Requiring Limited Date Submissions to Register FIFRA 25(b) Minimum-Risk Pesticides

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and its implementing regulations exempt from registration and data submission requirements a limited group of pesticides that are known as “minimum-risk” pesticides or FIFRA §25(b) products.  These products contain one or more minimum risk active ingredient, such as castor oil, and can only contain inert ingredients specified by the U.S. Environmental Protection Agency.   Pesticides generally, and insect repellents in particular, are a first line of defense against infectious diseases such as tick-borne Lyme disease and mosquito-borne West Nile Virus and encephalitis. Therefore, it is important to public health that pesticide products deliver the control that is claimed on the label.

In its March 15, 2006 petition, CSPA specifically requested that EPA initiate rulemaking to exclude the minimum risk exemption of pesticides that claim to control “pests of significant importance,” as defined in Pesticide Regulation Notice 2002-1.  Certain conditions qualify products for the §25(b) exemption. For example, §25(b) products containing certain active ingredients must not claim either to control or mitigate microorganisms that pose a threat to human health, including disease-transmitting bacteria or viruses, or claim to control insects or rodents carrying specific diseases.  The petition stated that this condition was being consistently violated and listed several examples of public health claims that were being made without any proof of efficacy.

In a July 18, 2007 letter, EPA responded that it intended to explore various options, including rulemaking, as CSPA had recommended, or actions short of rulemaking that would achieve the objective. EPA noted its intention to move “as expeditiously as possible to identify the most efficient approach to protect the public from unknowingly relying on products that target public health pests and have not been shown to work.” EPA was expected to issue a draft notice for public comment in 2011, but in September, 2011, CSPA was informed that EPA had decided to divide the 25(b) rulemaking into two rules. One would clarify products that are included or excluded from the 25(b) exemption. The other would propose efficacy testing for 25(b) products.

On December 31, 2012, EPA published in the Federal Register a notice of proposed rulemaking that more clearly described the active and inert ingredients permitted in products eligible for the minimum risk exemption from regulation.

Completing work on the second rule dealing with efficacy testing is taking longer than anticipated.   It will apply to active and inert ingredients. Its development has been slowed down by a third rule on which EPA is working, a Product Performance Data Requirements Rule. This third rule would put the actual data requirements for 25(b) products in the Code of Federal Regulations.

EPA views the three rules as related, so the whole timeframe has been slowed down to allow work on the Product Performance Data Requirements Rule to progress. However, recent budget constraints have prevented the agency from completing the Product Performance Data Requirements Rule, although it is still on the EPA regulatory agenda.

The EPA should protect public health by expediting the rulemaking to require efficacy and product chemistry data and set out limited registration requirements for §25(b) products.

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