Pesticide Label Statements: Pilot Program to Help Promote Environmental Sustainability
The Label Statement Pilot Program is a pilot project ending May 3, 2016. It allows certain statements that help promote environmental sustainability on qualifying pesticide product labels. This pilot was developed in cooperation with the Pesticide Program Dialogue Committee (PPDC), in an effort to better inform consumers of certain aspects of pesticide products. Background on the Label Statements pilot and the public process used to develop it are available in the EPA archive. Search EPA Archive
On this page:
- The label statements permitted
- How to apply
- The review process
- Public involvement is requested to help improve the pilot
The Label Statements Permitted
The Agency will allow for products with multiple formulations to participate in the pilot. If your product has multiple formulations, basic and alternates, then any accompanying label statement(s) must be true of the specific formulation product being sold. Products whose formulations violate these provisions will be considered misbranded and subject to Agency enforcement action. The following statements are permitted under the pilot:
Antimicrobial Products
- Dyes and/or Fragrance Free Statements. OPP will permit for the purposes and duration of this pilot the following label statements to be placed on qualifying antimicrobial pesticide products:
- “Dye-free.”
- “Fragrance-free.”
- “Dye and fragrance free.”
Registrants applying for this pilot must submit as part of their application the current Confidential Statement of Formula (CSF) and a draft label with the new statements. OPP will examine the CSF to verify the dye/fragrance free claim before granting use of the label. Upon EPA Pesticide Program's initial pre-acceptance of the statement(s), a final printed label must be submitted to the Agency before the labeling is stamped acceptable.
- Corporate Commitment Statements. EPA's Pesticide Program will permit for the purposes and duration of this pilot the following label statement to be placed on qualifying antimicrobial pesticide products:
“For technical assistance or information on [INSERT THE NAME OF THE COMPANY] environmental/sustainability initiatives, go to [INSERT COMPANY WEBSITE].”
Registrants applying for this pilot must submit as part of their application a link to their company’s website and their product’s draft label with the new statement. Upon our initial pre-acceptance of the statement(s), you must submit a final printed label before we will stamp the labeling as acceptable.
- Biodegradability Claims. We will permit for the purposes and duration of this pilot the following label statements on qualifying antimicrobial products:
- “100% Biodegradable. All ingredients in this product are readily biodegradable in water” or
- “The surfactants contained in this product are biodegradable.* (*Surfactants are cleaning agents).”
Registrants applying for this pilot must comply with the biodegradability criteria specific to the type of claim being pursued. Upon OPP initial pre-acceptance of the statement, you must submit a final printed label to us before the labeling is acceptable.
Any Type of Product
- USDA BioBased product certification. OPP will permit for the purposes and duration of this pilot the “USDA Certified BioBased Product” certification mark to be placed on the product label, provided it is accompanied by an acceptable disclaimer statement clarifying that the certification mark does not imply safety of the product and that users must read and follow all label instructions.
Registrants applying to include the BioBased certification mark on their labeling first must have received certification of their labeling through USDA’s BioPreferred program.
USDA’s BioPreferred Program was established by statute in the 2002 Farm Bill with a mandate to increase the use of biobased materials (derived from agriculture, forestry or aquatic organisms) in industrial, commercial and consumer products. It was expanded in 2008 to add promotion of biobased products for the consumer market by a voluntary program to allow a certification mark on product labels.
How to Apply
Fragrance, Corporate Commitment, and Biodegradation
Once you’ve ascertained whether or not your formulation product may qualify for the pilot, you need to determine what type of application you’ll submit to the Agency. The following are examples of the various types of applications that may involve label amendments under this pilot:
- Any PRIA new active ingredient application.
- Any PRIA new use application (excluding manufacturing use products).
- Any PRIA new product registration (excluding MUP).
- Any labeling amendment (PRIA or Non-PRIA).
Label amendments under PRIA include mandatory time frames as well as fees. Find additional information concerning PRIA statute, fees, fee waivers, and time frames. Non-PRIA amendments, or those under the Food Quality Protection Act (FQPA), typically do not involve data review other than minor chemistry formulation. FQPA amendments have mandatory time frames but do not require a fee.
Both PRIA and FQPA actions are required to be “complete” before the beginning of the review period. In general, the application is considered “complete” and the review period begins once all the following information has been received:
- 1 copy of the cover letter indicating the type of action being sought and participation in the Statements for Antimicrobial Labeling Pilot.
- 1 copy of transmittal document/bibliography with cover letter.
- 3 copies of EPA Form 8570-1, Application for Pesticide Registration.
- 3 copies of EPA Form 8570-4, Confidential Statement of Formula.
- 1 copy of EPA Form 8570-27, Formulator’s Exemption Statement, if applicable.
- 1 copy of EPA Form 8570-34, Certification with Respect to Citation of Data, if applicable.
- 1 copy of EPA Form 8570-35, Data Matrix, if applicable.
- 1 copy of EPA Form 8570-36, Summary of the Physical/Chemical Properties, if applicable.
- 1 copy of EPA Form 8570-37 Self-Certification Statement for Physical/Chemical Properties, if applicable.
- 5 copies of Proposed Labeling.
- 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 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: Harmonized Guideline 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.
If you have any questions concerning your application, contact your product manager for assistance in the submission of your application.
USDA BioPreferred Program
We will process applications requesting the addition of the USDA Certified BioBased Product certification mark as non-PRIA amendments.
The action is required to be “complete” before the beginning of the review period. In general, the application is considered “complete” and the review period begins once all the following information has been received:
- 1 copy of the cover letter indicating the type of action being sought and participation in the Statements for USDA Certified BioBased Product pilot.
- 1 copy of transmittal document/bibliography with cover letter.
- 3 copies of EPA Form 8570-1, Application for Pesticide Registration.
- 3 copies of EPA Form 8570-4, Confidential Statement of Formula.
- 1 copy of EPA Form 8570-27, Formulator’s Exemption Statement, if applicable.
- 1 copy of EPA Form 8570-34, Certification with Respect to Citation of Data, if applicable.
- 1 copy of EPA Form 8570-35, Data Matrix, if applicable.
- 1 copy of EPA Form 8570-36, Summary of the Physical/Chemical Properties, if applicable.
- 1 copy of EPA Form 8570-37 Self-Certification Statement for Physical/Chemical Properties, if applicable.
- 5 copies of Proposed Labeling, including the certification mark accompanied by a disclaimer statement.
- 1 copy of certification letter provided by USDA indicating that the product has received certification under the USDA BioPreferred program.
Note: For products with multiple formulations, all formulations must have either received BioBased product certification from USDA or be covered under USDA's "self-declaration" policy for the certification mark to be present on the pesticide label. - Disclaimer statement- a disclaimer statement must be placed directly below the certification mark on the proposed label. This statement should clarify that the mark does not imply safety of the product and that label directions should be read and followed. An example of a disclaimer statement the Agency would find acceptable is as follows, “This mark is not an indication of safety. Read and follow all label instructions.” The Applicant may submit an alternate disclaimer statement for evaluation.
If you have any questions concerning your application, contact your product manager (Registration Division and Antimicrobial Division products) or regulatory action leader (Biopesticide and Pollution Prevention Division products) for assistance before the submission of your application.
The Review Process
Fragrance, Corporate Commitment, and Biodegration
Upon receipt of the antimicrobial labeling claim(s), the Antimicrobials Division will review the confidential statement of formula to ensure the claim(s) are supported by the formulation. An acceptable determination will result in the company receiving a Pre-Acceptance letter from the Agency. At that time, the company must respond with the final printed label before receiving an EPA stamped accepted label for sale and distribution.
Under the terms of this pilot, an unacceptable determination would result in the fast track amendment application being rejected under the Food Quality Protection Act. An unacceptable determination for a label associated with a PRIA action 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 based upon the nature of the deficiency.
- The Agency may issue a “Not Grant” determination.
USDA BioPreferred Program
Upon receipt of the USDA Certified BioBased Product amendment request, the regulatory division responsible for that product will review the label amendment and the disclaimer statement to determine whether the proposed label is acceptable. An acceptable determination will result in the company receiving an acceptance letter and stamped approved label from the Agency.
Public Involvement is Requested to Help Improve the Pilot
The Agency will review additional label statements during the duration of the pilot. If you have additional statements that you believe are factual and not false or misleading, please contact Jacqueline Campbell (Campbell-McFarlane.Jacqueline@epa.gov) in EPA’s Office of Pesticide Programs.