Pesticide Product Laws: Understanding The Applicable Regulations

The regulation of pesticides is a complex and evolving area of law, with a variety of statutes and acts governing their use, sale, and distribution. The primary federal statutes that give the EPA the authority to regulate pesticides in the US are the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). FIFRA defines a pesticide as any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. Under FIFRA, the EPA is authorised to regulate the sale, use, and distribution of pesticides, requiring them to be registered and evaluated for potential human health and environmental effects. The FFDCA, meanwhile, gives the EPA authority to set limits on the amount of pesticide residue allowed on food or animal feed, known as tolerances. These two statutes form the backbone of pesticide regulation in the US, with additional laws and amendments addressing specific aspects of pesticide use and protection for vulnerable species and populations.

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is the primary federal statute that governs the registration, distribution, sale, and use of pesticides in the United States. FIFRA requires all pesticides sold or distributed in the country, including imported pesticides, to be registered and licensed by the Environmental Protection Agency (EPA). This law was first passed in 1947 and has since undergone several amendments to strengthen its enforcement and broaden its scope.

Before the EPA can register a pesticide under FIFRA, the applicant must demonstrate that using the pesticide according to its specifications will not generally cause "unreasonable adverse effects on the environment." This includes any unreasonable risks to humans or the environment, taking into account the economic, social, and environmental costs and benefits of using the pesticide. FIFRA also considers dietary risks from residues that may result from using the pesticide on food.

FIFRA defines a pesticide as any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or for use as a plant regulator, defoliant, desiccant, or nitrogen stabilizer. The Act includes several key provisions to regulate the use of pesticides:

• Labeling requirements: All registered pesticide products must have clear and prominent labels displaying information such as the product name, producer's address, product registration number, ingredient statement, and warning statements. Labels must also include adequate use directions, such as instructions for wearing protective clothing and handling procedures.
• Child-resistant packaging: FIFRA mandates child-resistant packaging for most residential-use pesticides with a signal word of "danger" or "warning." This packaging is designed to prevent children under five years old from accessing the pesticide.
• Worker Protection Standards: Facilities handling pesticides must adopt practices to reduce or eliminate worker exposure and establish procedures for responding to exposure-related emergencies. FIFRA prohibits the registration of pesticides that pose unreasonable risks to people, including agricultural workers.
• Restricted use pesticides: The EPA may classify certain pesticides as "restricted use," meaning only certified applicators or those under their supervision can use them. Certification is a statement of competence and authorisation to use or supervise the use of restricted pesticides.
• Record-keeping: FIFRA requires the maintenance of records for applications of restricted-use pesticides, except when applied by a certified private contractor.
• Training and certification: FIFRA mandates training for workers in pesticide-treated areas and certification for applicators of restricted-use pesticides.
• Recall of suspended pesticides: Amendments to FIFRA in 1988 require the recall of pesticides if their registration is suspended or if the EPA deems it necessary to protect health or the environment.
• Authority of States: While FIFRA is a federal law, it grants states the authority to regulate the sale or use of registered pesticides within their borders. However, state regulations must not permit any sale or use prohibited by FIFRA, and they cannot impose additional or different labelling or packaging requirements.

Federal Food, Drug, and Cosmetic Act (FFDCA)

The Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938 is a set of laws that authorise the Food and Drug Administration (FDA) to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics. The FFDCA is enforced by the FDA, a regulatory agency within the US Department of Health and Human Services.

The FFDCA was introduced to protect the general public from adulterated and misbranded products manufactured and sold in the US. The Act was largely influenced by a mass poisoning event in which an untested antibiotic containing the toxin diethylene glycol led to over 100 deaths across 15 states.

The FFDCA authorises the FDA to:

• Mandate drug manufacturers to submit evidence of new drugs' safety and effectiveness before marketing and distribution to the general public.
• Issue and enforce quality standards for food, drugs, medical devices, and cosmetics.
• Inspect facilities where food, drugs, medical devices, cosmetics, and tobacco products are manufactured, processed, packaged, and stored.
• Recall and/or seize products it deems unsafe or not FFDCA-compliant.
• Regulate advertising of prescription drugs and medical devices.
• Issue regulations for product labelling and claims, including nutrition information found on food packaging and health claims for foods and dietary supplements.
• Approve new drugs, medical devices, and food and colour additives.

The FFDCA has been amended several times to meet the ever-changing needs of the general public. Notable amendments include the Durham-Humphrey Amendment (1951), which established the over-the-counter and prescription medication categories; the Kefauver-Harris Amendment (1962), which required drug manufacturers to provide evidence of drug efficacy in addition to safety; and the Medical Device Amendments (1976), which classified medical devices into three risk-based categories.

The FFDCA continues to shape the FDA's mission to protect public health by ensuring the security, safety, and efficacy of food, drugs, medical devices, and cosmetics.

Food Quality Protection Act of 1996 (FQPA)

The Food Quality Protection Act (FQPA) of 1996 was passed unanimously by the US Congress and signed into law by President Clinton on August 3, 1996. The FQPA made significant amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), fundamentally changing the Environmental Protection Agency's (EPA) regulation of pesticides.

The FQPA introduced a new safety standard for pesticides, requiring the EPA to ensure that there is a "reasonable certainty of no harm" to infants and children from exposure to pesticide chemical residues. This included an additional tenfold margin of safety for pesticide risk assessments, to account for pre- and postnatal toxicity and any data gaps regarding exposure and toxicity, unless reliable data supported a different margin of safety. The FQPA also required the EPA to reassess all existing pesticide tolerances within a 10-year period, considering the special susceptibility of children and aggregate and cumulative risks from exposure to multiple pesticides.

The FQPA gave the EPA authority to immediately suspend a pesticide registration, with a notice of intent to cancel to be issued within 90 days. It also enhanced incentives for the development and maintenance of minor-use registrations and required the establishment of time-limited tolerances for pesticides registered under Section 18 of FIFRA.

The FQPA required the EPA to expedite the approval of reduced-risk pesticides and to give special consideration to minor uses of pesticides. It also mandated the EPA to provide a list of pests of significant public health importance, expedite the review of applications to register antimicrobial pesticides, and screen pesticides for potential disruption to the endocrine system.

The FQPA introduced a periodic review cycle for pesticide registrations, ensuring that changing scientific and pesticide practices are taken into account and that registered pesticides continue to meet safety standards.

Pesticide Registration Improvement Act (PRIA)

The Pesticide Registration Improvement Act (PRIA) is a US law that establishes a system for registering pesticides with the Environmental Protection Agency (EPA). The law was first passed in 2004 as part of the Consolidated Appropriations Act and has been reauthorized and amended several times since, with the most recent version, PRIA 5, enacted on December 29, 2022.

PRIA sets out a registration service fee system for applications for specified pesticide registration, amended registration, and associated tolerance actions. The fees cover a wide range of registration applications, with PRIA 3 covering 189 categories and PRIA 4 covering 212. The fees fund approximately one-third of the EPA's pesticide program activities, including the review of new applications and the reevaluation of older registered pesticides. PRIA also provides funding for worker protection and farmworker protection activities, as well as partnership grants and pesticide safety education programs.

Under PRIA, companies must pay service fees according to the category of the registration action. The act also sets decision review time periods, making the evaluation process more predictable for companies. Shorter decision review periods are provided for reduced-risk registration applications.

PRIA includes provisions for fee waivers for small businesses, with waivers or reductions for businesses with fewer than 500 employees and varying levels of global pesticide sales. It also provides for exemptions from the requirement of fees for federal and state agencies and for certain Inter-Regional Project Number 4 (IR-4) submissions.

Endangered Species Act (ESA)

The Endangered Species Act (ESA) is a federal law in the United States, administered by the Fish and Wildlife Service (FWS) of the Department of the Interior. The ESA makes it illegal to kill, harm, or collect endangered or threatened wildlife or fish, or to remove endangered or threatened plants from areas under federal jurisdiction.

The ESA requires federal agencies to ensure that any action they authorize, fund, or carry out does not jeopardize the continued existence of any listed species or result in the destruction or adverse modification of their designated critical habitat. This includes the EPA, which has a responsibility under the ESA to ensure that the registration of pesticides does not negatively impact the survival of endangered species. The EPA's Office of Pesticide Programs (OPP) implements key portions of the ESA, regulating the use of pesticides and establishing maximum levels for pesticide residues in food.

The EPA's work in this area includes assessing the effects of new pesticides on listed species, developing biological evaluations, and creating educational resources about pesticides and endangered species. The EPA also works with the FWS and the National Marine Fisheries Service (NMFS) to obtain measures to avoid jeopardy to listed species and adverse modification of critical habitats from pesticides.

The EPA faces challenges in implementing timely and effective strategies to protect listed species from possible pesticide effects, due to the large number of pesticide products and listed species, as well as limited information on the vulnerability, biology, and location of many species. To address these challenges, the EPA has developed a comprehensive, long-term approach, including the workplan "Balancing Wildlife Protection and Responsible Pesticide Use," which outlines administrative and other improvements to better protect endangered species.

Frequently asked questions