Design for the Environment (DfE) Certification: Information for Registrants

EPA’s Design for the Environment certification program is administered jointly between EPA’s Office of Pollution Prevention and Toxics (OPPT) and EPA’s Office of Pesticide Programs (OPP).

To obtain DfE certification, registrants must submit information to both offices. In most cases, applicants should complete the OPPT review process before engaging with the OPP’s Antimicrobials Division. Those who would like to pursue concurrent review should reach out to [email protected] and your Antimicrobials Division product manager for an initial coordination meeting.

• OPPT Requirements
• Requesting OPPT's Review
• OPP Requirements
• Requesting OPP's Review
• OPP's DfE Review Process
• Using the DfE Logo
• Frequent Questions About DfE Certification

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OPPT Requirements

Antimicrobial pesticide products composed of one or more of the active ingredients listed below may be considered for the DfE logo on a case-by-case basis.

All pesticide products must be reviewed and registered by EPA, which include evaluations of their active and inert ingredients. All ingredients in DfE pesticides, whether active or inert, must meet the DfE certification criteria. At present, the following eight chemicals meet both sets of criteria.

If you have an active ingredient that you would like to be considered for the DfE logo, please contact [email protected].

Active Ingredients	Year Approved
Citric acid	2009
Hydrogen peroxide	2009
L-lactic acid	2009
Ethanol	2012
Isopropanol	2012
Peroxyacetic acid	2015
Sodium Bisulfate	2015
Chitosan	2019

Requesting OPPT’s Review

Review OPPT’s DfE certification criteria to ensure all necessary information is provided for the OPPT review. The submission process is explained for products that currently bear the DfE logo in this diagram (pdf) (182.23 KB) and for new products that have not yet been DfE-certified in this diagram (pdf) (213.13 KB) . For questions on this portion of the DfE certification process, please contact [email protected].

OPP Requirements

In addition to meeting all of OPPT’s requirements associated with the DfE certification, products must meet the following criteria.

Human Health Effects

• Qualifies for inclusion in 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 mixing 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.

Ingredients

• All inert ingredients and mixtures are accepted by EPA's Office of Pesticide Programs.

Good Standing

To be eligible for DfE certification, a product may not have any:

• unresolved adverse effects reporting (i.e., FIFRA section 6(a)(2)) issues indicating potential unreasonable adverse effects for the product;
• unresolved efficacy failures (associated with the Antimicrobials Testing Program or otherwise) associated with the product; or
• unresolved compliance or enforcement actions associated with the product.

Formulations submitted for DfE review must also be identical to the Confidential Statement of Formula (CSF) identified for your antimicrobial pesticide registration.

Efficacy

If your product’s label claims that the product is effective against microorganisms that pose a threat to human health, you will need to provide laboratory testing data demonstrating the product’s effectiveness.

Registration

If your product is EPA-registered, please contact your Antimicrobials Division product manager with any questions on whether your product qualifies for the DfE logo.

If your product is not EPA-registered, use this list of contacts to find the product manager or branch chief associated with the active ingredient that has the highest concentration in your product’s proposed formulation.

• If your product contains only one active ingredient and the remainder of the formulation is composed of inert ingredients, your product manager 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 product manager would usually be the person assigned to active ingredient "Y" because this active ingredient is the highest.

Requesting OPP's Review

New DfE-certification requests should be submitted to the Office of Pesticide Programs, Antimicrobials Division, as a Pesticide Registration Improvement Act (PRIA) application. PRIA applications are subject to fees based on the application code assigned. A label amendment to add the DfE logo will be classified as PRIA code M011, which currently has a fee of $3,831.00 and a 120-day time frame for review.

If you are submitting a new product for registration with the DfE logo, the PRIA code A540 will be assigned, which currently has a fee of $5,363.00 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 EPA has received all the following information via an online submission through the external stakeholder portal:

• OPPT documents:
  • Cover letter indicating the type of action being sought and request for the DfE logo for Antimicrobial Pesticide Products
  • Design for the Environment Partnership Agreement Letter (pdf) (256.77 KB)
  • Design for the Environment product report with ingredient listing
• OPP Documents
  • OPP Certification statement concerning the DfE logo requirements
  • 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
  • EPA Form 8570-1, Application for Pesticide Registration
  • EPA Form 8570-4, Confidential Statement of Formula
  • Proposed labeling
    • 1 copy of the label with the changes highlighted
    • 1 clean copy of the label

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

• Product Chemistry (Bound Studies)
  • The transmittal document/bibliography 1 copy of cover letter per study set
  • The product properties studies: OPPTS Series 830, Group A and B
• Efficacy (Bound Studies)
  • The transmittal document/bibliography 1 copy of cover letter per study set
  • The efficacy studies
• Acute Toxicity (Bound Studies)
  • The transmittal document/bibliography 1 copy of cover letter per study set
  • The acute toxicity studies

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

OPP's DfE Review Process

EPA's Office of Pesticide Programs will review your submission to assess whether the product meets OPP's DfE Requirements.

If EPA finds that the product meets the DfE criteria, you will receive a pre-determination notification, with possible labeling annotations requested by the OPP. At that time, you must submit the final printed label with all annotations addressed 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 Agency may issue a "Not Grant" determination.

Using the DfE Logo

EPA expressly reserves all rights in the DfE Logo as a trademark owned by EPA’s Design for the Environment certification program. Authorized users of the DfE logo may use the DfE logo on the product label only after EPA has determined that all the chemical ingredients in the product have met EPA requirements. No additional claims, terms, words or images associated with the DfE logo or DfE certification program that imply safety are permitted without express EPA approval. Although products must meet the standard that is used for non-pesticidal products to qualify for the Safer Choice label, in addition to criteria developed to assess pesticides, to qualify for DfE certification, the Safer Choice messaging may not be used.

EPA’s regulations at 40 CFR 156.10(a)(5)(ix) and (x) preclude the use of safety claims or comparative statements about safety. EPA does not consider the DfE logo to be such a claim as it is only intended to express that a product meets DfE program criteria.

If you see a pesticide product that appears not to comply with this authorized use of the logo, please report potential violations to EPA. Using the DfE logo on a pesticide product without having prior approval from EPA could be a violation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and EPA may take action as part of its FIFRA enforcement program. Such unauthorized use of the DfE logo may also be a violation of The Trademark Act, 15 U.S.C. § 1125(a).

Frequent Questions About DfE Certification

Is the DfE logo an endorsement of the product?

No. EPA’s approval of the logo for use on a pesticide label is not an endorsement of the product. Similar to saying a pesticide is “EPA-registered” because EPA has found it meets the registration standard, the DfE logo indicates that a qualifying, registered product has been reviewed and meets the standards for the DfE program.

I need help understanding part of the application process. Who should I contact?

Throughout the certification process, you may wish to reach out to the following individuals for support:

OPPT Requirements and Review: Contact [email protected].

OPP Requirements and Review: Contact your Antimicrobial Division product manager. Use this table to find the product manager associated with the active ingredient that has the highest concentration in your product’s proposed formulation.

Questions about the DfE logo: Contact [email protected].

Is there a limit on the amount/percentage of active ingredient that is acceptable on a product label bearing the DfE logo?

No. However, the criteria that products must meet when submitted for EPA DfE review may effectively limit the amount of active ingredient that can be used. Among other factors, EPA’s DfE review considers the toxicity and physical/chemical properties of the formula, including its pH. The amount/percentage of the active ingredient in the formula affect the toxicity and other properties.

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, hydrogen peroxide, and chitosan.

EPA approves products based on the formulation. Should the registrant request to change the formula, a new DfE review involving both OPPT and OPP would be needed to determine if the product still qualifies.

Can concentrated products meet the criteria to qualify for the DfE logo?

Yes. The DfE logo is generally only allowed on products that fall in toxicity category III or IV. However, concentrated products that are in toxicity category II may qualify for the DfE logo if the toxicity data for the use dilution product demonstrate category III or IV (on the route of exposure triggering category II).

Concentrates that fall in toxicity category I do not qualify for the DfE logo.

Is information on alternate brand names and supplemental distributors available?

Yes. EPA's list of DfE-certified products includes products with primary registrations, supplemental distributor products, and alternative brand names.

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 to its label.

How does a product qualifying for the DfE logo differ from a minimum risk pesticide?

The DfE standard and minimum risk pesticide exemption requirements are similar only in that they both involve lists of qualifying ingredients. However, they have different processes and requirements that registrants must follow.

The DfE logo 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 ingredients). If the product qualifies the registrant may add the DfE logo to its label through a label amendment. 

In contrast, FIFRA 25(b) products are exempt from registration and are not evaluated by the EPA.

Is the DfE logo a safety claim?

No. EPA's regulations at 40 CFR 156.10(a)(5)(ix)and (x) preclude the use of safety claims and comparative statements about safety. EPA does not consider the DfE logo to be such a claim as it is conveys that a product meets DfE certification criteria. EPA anticipates future rulemaking activities associated with the regulations on safety claims and comparative safety claims. As with all regulatory changes, EPA will seek public feedback.