• Unlike most other types of product labels, pesticide labels are legally enforceable.

Pesticide product labels and labeling provide critical information about how to safely and legally handle and use pesticide products. A pesticide product’s label and labeling are of utmost importance as they are the primary mechanism to inform the end-user about how to use and apply the product to achieve the product’s useful functions, as well as which precautions must be followed to protect both human health and the environment.

Label versus labeling

A pesticide “label” includes any text or images printed directly on, or attached to, the product or its packaging. “Labeling,” on the other hand, includes the label, as well as any printed or written material that accompanies the product (for example, a booklet). Labeling can also include material to which the label (or other labeling material) refers. For instance, if a label refers to a manual on how to conduct a procedure, that manual is also labeling that the user must follow and the Environmental Protection Agency (EPA) must review and approve before the product may be sold or distributed.

The label is the law

Every pesticide product must bear a label containing the information specified by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S. Code section 136 et seq., and its implementing regulations at 40 CFR 156. FIFRA and Part 156 govern what must be included on pesticide labels.

Unlike most other types of product labels, pesticide labels and labeling are legally enforceable, and all of them carry the statement: “It is a violation of federal law to use this product in a manner inconsistent with its labeling.” One could say, “The label is the law.” Enforcement of pesticide regulations and label requirements is primarily carried out by state agencies acting under cooperative agreements with EPA.

Label review and approval

As part of any pesticide registration application submitted to EPA, applicants must provide a proposed label containing detailed information. The agency ensures that the pesticide label translates scientific data about the potential health and environmental effects of a pesticide into a set of conditions, directions, precautions, and restrictions that define who may use a pesticide, as well as where, how, how much, and how often it may be used.

During its review, EPA may approve the label as submitted, approve the label with comments, or disapprove the submitted label. The label must be approved before a pesticide can be sold or distributed in the United States.

Ultimately, the accuracy of a label is vital as it may impact:

• EPA and other agencies that use the label to manage and mitigate pesticide risks;
• EPA and other agencies that enforce pesticide production, distribution, and use;
• Registrants, including pesticide manufacturers, and their supplemental distributors;
• Pesticide applicators who rely on the label for hazard and safety information and use directions to ensure safe and effective use;
• Bystanders and other individuals who may be exposed to the pesticide; and
• Courts that consider a label to be a legal document.

Summary of requirements

• Determine whether the product is or is not a pesticide. See 40 CFR 152.
• Determine whether the product is exempted from FIFRA. See 40 CFR 152.
• Determine whether the pesticide product is exempted from registration. See 40 CFR 152.
• If the pesticide product is unregistered and non-exempt, then it is not exempted from registration:
  • Develop draft labeling that meets the Part 156 requirements, including for content and format.
  • Follow the application procedures at 152.50 for submitting applications and draft labeling. Submit five copies of the proposed draft labeling with an application. The draft labeling may be typed or otherwise printed but must be legible, reproducible, and on 8-1/2 x 11-inch paper. However, EPA encourages electronic submission. See the EPA Electronic Submission of Labels webpage for information.
  • EPA will review draft labeling submitted with the application and can approve the label as submitted, approve the label with comments, or disapprove the submitted label.
  • Once EPA has granted a registration, EPA not only notifies the registrant of the decision but also will approve a submitted label for the product.
  • Include an approved label on every package on all registered products.
  • Do not alter or change the label after the registration approval. If the product was previously registered with EPA and a change to the registration, such as a change to the labeling text, is needed, file an application to amend the registered product.
  • Do not sell or distribute a pesticide if any claims made for it differ from the claims made on labeling required for registration. (Advertising claims for a pesticide product must not contradict claims made in the product’s labeling.)
• Ensure that supplemental distributor products and their distributor labeling comply with 152.132. Distributor labels are not submitted for approval, but a Notice of Supplemental Distribution must be submitted to EPA before supplemental distribution of the product. A distributor label must be the same as that of the registered product label with some important exceptions.

Guidance

Given the high importance of labels in pesticide management, application, and regulatory enforcement, EPA has compiled a comprehensive Label Review Manual (LRM), which is available on the agency website. This instructional aid compiles existing interpretations of statutory and regulatory provisions and reiterates existing agency policies. The LRM also provides assistance and insight into how pesticide labels should generally be drafted.

Further regulatory guidance may be found in EPA Pesticide Registration Notices (PR Notices or PRN).