Under FIFRA, EPA registers  pesticides distributed, used, or sold, in the United States and prescribes  labeling and other regulatory requirements to prevent unreasonable  adverse effects on health and the environment. For example, when EPA conducts a  GLP inspection, it determines, among other things, whether the laboratory  is of suitable size and construction to facilitate the proper conduct of the  studies. The GLP Compliance  Monitoring Program selects laboratories for inspection from among the  population of laboratories that have conducted studies submitted to  OPP. Inspections can also be initiated at OPP’s request or that of another EPA  office. EPA Has Inspected Few Laboratories for GLP Compliance and Faced Challenges in Selecting Laboratories for Inspections

EPA’s OECA has inspected few laboratories on an annual basis that test  pesticides for GLP compliance for fiscal year 2009 through fiscal year  2013 and faced challenges in doing so. However, our analysis  showed that some laboratory information in the databases used to  prioritize laboratories for inspection was either inaccurate or incomplete,  and these data challenges may negatively affect prioritization. Given the concerns of some stakeholders about the infrequent  GLP inspections, OECA is considering other approaches, such as  charging fees or using third parties to review studies, in order to increase  the number of inspections. In August 2012, OECA developed a Budget Adjustment Plan,  which provided general information on potential future approaches to the  GLP Compliance Monitoring Program, including ways the program could  be run more efficiently given its recent budget cuts and inability to hire  GLP inspectors. EPA officials told us that they have  also conducted internal and informal discussions regarding the possibility  of using user fees for the GLP program, but the agency has not  conducted a formal evaluation of user fees. Without formally assessing  the need for such fees, EPA cannot determine whether charging and  retaining the fees would be possible and whether such fees could help  make the inspection program self-sustaining. EPA Rarely Used GLP Inspection Results in Initial Pesticide Registration Decisions but Sometimes Used Them for Later Reexamination

EPA rarely used GLP inspection results in making its initial pesticide  registration decisions. An OPP official told us that this is because most  inspections occur after those decisions have been made. According to OPP officials, OPP has not denied a pesticide registration or  revoked any registrations based on OECA laboratory inspection  information during the past 5 years, but OPP has taken other actions  because of that information, such as requiring a registrant to repeat a  study or requesting that a registrant voluntarily cancel its registration. EPA and FDA Do Not Regularly Collaborate on Laboratory Inspections and May Be Duplicating Each Other’s Work

EPA and FDA do not regularly collaborate on GLP inspections and may  be duplicating each other’s work by inspecting the same laboratories. In  1984, EPA and FDA entered into an interagency agreement to  collaborate on GLP inspections that was last renewed in 2004. Officials from both agencies said that it  would be useful to know which laboratories the other agency was  planning to inspect and to have the results from those inspections. Since  each agency only inspects a certain number of laboratories each year,  sharing such information could help both agencies leverage resources. For fiscal year 2005 to fiscal year 2012, EPA and FDA  conducted a total of 170 GLP inspections of the same 37 laboratories.In 38 of the 170 inspections, the agencies inspected the same laboratory  during the same fiscal year (see app. Without collaboration and information- sharing on planned and completed GLP inspections, EPA and FDA may  duplicate GLP inspections, and EPA will have difficulty efficiently using its  limited resources to increase the number of inspections it conducts. In response to our first  three recommendations, EPA agreed  to assess the authority and need for a fee-based GLP inspection  system;   to ascertain the exact causes of inaccurate and incomplete data  and ensure that the data are accurately recorded; and,   that OECA and OPP should develop written procedures to  coordinate and prioritize GLP inspections. Appendix I: Objectives, Scope and Methodology

Our objectives were to examine the extent to which (1) the Environmental  Protection Agency (EPA) inspects for GLP compliance laboratories that  test pesticides and the challenges, if any, EPA faces in doing so, (2) EPA  uses the information obtained through Good Laboratory Practices (GLP)  laboratory inspections in its pesticide decision-making process, and (3)  EPA and the U.S Food and Drug Administration (FDA) collaborate on  GLP inspections. In addition, we interviewed  EPA’s Office of Pesticide Programs (OPP) and OECA officials and  reviewed documentation they provided to obtain further information and  clarification on EPA’s pesticide registration process and how it relates to  the GLP process, and we interviewed FDA officials and reviewed  documentation they provided on FDA’s GLP process.
Why GAO Did This Study

Pesticides used to control weeds, unwanted insects, and fungi contribute to agricultural productivity and public health by preventing crop damage and controlling pests. However, pesticides may also have adverse effects. EPA's OPP reviews applications for pesticide products and registers those that it determines do not have unreasonable adverse effects on health and the environment. EPA's OECA inspects laboratories where these pesticides are tested to ensure that the laboratories followed EPA's GLP regulations. FDA also conducts GLP laboratory inspections. GAO was asked to review EPA's GLP Compliance Monitoring Program. This report examines the extent to which EPA (1) inspects for GLP compliance laboratories that test pesticides and the challenges EPA faces in doing so, (2) uses the information obtained through GLP inspections in its pesticide decision-making process, and (3) collaborates with FDA on GLP inspections. To conduct this work, GAO reviewed relevant agency documents and data, conducted a nongeneralizeable survey of 20 laboratories, and interviewed EPA and FDA officials and laboratory and other stakeholders.

What GAO Found

The Environmental Protection Agency (EPA) inspects few laboratories that test pesticides for Good Laboratory Practices (GLP) compliance and faces challenges in selecting laboratories to inspect. For fiscal years 2009 to 2013, EPA's Office of Enforcement and Compliance Assurance (OECA) GLP Compliance Monitoring Program inspected from 51 to 80 laboratories annually from an estimated 1,400 that conducted studies used to support applications for pesticide registrations. During the same period, EPA reduced OECA's GLP Compliance Program budget and staff by about half. Laboratory and other stakeholders told GAO that not having GLP inspections can negatively affect a laboratory's business domestically and abroad. OECA prioritizes laboratories for GLP inspections using criteria that reflect, among other things, how long it has been since the last inspection and the number of studies the laboratory has conducted that have been submitted to EPA's Office of Pesticide Programs (OPP) in support of a pesticide registration application. However, GAO found that some laboratory information in the OECA database used to prioritize inspections was either inaccurate or incomplete, making it difficult to target laboratories for inspections. GAO also found that OECA is considering ways the GLP program could be run more efficiently given its recent budget cuts and concerns of stakeholders about the infrequent GLP inspections. For example, OECA officials have informally discussed the possibility of charging user fees that may be used to fund the GLP program, as the U.S. Food and Drug Administration (FDA) and many other countries do, but the agency has not conducted a formal evaluation of user fees. Without formally assessing the need for such fees, EPA cannot determine whether charging and retaining the fees would be possible and whether such fees could help make the inspection program self-sustaining.
EPA rarely uses GLP inspection results in making its initial pesticide registration decisions. An OPP official said that this is because most inspections occur after decisions have been made. OPP officials said they have not denied or revoked any pesticide registrations based on OECA GLP inspections during the past 5 years, but OPP has taken other actions, such as requiring that a study be repeated because of subsequent laboratory inspection information. According to EPA officials, OPP and OECA have communicated on an informal basis about OPP's inspection priorities before a pesticide registration has taken place.
EPA and FDA do not regularly collaborate on laboratory inspections and may be duplicating each other's work at some of these laboratories. In 1984, EPA and FDA entered into an agreement to collaborate on GLP inspections and met quarterly to discuss upcoming inspections; the agreement ended in 2004 although meetings continued until 2007. From fiscal year 2005 to 2012, EPA and FDA conducted a total of 170 GLP inspections of the same 37 laboratories. In 38 of 170 inspections, the agencies inspected the same laboratory during the same fiscal year. EPA and FDA have independent but similar sets of GLP regulations. Officials from both agencies said it would be useful to know which laboratories the other agency was planning to inspect and to have those inspection results, since each agency can only inspect a certain number of laboratories each year. Absent collaboration and information sharing with FDA on planned and completed GLP inspections, EPA will have difficulty efficiently using its limited resources to increase the number of inspections it conducts.

What GAO Recommends

GAO recommends, among other things, that EPA assess its authority and need for a fee-based inspection system for the GLP Program, determine why the database information to prioritize laboratories is incomplete, and that EPA and FDA develop a process to collaborate and share information on planned and completed inspections. EPA and FDA agreed with GAO's recommendations.