What Agency Regulates Biotechnology for Plant Health?

Biotechnology, including genetic engineering and gene editing technology like CRISPR, is enabling developers to improve the genetics of a growing number of crops. CRISPR, for example, allows scientists and plant breeders to make small, precise changes to an organism’s DNA helping developers to respond quickly to constantly evolving agricultural pests by creating a wider variety of disease resistant crops.

Improvements in crop genetics have contributed roughly half of historical yield gains. Continued improvements have been projected to help protect crops from pests and disease, reduce deforestation, and decrease greenhouse gas emissions from agricultural production.

The regulatory environment plays a big role in determining if and how quickly promising new crop varieties reach the market and are then adopted by producers. Unlike conventional breeding and newer-non-biotech technologies like marker-assisted breeding, products developed with biotechnology are subject to pre-market regulation in the U.S. The regulatory burden is ultimately shouldered by developers, and when onerous or cost-intensive, can limit the diversity of products reaching the market, stifling innovation and depriving farmers of important tools to fight pests and disease and increase productivity.

The Animal and Plant Health Inspection Service (APHIS) at USDA is charged with carrying out pre-market regulation processes related to agricultural products developed using biotechnology. APHIS conducts rigorous, scientific reviews to ensure that there is no risk to the broader U.S. agricultural system or the country’s natural resources before biotechnology products are brought to market. Specifically, APHIS oversees regulations for some organisms developed using genetic engineering to ensure they do not pose a risk to plant health when released into the environment.

USDA oversight in this arena is important to protect the health of both agricultural crops as well as wild plants in uncultivated areas. In addition, global trust in APHIS biotechnology regulation eases international trade of American-made biotechnology products. Finally, credible regulation by APHIS provides reassurance to consumers of the safety of such products.

What role does BRS play in regulating biotechnology?

Three U.S. federal agencies have jurisdiction over various aspects of pre-market biotechnology regulation. These include the Department of Agriculture for plant health, the Food and Drug Administration for food safety, and the Environmental Protection Agency for pesticides. Biotech crops and their products are also subject to post-market regulations under the three agencies that protect farm workers, livestock, consumers, and the environment.

APHIS oversees regulations for plants and plant pests developed using genetic engineering. Two agencies within APHIS — Biotechnology Regulatory Services (BRS) and the Plant Protection and Quarantine (PPQ) — implement regulations for gene-edited and non-gene-edited plants, respectively.

BRS regulates the introduction of plants and plant pests developed using genetic engineering that may pose a risk to plant health. BRS also coordinates with other federal agencies as part of the Federal Coordinated Framework for the Regulation of Biotechnology, which sets cross-agency policy to ensure the safety, transparency, and efficiency of the regulatory systems that apply to biotechnology products.

Types of Plant Biotech Reviews

According to the USDA Economic Research Service, U.S. farmers today use biotechnology to grow more than 90 percent of the soybeans, corn, and cotton. While the federal government is well versed in regulating new varieties of U.S. commodities like corn and soy, new advances in biotechnology are also accelerating improvement of specialty crops (including most fruits, vegetables, and tree nuts).

BRS administers several pre-market regulatory processes that require application submissions from developers.

• Permits: BRS reviews permit applications to prevent the unauthorized importation, interstate movement, or release of plants, insects, or microbes developed using genetic engineering that may pose a risk. Developers are required to submit details about the nature of the organism and the conditions that will be used to prevent the spread and establishment of the organism in the environment. After review, APHIS will authorize field trials and the movement of organisms developed using genetic engineering.

• Regulatory Status Reviews: Developers can request regulatory status reviews for plants developed using genetic engineering that have not previously been evaluated. BRS reviews these submissions to evaluate the plant’s likelihood of posing an increased plant pest risk relative to other non-modified cultivated plants. BRS ultimately determines whether the modified plant can be safely grown and bred in the U.S. or if it will be subject to regulation. Recent regulatory status reviews found soybeans modified for herbicide resistance, brown mustard modified to improve flavor and texture, and bananas modified for non-browning, among others, to not be subject to biotech regulation.

• Exemptions and Confirmations: Developers can submit confirmation requests, to which BRS will respond with confirmation as to whether a modified plant qualifies for an exemption and is therefore not subject to APHIS biotech regulations. Under existing regulations, exemptions exist for 1) plants with modifications achievable through conventional breeding, and 2) plants with a plant-trait combination that has already been evaluated by APHIS and evaluated to be low-risk.

Recent Efforts to Streamline Biotech Regulation

For the first time since they were initially established in 1987, APHIS published its first comprehensive update to its biotechnology regulations in 2020. The SECURE rule streamlined USDA biotech regulation by exempting some low-risk products of gene editing and reducing application requirements for developers of organisms that are unlikely to pose risks to plant health.

These revisions and the agency’s efforts to reduce the burden of pre-market regulation for biotech crops appear to have ushered in a new wave of biotech innovation, with an increasing number of submissions to APHIS from small biotech developers and a greater diversity of crops, especially specialty crops.

How is BRS funded?

Congress authorizes agencies within USDA to regulate specific areas of U.S. agriculture. APHIS is authorized to disseminate and implement biotechnology regulations according to the Plant Protection Act, which is a part of the larger Agriculture Risk Protection Act of 2000.

BRS relies on annual appropriations from Congress to administer its regulatory activities. Recent appropriations bills have provided small increases for BRS to support salaries and program operations.

As BRS continues to streamline its existing regulatory oversight under the SECURE rule, consistent and reliable funding is essential in order for BRS to retain staff with specialized expertise in order to complete reviews without delays.

Further, as advances in biotechnologies used to improve agricultural animals in the livestock and poultry industry become more prevalent, BRS is poised to lead in providing technical and scientific services to support product-based regulation of farm-raised animals that are modified or developed using genetic engineering. To develop a science-based framework to guide this oversight, APHIS will need to use future available funds to hire the technical and scientific staff with livestock, wildlife, aquaculture, and biotechnology innovation expertise.

Key Takeaways

• The Animal and Plant Health Inspection Service (APHIS) at USDA sets regulations for some organisms developed using genetic engineering to ensure they do not pose a risk to plant health when released into the environment, which the Biotechnology Regulatory Services (BRS) then implements.

• BRS administers several pre-market regulatory processes to prevent the unauthorized importation, interstate movement, and environmental release of new varieties developed using genetic engineering. BRS evaluates application submissions from biotechnology developers for permits, regulatory status reviews, and exemption confirmations.

• Congress establishes the annual budget for BRS based on the President’s annual budget request and emerging regulatory priorities. Congressionally allocated funds for BRS have increased slightly in recent annual appropriations bills.