US EPA Pesticides Registration Overview  

Born in the wake of elevated concern about environmental pollution, the United States Environmental Protection Agency (EPA) was established on December 2, 1970 to consolidate in one agency a variety of federal research, monitoring, standard-setting and enforcement activities to ensure environmental protection. Since its inception, EPA has been working for a cleaner, healthier environment for the American people.

Pesticides must be registered with EPA unless they meet the criteria for a minimum risk pesticide. EPA evaluates pesticides to ensure that when they are used according to label directions they will not harm people, non-target species or the environment. Companies are required to submit to EPA for review information about the health effects of pesticides. EPA also funds pesticide research engaging the nation's best scientists and engineers to improve knowledge about how they are exposed to pesticides and their health effects. Once registered, pesticides are periodically reviewed for safety. If new concerns arise, EPA can change the conditions for using them or cancel their registrations.

It is illegal to use a pesticide product inconsistent with its label directions.

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What is a pesticide?

A pesticide is any substance or mixture of substances intended for

  • Preventing, destroying, repelling or mitigating any pest.
  • Use as a plant regulator, defoliant, or desiccant.
  • Use as a nitrogen stabilizer

Federal Pesticide Laws

The US regulates 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.
- Authorizes limited use of unregistered pesticides or pesticides registered for other uses to address emergencies and special local needs.
- suspends or cancels 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 EPA 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, which amended both FIFRA and FFDCA, EPA must find that a pesticide poses a "reasonable certainty of no harm" before it can be registered for use on food or feed. EPA must review each pesticide registration at least once every 15 years.

The Pesticide Registration Improvement Act of 2003 (PRIA) 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, EPA 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.

Office of Pesticide Programs (OPP)

What OPP Do

OPP regulates the manufacture and use of all pesticides (including insecticides, herbicides, rodenticides, disinfectants, sanitizers and more) in the United States and establishes maximum levels for pesticide residues in food, thereby safeguarding the nation's food supply. EPA has expanded public access to information about risk assessment and risk management actions to help increase transparency of decision making and facilitate consultation with the public and affected stakeholders.
In addition to regulatory functions, EPA provides information and coordinates with partners and stakeholders on issues ranging from worker protection to misuse of pesticides. EPA participates in a variety of partnerships related to pesticide use, including the Pesticide Environmental Stewardship Program, a voluntary private and public partnership dedicated to reducing pesticide use and risk, and Integrated Pest Management in Schools.

OPP includes

- Biological and Economic Analysis Division
- Biopesticides and Pollution Prevention
- Health Effects Division
- Field and External Affairs Division
- Antimicrobials Division
- Information Technology and Resources Management Division
- Environmental Fate and Effects Division
- Pesticide Re-evaluation Division
- Registration Division

OPP implements

- The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
- The Pesticide Registration Improvement Extension Act (PRIA 3)
- And key parts of the Food Quality Protection Act (FQPA), Federal Food, Drug, and Cosmetic Act (FFDCA), and Endangered Species Act

Programs and projects managed by the Office of Pesticide Programs

  • Assessing Pesticide Risks
  • Bed Bugs
  • Biotechnology under FIFRA
  • Endangered Species Protection Program
  • Ingredients used in Pesticides
  • Insect Repellents
  • Integrated Pest Management in Schools
  • Mosquito Control
  • Pesticide LabelsPesticide Registration
  • Pesticide Registration Review
  • Pesticide Tolerances
  • Pesticide Environmental Stewardship Program
  • Protecting Pets from Fleas and Ticks
  • Protecting Pollinators
  • Reducing Pesticide Drift
  • Worker Safety Protection

Types of Pesticides

  • Rodenticides
  • Soil fumigants
  • Chemically related pesticide groups
  • Biopesticides
  • Plant-incorporated protectants
  • Antimicrobial pesticides
  • Wood preservative pesticides

Types of Registrations under FIFRA

Federal pesticide law (the Federal Insecticide, Fungicide, and Rodenticide Act) provides for several types of registrations:

  •  Registration: Under Section 3 of FIFRA, EPA can register pesticides for use throughout the United States. We register some pesticides for more limited use in certain states. In addition, states, tribes and territories can place further restrictions on pesticides used or sold within their own jurisdictions.
  • Experimental Use Permits (EUPs): Under Section 5 of FIFRA, EPA can allow manufacturers to field test pesticides under development. Manufacturers of conventional pesticides must obtain experimental use permits before testing new pesticides or new uses of pesticides if they conduct experimental field tests on 10 acres or more of land or one acre or more of water. Biopesticides also require EUPs when used in experimental settings.
  • Emergency Exemptions: Under Section 18 of FIFRA, EPA can allow state and federal agencies to permit the unregistered use of a pesticide in a specific geographic area for a limited time if emergency pest conditions exist. Usually, this arises when agricultural growers and others encounter a pest problem on a site for which there is either no registered pesticide available, or for which there is a registered pesticide that would be effective but is not yet approved for use on that particular site. Also, exemptions can be approved for public health and quarantine reasons.
  • State-Specific Registrations: Under Section 24(c) of FIFRA, states can register a new pesticide product for any use, or a federally registered product for an additional use, as long as there is both a demonstrated "special local need," and a tolerance, exemption from a tolerance, or other clearance under FFDCA. We can disapprove a state's special local need registration.

Pesticide Registration Process

  • The process of registering a pesticide is a scientific, legal, and administrative procedure through which EPA examines:

- 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, EPA assesses 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 EPA’s testing guidelines.

  •  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.

  • 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

  • EPA evaluates 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

  • EPA evaluates environmental risks by reviewing data on:

- Potential for ground water contamination
- Risks to endangered and threatened species
- Potential for endocrine-disruption effects

  • EPA implements risk assessment and peer review:

- EPA reviews 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.

  • EPA makes risk management and regulatory decisions, where they:

- 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

The Pesticide Label

EPA reviews 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.

Compliance and Enforcement

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.
•    EPA's Compliance and Enforcement Process