U.S. Federal Pesticide Regulation Background
Pesticides are regulated by the U.S. Environmental Protection Agency (“EPA”) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Under FIFRA, no pesticide, as defined under the statute, may be sold or distributed unless it is first registered with EPA. EPA may register a pesticide only if it determines that the product will not cause any “unreasonable adverse effects on the environment” (FIFRA§3(a), 7 U.S.C. §136a(a)).
The U.S. EPA was created in 1970, and the pesticide regulatory program focuses on the environmental effects of pesticides as well as on food safety and the cumulative exposures to pesticides. In addition to FIFRA, there are several other federal environmental laws that impact the use of pesticides including the Endangered Species Act (“ESA”), the Toxic Substances Control Act (“TSCA”) and the Clean Water Act (“CWA”). In accordance with the ESA, the U.S. EPA is obligated to consult with the U.S. Fish and Wildlife Services (“FWS”) and the National Marine Fisheries Services (“NMFS”) with regard to agency actions to insure its regulatory activities are not likely to risk endangered or threatened species or their habitats.
The 1996 Food Quality Protection Act (FQPA) mandates registration review. All pesticides distributed and sold in the U.S. must be registered by EPA, based on scientific data showing that they will not cause unreasonable risks to human health, workers, or the environment when used as directed on product labeling. Although changes in science, public policy and pesticide use practices occur over time, EPA periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can still be used safely. The registration review program, in accordance with FIFRA §3(g), directs EPA to complete each pesticide’s registration review no later than every 15 years. EPA continuously improves its processes, science and information management to assure that all pesticides continue to meet FIFRA Standards.
The provisions of FIFRA specifically permit two or more registrants to cooperatively develop data required by EPA under FIFRA § 3(c)(2)(B). Registrants may form a Task Force to share in the cost to jointly develop or acquire data on an active ingredient or they may develop common data based on exposure. Costs to be shared by Task Force members include the direct cost of developing the required data, cost of study management, and administrative overhead related to compiling and submitting the data to EPA. Each Task Force operates under a legally binding agreement that outlines the purpose of the Task Force, but many times a Task Force is formed to address a Data Call-In (DCI) requirement from EPA.
Data call-ins (DCIs) are requirements by EPA issued to pesticide registrants to obtain data or other information in support of an existing active ingredient or product registration. DCIs are issued when there is no existing, reliable information available to characterize a pesticide’s risk, exposure, or to otherwise complete a risk assessment. EPA has authority to issue a DCI under Section 3(c)(2)(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
U.S. EPA’s Registration Review Process
While each pesticide review is unique, all pesticides go through a registration review process based upon EPA’s Schedule and in accordance with their registration review rules. The basic registration review process consists of the following general steps:
Focus Meetings – These are usually encouraged by EPA to enhance transparency and involvement and typically involve registrants and various EPA representatives. These meetings focus on the information needs identified by a chemical review team and EPA management for consideration during the agency’s registration review. Focus meetings provide an opportunity to address areas of uncertainty that may affect EPA’s risk assessment and risk management decisions for a pesticide. By registrants providing better information early in the process, EPA can conduct high quality risk assessments that reflect the labeled use of the pesticide and thereby narrow the scope of their reevaluation to areas that pose real concerns, based on current data and use patterns.
Focus Meetings provide registrant(s) with an opportunity to:
- Clean up labels (clarify use patterns, remove ambiguities, etc.) before risk assessment;
- Identify supported products, uses and use patterns;
- Review and comment on EPA’s Label Use Information System Report;
- Clarify usage and address label uncertainty (which could possibly reduce data requirements or reduce the use of conservative assumptions in the risk assessment);
- Identify data already generated by or requested from registrants; and
- Identify use patterns likely to result in an Endangered Species “May Effect” Determination.
Docket Opening – EPA initiates the registration review process by establishing a docket for a registration review case and opening the docket for public review and comment. A Federal Register notice is published that announces the docket and provides a 60-day comment period. EPA considers information received during the comment period in conducting their registration review for each pesticide. The docket will contain a Summary Document that explains the path forward for the compound, a Preliminary Work Plan that highlights anticipated risk assessment and data requirements. In addition, EPA provides a timeline, fact sheet, ecological risk assessment problem formulation and human health scoping with scientific analyses expected to be necessary to complete the pesticide’s registration review.
Case Development – In conducting a pesticide’s registration review, EPA will review the data and information it believes should be considered in the review.
The Agency will subsequently:
Assess changes since the pesticide’s last review, assess any changes to determine the significance of the changes and if the pesticide still satisfies FIFRA standard for registration. EPA will consider whether any new data on the pesticide warrants conducting a new risk assessment or a new risk/benefit assessment.
If EPA finds a new assessment is needed, they will determine whether it can be based on available data or if additional data is needed to conduct the review. If necessary, EPA will issue a Data-Call In Notice under FIFRA 3(c)(2)(B).
Registration Review Decision – EPA’s determination whether the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment.
Proposed Decision – issued through the Federal Register with a 60-day comment period where EPA presents its proposed findings, identifies proposed risk mitigation measures or other proposed requirements, state whether EPA believes additional data are needed, specify proposed labeling changes, and identify deadlines for completing required actions.
Final Decision – After EPA considers comments during the proposed decision, EPA will issue a registration review decision, including an explanation of any changes to the proposed decision and a response to significant comments.
Interim Decision – EPA may issue, when appropriate, an interim registration review decision before completing a registration review.
The interim decision may require:
1. New or impose interim risk mitigation measures
2. Identify data or information needed to complete the review (data call in may be issued)
3. Include schedules for submitting the required data, conducting the new risk assessment, and completing the registration review.