FIFRA 25(b) exempt pesticides: Regulatory perspectives and challenges in the United States

As consumers look for alternatives to conventional pesticides, a category of pesticide products considered to be minimum risk pesticides is gaining in popularity. From herbal insect repellent bracelets to citronella candles, we are seeing more of these types of products on the market in the USA.

However, while the United States Environmental Protection Agency (EPA) has exempted minimum risk pesticides from federal registration, many states do require them to be registered, wherein lies the challenge.

This paper outlines the key challenges of state registration so that producers can anticipate and prepare for them early in the product’s lifecycle.

FIFRA 25(b) exempt pesticides

The US EPA has exempted certain pesticides that pose little to no risk to man or the environment from federal registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). These pesticides are known as FIFRA 25(b) exempt, or minimum risk, pesticides. From no review time or fees at the federal level to a greatly reduced and less costly data set, the benefits of exemption from federal registration are easy to understand. However, this does not mean that minimum risk pesticides are without their regulatory challenges, as we will find out in this paper.

A pesticide must meet six criteria to qualify for exemption from federal registration:

1. The formula’s active ingredient(s) must be on EPA’s approved list

2. The formula’s inert ingredients must be on one of several EPA lists

3. The product label must list all the product’s ingredients, both active and inert

4. The label may not make claims to mitigate organisms that pose a threat to human health and, while claims to mitigate insects or mammals that vector disease are allowable, the specific diseases that may be vectored may not be stated on the label

5. The company name and address must appear on the label

6. The label may not contain any false or misleading statements

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