GAO-15-404SP: Agriculture: 1. EPA's and FDA's Laboratory Inspections

Agriculture > 1. EPA's and FDA's Laboratory Inspections

To avoid potential duplication of certain types of laboratory inspections and better leverage limited resources, the Environmental Protection Agency and the Food and Drug Administration should develop a formal process to collaborate and share information on planned inspections.

Why This Area Is Important

Pesticides that are used to destroy or control weeds and pests contribute to agricultural productivity by preventing crop damage and to improving public health by controlling disease-carrying pests. However, the use of pesticides may also have adverse effects on human health and the environment. The Federal Insecticide, Fungicide, and Rodenticide Act generally requires registration of pesticides, and under implementing regulations, the Environmental Protection Agency (EPA) reviews applications for pesticides. EPA also inspects the laboratories where these pesticides are first tested for safety. Laboratories must conduct studies in accordance with regulations called Good Laboratory Practices (GLP), which are intended to ensure the quality and integrity of data.

The Department of Health and Human Services’s Food and Drug Administration (FDA) also uses its own GLP regulations, promulgated under the Federal Food, Drug, and Cosmetic Act, to ensure the quality and integrity of the data for nonclinical laboratory studies of investigational drugs, medical devices, food additives, and other products through laboratory inspections and reviews of studies to ensure GLP compliance. GLP regulations were developed and promulgated in the late 1970s and early 1980s, in response to fraudulent laboratory activities and poor laboratory practices that occurred during that time.

According to EPA and FDA officials, the GLP standards of the two agencies are largely similar. Moreover, a senior EPA official and representatives from three laboratories that were inspected by both EPA and FDA stated that the inspections performed by the two agencies were comparable. In some cases, EPA and FDA also receive studies from the same laboratories.

EPA inspected about 4 to 6 percent of the eligible 1,400 laboratories each year from fiscal year 2009 to fiscal year 2013. EPA inspected an average of 67 laboratories for GLP compliance from fiscal year 2009 to fiscal year 2012.[1] EPA officials said that a limited number of inspectors and tight budgets have hindered their ability to perform more inspections. From fiscal year 2009 to fiscal year 2013, EPA reduced the budget for its GLP Compliance Monitoring Program—which conducts inspections for GLP compliance—from about $1.4 million to about $700,000 annually, and the number of full-time equivalent staff was reduced by 50 percent from eight to four inspectors.[2] EPA officials said that the reduction in the number of full-time equivalent staff was due to retirements, an inability to hire new inspectors because of budgetary constraints, and most importantly, according to these officials, the inability to find inspector candidates with the requisite skills. From fiscal year 2009 to fiscal year 2012 (the most recent year for which data are available), FDA inspected an average of 61 laboratories per year for GLP compliance.[3]



[1]In comparing EPA and FDA data, GAO used the 2009 through 2012 time frame, since 2012 is the latest year for which both agencies have data.

[2]GAO used the EPA budget numbers from 2009 through 2013 to get a 5-year budget figure, since EPA had budget data through 2013. Because FDA does not budget by inspection type, but by overall program activity, GAO was not able to determine annual cost of FDA’s GLP inspections.

[3]GAO was unable to determine the percentage of eligible laboratories that FDA inspected because FDA could not provide GAO with the total number of laboratories eligible for inspection.

What GAO Found

GAO found in May 2014 that EPA and FDA do not regularly collaborate on GLP laboratory inspections and may be duplicating each other’s work by inspecting the same laboratories. In addition, GAO found that EPA and FDA do not regularly communicate about future inspections or share results from completed inspections. In 1984, EPA and FDA entered into an interagency agreement to collaborate on GLP inspections. Under the agreement, FDA’s responsibilities included conducting a certain number of on-site inspections of laboratories identified by EPA. FDA performed some inspections of laboratories identified by EPA until 2007, although the agreement was not renewed after 2004. EPA officials said they also formally met with FDA officials on a quarterly and annual basis to discuss upcoming inspections but that communication ended by 2007, when, according to EPA officials, FDA began selecting laboratories for inspection on an annual basis instead of on a quarterly basis as EPA does. Since these meetings ended, EPA officials said that they do not always know if a laboratory has been inspected by FDA until they arrive on site. 

As a result, GAO found that EPA and FDA may be duplicating each other’s work in some of their GLP inspections. For fiscal years 2005 to 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.

GAO found that there is some degree of overlap in the laboratories that are eligible for inspection by the two agencies. Some laboratories covered by GLP regulations conduct tests yielding data that will be submitted only to EPA, but other laboratories conduct tests for review by both EPA and FDA and are therefore eligible for inspection by both agencies. FDA officials told GAO that they did not have data to identify the total number of laboratories that submit data to both agencies and would therefore be subject to GLP inspections by both agencies. EPA officials and stakeholders GAO interviewed, however, said that laboratories that conduct toxicology testing are the most likely to perform tests that are submitted to both EPA and FDA. For example, one representative from a laboratory in Maryland that had been inspected by both EPA and FDA eight times from fiscal year 2005 to fiscal year 2012 told GAO that some of the information in the laboratory’s toxicology studies FDA officials examined during a 2011 GLP inspection could have been shared with EPA officials. FDA officials said that they would welcome a list of inspections planned and conducted by EPA and that it would be helpful if EPA shared information on potential problems that it may have found during its inspections. EPA officials also said collaborating and communicating on inspections would be helpful.

By not collaborating and communicating regularly, EPA and FDA may be missing opportunities to improve efficiency and effectiveness. For example, if EPA knew in advance that a laboratory was recently inspected by FDA, EPA inspectors could use FDA’s inspection results to inform their decision regarding whether to conduct their own inspection. In some circumstances, it may be necessary for both agencies to inspect the same laboratory. However, sharing information could help both agencies leverage and extend resources, since each agency can only inspect a certain number of laboratories each year. This coordination also could increase the number of laboratories that are inspected for GLP compliance. The federal government uses a range of mechanisms to implement interagency collaboration, such as interagency groups and interagency agreements and memorandums of understanding.[1] GAO has identified key practices that can strengthen agencies’ commitment to working collaboratively, including articulating their agreements in formal documents.[2] Written agreements are most effective when they are regularly updated and monitored. Officials from both agencies said that collaborating and communicating on inspections would be helpful. Absent a formal written agreement, it is not clear that the agencies would regularly collaborate on future planned inspections and share results from completed inspections.



[1]GAO, Managing for Results: Key Considerations for Implementing Interagency Collaborative Mechanisms, GAO‑12‑1022 (Washington, D.C.: Sept. 27, 2012).

[2]GAO, Results-Oriented Government: Practices That Can Help Enhance and Sustain Collaboration among Federal Agencies, GAO‑06‑05 (Washington, D.C.: Oct. 21, 2005).

Actions Needed

In May 2014, GAO recommended that the EPA Administrator and the FDA Commissioner

  • develop a formal written agreement, such as a memorandum of understanding, which outlines how the two agencies plan to regularly collaborate and share information on GLP inspections and avoid duplication of inspections so that EPA can more efficiently use its limited resources.

GAO was not able to ascertain the financial benefits of taking this action because the two agencies did not use comparable methods to establish the cost estimate of a GLP inspection. In addition, the number of inspections EPA and FDA would be able to leverage in any given year is unknown, adding further uncertainty to the quantification of financial benefits. However, by sharing information on planned inspections, both agencies may be able to expand their inspection coverage.

How GAO Conducted Its Work

The information contained in this analysis is based on findings from the product listed in the related GAO products section. To determine the extent to which EPA and FDA collaborated on inspections, GAO analyzed EPA and FDA GLP laboratory inspection data. GAO also conducted a web-based survey of 53 laboratories and other entities. GAO received responses from 20 laboratories and analyzed these responses to determine, among other things, if the laboratories had conducted GLP tests or studies for submission to both EPA and FDA since 2008.[1] GAO reviewed agency documents, such as a 1984 interagency agreement between EPA and FDA to cooperate on GLP inspections, and GAO interviewed EPA and FDA officials and laboratory representatives about the potential for the two agencies to collaborate.



[1]GAO initially selected a random sample of 80 laboratories and other entities that sent study data to EPA from fiscal year 2010 to fiscal year 2012 using EPA’s Office of Pesticide Program Information Network database. Because the database did not include e-mail addresses, GAO searched for e-mail addresses and found them for 53 of the 80 in our sample. GAO administered the survey to these 53 and received responses from 26. Of these 26, 6 reported that they were not a laboratory and did not conduct GLP testing. Therefore, these 6 were considered out-of-scope, leaving 20 for analysis. The results of our analysis are not generalizeable to all laboratories that are covered by the GLP Program.

Agency Comments & GAO Contact

In commenting on the May 2014 report on which this analysis is based, EPA agreed to work with FDA to develop written procedures that outline how EPA and FDA will collaborate and share information on GLP inspections. EPA also stated that it did not agree that a formal memorandum of understanding between the two agencies was necessary. However, GAO’s recommendation did not prescribe the type of agreement the agencies should undertake and offered a memorandum of understanding as one example. The Department of Health and Human Services also agreed with GAO’s recommendation, but reiterated that there are legitimate reasons why some GLP inspections may be conducted by both EPA and FDA at a single laboratory within a short period of time.

GAO provided a draft of this report section to EPA and FDA in February 2015. An EPA official told us that EPA and FDA representatives had held initial meetings to discuss coordination on strategies to implement a formal written agreement for sharing information on GLP inspections.

For additional information about this area, contact John Neumann at (202) 512-3841 or neumannj@gao.gov.