Table Of Contents
- Label Basics
- Parts of the Label
- Special Issues
- Applying the Principles of Pesticide Label Review
- Emerging Issues and Course Completion
Active Ingredient: In the case of a pesticide (other than a plant regulator, defoliant, desiccant, or nitrogen stabilizer), an ingredient that will prevent, destroy, repel, or mitigate any pest.
Acute Toxicity Data Evaluation Records (DERs): A record of what submitted studies show about toxicity and, therefore, potential risks. DERs are provided to label reviewers to help them determine appropriate precautionary language and other directions.
Acute Toxicity Studies: Six studies performed on pesticide products to determine toxicity. These include acute oral, acute dermal, acute inhalation, primary eye irritation, primary skin irritation, and dermal sensitization studies.
Advisory Statement: Statements that are intended to be informational. They provide information to the product user on such topics as product characteristics and how to reduce risk and maximize efficacy while using the product.
Agricultural Plant: Any plant grown or maintained for commercial or research purposes. Includes, but is not limited to, food, feed, and fiber plants; trees; turf grass; flowers and shrubs; ornamentals; and seedlings.
Amendment: A modification to a currently registered pesticide.
Chemigation: The application of pesticides to crops through an irrigation system.
Child Hazard Warning Statement: This specific statement (“Keep Out of Reach of Children”) appears on almost all end-use pesticide products except those pesticides that are intended for use on children or where it is demonstrated that children will not come in contact with the products. Also known as the “keep out of reach of children” or KOROC statement.
Core Principles: The principles that guide the label review process, including clarity, accuracy, consistency with EPA policy, and enforceability.
Defoliant: Any substance or mixture of substances intended for causing the leaves or foliage to drop from a plant.
Desiccant: Any substance or mixture of substances intended for artificially speeding up the drying of plant tissue.
Directions for Use: The section of the label that provides instructions to the user on how to use the product, and identifies the pest(s) to be controlled, the application sites, application rates, and any required application equipment.
Efficacy Data: Data that documents how well pesticide products perform as pest control agents.
Enforcement: Efforts made by OECA, the EPA Regions, states, and tribes to ensure that pesticides sold, distributed, and used in this country comply with FIFRA.
Engineering Controls: Equipment or design features usually intended to protect the user (e.g., an enclosed tractor cab with a filtered air supply).
Environmental Hazards Statement: A precautionary statement that advises of the potential hazards to the environment from transport, use, storage, or spill of a product.
EPA Establishment Number: A number identifying the final physical location where the pesticide product was produced or labeled.
EPA Registration Number: A number indicating which company holds the registration for the pesticide product, and in what sequence the product was submitted to EPA by the company.
Experimental Use Permit (EUP): A permit that authorizes testing of an unregistered pesticide or unregistered use(s) of a registered pesticide.
Extension Services: Organizations that provide educational programs to certify and train restricted-use pesticide users. Extension services also give advice to growers and the general public on a wide variety of agricultural topics, including pest control.
Fast Track: The review process for submission that involves no data or only product chemistry data.
Federal Food, Drug, and Cosmetic Act (FFDCA): Legislation that authorizes EPA to set maximum residue levels, or tolerances, for pesticides used in or on foods or animal feed.
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA): Legislation that provides the basis for regulation, sale, distribution, and use of pesticides in the United States.
First Aid Statement: Information to the pesticide user and physicians concerning appropriate first aid for the various routes of exposure associated with accidental exposure.
Food Quality Protection Act (FQPA): Legislation that amends FIFRA and FFDCA, setting tougher safety standards for new and old pesticides and making uniform requirements regarding processed and unprocessed foods.
Hazards to Humans and Domestic Animals Statement: A precautionary statement that advises of potential hazards to humans and domestic animals.
Ingredient Statement: The part of the label that identifies the name and the percentage by weight of each active ingredient and the percentage by weight of other/inert ingredients.
Label: The written, printed, or graphic matter on, or attached to, a pesticide product or any of its packaging.
Label Claim: A statement of something as a fact or an assertion on the label open to challenge.
Label Committee: A committee made up of representatives from OPP's registering divisions, the Office of General Counsel, and the Pesticide Re-Evaluation Division that addresses labeling issues.
Labeling: All labels and all other written, printed, or graphic matter accompanying a pesticide product, or to which the label or accompanying literature refers.
Label Review: The process of ensuring that a label is clear, accurate, consistent with EPA policies, and enforceable by the states or EPA 's Office of Enforcement and Compliance Assurance (OECA).
Label Review Manual: A comprehensive informational document for EPA employees and product management team members responsible for performing label reviews.
Mandatory Statement: Statements that are intended to be enforceable. They generally relate to the actions that are necessary to ensure the proper use of the pesticide and to prevent the occurrence of unreasonable adverse effects on the environment.
Manufacturing–Use Product: A product that is used to manufacture or formulate other pesticides.
Master Label: A label that contains claims and directions for all of the approved uses for a given product.
Me–Too Registration: Registration of a pesticide product and proposed use that is identical or substantially similar to a currently registered pesticide or differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.
National Organic Program (NOP): A marketing program of the U.S. Department of Agriculture that develops, implements, and administers national production, handling, and labeling standards for organic agricultural products.
National Organic Program (NOP) Rule: Regulations that will ensure that organically labeled products meet consistent national standards.
Net Contents/Net Weight: The weight or volume of pesticide in a container, not including the wrapper or other packaging materials.
Non–Notification: The process of modifying a registered product in such a way that does not require EPA approval or notification.
Notification: The process of notifying EPA about product modifications that do not require EPA approval. This process involves an Application for Registration form marked “Notification,” a copy of the labeling with changes highlighted, and a Certified Statement of the Notification, submitted to the Document Processing Desk.
Office of Pesticide Programs (OPP): The EPA office responsible for protecting public health and the environment from the risks posed by pesticides and promoting risk-reducing means of pest control.
Other Ingredient: Any substance (or group of structurally similar substances if designated by the Agency) other than an active ingredient that is intentionally included in a pesticide product (except as provided by 40 CFR 174.3, as it relates to plant-incorporated protectants).
Personal protective equipment (PPE): Protective clothing or other equipment used to protect a pesticide user's body.
Pesticide: Generally, products intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant.
Pesticide Registration: The process through which EPA examines the ingredients of a pesticide; the site or crop on which it is to be used; the amount, frequency, and timing of its use; health and environmental data; and storage and disposal practices.
Pesticide Registration Improvement Act (PRIA): Legislation that establishes pesticide registration service fees for registration actions.
Physical and Chemical Hazards Statement: A precautionary statement that addresses flammability, explosive potential, and precautions.
Plant Regulator: Any substance or mixture of substances intended to speed or slow a plant's rate of growth (but not including plant fertilizers or nutrients), or to otherwise alter a plant's behavior. Plant regulators are also called “plant growth regulators” and usually have a hormonal mode of action.
Precautionary Statements: Statements designed to provide the pesticide user with information regarding the toxicity, irritation, and sensitization hazards associated with the use of a pesticide, as well as treatment instructions and information to reduce exposure potential.
Pre–Harvest Interval: The minimum number of days a grower must wait before harvesting a treated crop.
Registrants: People or companies who have registered any pesticide in compliance with FIFRA.
Registration Review: EPA's program for systematically reviewing all registered pesticides every 15 years to make sure that every pesticide can still perform its intended function without unreasonable adverse effects on human health or the environment.
Registration Review Decision: EPA will make either an interim or final registration review decision after posting a proposed decision for public comment. The decision will include EPA's findings regarding the FIFRA standard and, if necessary, additional data requirements and risk mitigation measures.
Registration Standards: A detailed review for purposes of reregistration of older chemicals. Reregistration eligibility decision documents (REDs) replaced registration standards after 1988.
Regulators: The parties (namely EPA and the states) responsible for regulating pesticides by registering or licensing pesticides for use in the United States.
Reregistration: EPA's review of older pesticides (those initially registered prior to November 1984) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to ensure that they meet current scientific and regulatory standards. Reregistration, which began in 1988, is now complete.
Reregistration Eligibility Decision (RED) Document: A summary of the results of EPA's reregistration review of a product registered prior to 1984.
Restricted Entry Interval: The period of time after an area is treated with a pesticide during which entry into that area is restricted in order to protect workers and other people from potential exposure to hazardous levels of pesticide residues.
Restricted Use Pesticides: Pesticides that may only be sold to and applied by or under the direct supervision of trained and certified applicators.
Restricted Use Pesticide (RUP) Statement: The statement required on pesticides whose toxicity exceeds certain hazard criteria.
Signal Word: A word (“Caution,” “Warning,” or “Danger”) that indicates the most severe toxicity category assigned to the five acute toxicity studies, or the presence of methanol in concentrations of 4 percent or more.
Skull and Crossbones Symbol: The symbols used to identify pesticide products that are determined to be in Toxicity Category I. Must be accompanied by the word “Poison.”
Special Local Need (SLN): A particular state's need to register additional uses for a federally registered pesticide. For example, a certain crop grown within a state may be attacked by a new pest not on a current label, thereby creating a special pest problem.
Spray Drift: The physical movement of a pesticide through air at the time of application or soon thereafter to any site other than that intended for application.
State Lead Agencies (SLAs): State agencies that sign a cooperative agreement with EPA to enforce FIFRA. SLAs are usually state departments of agriculture.
Storage and Disposal Instructions: Instructions for storing the pesticide product and for disposing of any unused pesticide and the pesticide container.
Sub–Label/Split–Label: A label that contains claims and directions for only a portion of the approved uses under a given master label.
Supplemental Distributor Labeling: Labels for a product that is registered to one company, but distributed by another company.
Supplemental Labeling: Labels that contain newly approved uses, use directions, or other instructions that have been added since the last accepted master label.
Users: People who apply pesticides.
Warranty Statement: A disclaimer statement included voluntarily in most pesticide products by the registrant.
Worker Protection Standard (WPS): Regulations that establish standards and labeling requirements for the protection of occupational users of pesticides, including agricultural workers and handlers.