government agencies that oversees different aspects of biotechnology have laid out a roadmap for clarifying and streamlining regulatory authority for food safety and spelling out federal rules for everything from microbial bio-stimulants to cell-cultured meat products.

The Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and USDA released "The Coordinated Framework for the Regulation of Biotechnology" following an executive order by President Biden in 2022.

Under the framework, the agencies look to spell out regulations for gene-edited plants and "ensure their regulatory approaches are risk-proportionate."

When it comes to overseeing genetically modified plants, the three agencies have collectively created "cumbersome and lengthy regulatory processes" and lacked harmony over timelines and reviews.

MODIFIED AND GENE-EDITED PLANTS

EPA and USDA indicated they are looking for ways to streamline regulatory reviews for crops with "plant-incorporated protectants (PIP)." Both agencies laid out several plans for clarifying regulation of PIPs, including a recent EPA rule that exempted some of those products from regulations.

-- USDA and EPA are asking for feedback on additional modifications to plants that can be exempted from regulations based on available scientific data looking at conventional breeding techniques for those plants.

-- FDA issued guidance for industry in February, which largely clarifies that companies wishing to introduce gene-edited foods to the market will need to follow a 1992 FDA policy on "Foods Derived from New Plant Varieties."

-- By the end of the year, the agencies intend to post brief summaries better defining each of their regulatory roles for specific products for both developers and consumers.

GENETIC ENGINEERING OF FOOD CROPS

USDA and FDA have seen interest grow for using genetic engineering to produce food crops or ingredients for foods. The agencies say that poses food-safety issues. There are concerns about creating ingredients and producing allergies from crops that have not occurred in the past.

"This issue is almost unique to genetic engineering because of its ability to transfer genes from distantly related organisms," such as between plants and animals, the agencies stated.

Companies developing engineered crops will have to ensure they are directed toward intended uses and prevent those materials from inadvertently entering the food supply.

USDA also will continue updating its List of Bioengineered Foods to help identify foods or ingredients that require bioengineered labels.

CELL-CULTURED PRODUCTS

This will be an area to watch going forward, especially as more states are banning the sale of cell-cultured meat products.

FDA and USDA also intend to clarify and provide guidance on the regulation of cell-cultured foods. Staff for FDA and USDA have been meeting regularly on the topic. FDA is overseeing consultations with companies about the food-safety issues before they go to market, as well as how companies organize necessary scientific reports backing arguments that their food is safe.

USDA is expected to propose new regulations for labeling meat and poultry products that contain cultured cells from animals that otherwise would be subject to Food Safety and Inspection Service oversight. USDA also will issue guidance to the processors making cell-cultured products.

At least four states have passed laws banning the sale of lab-grown meat -- Alabama, Arizona, Florida and Tennessee.

GENETICALLY ENGINEERED ANIMALS

Groups have complained about FDA operating in slow motion when it comes to approving genetically modified animals. FDA and USDA have signed a memorandum of understanding (MOU) to share regulatory oversight of genetically modified animals.

BIO-STIMULANTS AND OTHER MICROORGANISMS

Another area where the market is growing involves microbial biotechnology. The broad scope of microorganisms includes products used frequently for agriculture, mining, water, chemicals, textiles and even personal care and cosmetic products.

Stakeholders have said the agency roles are unclear when it comes to who oversees products such as bio-stimulants or inoculants used for plant growth or dealing with plant pests as well as products such as microbial biomass used in human or animal feed.

With that, EPA and USDA are looking for ways to reduce regulatory overlaps where possible and harmonize requirements. USDA also will develop a better list of organisms that contain plant pests, which fall under its oversight. USDA will look for ways to spell out potential exemptions from regulation when a microorganism is not a plant pest or registered with EPA as a microbial pesticide.

MEDICAL OVERSIGHT

FDA also has several areas where the agency intends to issue new guidelines for companies using biological products in health care. That includes spelling out oversight of gene-edited products for therapeutics.

The full report on the U.S. Coordinated Framework for Biotechnology Products" can be viewed here: https://usbiotechnologyregulation.mrp.usda.gov/….

Chris Clayton can be reached at Chris.Clayton@DTN.com

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