Pesticides are Thoroughly Reviewed and Tested for Use
Pesticide products used to control insects, weeds and diseases have been thoroughly tested for effects on health and the environment. The U.S. Environmental Protection Agency (EPA) regulates and enforces pesticide testing, registration, labeling and use. State and local governments cooperate in applicator training and certification and may have additional pesticide requirements.
To register a pesticide for public use, the EPA must conclude, based on all of the required studies, that the pesticide may be used as directed without undue risk to people or the environment. All pesticides undergo rigorous testing.
The EPA requires up to 120 tests, many to evaluate environmental and health impacts. The testing, evaluation, EPA registration and label approval takes 8 to 10 years and costs between $150 million and $185 million. Only one in 140,000 potential products makes it from the research lab to the market. In addition, EPA monitors and evaluates pesticides to assure that products already on the market continue to meet scientific and regulatory requirements for health, safety and environmental effects.
The EPA Registration Process
EPA requires that all pest control products available for public use are first subject to thorough testing procedures to ensure that they meet all federal safety standards that protect both human health and the environment.
The process of registering a pest control product is a scientific, legal, and administrative procedure through which EPA examines all ingredients; the particular site or crop on which it is to be used; the amount, frequency, and timing of its use; and the safety of storage and disposal practices. These tests evaluate whether a pesticide has the potential to cause adverse effects on humans, wildlife, fish, and plants, including endangered species and non-target organisms, as well as possible contamination of surface or ground water from leaching, runoff, and spray drift.
Current Federal Laws
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires all pest control products sold or distributed in the United States (including imported pesticides) to be registered by EPA.
Types of Registrations Under FIFRA
Federal Registration Actions: EPA can register products for use throughout the United States. States, Tribes and Territories can place further restrictions on EPA-registered products used or sold within their own jurisdictions.
Experimental Use Permits (EUPs): EPA can allow manufacturers to field test products under development. Manufacturers are required to obtain experimental use permits before testing new products or new uses of those products.
Emergency Exemptions: EPA can allow State and Federal agencies to permit the unregistered use of a pest control product in a specific area for a limited time if emergency pest conditions exist.
State-Specific Registrations: States can register a new 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 clearance under FFDCA. EPA can disapprove of any State's special local need registration.
Active and Inert Ingredients
Active Ingredients: Must be identified by name on the label along with percentage of product composition by weight.
Inert Ingredients: Not required to be identified by name and percentage on the label, but the total percentage of such ingredients must be declared. Note: In September 1997, EPA issued Pesticide Regulation Notice 97-6 which encourages manufacturers, formulators, producers, and registrants of pest control products to substitute the term “other ingredients” for “inert ingredients” on the label of any pest control product.
The Federal Food, Drug and Cosmetic Act (FFDCA) requires EPA to set tolerances, the maximum permissible level for pesticide residues allowed in or on commodities for human food and animal feed, for all pest control products used in or on food.
Food Quality Protection Act - EPA must find that a pest control product poses a "reasonable certainty of no harm" before that product can be registered for use on food or feed.
The Product Label - All label language must be approved by EPA before a product can be sold or distributed in the United States. It is a violation of federal law to use a pest control product in a manner inconsistent with its labeling. Courts consider the label to be a legal document.
The Three-Step Registration Process:
Note: EPA places high priority on registering products safer than those currently on the market, particularly those with public health benefits, and those that are of particular and immediate economic importance to producers.
I. Manufacturer Submits Product Registration Application
Required in Application are:
Required Test Data: product chemistry, human and environmental assessment for food safety, tolerance information, and proof that the manufacturing process is reliable
Labeling Information:occupational data, directions for use, appropriate warnings
Evidence of Meeting All Legal and Financial Obligations
II. EPA Processes Applications and Conducts Evaluation
1. EPA assigns applications to the appropriate internal division to evaluate:
Human health risks
2. Risk Assessment and Peer Review:
EPA compiles all the scientific data to determine the impact that the product will have on the human population and surrounding environment.
The health and environmental risk assessment undergoes a process of peer review by scientific experts.
3. Risk Management and Regulatory Decisions, where EPA:
Considers its risk assessments and the peer review
Reviews risk mitigation measures
Researches alternative pesticides already registered
Coordinates risk management with applicants
III. EPA Makes Decision on Pesticide Registration
Does the proposed pesticide use meet EPA's standards for human health protection?
Does the proposed pesticide use meet EPA's standard for worker protection?
Does the proposed pesticide use meet EPA's standard for protecting the environment?
If the application fails to meet these standards, EPA:
Notes the need for more or better data
Notes any labeling modifications
Notes any use restrictions
Communicates the deficiencies to the applicant
If approved, EPA:
Establishes a tolerance if the pesticide is intended for use on food
Approves the registration, possibly with risk mitigation
Publishes a notice in the Federal Register, the official publication of the Executive Branch