Personal Insect Repellents and Minimum Risk Pesticides

I want to make a sunscreen, insect repellent product that contains pesticidal active ingredients listed under 40 CFR 152.25(f)(1) and that is to be applied to human skin. Would this product qualify as a minimum risk pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)?

All six of the following conditions found in 40 CFR 152.25(f) must be met for a combination sunscreen and insect repellent product to qualify as a minimum risk pesticide.

1. All pesticide active ingredients in the product must be among those listed in 40 CFR 152.25(f)(1).
2. The inert ingredients in the product must be among those listed in 40 CFR 152.25(f)(2)(iv) or must be considered a commonly consumed food commodity, an animal feed item, or an edible fat or oil as described in 40 CFR 180.950(a), (b), and (c), respectively.
3. All ingredients (both active and inert) must be listed on the label. All ingredients must be listed by the name used in 40 CFR 152.25(f)ⁱ (label display name). The label must also list the percentage by weight of each active ingredient.
4. The product must not bear claims either to control or mitigate organisms that pose a threat to human health, including insects or rodents carrying diseases.
5. The name of the producer or the company for whom the product was produced and the company’s contact information must be displayed prominently on the product label.
6. The product’s label must also comply with the labeling requirements established under 40 CFR 152.25(f)(3), which include, among other things, a requirement that the product’s label not bear any false or misleading labeling statements, including those listed in 40 CFR 156.10(a)(5)(i) through (viii).

If your combination sunscreen and insect repellent product does not meet all six conditions of eligibility for exemption from FIFRA regulation, it must be registered with the EPA’s Office of Pesticide Programs to be legally sold or distributed in the United States. All sunscreen products must also comply with applicable Food and Drug Administration requirements, such as FDA labeling and effectiveness testing regulations.

What is the status of the EPA rulemaking to exclude personal insect repellents from the exemption?

A label for an exempt pesticide product may not bear claims to control rodent, insect or microbial pests in a way that links the pests with any specific disease. The claim may only be for the pest, as a pest, and not as a disease vector. 

For example, the label may not say:

• "controls ticks that carry Lyme disease;" or
• "controls mosquitoes that can transmit malaria or encephalitis;"

but can say:

• “controls ticks;” or
• “controls mosquitoes.” 

EPA received a petition from the Consumer Specialty Products Association (CSPA) dated March 15, 2006, requesting that we exclude from the minimum risk pesticide exemption those pesticides that claim to control “pests of significant public health importance” and require an abbreviated registration for minimum risk products that are to be used for the control of public health pests. 

We received approximately 60 comments, both in support of and in opposition to the petition, during the public comment period. We have analyzed the comments on the petition and concluded that public health products must be supported by evidence that they are effective against the target pest. CSPA’s letter of June 11, 2007, suggested that EPA engage in expedited rulemaking, including promulgating an interim final rule without notice and comment. In a letter dated July 18, 2007, EPA responded to that letter as well as the initial petition. 

To that end, we have explored rulemaking regarding personal insect repellents and in a future rulemaking are considering a proposal to remove personal mosquito and tick repellents from the minimum risk pesticides exemption currently in 40 CFR 152.25(f).

• This means that once removed from the exemption, personal mosquito and tick repellents would need to be registered as a pesticide product with EPA before sale or distribution in the United States.
• We are considering allowing up to five years for any personal mosquito and tick repellent that currently meets the active and inert ingredient criteria of the exemption to become a registered pesticide product. 

Additional information on this future rulemaking (www.regulations.gov, docket identifier EPA-HQ-OPP-2010-0227).