About Pesticide Registration
The process of registering a pesticide is a scientific, legal, and administrative procedure through which we examine
- the ingredients of the pesticide;
- the particular site or crop where it is to be used;
- the amount, frequency, and timing of its use; and
- storage and disposal practices.
In evaluating a pesticide registration application, we assess a wide variety of potential human health and environmental effects associated with use of the product. The company that wants to produce the pesticide must provide data from studies that comply with our testing guidelines.
We develop risk assessments that evaluate the potential for
- Harm to humans, wildlife, fish, and plants, including endangered species and non-target organisms.
- Contamination of surface water or ground water from leaching, runoff, and spray drift.
Potential human risks range from short-term toxicity to long-term effects such as cancer and reproductive system disorders.
We also evaluate and approve the language that appears on each pesticide label to ensure the directions for use and safety measures are appropriate to any potential risk. Following label directions is required by law and is necessary to ensure safe use.
Companies submit an application for a registration action, such as to register a new pesticide active ingredient, new product for an existing pesticide, or adding a new use to an existing product.
The company's application typically includes:
- Service fee(s) required by the Pesticide Registration Improvement Act (PRIA).
- Forms describing the requested action.
- The identity and quantity of all chemicals in the product.
- Data on potential risks to human health and the environment, including about the potential for pesticide residues on food (if applicable).
- Proof that the product manufacturing process is reliable.
- Labeling, including directions for use, contents, and appropriate warnings.
- Evidence of meeting all legal and financial obligations.
We publish a notice of receipt in the Federal Register for each application for registration of a new product that contains a new pesticide active ingredient or that proposes a new use for an existing pesticide.
Applications are assigned to the appropriate pesticide division, where it is processed and tracked. A project manager is then assigned to:
- Complete a detailed review of the application
- Assign and coordinate the appropriate scientific review
- Implement priorities and timetable as set by PRIA
- Coordinate administrative action
- Communicate with applicant, otherwise known as the registrant, about the review
The Evaluation Process
- We evaluate human health risks (including sensitive groups such as children and immune-suppressed individuals), by reviewing data on:
- Aggregate risks–through food, water, and residential uses
- Cumulative risks–from different pesticides with the same effects
- Occupational risks to those applying the product during their work
- We evaluate environmental risks by reviewing data on:
- Potential for ground water contamination
- Risks to endangered and threatened species
- Potential for endocrine-disruption effects
- We implement risk assessment and peer review:
- We review all the scientific data on the pesticide product and develop comprehensive risk assessments that examine the potential effects of the product or ingredient on the human population and environment.
- The health and environmental risk assessments undergo a process of peer review by scientific experts.
- We make risk management and regulatory decisions, where we:
- Consider the results of the risk assessments and the peer review
- Research alternative pesticides that are already registered
- Review any measures needed to mitigate any identified risks
- Discuss with the applicant if modifications to the product or labeling must be made to mitigate risk
- Establish new food tolerances if needed, after publishing notices for comment in the Federal Register
- Grant the registration if no changes are needed, or if necessary modifications are accepted by the applicant
- Publish in the Federal Register a notice of issuance of the registration
We regulate pesticides under broad authority granted in two major statutes, the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act. These laws have been amended by the Food Quality Protection Act and the Pesticide Registration Improvement Act.
- Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) - Requires all pesticides sold or distributed in the United States (including imported pesticides) to be registered by EPA.
- Registration is based on evaluation of scientific data and assessment of risks and benefits of a product's use.
- Label directions control how products are used.
- We can authorize limited use of unregistered pesticides or pesticides registered for other uses to address emergencies and special local needs.
- We can suspend or cancel a product's registration.
- Training is required for workers in pesticide-treated areas and certification and training for applicators of restricted use pesticides.
- Federal Food, Drug and Cosmetic Act (FFDCA) - Requires us to set pesticide tolerances for all pesticides used in or on food or in a manner that will result in a residue in or on food or animal feed. A tolerance is the maximum permissible level for pesticide residues allowed in or on human food and animal feed.
- Includes strong provisions for protecting infants and children, as well as other sensitive subpopulations.
- Provides for exemption from the requirement for a tolerance.
- Under the Food Quality Protection Act, of 1996 (FQPA), which amended both FIFRA and FFDCA, we must find that a pesticide poses a "reasonable certainty of no harm" before it can be registered for use on food or feed. We must review each pesticide registration at least once every 15 years.
- Several factors must be addressed before a tolerance can be established, including:
- the aggregate, non-occupational exposure from the pesticide (exposure through diet and drinking water and from using pesticides in and around the home);
- the cumulative effects from exposure to pesticides that have a common mechanism of toxicity, that is, two or more pesticide chemicals or other substances that cause a common toxic effect(s) by the same, or essentially the same, sequence of major biochemical events (i.e., interpreted as mode of action);
- whether there is increased susceptibility to infants and children, or other sensitive subpopulations, from exposure to the pesticide; and
- whether the pesticide produces an effect in humans similar to an effect produced by a naturally-occurring estrogen or produces other endocrine-disruption effects.
- Several factors must be addressed before a tolerance can be established, including:
- The Pesticide Registration Improvement Act of 2003 (PRIA) (455 pp, 1.23 MB, About PDF) also amended FIFRA and FFDCA. PRIA was reauthorized by the Pesticide Registration Improvement Renewal Act of 2007 and the Pesticide Registration Improvement Extension Act of 2012. Under PRIA:
- Companies must pay service fees according to the category of the registration action.
- EPA must meet decision review time periods, which result in a more predictable evaluation process for companies.
- Shorter decision review periods are provided for reduced-risk registration applications.
- The Endangered Species Act (ESA) requires federal agencies to ensure that any action they authorize, fund, or carry out, will not likely jeopardize the continued existence of any listed species, or destroy or adversely modify any critical habitat for those species. EPA is responsible for reviewing information and data to determine whether a pesticide product may be registered for a particular use. As part of that determination, we assess whether listed endangered or threatened species or their designated critical habitat may be affected by use of the product. All pesticide products that EPA determines “may affect” a listed species or its designated critical habitat may be subject to EPA's Endangered Species Protection Program.
Regulations implementing the pesticide statues are available at 40 CFR Part 150-189.
We review pesticide product labels as part of the licensing/registration process and must approve all label language before a pesticide can be sold or distributed in the United States. The overall intent of the label is to provide clear directions for effective product performance while minimizing risks to human health and the environment. It is a violation of federal law to use a pesticide in a manner inconsistent with its labeling. The courts consider a label to be a legal document. In addition, following labeling instructions carefully and precisely is necessary to ensure safe and effective use.
- Guidance on developing product labels
- Search for registered pesticide labels.
Anyone applying pesticides must comply with federal and state laws. In general, states have primary authority for compliance monitoring and enforcing against illegal pesticide use. Often, a state's department of agriculture has this responsibility, but it can be a state's environmental or other agency.