The primary federal laws that govern how EPA regulates pesticides in the United States are FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Under FIFRA implementing regulations, EPA is to review applications for pesticide products and register those that it determines will meet the FIFRA statutory standards for registration. If the use of a pesticide would result in a residue of the substance in or on food or animal feed, EPA may not register a pesticide under FIFRA unless it can determine that the residue is “safe” as defined by FFDCA. Under FFDCA, safe means that EPA has determined, among other things, that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide residue, including all anticipated dietary exposures and all other nonoccupational exposures for which there is reliable information. EPA may establish a tolerance level—the maximum permissible pesticide residue in or on food or animal feed that is sold—that meets the FFDCA safety standard or may choose to grant an exemption for a tolerance. OPP—the EPA office primarily responsible for regulating the use of pesticides—has regulatory staff in three divisions—Registration, Biopesticides and Pollution Prevention, and Antimicrobials—that are responsible for registering pesticides. The registration process formally begins when a registrant submits an application to OPP for a particular pesticide. This application is to include data to support the registration of the pesticide. In reviewing the application, OPP is to examine, among other things, the pesticide’s ingredients; the site or crop on which it is to be used; the amount, frequency, and timing of its use; and storage and disposal practices. OPP is also to review toxicity tests and studies showing how the pesticide affects human health and the environment. According to OPP officials, the length of time OPP takes from the initial review of an application to the final decision on whether to register a pesticide depends on many factors—including whether the pesticide being reviewed is similar to any pesticide EPA has previously reviewed— and, according to OPP officials, can take from 3 to 24 months. After OPP completes its review and approves the submitted package, EPA may register the pesticide without imposing requirements for additional data (unconditional registration) under FIFRA 3(c)(5) if EPA determines, among other things, that use of the pesticide in accordance with label directions will not have unreasonable adverse effects on the environment. Alternatively, FIFRA section 3(c)(7) allows EPA to grant a conditional registration for pesticides in the following circumstances: Identical/substantially similar pesticides (FIFRA Section 3(c)(7)(A)). EPA may conditionally approve an application for registration or an amended registration for a pesticide product if the agency determines that the pesticide and proposed use are identical or substantially similar to any currently registered pesticide and its uses, or differ only in ways that will not significantly increase the risk of unreasonable adverse effects on the environment; and approving the registration or amendment in the manner proposed would not significantly increase the risk of any unreasonable adverse effect on the environment. Each registration issued under 3(c)(7)(A) must submit or cite the same data that would be required for the unconditional registration of a similar product. New uses (FIFRA Section 3(c)(7)(B)). A current pesticide registration may be amended to allow additional uses, even if the data concerning the pesticide may be insufficient to support unconditional registration, if EPA determines that the applicant has submitted satisfactory data pertaining to the proposed additional use; and amending the registration would not significantly increase the risk of unreasonable adverse effect on the environment. Each registrant must submit or cite the same data that would be required for the unconditional registration of a similar product. New active ingredients (FIFRA Section 3(c)(7)(C)). A pesticide containing a new active ingredient not found in any currently registered pesticide can be conditionally registered for a period reasonably sufficient for the generation and submission of required data, if EPA determines insufficient time has elapsed since the imposition of the data requirement for those data to be developed and on the condition that when the agency receives such data that they do not meet or exceed risk criteria stated in the regulations issued under FIFRA and other conditions issued by the agency; the use of the pesticide during the period of the conditional registration will not cause unreasonable adverse effect on the environment; and the use of the pesticide is in the public interest. After a pesticide product is conditionally registered under FIFRA section (3)(c)(7), the registrant receives a notice indicating the terms of the conditional registration, including a list of any additional data that will need to be submitted and deadlines for submitting these data. Figure 1 summarizes the pesticide registration and tolerance setting process. According to EPA officials, once a pesticide is conditionally registered, EPA typically grants a period of time, generally 1 to 4 years, for the registrant to provide the required data. The registrant can ask EPA to waive the requirement for additional information or, according to EPA officials, extend the time frame. If the registrant does not submit the data specified within the required time frame, EPA can cancel the pesticide registration. Before a pesticide can be sold or distributed in the United States, it must be registered under FIFRA. At any time, EPA may initiate a suspension or cancellation proceeding for a pesticide registration if safety concerns develop. For example, EPA began proceedings to cancel some uses of Carbofuran—an insecticide and nematicide that was registered to control pests in soils and on leaves in a variety of field, fruit, and vegetable crops—after the agency determined that the dietary, worker, and ecological risks of this pesticide were unacceptable. Another check on the safety of registered pesticide products is the requirement in FIFRA section 6(a)(2) and FIFRA implementing regulations that registrants report adverse effects-related information to EPA. For example, registrants are required to submit certain toxicity information concerning the product both before and after registration, such as information on the product’s toxicity to nontarget plant species. In addition, as required by FIFRA,registered pesticide every 15 years to help ensure that each pesticide registration continues to satisfy the regulatory standard. In 2007, EPA EPA is to review the safety of each began conducting these reviews under its registration review program.As a part of this program, if EPA determines that additional data are needed to support the continued registration of a pesticide, the agency may issue a Data Call-In (DCI) notice, as authorized by FIFRA section 3(c)(2)(B), requiring the registrant to provide the data by a specific date. Also, at any time after a pesticide is registered, a registrant may apply to amend the registration and, according to OPP officials, such requests are reviewed as though the registrant is seeking approval for a new pesticide. While reviewing such requests, the agency may also issue a DCI notice requiring the registrant to provide additional data by a specific date. If a registrant fails to provide the data requested through a DCI, EPA may suspend the pesticide’s registration under authority of FIFRA section 3(c)(2)(B). The Pesticide Registration Improvement Act of 2003 (PRIA), Pub. L. No. 108-199, Div. G, Tit. V, § 501, 118 Stat. 419 (2004), amended FIFRA by, among other things, establishing pesticide registration fees for some registration actions. PRIA was reauthorized in 2007 (Pesticide Registration Improvement Renewal Act of 2007, Pub. L. No. 110-94, 121 Stat. 1000 (2007) or PRIA 2) and again in 2012 (Pesticide Registration Improvement Extension Act of 2012, Pub. L. No. 112-177, 126 Stat. 1327, or PRIA 3). registrations the agency had issued, whether registrants had submitted the additional data required by the registrations, and whether EPA had reviewed the data submitted. OPP provided the group with information from the OPPIN data system on the number of pesticide registrations that had been categorized as conditional. Subsequently, in September 2010, the environmental group raised concerns about EPA’s use of its conditional registration authority, and several other environmental groups and other interested parties supported this position. 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. In addition, the group noted that the information EPA provided indicated that many pesticides have remained in conditional status for many years. For example, the information showed that over 3,200 pesticides had been in conditional status since 1995 (15 years) and that 2,100 pesticides had been in conditional status since 1990 (20 years). 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. In addition, based on the internal review, OPP officials concluded that several weaknesses contributed to this misclassification problem, including insufficient guidance and training, management oversight, and data management. 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. According to OPP officials, following an internal review of its conditional registration program that it completed in March 2011, OPP concluded that the OPPIN data on the number of conditional registrations were inaccurate.