John Dillard: USDA Modernizes Biotech Trait Approval

02:07PM Jul 31, 2020
John Dillard
No stranger to dirty boots, John Dillard, an attorney with OFW Law, focuses his practice on agricultural and environmental litigation.
( Farm Journal )

One of the chief complaints of crop biotechnology detractors is most of the products that reach the market are designed to sell more herbicides. Yes, large genetics/crop protection corporations have a major commercial incentive to produce herbicide-resistant seeds to drive their chemical sales.

However, without the financial incentive of accompanying pesticide sales, many useful traits cannot generate enough revenue to justify the oftentimes multimillion-dollar investment necessary to clear the federal regulatory gauntlet of USDA, FDA and often, EPA.

Rule Assesses Risk

In May, USDA finalized the SECURE (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) Rule.

It modernizes USDA’s Animal and Plant Health Inspection Services’ (APHIS) Plant Protection Act review process for evaluating whether biotech traits will pose a plant pest risk or harm plant health.

In the past, APHIS’ efforts focused on whether a plant pest was used in the development of a new trait or crop.

APHIS has noted, based on its extensive experience, whether a plant pest is used in the introduction of a trait (e.g., viruses, bacteria) isn’t determinative of whether the resulting plant will pose a risk to plant health.

Under the SECURE Rule, APHIS will evaluate the properties of the organism, rather than the method used to produce it, to determine whether the organism will pose a plant health risk.

Faster Path to Approval

A big achievement of the SECURE Rule is the use of broad exemptions for categories of plants not regulated under the Plant Protection Act. For instance, if a plant could have been developed using conventional breeding techniques, it is not regulated under the Plant Protection Act. This will allow many crops produced through gene editing techniques to avoid the APHIS review process.

In addition, new varieties of plants that are the same as genetically engineered plants APHIS has already reviewed will not need to be re-approved.

Hurdles Still Exist

Although the SECURE Rule will eliminate some major regulatory hurdles, plant breeders must also clear other federal agencies before bringing a product to market. Most plant breeders work with FDA’s voluntary plant biotechnology consultation program to verify the products are as safe as their conventional counterparts.

Biotech crops with any “plant incorporated protectants” to provide pest resistance to disease are evaluated by EPA. FDA and EPA have not made changes and still pose a hurdle for plant breeders.