Among other things,  the environmental group asserted that EPA had overused conditional  registrations and did not appear to have a reliable tracking system to  identify the status of conditionally registered pesticides to ensure that  registrants submitted, and EPA reviewed, additional data in a timely  manner. Total Number of Conditional Registrations Granted Is Unclear, as EPA Found Data to Be Inaccurate

The number of active conditional registrations EPA has granted is  unclear, according to OPP officials who, as a result of a 2011 EPA  review, found the agency’s registration data to be inaccurate and the  basis for granting some of these registrations to be inappropriately  classified. Specifically, an internal review of OPP’s conditional registration  program found that OPPIN does not allow officials to change a pesticide’s  registration status from conditional to unconditional once the registrant  has satisfied all data requirements, and the basis for many registration  decisions was mischaracterized as conditional. As  of July 2013, OPP officials told us that the office has taken or is planning  to take several actions to more accurately account for conditional  registrations. Second, according to  OPP’s internal review, there was limited, organized management  oversight to ensure that regulatory actions not subject to the narrow  scope of section 3(c)(7) were not mischaracterized by OPP staff as  conditional registrations. To more accurately  report on the number of pesticide products that are conditionally  registered, OPP officials told us that the office has taken or planned to  take the following actions:
Beginning in the fall of 2010, representatives of the OPP divisions that  deal with pesticide registrations began meeting with OPP  management at least quarterly to, among other things, review  proposed conditional registrations for pesticide products with new  active ingredients to ensure that (1) any new conditional registrations  granted for these products meet the circumstances outlined in FIFRA  Section 3(c)(7)(C); (2) the additional data that would be requested as  a part of the conditional registration are really needed; and (3) if the  data are needed, EPA is still able to make the determination that the  information available concerning the pesticide demonstrates that the  FIFRA safety standard will be met, which requires that the use of the  product during the time needed to generate the necessary data will  not cause unreasonable adverse effects on the environment. In particular, OPP does not have a  reliable system, such as an automated data system, designed specifically  to track key information related to conditional registrations, including  whether registrants submitted additional data within required time frames  and OPP reviewed these data. While these program operations may help to identify  some situations where required data are missing, they fall short of what is  needed because they are neither comprehensive nor do they ensure the  timely submission of these data. A state may be more  stringent in registering a pesticide for use in that state, but its  registration requirements generally may not be less stringent than the  federal requirements. Respondents Generally Reported That EPA Needs to Improve Its Conditional Registration Process

In responding to our questionnaire, respondents in the consumer,  environmental, industry, legal, science, and state government stakeholder  groups generally reported concerns with submission or review of required  data as follows:
Of the 19 respondents in the consumer, environmental, legal,  producer, science, and state government groups, 17 reported  concerns related to registrants not submitting additional required data  on time, including concerns about pesticides that remain in the  marketplace when their environmental and health impacts have not  been fully evaluated. Of the 5 respondents from industry, 3 stated that there are cases  when EPA grants a conditional registration for a pesticide that should  have qualified for an unconditional registration. Seven of these 14 respondents also  generally stated that conditional registrations promote innovation by  bringing new technologies and products to the marketplace faster. According to OPP officials  and documents, weaknesses in guidance and training, management  oversight, and data management contributed to the misclassification of  other pesticide-related activities as conditional registrations. Recommendations for Executive Action

To improve EPA’s management of the conditional registration process,  we recommend that the Administrator of EPA direct the Director of the  Office of Pesticide Programs to take the following three actions:
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,
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. Appendix I: Objectives, Scope and Methodology

Our objectives were to examine the (1) number of conditional pesticide  registrations the Environmental Protection Agency (EPA) has granted and  the basis for granting these registrations; (2) extent to which EPA ensures  that registrants submit the additional data EPA required as part of  conditional registrations and reviews these data; and (3) views of relevant  stakeholders on EPA’s use of conditional registrations, including ways, if  any, to improve the conditional registration process. Pesticides: EPA’s Information Systems Provide Inadequate Support for  Reregistration.
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.

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.

What GAO Recommends

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.