Regulating the Regulator of Plant Growth Regulators.

• Author: Cohrssen, John J.

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."

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...