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How to Apply for the DfE for Antimicrobial Products Pilot

February 2013

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Factors to Consider Before Applying

Products submitted for EPA review for the Pilot must meet the following criteria:

  1. Must qualify for acute toxicity category III or IV. However, products supporting a "WARNING" signal word may qualify for the logo provided that use dilution acute toxicity testing is submitted for the route of exposure that triggered the WARNING signal word.– EPA-registered antimicrobial pesticide products that bear a signal word of "Danger" do not qualify for the Pilot.
  2. Active ingredients are unlikely to possess carcinogenic or endocrine disruptor properties.
  3. Active ingredients are unlikely to possess developmental, reproductive, mutagenic, or neurotoxicity issues.
  4. The product has no outstanding "conditional registration" data issues.
  5. All inert ingredients and mixtures are accepted by EPA/OPP.
  6. Agency-mandated Personal Protective Equipment are not required to use the product.
  7. There are no unresolved adverse effects reporting (i.e., 6(a)(2)) issues indicating potential unreasonable adverse effects for the product.
  8. There are no unresolved efficacy failures (associated with the Antimicrobials Testing Program or otherwise) associated with the product.
  9. There are no unresolved compliance or enforcement actions associated with the product.
  10. 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.

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Application Procedures

  1. Obtain review by the Design for the Environment program
  2. Once you’ve ascertained that your product may qualify for the Pilot, review the DfE screening requirements to ensure all necessary information is provided for the DfE review. For additional information about this portion of the Pilot, please contact David DiFiore (difiore.david@epa.gov).

    If you are applying for DfE partnership as part of the DfE for Antimicrobial Pesticides Pilot, contact Kelly Grant (grant.kelly@epa.gov) or 202-564-9910. Also, familiarize yourself with the Steps to Partnership on the DfE website.

    Note that with respect to Step 3, "Assessing Ingredients and Identifying Safer Alternatives," DfE has not yet developed a component class screen for active ingredients in pesticide products. Therefore, DfE will apply its general screen pending the development of a customized screen for pesticide active ingredients. Inert ingredients will be reviewed as described in DfE's Standard for Safer Cleaning Products.

  3. Obtain EPA Pesticide Program review
  4. 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. 1 copy of the cover letter indicating the type of action being sought and participation in the DfE for Antimicrobial Products Pilot
    2. 1 copy of the certification statement (PDF) (2 pp, 88k, about PDF) concerning the conditions of the Pilot
    3. 1 copy of the DfE Acceptance Letter
    4. 1 copy of the certification statement concerning the DfE accepted formulations for the basic and all alternate formulations associated with the CSF
    5. 1 copy of the Information Request Application to the NSF Green Chemistry Program.
    6. 1 copy of transmittal document/bibliography with cover letter
    7. 3 copies of EPA Form 8570-1, Application for Pesticide Registration
    8. 3 copies of EPA Form 8570-4, Confidential Statement of Formula
    9. 1 copy of EPA Form 8570-27, Formulator's Exemption Statement, if applicable
    10. 1 copy of EPA Form 8570-34, Certification with Respect to Citation of Data, if applicable
    11. 1 copy of EPA Form 8570-35, Data Matrix, if applicable
    12. 1 copy of EPA Form 8570-36, Summary of the Physical/Chemical Properties, if applicable
    13. 1 copy of EPA Form 8570-37 Self-Certification Statement for Physical/Chemical Properties, if applicable
    14. 5 copies of Proposed Labeling
    15. 1 copy of Permission Letter for cited data, if applicable

    If product-specific data are being submitted, the application must also contain:

    Product Chemistry (Bound Studies)

    1. 1 copy of transmittal document/bibliography loose in front of first bound volume of studies
    2. 1 copy of cover letter per study set
    3. 3 copies of product properties studies: OPPTS Series 830, Group A and B

    Efficacy (Bound Studies)

    1. 1 copy of transmittal document/bibliography loose in front of first bound volume of studies
    2. 1 copy of cover letter per study set
    3. 3 copies of efficacy studies

    Acute Toxicity (Bound Studies)

    1. 1 copy of transmittal document/bibliography loose in front of first bound volume of studies
    2. 1 copy of cover letter per study set
    3. 3 copies of acute toxicity studies

If you have any questions concerning your application, contact your PM for assistance before submitting it.

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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:

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:

Under the terms of this Pilot, an unacceptable determination would result in one of the following:

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