How to Apply for the DfE Logo for Biopesticide Products
Factors to Consider Before Applying
Products submitted for EPA review are evaluated on a case by case basis for the DfE logo and must meet the following criteria:
- Must qualify for inclusion in 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 biopesticide products that bear a signal word of "Danger" do not qualify for the DfE logo.
- Active ingredients are unlikely to possess carcinogenic or endocrine disruptor properties.
- Active ingredients are unlikely to possess developmental, reproductive, mutagenic or neurotoxicity issues.
- The product has no outstanding "conditional registration" data issues.
- All inert ingredients and mixtures are accepted by EPA/OPP.
- There are no unresolved adverse effects reporting [6(a)(2)] issues indicating potential unreasonable adverse effects for the product.
- There are no unresolved efficacy failures 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 biopesticide product registration.
If you have questions as to whether your existing product qualifies, please contact your Biopesticides and Pollution Prevention Division Product Manager (PM) for assistance. If you are unsure whom to contact, see the listing of staff in the Biopesticides and Pollution Prevention Division.
If you are attempting to apply for the DfE logo and your product is currently unregistered, contact the Biopesticides and Pollution Prevention Division PM for assistance. Find the PM based on 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 on 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 for the Design for the Environment Logo
Once you’ve ascertained that your product may qualify for the DfE logo, 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 DfE logo process, please contact [email protected]. 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 biopesticide product may be submitted to the Office of Pesticide Programs, Biopesticides and Pollution Prevention Division, as a Pesticide Registration Improvement Act (PRIA) application. PRIA applications are subject to fees based on the application code assigned. Labeling amendments for the DfE logo will be classified as PRIA code B680, which has a fee of $5,107.00 and a five-month time frame for review unless a new use is associated with the application.
If you're submitting a new product for registration with the DfE logo, the PRIA code B670 will be assigned, which has a fee of $5,107.00 and a seven month time frame for review unless a new active ingredient, new use, or an “other” biopesticide use is involved under FIFRA Section 2(mm). Read more about PRIA, fees, fee waivers and time frames.
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 request for the DfE logo for Biopesticide Products
- Certification statement concerning the conditions of the DfE logo
- Safer Choice Partnership Agreement 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 Pesticide Program’s Biopesticides and Pollution Prevention 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 for the DfE logo.
- A review of the product acute toxicology profile to validate that the formulation meets the requirements for the DfE logo.
- 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.
If all of the above are acceptable the company will receive 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. To receive approval to use the DfE logo on the labeling, your label must meet the following criteria:
- 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).
If the results of the Agency’s review show the above requirements have not been met, the following options are available:
- 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.