In June 2017, EPA registered four products containing the Ribonucleic acid interference (RNAi) based Plant-Incorporated Protectant (PIP) called SMARTSTAX PRO. This product will help U.S. farmers control corn rootworm, a devastating corn pest that has developed resistance to several other pesticides.

• Docket for SMARTSTAX PRO: EPA-HQ-OPP-2014-0293 at www.regulations.gov  

• What is RNAi and how is it useful?
• How is RNAi technology regulated?
• How does EPA evaluate the safety of RNAi pesticides?

What is RNAi and how is it useful? 

RNAi occurs naturally in a wide variety of organisms (e.g., plants, animals and humans) and is used by organisms to regulate the activity of genes. For example, RNAi is responsible for striped coloration in certain flowers.  The areas with little or no color arise when RNAi  tells the flower cells how to produce a color.  Scientists can harness this naturally occurring process as a tool in biotechnology to address real world problems in human health, environmental protection and agriculture.

RNAi can be applied to agricultural problems in a way that benefits the environment. Using RNAi researchers can make a pesticide that targets a single insect pest and only that single pest.  No other organisms would be harmed by such an RNAi pesticide, e.g., no animals incidentally in the field would be affected. This approach does not add even trace amounts of chemical pesticides to the environment or the food produced from the plant.

In the case of SMARTSTAX PRO, scientists harnessed RNAi  to create a pesticide that works by silencing or turning-off the activity of a gene critical to corn rootworm survival. Corn rootworm damages corn plants growing in the field by eating the roots. Scientists have engineered the corn plant so that when the corn rootworm feeds on the plant, RNAi turns off a function that the corn rootworm needs for growth. This eventually kills the corn rootworm.  Because the RNAi technology found in SMARTSTAX PRO is specific to the corn rootworm, it would not affect the corn plant, people, animals or even other insects eating the plant.

How is RNAi technology regulated?

Three agencies are involved in various aspects of assessing the safety of crops with RNAi pesticide traits in the United States:

• The Food and Drug Administration (FDA) ensures the food from crops containing RNAi is as safe as its conventional counterpart.
• The U.S. Department of Agriculture (USDA) ensures there is no risk to agriculture from the use of RNAi.
• The EPA ensures that the PIP can perform its intended function with a reasonable certainty of no harm to people from dietary and residential exposure, and no unreasonable risks to the environment.

The three US regulatory agencies, the EPA, FDA and USDA, have now all reviewed the SMARTSTAX PRO product and agree that it is safe for human consumption and will not harm the environment.

How does EPA evaluate the safety of RNAi pesticides?

Before any pesticide, including RNAi products, can be licensed and used in the United States, EPA reviews and evaluates information on the pesticide and assesses whether using the pesticide could harm people, other animals or the environment, and determines if and how the pesticide can be safely used. EPA will not license the pesticide if it should find a risk that cannot be controlled.

EPA’s approach to the review of RNAi pesticides is focused on whether or not the RNAi pesticide is specific enough that it would only interfere with the target pest and not affect people and other animals or wildlife. EPA also ensures that people and non-target animals can safely consume food from crops that contain the RNAi pesticide. Companies that wish to register RNAi products must submit data and information to EPA showing that the pesticide would not interfere with any genetic messages found in people as well as non-target animals and wildlife.