Office of Pesticide Programs Barrier Products Clarification DocumentMarch 1, 2007
In accordance with 40 CFR 152.10(c), certain products may qualify as, barrier products, in which case they are not considered to be pesticides and, therefore, do not have to be registered under FIFRA.
To be considered a barrier product as contemplated under 40 CFR 152.10(c), the following must be true:
- The product is not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate or regulate the growth of plants.
- The product or article does not make a pesticidal claim on the labeling or in connection with sale and distribution.
- The product is intended to exclude pests only by providing a physical barrier against pest access, and contains no toxicants (i.e., certain pruning paints for trees).
Failure to meet the criteria above requires the alleged barrier product to be registered as a pesticide product.
II. Addressing Uncertainties
If an applicant is not sure whether their product meets the barrier product criteria as outlined in 40 CFR §152.10(c), or the applicant desires a letter from the Agency stating that their product is a barrier, an applicant may submit, at a minimum, the following data to the Agency for consideration:
- Complete disclosure of the formula, including identification of any proprietary ingredients
- Chemistry data
- Label which clearly delineate the claims of the product and what it is intended to repel
- Detailed explanation of the mode of action
- Leaching data
- Efficacy data to demonstrate that the ingredient is not performing as a pesticide. Agency review of an efficacy protocol may be required on a case-by-case basis
- Abstracts from a literature search (most recent 5 year period).
As deemed necessary by the Agency, additional data also may be required in order for the applicant to substantiate the product’s barrier claim. In addition, if the applicant believes that any of the aforementioned data are not applicable to their product, then the applicant may provide, in writing to the Agency, its rationale why such data are not applicable.Upon the completion of review of the aforementioned data, the Agency will provide, in writing to the applicant, its decision. If the Agency decides that the product qualifies as a barrier product, then the Agency will issue a letter stating such. The letter issued by the Agency is specific to a given formulation; therefore, any subsequent change to the formulation requires Agency notification.