As the world confronts population challenges, limited resources, environmental pressures, climate change, and market competition, advances in agriculture will be essential. They will likely include increased plant productivity as well as more nutritious foods and other new products. However, some of the very valuable improvements now possible using innovative and cost-beneficial molecular technology such as gene-editing are being stifled by burdensome and costly regulation from the Environmental Protection Agency.

Federal regulation / An example is the EPA regulation of a “plant regulator,” which is any agricultural input applied to plants to alter how quickly or large they grow, their maturity, and other desirable characteristics. The Nematocide, Plant Regulator, Defoliant, and Desiccant Amendment of 1959 added these substances to the categories of pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The law was intended to ensure that chemicals are not “adulterated.” It sets tolerances for their use when applied to the exterior of plants, and it includes requirements on the labeling of the contents and directions.

Industry sought the 1959 amendment because no federal law regulated chemicals used as a plant regulator, and states were enacting a patchwork of requirements. Subsequent FIFRA amendments have added the evaluation of plant regulators for possible health and environmental hazards.

Modern genetic engineering technology has made possible the incorporation of precise gene-edited plant growth regulators (PGRs) into a plant, an enhancement not directly comparable in its hazard potential to a chemical substance applied externally to a plant. Rather, gene-modulated growth regulation is analogous to the kinds of genetic modification achieved by the slower, less precise, and less predictable processes of conventional plant breeding. Examples include the semi-dwarf, high-yield, disease-resistant wheat varieties developed by Nobelist Norman Borlaug, the father of the “Green Revolution.”

EPA review of gene-edited plant growth regulators has imposed stifling compliance costs on an important segment of U.S. agricultural innovation.

In 1986 the U.S. Coordinated Framework for the Regulation of Biotechnology established what was intended to be a uniform national oversight policy for this research and the products developed through genetic engineering under existing federal law. The Framework addressed the management of the hypothetical unreasonable risks mainly from the combination of genetic material from dissimilar source organisms. The EPA’s focus at the time was on genetically modified microorganisms used as pesticides, to produce chemicals, and for other purposes.

Modifying plants / Eight years later, the EPA announced broad new FIFRA policies to regulate genetically engineered whole plants with augmented pest resistance and to expand the definition of a plant regulator to include changes conferred by the genetic modification of a plant.

Arguing for its expanded interpretation of the statutory definition of a “plant regulator,” the EPA declared that Congress in 1959 had addressed substances applied to plants but failed to clarify how the definition applied to substances produced within plants themselves. The EPA speculated that if Congress had known about technologies to modify PGRs via genetic modification, the practice would have been included in the FIFRA definition of a “plant regulator.” According to the EPA:

Congress did not provide direct guidance on the implications of the definition of plant regulator for substances produced in plants. EPA, therefore, believes that it has the discretion to develop a reasonable approach to defining what constitutes a plant regulator for substances produced in plants.
EPA looked at previous Congressional action relating to “plant regulators,” plant science, the traditional roles of EPA and [the Food and Drug Administration] in this area, and the extent to which risk concerns would go unaddressed if EPA did not include certain plant substances in the definition of “plant regulator.”

Thus, the EPA made a broad new rule that a substance produced in a plant as a result of a genetic change in the plant’s physiology is a plant regulator when:

It is intended to accelerate or retard the rate of growth or rate of maturation, or alter the behavior of the plants and meets one of the following criteria: (1) Is a plant hormone. (2) Acts to prevent, destroy, repel, or mitigate a pest. (3) Is toxic in concentrations found in the plant (undiluted package).

The EPA further widened the regulatory net, adding:

Plant hormones that are produced in plants as the result of an intentional change in the plants’ physiology would be considered plant regulators. As plant regulators, they would also be considered a plant-pesticide and under EPA’s authority.

The EPA FIFRA review and labeling of gene-edited PGRs has imposed stifling compliance costs on an important segment of U.S. agricultural innovation because of the agency’s inferred congressional authority to meet a questionable regulatory need. (It should be noted the FDA has regulatory authority over foods derived from plants.)

Biostimulants / The EPA’s “plant regulator” definition has caused alarm in the relatively new plant biostimulant industry because some of its products would be subject to FIFRA’s high compliance costs. The term “plant biostimulant” was initially adopted to describe substances used in minute quantities that promote plant growth without being nutrients, soil improvers, or pesticides. “Plant biostimulants are not intended to mitigate or kill pests and are not intended to alter the natural growth behavior of a plant in a manner which it would not normally behave under optimal growing conditions,” according to the Biostimulants Council, an industry trade group. Biostimulants are biochemical, microbial, or chemical substances that influence the intrinsic properties that modulate the growth of plants, in contrast to fertilizers that simply add nutrients. According to the EPA, “They enhance agricultural processes in the plant and in soil using substances and microbes already in the environment and can promote greater water and nutrient use efficiency.” The global biostimulant market was estimated to be around $2.3 billion in 2020 and is expected to reach $3.9 billion by 2025. The United States has a significant share of that market.

The EPA’s 2020 draft guidance for plant biostimulants focuses on whether they fit the FIFRA definition of a plant regulator, i.e., whether a biostimulant “physiologically influences the growth and development of plants in such a way as to be considered a plant regulator under FIFRA.… A key consideration is what claims are being made for products, which is the focus of this guidance.” Depending on the claim for a particular biostimulant, the EPA would determine whether the product has pesticidal properties.

The Washington State Department of Agriculture explains a definitional nicety:

Most biostimulants seem to focus on secondary functions and claims, for example, that the hormones will increase root growth, which will improve drought resistance. If the claim is drought resistance, producers tend to think it should not be regulated as a pesticide.

The EPA draft guidance notes that certain products are exempt because they are excluded from the legal definition of a plant regulator such as plant nutrients, plant inoculants, soil amendments, and vitamin hormone products. The draft guidance does not identify risks associated with biostimulants.

It should be noted that biostimulants that the EPA does not regulate as pesticides may be regulated as a fertilizer by individual states. The European Union regulates biostimulants as fertilizers.

Turf-building / The EPA has expanded its FIFRA reach by simply broadening the definition of a plant regulator. The agency concluded that even though Congress did not regulate PGRs internal to a plant in 1959, Congress would want the EPA to do so today, even though internal PGRs do not present the chemical risks that prompted the 1959 law. The agency concluded that Congress gave it authority to expand its regulatory scope because “without it, regulatory concerns would go unaddressed.” Considering biostimulants as plant regulators raises similar concern about whether the EPA’s regulation reflects congressional intent or agency turf-building.

Because some firms fear retribution, industry is not well-positioned to vigorously oppose expansive agency regulation. Other firms may seek competitive advantage from greater regulation. Congress should clarify its intended scope of FIFRA regulation rather than allow a regulatory agency unbounded discretion to presume authority for concerns not specifically recognized by Congress.

To eliminate the threat of suffocating EPA regulation, Reps. Jimmy Panetta (D–CA) and Jim Baird (R–IN) introduced the Plant Biostimulant Act of 2022. It would exclude biostimulants from the definition of “plant regulator” and, accordingly, obviate the necessity for FIFRA compliance. Similar legislation may be introduced in the next Congress.

The two congressmen are similarly concerned about government-imposed obstacles to gene-editing. They recently took remedial legislative action via an amendment to the House-passed “minibus” appropriations bill. The amendment directs the FDA to speed up regulatory modernization and consistency for products of plant gene editing. It directs the Department of Agriculture to modernize the regulatory pathway for genetically engineered microbes, encourage transgenic plant research, and focus on the use of biotechnology to find solutions to agricultural challenges. Importantly, it also requires the USDA and FDA to collaborate on developing needed viable animal biotechnology regulations.

A legislative fix to exclude gene-edited PGRs from the EPA’s definition of “plant regulator” that follows the Panetta–Baird proposal to exclude biostimulants from the “plant regulator” definition would remove a troublesome barrier to innovation in plant agriculture. It is encouraging that lawmakers are moving to reinvigorate the role of Congress to rein in regulatory agencies and claw back costly and excessive regulation.