In the United States, the Environmental Protection Agency (EPA) is mainly responsible for regulating pesticides. In the United States, pesticides were not regulated for safety until the 1950s. The Pesticides Control Amendment (PCA) in 1954 was the first time Congress provided rules about setting safe limits for pesticide residues on food. This law allowed the Food and Drug Administration (FDA) to ban pesticides they found unsafe if they were sprayed directly on food. The Food Additives Amendment, which included the Delaney Clause, prevented any pesticide residues from carcinogenic pesticides in processed food. In 1959, pesticides were required to be registered.
In 1970, President Richard Nixon created the EPA and moved control of pesticide regulation from the US Department of Agriculture (USDA), the US Department of the Interior (DOI), and the FDA to the new agency. By this time, more people were aware of possible effects on human health and the environment. Some members of Congress also began to worry about whether pesticide rules were enough. In 1972, the Federal Environmental Pesticides Control Act (FEPCA) required companies that make new pesticides to perform tests to prove the pesticide would not cause "unreasonable adverse effects" on human health or the environment.
Today, the EPA must consider the "ingredients of the pesticide; the specific site or crop where it will be used; the amount, frequency, and timing of its use; and storage and disposal practices." The EPA evaluates potential human health and environmental effects from using the pesticide. A company that wants to register a pesticide must provide data from tests done following EPA guidelines. These tests include: acute toxicity test (short-term toxicity test) and chronic toxicity test (long-term toxicity test). These tests check whether the pesticide could cause harmful effects, such as cancer or reproductive system problems, in humans, wildlife, fish, plants, endangered species, and non-target organisms. They also examine possible contamination of surface water or groundwater from leaching, runoff, or spray drift. The registration process can take 6 to 9 years, and the cost of registering a single pesticide can be in the range of millions of dollars.
Background
In most countries, pesticides must be approved by a government agency before they can be sold or used. In the United States, the Environmental Protection Agency (EPA) is responsible for regulating pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Food Quality Protection Act (FQPA). Tests are done to determine the conditions under which the pesticide is safe to use and how well it works against the target pests. The EPA ensures that pesticides do not cause harm to people or the environment. Pesticides made before November 1984 are reviewed again to meet current scientific and regulatory standards. All registered pesticides are checked every 15 years to confirm they meet proper standards. During the registration process, a label is created. This label includes instructions for correct use and safety rules. Based on how harmful a pesticide is, it is assigned to a Toxicity Class.
Some pesticides are too dangerous for the general public to buy and are called restricted use pesticides. Only trained applicators, who have passed an exam, can buy or oversee the use of these pesticides. Records of sales and use must be kept and may be checked by government agencies that enforce pesticide rules. These records must be shared with workers and state or territorial environmental agencies.
The EPA regulates pesticides under two main laws, both of which were changed by the Food Quality Protection Act of 1996. In addition to the EPA, the USDA and FDA set limits for how much pesticide residue is allowed on or in food crops. The EPA evaluates the possible effects on human health and the environment from using a pesticide.
The EPA uses a four-step process from the National Research Council for human health risk assessment: (1) Hazard Identification, (2) Dose-Response Assessment, (3) Exposure Assessment, and (4) Risk Characterization.
History
Congress passed the first law regulating pesticides, the Federal Insecticide Act, in 1910. This law aimed to protect farmers from false claims about pesticide products.
In 1947, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was created through cooperation between the federal government and the chemical industry. This law came about because pesticide production increased during and after World War II. At that time, concerns about pesticides focused on whether they worked well and whether companies told the truth. FIFRA was a "truth in labeling" law, meaning it required pesticide labels to be accurate. The law allowed new pesticides to enter the market quickly while keeping standards for their use. This law formed an "iron triangle" involving the House Committee on Agriculture, the USDA, and the pesticide industry. The law required pesticide formulas to be registered with the USDA and labels to be correct. It did not create a strong regulatory system but aimed to help the pesticide market remain stable. At the time, the public was not very concerned about pesticides, and agricultural interests in Congress limited major changes to the law.
Between 1950 and 1951, hearings led by Congressman James Delaney of New York were the first government investigations into pesticide safety. These hearings led to two changes in the Federal Food, Drug, and Cosmetic Act: the Pesticides Control Amendment (PCA) and the Food Additives Amendment (FAA). These changes brought the FDA into pesticide regulation. The PCA, passed in 1954, was the first time Congress set safety limits for pesticide residues on food. It allowed the FDA to ban pesticides used directly on food if they were unsafe. The Food Additives Amendment included the "Delaney Clause," which banned any pesticide residues that could cause cancer in processed food. In 1959, FIFRA was updated to require pesticide registration.
In 1962, The New Yorker published a series of essays by Rachel Carson, later made into a book called Silent Spring. These writings highlighted the harm pesticides caused to wildlife. This, along with new evidence about pesticide dangers to human health, helped start the modern environmental movement. Government agencies, including the Public Health Service, the Fish and Wildlife Service, and the President's Science Advisory Committee, found that pesticides harmed human health. In the 1960s, proposals to change FIFRA included moving oversight to the FDA, increasing public access to pesticide data, and improving cooperation between agencies. None of these proposals passed Congress. However, in 1964, Congress passed an amendment allowing the USDA to suspend or cancel a pesticide’s registration to prevent immediate health risks.
In 1970, President Richard Nixon created the EPA, shifting pesticide regulation from the USDA, FDA, and DOI to the new agency. By this time, public awareness of pesticide dangers to health and the environment had grown. Some members of Congress also worried about the adequacy of pesticide rules. This growing concern led to changes in pesticide regulation. In 1972, FIFRA was updated by the Federal Environmental Pesticides Control Act (FEPCA). FEPCA required pesticide manufacturers to test new products to prove they did not cause "unreasonable adverse effects" on health or the environment. Existing pesticides had to be re-registered using these new rules. The EPA gained the power to refuse registration for any pesticide it found too risky. Public access to pesticide registration data was also required. Pesticides registered before 1972 could only be banned after a special review board decided they were hazardous. If this happened, the FEPCA indemnity clause required the EPA to pay for unused pesticide stock. FEPCA also required the EPA to review old pesticide data, but no funds were provided for this task.
The re-registration process faced challenges in the 1970s. FEPCA required re-registration to be completed by 1976, but the EPA did not start until 1975. Investigations later found the EPA was not properly checking data and that many studies from the Industrial Bio-Test Laboratories (IBT) were fake. Only about 10% of IBT’s 2,000 studies were valid. After these issues, the EPA paused re-registration in 1976 and did not restart it until 1978.
After President Ronald Reagan was elected in 1980, industry groups tried to change FIFRA. They wanted less public access to data, longer exclusive use periods for pesticides, and the right to sue over use of their data. Environmental and labor groups opposed these changes. Short-term reauthorizations of FIFRA passed until the late 1980s, but no major changes occurred.
In 1986, the Campaign for Pesticide Reform (CPR) and the National Agricultural Chemicals Association (NACA) proposed FIFRA amendments. CPR included environmental, consumer, and labor groups. They worked together because they were all unhappy with FIFRA. Pesticide manufacturers wanted faster approval for new products, while environmental groups wanted changes to the indemnity clause, which made the EPA hesitant to ban pesticides. The proposed bill required the EPA to find data gaps and required manufacturers to fix them. It also protected public access to data. However, the CPR-NACA group did not include farm groups, which hurt the proposal’s chances.
In 1988, Congress passed an FIFRA amendment, signed by President Reagan. It required the registration of about 600 pesticide ingredients within nine years and required
Federal Insecticide, Fungicide, and Rodenticide Act
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires that all pesticides (from the United States or other countries) sold or used in the United States must be registered.
There are four types of pesticide registrations allowed under FIFRA:
- Federal Registration Actions: The Environmental Protection Agency (EPA) can approve pesticides for sale in the United States under Section 3 of FIFRA.
- Experimental Use Permits (EUPs): The EPA allows pesticide manufacturers to test new products in the environment under Section 5 of FIFRA.
- Emergency Exemptions: The EPA permits state and federal agencies to use an unregistered pesticide if there is an emergency pest problem in a specific area, as allowed under Section 18 of FIFRA.
- State-Specific Registration: States can register a new pesticide for general use, or a federally registered pesticide for an additional use, if there is a demonstrated "special local need" and approval through the Federal Food, Drug, and Cosmetic Act (FFDCA) under Section 24(c) of FIFRA.
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires the EPA to set limits, called tolerance levels, on the amount of pesticide that can be in or on food. A tolerance level is the highest allowed amount of pesticide residues in or on food that people eat and animal feed.
Food Quality Protection Act of 1996
The EPA must determine that a pesticide has a very low chance of causing harm before it can be approved for use on food or animal feed.
Before setting a safe level of pesticide exposure, the EPA considers several factors:
– Total exposure from non-work-related sources, such as food, drinking water, and pesticide use at home;
– Combined effects of exposure to multiple pesticides that have similar impacts on the body;
– Whether infants, children, or other sensitive groups are more likely to be harmed by the pesticide; and
– Whether the pesticide affects the body in a way similar to natural estrogen or disrupts the body’s hormone systems.
The law gives special attention to how pesticides might affect infants and children. It also requires that all pesticides be reviewed again every 15 years.
Before a pesticide can be sold or used in the United States, it must go through a registration process with the EPA. During this process, the EPA examines:
– The ingredients of the pesticide;
– The specific crop or location where it will be used;
– How much, how often, and when the pesticide will be applied; and
– How it will be stored and disposed of.
The EPA evaluates possible risks to human health and the environment from using the pesticide. The company wanting to register the pesticide must provide test results following EPA guidelines. These tests include:
– Acute toxicity tests (short-term tests) and chronic toxicity tests (long-term tests).
These tests check if the pesticide could cause harm, such as cancer or reproductive issues, to humans, animals, plants, or endangered species. They also look for possible contamination of water sources from pesticide runoff or drift. The registration process can take 6 to 9 years and costs millions of dollars for a single pesticide.
The EPA requires companies to report any problems with registered pesticides. If issues arise, the EPA quickly removes the product from stores. Problems may include faulty products, poor quality, or risks to users.
The Pesticide Registration Fund helps pay for studies and practices related to new pesticide ingredients. To register new pesticides, there are about 140 categories divided into three groups: new ingredients, product use updates, and reassessments of existing pesticides. Costs for registration are:
– $630,000 for new ingredients,
– $20,000 for product use updates, and
– At least $75,000 for reassessments.
Pesticides can only be used legally as directed on the label, which must be approved by the EPA before sale. The label provides clear instructions to ensure the pesticide works effectively while protecting human health and the environment. A label is a legal document that outlines how the pesticide must be used. Not following the label is a federal violation.
States can create their own pesticide rules as long as they are at least as strict as federal rules. States gain this authority through FIFRA and their own laws. They can also register pesticides that are not covered by federal rules. If a special local need exists, states can add new uses for a pesticide under FIFRA section 24(c).
State pesticide regulation began in 1975. The EPA tested a program with six states to handle FIFRA enforcement. In 1978, FIFRA was changed to allow states to take primary enforcement responsibility if they met three conditions:
1. Their rules are as strict as federal rules;
2. They have procedures for enforcement;
3. They keep detailed records of enforcement actions.
If the EPA finds a state is not fulfilling its responsibilities, it reports the issue to the state. The state has 90 days to respond. If no action is taken, the EPA may revoke the state’s enforcement authority. Enforcement duties include checking that pesticide users follow label rules, investigating complaints, and inspecting users, sellers, and producers. State agencies also train and certify pesticide applicators.
Today, all states have enforcement responsibility, and most have certification authority. The main agency for pesticide regulation varies by state but is often the state agriculture department. The EPA provides funding for state programs, and many states add money through user fees like registration charges.
The EPA and state agencies agree on the number of annual inspections required. These include:
– Follow-up inspections after complaints about pesticide use (e.g., drift, label violations, or health concerns);
– Inspections of commercial or private pesticide users to ensure label rules are followed;
– Inspections of pesticide sellers to ensure only registered products are sold and records are kept; and
– Inspections of pesticide producers to ensure only approved ingredients are made and records are maintained.
Most states require commercial applicators to pass a written exam for certification. Private applicators, like farmers, usually do not need to take exams.
States can register new pesticide uses or additional uses for federally approved products if they meet FIFRA section 24(c) requirements:
– If there is a special local need;
– If the use involves food or feed, it must have proper federal tolerances or exemptions;
– If the use has not been suspended or canceled due to health or environmental concerns; and
– If the use aligns with FIFRA goals.
FIFRA allows states to issue experimental use permits (EUPs), special local needs registrations (SLNs), and apply for emergency exemptions. EUPs are usually for research to support SLN applications or for testing. Section 5 of FIFRA lets state agencies grant EUPs under their EPA-approved plans.
States can permit new uses of federally registered pesticides under FIFRA section 24(c) if the conditions are met.
2022 pesticide regulation
On April 14, 2022, the Environmental Protection Agency (EPA) released a policy about pesticide effectiveness. This policy became official on June 14, 2022. It requires strong evidence showing that a pesticide works well against specific invertebrate pests. These pests include those that harm human health, damage wood structures, and are invasive species. Ticks and mosquitoes are examples of pests that harm health because they can spread diseases like Dengue Fever, Malaria, and Lyme disease. Invasive species, such as the Asian Longhorn Beetle, are a problem because they harm plants that support ecosystems. Ecosystem services are benefits from nature, such as clean air, food, and climate control, that help humans. The policy’s main goals are to keep a clear record of which pesticides work and to set clear rules for pesticide makers, farmers, and researchers.
The EPA wants to collect data on pesticide use because pesticides can harm unintended targets, like important insects in the environment. Even if a pesticide controls pests in farms, it might harm insects that help ecosystems. Some pesticides can also reduce pollinator numbers, such as bees. Other animals, like fish, may be harmed directly or indirectly if pesticides enter water. When pesticides get into fish, they can cause serious diseases that affect the food chain in water systems. Data from the 87 Fed. Reg. 22464 policy can help evaluate whether pesticides work on target pests and identify possible harm to ecosystems.
Health and safety
Properly using pesticides and sharing information about them can prevent legal problems, just like how not using them correctly can lead to serious harm.
In many places, doctors are required by law to report injuries caused by physical harm or abuse. These reports must include:
1. The name and location of the injured person, if known.
2. How serious the injuries are.
3. The name of the person the injured person says caused the harm.
Employers must train workers about pesticides before they are exposed to avoid legal problems. This is important because failing to follow safety rules can lead to legal issues even if the worker is also covered by workers’ compensation.
In US law, non-criminal battery is harmful or offensive contact that does not involve intent to harm. This is called tortuous battery and is treated like an accident, which is handled through workers’ compensation. This applies even if the injury happens later.
Criminal battery is defined as:
1. Unlawful use of force,
2. Against another person,
3. Causing bodily harm.
For example, if an employer does not follow pesticide safety laws (unlawful force) and then violates product labels in the workplace (to the person), causing permanent injury (bodily harm), this is a crime.
Pesticide-related injuries are considered accidents, not crimes, if the following conditions are met:
– The state or local environmental agency is informed,
– Workers are trained and informed about pesticide use,
– Product labels are followed.
These rules also apply to people in rental homes, schools, public buildings, and customers exposed to pesticides.
The Occupational Safety and Health Administration (OSHA) provides information about workers’ rights.
The Hazard Communication Standard (HCS) was first created in 1983 and expanded in 1987 to cover more workplaces. It requires employers and chemical makers to share information about chemical dangers with workers, including training. The HCS is managed by OSHA nationally or by states with approved plans. The standard is listed in 29 C.F.R. 1910.1200.
The US Department of Defense handles environmental dangers in a way that may differ from public laws.
Employers must train workers in a language they understand. Training must happen when workers start a job and when new hazards are introduced. This helps workers understand risks and know how to protect themselves.
During OSHA inspections, inspectors check training records and ask workers about chemical hazards to ensure they understand the risks.
The US Department of Transportation (DOT) regulates the transport of dangerous goods using Title 49 of the Code of Federal Regulations.
Chemical makers and importers must share hazard information through product labels and Material Safety Data Sheets (MSDSs). Employers must provide this information to workers using MSDSs, labeled containers, training, and a written safety plan. Employers must also keep a list of all hazardous chemicals used and ensure MSDSs are up-to-date and accessible.
Hazardous chemicals include those that cause health risks or physical dangers, such as fire or explosions. Sources of information about hazardous chemicals include:
– OSHA standards and air contaminant regulations,
– Substances listed as cancer-causing by the National Toxicology Program or the International Agency for Research on Cancer,
– Threshold Limit Values from the American Conference of Governmental Industrial Hygienists,
– Restricted Use Products (RUP) reports from the Environmental Protection Agency.
Other information comes from state and federal laws, such as the Community Right to Know Act.
In California, the Air Resources Board handles public hazard disclosures. Pest control supervisors report pesticide use to the County Agricultural Commission. Health care professionals can use the California Pesticide Information Portal to find information about environmental illnesses.
In Oregon, the Office of the State Fire Marshal collects information about hazardous substances under the Oregon Community Right to Know Act and the Superfund Amendments and Reauthorization Act (SARA) Title III. Companies must report:
– Amounts and types of hazardous substances stored,
– Annual releases of toxic chemicals,
– Emergency reports for accidental chemical releases.
This information is available as annual reports from the Fire Marshal’s Office and is usually free unless large amounts of data are requested.
The Environmental Protection Agency (EPA) registers pesticides and insecticides as either unclassified or restricted use (RUP). Unclassified pesticides are sold without a prescription. This process works with the USDA and state agencies.
All registered pesticides and insecticides must have:
– A product label,
– A Material Safety Data Sheet (MSDS).
The product label explains how to use the pesticide. The MSDS provides safety and hazard details and must be given to doctors if the pesticide is misused so they can treat the person quickly.
Restricted Use Pesticides (RUP) require a license to buy. Licensing rules are set by state laws, federal laws, common law, and company policies.
All RUP applications must be recorded to show the date, location, and type of pesticide used. Federal law requires keeping these records for at least 24 months, or longer if state laws require it.