How to Apply for the DfE for Antimicrobial Products Pilot
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Factors to Consider Before Applying
Products submitted for EPA review for the Pilot must meet the following criteria:
- Must qualify for acute toxicity category III or IV. If a product is a concentrate, the resulting solution following dilution directions must qualify for acute toxicity category III or IV.
- For a dilution of a concentrate product to qualify, a closed-loop dispensing system must be used such that the worker/user is not exposed to the concentrate.
- The secondary container containing the diluted solution will not be sold or distributed but used solely at the site. This container must have labeling as specified on Secondary Containers and Service Containers for Pesticides.
- Active ingredients are unlikely to possess carcinogenic or endocrine disruptor properties.
- Active ingredients are unlikely to possess developmental, reproductive, mutagenic, or neurotoxicity issues.
- All inert ingredients and mixtures are accepted by EPA/OPP.
- Agency-mandated Personal Protective Equipment are not required to use the product.
- There are no unresolved adverse effects reporting (i.e., 6(a)(2)) issues indicating potential unreasonable adverse effects for the product.
- There are no unresolved efficacy failures (associated with the Antimicrobials Testing Program or otherwise) associated with the product.
- There are no unresolved compliance or enforcement actions associated with the product.
- Formulations submitted for DfE review are identical to the Confidential Statement of Formula (CSF)identified for your antimicrobial pesticide registration.
In addition, you will need to provide test results demonstrating effectiveness on hard, nonporous surfaces against microorganisms that pose a threat to human health for which the product has label claims.
If you have questions as to whether or not your existing product qualifies, please contact your Antimicrobial Division Product Manager (PM) for assistance. If you are unsure of whom to contact, see the listing of potential contacts.
If you are attempting to apply for the Pilot, and your product is currently unregistered, contact the potential Antimicrobials Division Product Manager for assistance. Find the PM based upon the active ingredient in the proposed product’s formulation that has the highest concentration.
- If your product contains only one active ingredient and the remainder of the formulation is composed of inert ingredients, your PM assignment would be based upon the sole active ingredient.
- If you have multiple active ingredients, for example, 5% active ingredient "X", 10% active ingredient "Y", and 85% inert ingredients, your PM would be the person assigned to active ingredient "Y".
Application Procedures
Obtain Review by the Design for the Environment Program
Once you’ve ascertained that your product may qualify for the Pilot, review the Safer Choice screening requirements to ensure all necessary information is provided for the Safer Choice review. For additional information about this portion of the Pilot, please contact Melanie Adams (adams.melanie@epa.gov). Also, familiarize yourself with the Steps to Partnership on the Safer Choice website.
Note that with respect to Step 3, "Assessing Ingredients and Identifying Safer Alternatives," Safer Choice has not yet developed a component class screen for active ingredients in pesticide products. Therefore, Safer Choice will apply its general screen pending the development of a customized screen for pesticide active ingredients. Inert ingredients will be reviewed as described in the Safer Choice Standard.
Obtain EPA Pesticide Program Review
Upon successful completion of the DfE review, the antimicrobial product may then be submitted to the Office of Pesticide Programs, Antimicrobials Division (AD), as a Pesticide Registration Improvement Act (PRIA) application. PRIA applications are subject to fees based upon the application code assigned. Labeling amendments under this Pilot will be classified as PRIA code A570 which has a fee of $3,474.00 and a 150-day time frame for review unless a new use is associated with the application.
If you're submitting a new product for registration under this Pilot, the PRIA code A540 will be assigned, which has a fee of $4,631.00 and a 150-day time frame for review unless a new active ingredient, new use, or an “other” antimicrobial use is involved under FIFRA Section 2(mm).
Read more about the PRIA statute, fees, fee waivers, and timeframes.
In general, the PRIA application is considered complete and the review period begins when we have received all the following information:
- 1 copy of the:
- cover letter indicating the type of action being sought and participation in the DfE for Antimicrobial Products Pilot
- certification statement concerning the conditions of the Pilot
- DfE Acceptance Letter
- certification statement concerning the DfE accepted formulations for the basic and all alternate formulations associated with the CSF
- Information Request Application to the NSF Green Chemistry Program
- transmittal document/bibliography with cover letter
- EPA Form 8570-27, Formulator's Exemption Statement, if applicable
- EPA Form 8570-34, Certification with Respect to Citation of Data, if applicable
- EPA Form 8570-35, Data Matrix, if applicable
- EPA Form 8570-36, Summary of the Physical/Chemical Properties, if applicable
- EPA Form 8570-37 Self-Certification Statement for Physical/Chemical Properties, if applicable
- Permission Letter for cited data, if applicable
- 3 copies of :
- EPA Form 8570-1, Application for Pesticide Registration
- EPA Form 8570-4, Confidential Statement of Formula
- 5 copies of Proposed Labeling
If product-specific data are being submitted, the application must also contain:
- Product Chemistry (Bound Studies)
- 1 copy of transmittal document/bibliography loose in front of first bound volume of studies
- 1 copy of cover letter per study set
- 3 copies of product properties studies: OPPTS Series 830, Group A and B
- Efficacy (Bound Studies)
- 1 copy of transmittal document/bibliography loose in front of first bound volume of studies
- 1 copy of cover letter per study set
- 3 copies of efficacy studies
- Acute Toxicity (Bound Studies)
- 1 copy of transmittal document/bibliography loose in front of first bound volume of studies
- 1 copy of cover letter per study set
- 3 copies of acute toxicity studies
If you have any questions concerning your application, contact your PM for assistance before submitting it.
Review by the Pesticide Program
Once a completed application has been received, the Antimicrobials Division will review the application. This review is separate from the previous DfE review and includes:
- A review of the human health risk assessment to validate that the active ingredient meets the requirements of the Pilot.
- A review of the product acute toxicology profile to validate that the formulation meets the requirements of the Pilot.
- Review of any data submitted in support of registration.
- Confirmation that the formulation identified on the pesticide CSF is identical in composition and concentration to the previously reviewed DfE formulation.
- Review of the entire product labeling.
An acceptable determination will result in the company receiving a pre-acceptance notification. At that time, you must submit the final printed label before you can receive an EPA-stamped, accepted label for sale and distribution. If your label meets the following criteria, you will receive approval to use the DfE for Pesticides logo on the labeling:
- Logo may appear anywhere on the label.
- Logo size for containers under a gallon should be 21.21 mm in diameter (size of a nickel)
- Logo size for containers over a gallon should be 24.26 mm in diameter (size of a quarter)
Under the terms of this Pilot, an unacceptable determination would result in one of the following:
- The registrant agrees to withdraw the submission.
- The registrant may request a minimum of at least 45 days negotiation of the PRIA due date depending upon the nature of the deficiency.
- The Agency may issue a "Not Grant" determination.