Pesticides: EPA Should Take Steps to Improve Its Oversight of Conditional Registrations
Highlights
What GAO Found
The total number of conditional registrations granted is unclear, as the Environmental Protection Agency (EPA) reports that its data are inaccurate for several reasons. First, the database used to track conditional registrations does not allow officials to change a pesticide's registration status from conditional to unconditional once the registrant has satisfied all requirements, thereby overstating the number of conditional registrations. Second, EPA staff have misused the term "conditional registration," incorrectly classifying pesticide registrations as conditional when, for example, they require a label change, which is not a basis in statute for a conditional registration. According to EPA documents and officials, weaknesses in guidance and training, management oversight, and data management contributed to these misclassification problems. For example, according to EPA documents, there was limited, organized management oversight to ensure that regulatory actions were not misclassified as conditional registrations. As of July 2013, EPA officials told GAO that the agency has taken or is planning to take several actions to more accurately account for conditional registrations, including beginning to design a new automated data system to more accurately track conditional registrations.
The extent to which EPA ensures that companies submit additional required data and EPA reviews these data is unknown. Specifically, EPA does not have a reliable system, such as an automated data system, to track key information related to conditional registrations, including whether companies have submitted additional data within required time frames. As a result, pesticides with conditional registrations could be marketed for years without EPA's receipt and review of these data. In the absence of a reliable system for managing conditional registrations, EPA relies on a variety of routine program operations, such as its review of a company's changes to a pesticide registration, to discover that data are missing. However, these methods fall short of what is needed because they are neither comprehensive nor do they ensure timely submission of these data. According to federal internal control standards, EPA's lack of a reliable system for managing conditional registrations constitutes an internal control weakness because the agency lacks an effective mechanism for program oversight and decision making.
Stakeholders GAO surveyed--representatives of consumer, environmental, industry, legal, producer, science, and state government groups--generally said EPA needs to improve its conditional registration process. For example, some stated EPA should improve its data systems for tracking conditional registrations to ensure that required data are submitted and reviewed in a timely manner. However, stakeholder views varied on the benefits and disadvantages of conditionally registering pesticides. For example, some consumer, industry, legal, producer, and state government stakeholders stated that the conditional registration process promotes innovation by bringing new technologies to the marketplace more quickly. In contrast, some consumer, environmental, legal, science, and state government stakeholders voiced concerns that conditional registration allows products with safety that has not been fully evaluated into the marketplace.
Why GAO Did This Study
As of September 2010, more than 16,000 pesticides were registered for use in the United States, according to EPA. EPA reviews health and environmental effects data submitted by a company and may register a pesticide or, alternatively, grant a "conditional registration" for a pesticide under certain circumstances, even though some of the required data may not have been submitted or reviewed. The company must provide the missing data within a specified time. In 2010, environmental and other groups charged that EPA had overused conditional registrations and did not appear to have a reliable system to identify whether the required data had been submitted. GAO was asked to examine issues related to EPA's use of conditional registrations for pesticides. This report examines the (1) number of conditional registrations EPA has granted and the basis for these, (2) extent to which EPA ensures that companies submit the required additional data and EPA reviews the data, and (3) views of relevant stakeholders on EPA's use of conditional registrations. GAO reviewed EPA data and surveyed stakeholders, among other things.
Recommendations
GAO recommends, in part, that EPA consider and implement options for an automated system to better track conditional registrations. EPA agreed with GAO's recommendations and noted specific actions it will take to implement them.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Environmental Protection Agency | To improve EPA's management of the conditional registration process, the Administrator of EPA should direct the Director of the Office of Pesticide Programs to complete plans to automate data related to conditional registrations to more readily track the status of these registrations and related registrant and agency actions and identify potential problems requiring management attention. |
As of June 2024, EPA provided additional documentation demonstrating that while the agency's reliance on conditional registration authority has declined significantly, the agency has put into place an automated system for providing oversight of their use. The agency is no longer using conditional registrations for new active ingredients, though it considers them an important tool under FIFRA 3(c)(7) for new uses or new products. Where EPA is using conditional registrations, their status is now managed through a workload tracking system based in Salesforce. The system provides real-time, automated reports for a variety of metrics including conditional registrations. EPA included virtual staff training on the system in its roll out this fiscal year, as well as guidance documents, training resources, and procedure documents to support the review and regulatory development process. This improved management system for tracking and overseeing the status of these registrations is consistent with the intent of GAO's recommendation.
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| Environmental Protection Agency | To improve EPA's management of the conditional registration process, the Administrator of EPA should direct the Director of the Office of Pesticide Programs to, pending development of an automated data system for tracking the status of conditional registrations, develop guidance to ensure that product managers use a uniform methodology to track and document this information, including when data are submitted by registrants and reviewed by EPA, in the files maintained by each pesticide product manager. |
As of December 2016, EPA reported that in 2013 the agency updated its guidance and provided training to product managers. This training, according to EPA, directed product managers to use a uniform methodology to track and document this information, including when data are submitted by registrants and reviewed by EPA, in the files maintained by each pesticide product manager.
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| Environmental Protection Agency | To improve EPA's management of the conditional registration process, the Administrator of EPA should direct the Director of the Office of Pesticide Programs to review and correct, as appropriate, Office of Pesticide Programs' (OPP) website on conditional registrations to ensure that the information presented is clear, concise, and accurate, including defining technical terms. |
As of December 2016, EPA reported that its OPP conditional registration Webpage was revised in 2014 and is updated periodically. According to EPA, in May and July 2016, the Webpage was updated and will continue to be updated as necessary. See: https://www.epa.gov/pesticide-registration/conditional-pesticide-registration.
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