U.S. Pesticide Regulation

Widely produced and used in the United States, pesticides are regulated by the Office of Pesticide Programs (OPP) within the U.S. Environmental Protection Agency (EPA) as well as by the 50-states and U.S. territories. EPA receives its authority to register pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetics Act (FFDCA). States are authorized to regulate pesticides under FIFRA and state pesticide laws, some of which place more restrictive requirements on pesticides than EPA (e.g. California). EPA’s principal pesticide regulatory duties are to register new pesticides, establish tolerances for pesticide residues in or on human food and animal feed, systematically review existing pesticide registrations and tolerances, and enforce FIFRA. As defined by EPA, a pesticide is “any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest.”

EPA


Before selling or distributing a pesticide in the U.S., a person must register the product with EPA. An applicant submits prescribed studies, which the Agency reviews to ensure that the pesticide, when used according to its label directions, will not cause “unreasonable adverse effects to humans or the environment.” If the pesticide is applied to crops used for human food or animal feed, EPA must also establish a tolerance (maximum residue level) for the amount of pesticide that may legally remain in or on the raw agricultural commodity or processed food. A tolerance will only be established if EPA determines that the chemical residue of a pesticide is “safe” at a certain level.

In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product, which is provided through study data conducted under EPA guideline standards. These studies 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. While most commonly associated with agriculture use sites, conventional pesticides include many different classes of products, such as herbicides, insecticides, fungicides and rodenticides.


EPA regulates not only the sale and distribution of pesticides
under its FIFRA authority, but also the use of pesticides. When
EPA registers a pesticide, it reviews the proposed pesticide label for compliance with federal guidelines, such as an ingredient statement identifying the active ingredient(s), a signal word to indicate the toxicity category of the product, precautionary statements, environmental hazard statements, storage and disposal directions, and directions for use. The proposed uses will determine the data requirements necessary to support the pesticide product’s registration. Once approved by EPA, most states conduct a review of the pesticide label to ensure that it complies with EPA labeling requirements; however, some states have additional restrictions that must be met in order to obtain the state-specific registration.

States


States have substantial authority in the regulation of pesticides and obtaining state registrations are crucial to bringing a federally registered product to market. Once an EPA registration is issued, registration must be obtained from every state and territory where the product will be distributed or sold. States may also require the registration of pesticides and inert ingredients that are exempt from EPA registration requirements under Section 25(b) of FIFRA. In addition, state registrations must also be maintained in every state a product is registered, requiring companies to comply with each state’s regulatory requirements every time pesticide renewals are due.

U.S. Pesticide Services


TSG’s consultants have expertise in all aspects of pesticide regulation in the United States, from EPA and state registration to product compliance, maintenance and defense. Services include:

Federal (EPA): States:
  EPA registration overview   State registration overview
  Data generation   California
  Data compensation   New York & Florida
  Data waivers   Devices & exempt pesticides
  Label development   Enforcement & product defense
  Human health risk assessment   State renewals
  Environmental risk assessment  
  Pesticide tolerance/MRL  
  Establishment registration  
  Importation of pesticides into U.S.  
  U.S. registration agent  
  Product defense
  FIFRA compliance audit
  Training  

Pesticide Regulation HandbookPesticide Regulation Handbook: To order a copy, please click here.