We have been hearing about the promises of biotechnology for decades,

No stranger to dirty boots, John Dillard, an attorney with OFW Law, focuses his practice on agricultural and environmental litigation.

© Farm Journal

We have been hearing about the promises of biotechnology for decades, and we have been able to reap some of the rewards in the form of insect- and herbicide-resistant crops. However, many potential innovations have been held back. Part of this stems from consumer attitudes that are slow to change, but much can be laid at the feet of federal regulators.

Although there have been major developments in the science and our understanding of biotechnology the past 30 years, the regulatory framework is largely unchanged. Bringing a new trait to market requires a substantial investment of time and money. Many would-be innovators do not have the resources to clear all of these hurdles.

No APHIS Review Necessary

Due to recent developments, things might be looking up. In June, USDA’s Animal and Plant Health Inspection Service (APHIS) announced a proposal to substantially update its regulations under the Plant Protection Act (PPA) to allow many genetically engineered traits to forego cumbersome reviews.

Currently, genetically-engineered crop traits are evaluated by APHIS to determine whether the trait would pose a plant pest risk, regardless of whether the plants or genes contain plant pest genetic material. This might have made sense when genetic engineering was new technology, but we now have decades of experience demonstrating the genetic engineering process does not pose a plant pest risk.

Under the proposal:

• APHIS will focus its analysis on the properties of genetically engineered crops rather than the method of breeding to determine if the plant should be evaluated to verify if it poses a plant pest risk.
• The agency proposes to exempt a trait from PPA review if it could result from traditional breeding techniques. This would include traits developed through gene-editing techniques. The proposed regulatory change would establish a clearer, more consistent framework for seed developers.

Potential FDA and EPA Oversight

If implemented, APHIS’ proposed regulation would not completely eliminate regulatory burdens for trait developers. In many instances, these traits must still be reviewed by the Food and Drug Administration (FDA; if the trait enters the food supply) or the Environmental Protection Agency (EPA; if it has pesticide properties).

Trump Weighs In

Shortly after APHIS announced its proposal, President Donald Trump issued an Executive Order to streamline and modernize the federal government’s regulatory framework for reviewing biotech crops. The Executive Order directs USDA, FDA and EPA to review their respective biotech regulations to identify and remove regulatory burdens that aren’t vital to protect health or the environment. This is a tall order, but a step in the right direction.