Questions about the DfE Antimicrobial Pesticides Pilot
The following are some frequent questions about the pilot and EPA responses:
Does EPA consider the DfE logo to be an endorsement?
Does the pilot set limits on the amount/percentage of active that is acceptable in a labeled product?
How does OPP handle concentrated products in this pilot?
Will information on alternate brand names and supplemental distributors be available?
How will EPA handle cases of unauthorized use of the DfE logo?
How does a product qualifying under the DfE program differ from a FIFRA 25(b)-exempt product?
Does the pilot include adjuvants and might such products be eligible for the DfE label?
Does EPA consider the DfE logo to be an endorsement?
EPA response: No, EPA does not consider the logo to be an endorsement. Similar to saying a pesticide is “EPA registered” because EPA has found it meets the registration standard, the DfE logo indicates that the product has been reviewed and meets the standard for the DfE pilot. The logo must be accompanied by a reference to the DfE pesticides pilot website that explains what the logo means, how the product was reviewed, and what passing the review means about the product’s hazard profile.
Does the pilot set limits on the amount/percentage of active that is acceptable in a labeled product?
EPA response: No, however, the criteria may effectively limit the amount of active that can be used. Under the pilot, candidate product formulations are reviewed to determine if they meet the DfE criteria. This includes reviewing the toxicity and physical/chemical properties such as pH of the formula. The toxicity and other properties are affected by the amount/percentage of the active ingredient in the formula. To date, EPA has determined that products containing the following active ingredients may qualify depending on the specific properties of the formulated product: citric acid, lactic acid, peracetic acid, ethanol, isopropanol, sodium bisulfide, and hydrogen peroxide. Products are approved on a formulation basis. Should the registrant request to change the formula, a new DfE review would be needed to determine if the product still qualifies.
How does OPP handle concentrated products in this pilot?
EPA Response: The DfE logo is only allowed on qualifying products after EPA has taken toxicity and pH into consideration. These products must also be approved for EPA registration. The pilot generally only allows products that are toxicity category 3 or 4. However, concentrated products that are toxicity category 2 may qualify for the DfE logo if the toxicity data for the use dilution product demonstrate category 3 or 4 (on the route of exposure triggering category 2).
Concentrates supporting toxicity category I do not qualify for the pilot.
Will information on alternate brand names and supplemental distributors be available?
EPA Response: Yes. The web page lists the alternate brand names for qualifying pilot products as well as supplemental distributer company number and brand names, if applicable.
Supplemental distributor products cannot qualify for the DfE logo on their own. The parent product must qualify for the DfE logo before a supplemental distributor product may add the DfE logo on its label.
How will EPA handle cases of unauthorized use of the DfE logo?
EPA Response: Using the logo associated with a pesticide product without having prior approval would be a violation under FIFRA, and EPA may take action as part of its FIFRA enforcement program. Also, unauthorized use of the DfE logo could be handled under Safer Choice procedures.
Unauthorized use of an EPA mark, for example, placing the DfE logo on a product prior to its being qualified to participate in the OPP-DfE pilot, constitutes fraud and is punishable as a crime. It is the responsibility of EPA’s Office of Inspector General (OIG) to investigate allegations of fraud relating to an Agency logo and refer cases to regional and state counsel for prosecution. DfE will bring all cases of fraud involving the logo to the OIG; currently, DfE has one fraud case in the OIG system.
How does a product qualifying under the DfE program differ from a FIFRA 25(b)-exempt product?
EPA Response: They are similar only in that they involve lists of qualifying ingredients, but very different in the process and requirements that participants must follow. In brief, the DfE program/pilot requires a registered-pesticide candidate product to undergo an assessment against the DfE standard (e.g., to evaluate the toxicity of the active and inert chemicals). If the product qualifies it may add the DfE logo to its label through a label amendment.
In contrast, 25(b) products are exempt from registration and are not evaluated by the EPA, and therefore these products are not eligible for the DfE label. It should also be noted that any product bearing claims to either control or mitigate microorganisms that pose a threat to human health including but not limited to disease transmitting bacteria or viruses, or claims to control insects or rodents carrying specific diseases, but not limited to ticks that carry Lyme disease are not exempt under the 25b Program (40 CFR Part 152.25 (f)(3)(ii)).
Does the pilot include adjuvants and might such products be eligible for the DfE label?
EPA response: Adjuvants would be included only when the adjuvant is part of the registered pesticide product. The pilot is currently open to antimicrobial products and a limited number of biopesticides. Adjuvants are a class of products -- usually additives intended to be combined with a pesticide -- that are regulated by some states. Adjuvants packaged with a pesticide are eligible for the pilot if both the pesticide and adjuvant meet the pilot criteria. An adjuvant that is used in non-pesticidal products may qualify for DfE; however, to date, EPA has not reviewed any adjuvants under the DfE or Safer Choice program.