Pesticide product labels provide critical information about how to safely and legally handle and use pesticide products. A pesticide product’s label is of utmost importance as the label is 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.
Unlike most other types of product labels, pesticide labels 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.” In other words, the label is the law.
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.
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;
- Bystanders and other individuals who may be exposed to the pesticide; and
- Courts that consider a label to be a legal document.
Scope
Every pesticide product must bear a label containing the information specified by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., and its implementing regulations at 40 CFR 156. FIFRA and Part 156 govern what must be included on pesticide labels. Other EPA documents such as Pesticide Registration Notices (PR Notices or PRN) and EPA’s Label Review Manual provide guidance on what should be included on pesticide labels.
Note: OSHA 29 CFR 1910.1200 has direct authority over safety data sheets (SDS), formerly called material safety data sheets (MSDS). When an SDS is distributed with a pesticide it becomes a part of the pesticide labeling because it is accompanying the product. Therefore, if an SDS includes warnings, precautions or any other information that conflict with the FIFRA-approved label, it could be misleading to users of the pesticide and therefore cause the pesticide to be considered misbranded and unlawful for sale or distribution. For example, in 2012 OSHA adopted a revised Hazard Communication Rule for SDSs which utilizes the criteria for signal words adopted by multiple countries under the Globally Harmonized System (GHS) for hazard communication language and symbols. EPA has not adopted the GHS criteria, and thus an OSHA SDS may have a signal word that differs from the one EPA requires for a pesticide product label. PR Notice 2012-1 explains how a company can explain and justify such a difference if it occurs in order to prevent users from being misled by the inconsistencies.
Regulatory citations
- 40 CFR 152 — Pesticide registration and classification procedures
- 40 CFR 156 — Labeling requirements for pesticides and devices
Key definitions
- Act or FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136-136y).
- Active ingredient: Any substance (or group of structurally similar substances if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA sec. 2(a), except as provided in 174.3 of this chapter.
- Acute dermal LD50: A statistically derived estimate of the single dermal dose of a substance that would cause 50 percent mortality to the test population under specified conditions.
- Acute inhalation LC50: A statistically derived estimate of the concentration of a substance that would cause 50 percent mortality to the test population under specified conditions.
- Acute oral LD50: A statistically derived estimate of the single oral dose of a substance that would cause 50 percent mortality to the test population under specified conditions.
- Administrator: The Administrator of the United States Environmental Protection Agency or his delegate.
- Agency: The United States Environmental Protection Agency (EPA), unless otherwise specified.
- Applicant: A person who applies for a registration or amended registration under FIFRA sec. 3.
- Dilutable: The pesticide product’s labeling allows or requires the pesticide product to be mixed with a liquid diluent prior to application or use.
- Distribute or sell and other grammatical variations of the term such as “distributed or sold” and “distribution or sale”: The acts of distributing, selling, offering for sale, holding for sale, shipping, holding for shipment, delivering for shipment, or receiving and (having so received) delivering or offering to deliver, or releasing for shipment to any person in any State.
- Distributor label: A label is used when a product is registered to one company but is distributed or sold (known as “supplemental distribution”) by another company (known as the “distributor” or “sub-registrant”). Distributor labels are not submitted for approval, but a Notice of Supplemental Distribution must be submitted to EPA before supplemental distribution of the product. The registrant is responsible for the contents of both the distributor product and the distributor label.
- Final printed labeling: The label or labeling of the product when distributed or sold. Final printed labeling does not include the package of the product, unless the labeling is an integral part of the package.
- Inert ingredient: Any substance (or group of structurally similar substances if designated by the Agency), other than an active ingredient, which is intentionally included in a pesticide product, except as provided by 174.3 of this chapter.
- Label: The written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers.
- Labeling: All labels and all other written, printed, or graphic matter accompanying the pesticide or device at any time, or to which reference is made on the label or in literature accompanying the pesticide or device, except to current official publications of the EPA, the U.S. Departments of Agriculture and Interior, and the Department of Health and Human Services, state experiment stations, state agricultural colleges, and other similar federal or state institutions or agencies authorized by law to conduct research in the field of pesticides.
- Package or packaging: The immediate container or wrapping, including any attached closure(s), in which the pesticide is contained for distribution, sale, consumption, use, or storage. The term does not include any shipping or bulk container used for transporting or delivering the pesticide unless it is the only such package.
- Pesticide: Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, other than any article that: (1) Is a new animal drug under FFDCA sec. 201(w), or (2) Is an animal drug that has been determined by regulation of the Secretary of Health and Human Services not to be a new animal drug, or (3) Is an animal feed under FFDCA sec. 201(x) that bears or contains any substances described by paragraph (s) (1) or (2) of this section.
- Pesticide product: A pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold. The term includes any physical apparatus used to deliver or apply the pesticide if distributed or sold with the pesticide.
- Plant-incorporated protectant: A pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof.
- Released for shipment: A product becomes released for shipment when the producer has packaged and labeled it in the manner in which it will be distributed or sold, or has stored it in an area where finished products are ordinarily held for shipment. Products stored in an area where finished products are ordinarily held for shipment, but which are not intended to be released for shipment must be physically separated and marked as not yet released for shipment. Once a product becomes released for shipment, the product remains in the condition of being released for shipment unless subsequent activities, such as relabeling or repackaging, constitute production.
- Residential use: Use of a pesticide directly: (1) On humans or pets, (2) In, on, or around any structure, vehicle, article, surface, or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles, or (3) In any preschool or day care facility.
- Safety data sheet (SDS): Written or printed material concerning a hazardous chemical that is prepared in accordance with OSHA 29 CFR 1910.1200(g).
- Supplemental distributor labeling: See distributor label.
- Supplemental label: A label used to add new uses or directions for a product.
- Transport vehicle: A cargo-carrying vehicle such as an automobile, van, tractor, truck, semitrailer, tank car or rail car used for the transportation of cargo by any mode.
Summary of requirements
- Determine whether your product is or is not a pesticide.
- Determine whether your product is exempted from FIFRA.
- Determine whether your pesticide product is exempted from registration.
- If you have an unregistered, non-exempt pesticide product, and you are 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. 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 you 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 your product was previously registered with EPA and you wish to make a change to the registration such as change the labeling text, 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.
- Follow PR Notice 2012-1 when developing SDS for a pesticide product. The PR notice explains how a company can explain and justify a difference between the label and the SDS if it occurs in order to prevent users from being misled by the inconsistencies.
- Review state restrictions or directions to assure that they do not conflict with the requirements of federal EPA.
- Follow the pesticide label when using any pesticide.
