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United States Government Accountability Office: 
GAO: 

Report to the Ranking Member, Subcommittee on Environment and the 
Economy, Committee on Energy and Commerce, House of Representatives: 

May 2014: 

Pesticide Safety: 

Improvements Needed in EPA's Good Laboratory Practices Inspection 
Program: 

GAO-14-289: 

GAO Highlights: 

Highlights of GAO-14-289, a report to the Ranking Member, Subcommittee 
on Environment and the Economy, Committee on Energy and Commerce, 
House of Representatives. 

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 
nongeneralizable 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. 

View GAO-14-289. For more information, contact John Neumann at (202) 
512-3841 or neumannj@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

EPA Has Inspected Few Laboratories for GLP Compliance and Faced 
Challenges in Selecting Laboratories for Inspections: 

EPA Rarely Used GLP Inspection Results in Initial Pesticide 
Registration Decisions but Sometimes Used Them for Later Reexamination: 

EPA and FDA Do Not Regularly Collaborate on Laboratory Inspections and 
May Be Duplicating Each Other's Work: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Objectives, Scope and Methodology: 

Appendix II: Web-Based Survey to Laboratories: 

Appendix III: Laboratories Inspected for GLP Compliance by EPA and 
FDA, FY 2005-2012: 

Appendix IV: Comments from the Environmental Protection Agency: 

Appendix V: Comments from the Department of Health and Human Services: 

Appendix VI: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: Number of Pesticide Studies Submitted, Inspections, Full-Time 
Equivalents, and Budget for EPA's Good Laboratory Practices (GLP) 
Compliance Monitoring Program from Fiscal Year 2009 to Fiscal Year 
2013: 

Table 2: Actions by EPA's Office of Pesticide Programs Based on Good 
Laboratory Practices (GLP) Inspection Results, Fiscal Years 2008 to 
2012: 

Table 3: Average Time from EPA's Office of Compliance and Assurance's 
(OECA) Good Laboratory Practices (GLP) Inspection of Laboratory to 
EPA's Office of Pesticide Program's (OPP) Review of Inspection's 
Impact on Laboratory's Study, Fiscal Year 2008 to Fiscal Year 2012: 

Figures: 

Figure 1: The Role of Good Laboratory Practices in the Pesticide 
Registration Process: 

Figure 2: EPA Office of Enforcement and Compliance Assurance (OECA) 
GLP Compliance Monitoring Program's Inspection Process: 

Figure 3: Laboratories Inspected for GLP Compliance by EPA and FDA, FY 
2005-2012: 

Abbreviations: 

CFO: Chief Financial Officer: 

EPA: Environmental Protection Agency: 

FDA: Food and Drug Administration: 

FFDCA: Federal Food, Drug and Cosmetic Act: 

FIFRA: Federal Insecticide, Fungicide, and Rodenticide Act: 

GLP: Good Laboratory Practices: 

HHS: Department of Health and Human Services: 

IBT: Industrial Bio-Test Laboratories: 

ICIS: Integrated Compliance Information System: 

LISA: Laboratory Information and Study Audit: 

MAD: Mutual Acceptance of Data: 

OCE: Office of Civil Enforcement: 

OCEFT: Office of Criminal Enforcement, Forensics and Training: 

OECA: Office of Enforcement and Compliance Assurance: 

OECD: Organisation for Economic Co-operation and Development: 

OIG: Office of Inspector General: 

OMB: Office of Management and Budget: 

OPP: Office of Pesticide Programs: 

OPPIN: Office of Pesticide Program Information Network: 

PRIA: Pesticide Registration Improvement Act of 2003: 

TSCA: Toxic Substances Control Act: 

[End of section] 

United States Government Accountability Office: 
GAO:
441 G St. N.W. 
Washington, DC 20548: 

May 15, 2014: 

The Honorable Paul D. Tonko: 
Ranking Member: 
Subcommittee on Environment and the Economy: 
Committee on Energy and Commerce: 
House of Representatives: 

Dear Mr. Tonko: 

Pesticides that are used to destroy or control weeds, unwanted 
insects, fungi, rodents, bacteria and other pests contribute to 
agricultural productivity by preventing crop damage and improving 
public health by controlling disease carrying pests. However, the use 
of pesticides may also have adverse effects on human health and the 
environment. For example, some pesticides in large doses may 
contribute to the risk of cancer and other serious human health 
problems and may also cause environmental damage, such as 
contamination of water supplies or unintended impacts on species not 
targeted by the pesticide. The Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), as amended,[Footnote 1] generally requires 
registration of pesticides and authorizes the Environmental Protection 
Agency (EPA) to limit the distribution and sale of unregistered 
pesticides to the extent necessary to prevent unreasonable adverse 
effects on the environment.[Footnote 2] Under FIFRA implementing 
regulations, EPA reviews applications for pesticide products and 
registers those that it determines will meet the FIFRA statutory 
standards for registration.[Footnote 3] EPA also inspects the 
laboratories where these pesticides are first tested for safety. 
Laboratories must conduct studies in support of pesticide registration 
applications in accordance with regulations called Good Laboratory 
Practices (GLP), which are intended to ensure the quality and 
integrity of data.[Footnote 4] GLP regulations were developed and 
promulgated in the United States during the late 1970s and early 1980s 
in response to fraudulent laboratory activities and poor laboratory 
practices that occurred during that time. 

To monitor a laboratory's GLP compliance with these standards, EPA 
conducts both an audit of the studies conducted by the laboratory and 
submitted to EPA and an on-site inspection of the laboratory; these 
two types of reviews together are referred to as a GLP 
inspection.[Footnote 5] EPA's Office of Pesticide Programs (OPP) 
reviews studies that support applications for registration of 
pesticide products submitted by study sponsors and makes registration 
decisions based on whether or not the pesticide products meet the 
FIFRA standard for registration.[Footnote 6] EPA's Office of 
Enforcement and Compliance Assurance (OECA) has a Compliance 
Monitoring Program that conducts inspections to ensure that 
laboratories comply with the agency's GLP regulations. If OECA's 
inspectors find a problem with the studies they audit[Footnote 7] or 
the laboratories they inspect, OECA submits this information to OPP 
for reexamination of the studies to ensure that the data they 
generated are valid and reliable to support pesticide decisionmaking. 
If OPP determines the data upon which a registration decision was 
based are not valid or reliable, it can ask the manufacturer of the 
pesticide to repeat a study, or it may initiate steps to change a 
registration decision. 

The Food and Drug Administration (FDA), an agency of the Department of 
Health and Human Services (HHS), also requires that laboratories 
follow FDA's GLP regulations, promulgated under the Federal Food, Drug 
and Cosmetic Act (FFDCA)[Footnote 8] for conducting nonclinical 
laboratory studies of investigational drugs, medical devices, food 
additives, and other products to ensure the quality and integrity of 
the safety data.[Footnote 9] In some cases, EPA and FDA receive 
studies from the same laboratories. 

Environmental and other groups have raised concerns about OPP's 
pesticide registration program, as we reported in August 
2013,[Footnote 10] when we recommended that EPA take steps to improve 
the program. Pesticide manufacturers have also expressed concern about 
how infrequently OECA conducts GLP inspections, which they have stated 
affects firms' ability to register and market their products in the 
United States and abroad. 

You asked us to review EPA's GLP Compliance Monitoring Program. This 
report examines the extent to which (1) 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 GLP laboratory inspections in its pesticide decision-making 
process; and (3) EPA and FDA collaborate on GLP inspections. 

To conduct this work, we reviewed relevant laws, regulations, EPA and 
FDA guidance, EPA data on pesticide studies, and GLP inspection 
results. We interviewed OECA and OPP officials, as well as FDA 
officials. We reviewed recent literature related to GLP, including 
information and documents found on the websites of a variety of 
industry, international, environmental, and academic organizations, 
and foreign government GLP inspection programs. To determine the 
extent to which EPA inspects for GLP compliance laboratories that test 
pesticides, we collected and analyzed documentation from EPA officials 
on its GLP inspection process and analyzed EPA laboratory and 
inspection data, the agency's use of the data, and the accuracy and 
completeness of the data. We determined that inspection data were 
sufficiently reliable to present results on the number of inspections 
conducted during fiscal year 2009 to fiscal year 2013, based on a 
comparative analysis of inspection data contained in two of EPA's 
databases and interviews with agency officials. We determined that 
data on laboratories' identification numbers and addresses were not 
sufficiently reliable to assess the number and location of 
laboratories that had conducted studies submitted to EPA and, as a 
result, were subject to a GLP inspection. We determined the data were 
not sufficiently reliable, based on our analysis of the data, 
identification of erroneous data, and interviews with agency and 
laboratory representatives. However, EPA did provide estimates of the 
number and percentage of eligible laboratories that were inspected 
each year, and we used that information in this report. We obtained 
opinions on the GLP inspection program, including potential 
challenges, by interviewing individuals representing 25 entities, 
including laboratories; pesticide manufacturers; international 
organizations; environmental and health organizations; national and 
trade associations; and foreign government GLP programs, which we 
selected based on referrals from various stakeholders and EPA 
officials. In addition, we obtained survey responses from 20 
laboratories of a nongeneralizable random sample of 53 laboratories 
and other entities that had sent supporting studies to OPP for a 
pesticide registration application for fiscal year 2010 to fiscal year 
2012 to determine if they had been inspected by EPA[Footnote 11] (see 
appendix II). If they had not had a GLP inspection, we asked what 
impact, if any, they thought not having a GLP inspection had on their 
business. Although the results of this sample are not generalizable, 
the laboratories were randomly selected, and the results can 
illustrate such laboratories' experiences and challenges with GLP 
inspections. To assess the extent to which OPP uses the information 
obtained through GLP laboratory inspections in its pesticide 
registration decision-making process, we analyzed relevant documents 
and databases to determine the number of OECA's GLP inspections that 
produced results that were referred to OPP for reexamination, the time 
it took to conduct these reexaminations, and any impact the 
inspections had on OPP's pesticide registration decisions. To 
determine the extent to which EPA and FDA collaborate on inspections, 
we analyzed EPA and FDA GLP laboratory inspection data. We determined 
that the inspection data were sufficiently reliable for our purposes. 
We also analyzed the 20 survey responses to determine if the 
laboratories had conducted GLP tests or studies for submission to both 
EPA and FDA since 2008. We reviewed agency documents, such as a 1984 
interagency agreement between EPA and FDA to cooperate on GLP 
inspections, and we interviewed EPA and FDA officials and laboratory 
representatives about the potential for the two agencies to 
collaborate. Appendix I contains more detailed information on our 
objectives, scope, and methodology. 

We conducted this performance audit from November 2012 to May 2014 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

Background: 

The primary federal laws that govern how EPA regulates pesticides in 
the United States are FIFRA and FFDCA. 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.[Footnote 
12] If use of a pesticide would result in a residue of the substance 
in or on food, EPA may not register a pesticide under FIFRA unless, 
among other things, it can determine that the residue is "safe" as 
defined by section 408 of the FFDCA.[Footnote 13] 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 
set forth in section 408 or may choose to grant an exemption for a 
tolerance. To obtain a pesticide registration, or petition to 
establish a tolerance level, a registrant (company or person) submits 
an application for EPA's review containing health and environmental 
effects data and other information on a pesticide.[Footnote 14] In 
addition to testing conducted in a laboratory, these data can include 
studies based on the analysis of data collected from field 
applications of the pesticide and other information on the pesticide. 
The application is submitted with a pesticide registration fee, with 
the fee amount depending on certain factors, such as the type of 
registration action that is being requested. According to an OPP 
official, registrants are required to provide data relating to the 
pesticide's hazard and exposure levels to accompany a proposed 
registration. All studies submitted in support of a product 
registration are subjected to an initial screening and regulatory and 
scientific review by OPP staff to determine potential human and 
environmental risks. OPP reviews the applications and registers those 
products determined to meet FIFRA's standards for registration and 
other regulatory requirements so that they can be marketed 
domestically. 

Under FIFRA, when a registrant submits an application for pesticide 
products to OPP, the accompanying data to support the registration are 
required to be prepared in accordance with the agency's GLP 
regulations to ensure the quality and integrity of the data in the 
study. Each study submitted is reviewed by OPP to see if GLP criteria 
have been met. OPP staff prepare science reports and/or data 
evaluation records to address the quality of each study. If studies 
submitted in support of this process contain questionable data, this 
can result in adverse action by OPP. For example, according to OPP 
officials, if OPP finds that a registrant provided false or inaccurate 
information about the certified limits of the active ingredients of a 
pesticide, or if there is a discrepancy in the number of formulas used 
to check concentrations, a study would be rejected, and OPP might deny 
such an application or request that it be withdrawn. 

OECA's GLP Program is tasked with monitoring compliance with the GLP 
regulations through on-site inspections of laboratories, as well as 
audits of the laboratories' studies. According to EPA officials, the 
purpose of the study audit is to ensure that the study was conducted 
in accordance with the agency's GLP regulations and that the study is 
supported by data generated by the laboratory. A study's sponsor or 
applicant must include one of the following statements in the 
submission: (1) that the study was conducted in accordance with GLP, 
(2) a detailed description of all the differences between the 
practices used in the study and those required by GLP, or (3) that 
they do not know if their study was conducted in accordance with 
GLP.[Footnote 15] Laboratories eligible for inspection are those that 
have conducted studies submitted to the agency. In some instances, a 
single laboratory may have conducted more than one submitted study. 
During an inspection, OECA's GLP Program inspectors will verify the 
accuracy of a study's GLP compliance statement. GLP inspections can 
take place while OPP is still reviewing a pesticide registration 
application or a petition for a tolerance-setting, or it can take 
place after a pesticide has been registered, or the tolerance has been 
established. Figure 1 summarizes the pesticide registration and 
tolerance-setting process, as well as its relationship to OECA's 
inspection of GLP laboratories. 

Figure 1: The Role of Good Laboratory Practices in the Pesticide 
Registration Process: 

[Refer to PDF for image: process illustration] 

1. Registrant uses in-house laboratory or outside laboratory to 
conduct Good Laboratory Practices (GLP) testing for study. 

2. Registrant compiles studies for a pesticide registration 
application. 

3. Registrant submits application to EPA Office of Pesticide Programs 
(OPP). 

4. [Conditional step] OECA considers laboratories for possible 
inspection: 
OECA inspects laboratory; or: 
OECA does not inspect laboratory. 

5. OPP reviews applications and supporting studies and decides 
if pesticide should be approved. 

6. No: The application; is withdrawn or denied; or: 
Yes: EPA approves registration. 

7. [Conditional step] OPP requests that the Office of Enforcement and 
Compliance Assurance (OECA) inspects a laboratory for GLP compliance; 
Go to step 4. 

Source: GAO analysis of EPA documents. 

[End of figure] 

EPA and FDA have each developed their own GLP standards to address 
problems found with laboratory studies submitted for the agencies' 
review. Investigations by these agencies in the mid-1970s revealed 
that some studies had not been conducted in accordance with commonly 
accepted laboratory practices. For example, according to an industry 
representative, one of the first laboratories to attract regulatory 
and media attention was Industrial Bio-Test Laboratories (IBT), a 
contract toxicological research laboratory that conducted much of the 
U.S. toxicological testing at the time. As a result of EPA's and FDA's 
investigations of IBT, several hundred studies were invalidated 
because of deliberate fraud, and hundreds of chemicals had to be 
retested. Specific findings included poor recordkeeping, testing 
conducted by untrained and unqualified personnel, and data 
fabrication. For example, data were submitted on rats that had 
previously been reported as deceased. As a result, in 1978, FDA 
formulated and published GLP regulations under FFDCA.[Footnote 16] In 
1983, EPA published its GLP standards for pesticide toxicology 
studies, and in 1989, EPA extended the standards' coverage to include 
nearly all research data supporting pesticide registrations under 
FIFRA. The Organisation for Economic Co-operation and Development 
(OECD), which includes more than 30 member countries including the 
United States, published OECD Principles of Good Laboratory Practices 
and OECD Guidelines for the Testing of Chemicals in 1981.[Footnote 17] 

GLP standards cover the proper handling of laboratory test substances, 
equipment maintenance and calibration, testing operations, study 
plans, quality assurance, recordkeeping and reporting requirements, 
and facility management, among other things. 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. Specifically, an EPA inspection would 
determine, among other things, whether the laboratory has a sufficient 
number of rooms or other areas for proper separation of species and 
testing, as well as for the collection and disposal of contaminants 
and waste. 

In 1981, OECD established the Mutual Acceptance of Data program 
designed to obtain international recognition of testing data in 
support of pesticide registrations. As of August 2012, there were 31 
member countries, including the United States, and 5 nonmember 
countries, each participating on a rotating basis in evaluating each 
other's testing programs compared with OECD test guidelines. EPA has 
signed memorandums of understanding with seven countries under the 
Mutual Acceptance of Data Program and has a bilateral agreement with 
China.[Footnote 18] According to EPA documents, U.S. companies seeking 
to sell pesticides in foreign countries and multinational companies 
seeking registration of pesticides to sell in the United States must 
meet two Mutual Acceptance of Data program criteria: (1) the country 
where a study was conducted has a valid and active GLP Compliance 
Monitoring Program and (2) the testing facility (or laboratory) was 
inspected by the country's GLP compliance monitoring authority. Some 
other countries fund their GLP inspections through fee-based systems, 
under which the registrant or laboratory pays a portion or all of the 
inspection costs. For example, according to a European Commission 
official, there are currently 17 European Union member countries that 
charge some type of fee for conducting GLP inspections. According to 
FDA officials, FDA charges user fees for medical and animal product 
application reviews; these fees, together with appropriated funds, 
provide resources that FDA uses for conducting GLP inspections related 
to such products. According to EPA officials, although the agency 
charges fees for review of pesticide applications by OPP, it does not 
charge a fee for OECA's GLP laboratory inspections. 

EPA's GLP inspection process includes three stages: (1) the 
preinspection targeting stage, (2) the inspection stage or on-site 
inspection of the laboratory, and (3) the postinspection stage. 

Preinspection Targeting Stage: 

The preinspection targeting stage includes a series of activities 
performed by inspectors before the actual on-site inspection is 
conducted. OECA's GLP Compliance Monitoring Program usually initiates 
its own inspections by using a targeting module--referred to as the 
"Neutral Scheme Targeting Module"--that automatically searches the GLP 
Program's Laboratory Information and Study Audit (LISA) database to 
target potential studies and pesticide test laboratories. The GLP 
Compliance Monitoring Program selects laboratories for inspection from 
among the population of laboratories that have conducted studies 
submitted to OPP.[Footnote 19] Using the Neutral Scheme Targeting 
Module, the inspector identifies laboratories and applies numerical 
weights to them based on a set of criteria (e.g., the length of time 
since the last inspection, the severity of the last and prior 
inspection findings, and the number of submitted studies conducted by 
the laboratory) to establish a list of potential laboratories to 
inspect. Most laboratories are selected for inspection through the 
Neutral Scheme Targeting Module.[Footnote 20] When laboratories are 
identified for inspection through use of the Neutral Scheme Targeting 
Module, the GLP Program Manager assesses these laboratories to 
determine their eligibility for inspection along with the studies 
selected for audit. The assessment includes performing a preliminary 
review of studies to determine, among other things, whether the 
laboratory is still in business and whether any studies conducted by 
the laboratory have been rejected by OPP in a review of a pesticide 
application. The GLP Program Manager will then prioritize and select 
the laboratories for inspection. Criteria for selection can include 
whether the eligible laboratories are in the same geographic area. The 
inspector determines when the laboratory will be inspected and, 10 
days prior to the inspection, notifies the laboratory of the impending 
inspection. 

Inspections can also be initiated at OPP's request or that of another 
EPA office. For example, as OPP reviews studies, it may have questions 
or problems with the supporting data. In those cases, OPP can request 
that OECA's GLP Program conduct an audit of particular studies and 
inspect the laboratories used for these studies. In addition, 
according to EPA officials, foreign governments can request an EPA 
inspection if a U.S. registrant is applying to use its pesticide in a 
foreign country and that country requires a GLP inspection of the U.S. 
laboratories whose studies are to be used in support of the 
registration. Finally, according to EPA officials, OECA can conduct a 
"for cause" GLP inspection based on a tip or complaint received 
through anonymous phone calls, e-mails or letters about potential GLP 
violations at a laboratory. 

Inspection Stage: 

The inspection stage begins with the OECA inspectors, prior to 
visiting a laboratory, conducting study audits and evaluating the 
laboratory studies submitted to OPP to determine whether they adhere 
to GLP standards. GLP Compliance Monitoring Program inspectors 
previously performed this data audit during the inspection of the 
laboratory. In April 2012, EPA changed its process to have inspectors 
audit studies before inspecting the laboratory to save time spent at 
the laboratory and therefore reduce travel expenses. However, OECA 
officials told us that its inspectors follow the old process if 
appropriate to the situation. The inspectors are also to verify that 
data generated by the laboratory support the conclusions made in the 
study. 

Next, an inspector travels to the laboratory to perform the on-site 
inspection of the laboratory. As part of this inspection, the 
inspector performs a walk-through of the laboratory to gain an 
understanding of its capabilities. The inspector will ask to see and 
review inspection documentation associated with the laboratory, 
including qualifications and responsibilities of laboratory personnel, 
the receipt and storage of test substances, the laboratory's standard 
operating procedures, and animal rooms. The inspector then conducts a 
compliance inspection to gauge the laboratory's current practices and 
procedures by selecting one or two ongoing or recently completed 
studies from the laboratory's master schedule to see whether they 
adhered to GLP standards. The inspector also observes a procedure in 
an ongoing study to determine adherence to standard operating 
procedures, the study plan, and GLP, as well as whether the person 
performing the procedure has the appropriate education and experience. 

Postinspection Stage: 

The postinspection stage involves activities such as preparing an 
inspection report that contains a description of the general nature of 
the inspection and the laboratory being inspected. Report appendixes 
cover the findings from the study audits and the on-site inspection. 
Inspection reports are next reviewed by another GLP inspector to 
ensure the reports are complete and consistent. According to an EPA 
official, the GLP Program Manager then reviews the inspection report 
and assigns one of the following categories to the laboratory as 
specified in the Enforcement Response Policy for FIFRA GLP 
Regulations: (1) no GLP deficiencies noted, (2) minor GLP deviations, 
or (3) major/significant GLP violations. For laboratories given 
ratings in the first two categories, the inspector closes out the 
inspection and enters all the inspection information and the review 
category into the LISA database. The inspector also enters some of 
this information, such as laboratory information, inspection dates, 
number of study audits, and potential deficiencies, into OECA's 
Integrated Compliance Information System (ICIS), which is used for 
OECA-wide compliance reporting results. 

The GLP Program Manager sends a letter to the laboratory and the 
registrant notifying them of the results of the inspection and, in the 
case of any deficiencies, requesting assurances that appropriate 
action will be taken to remedy the deficiencies. In the case of a 
significant violation of the GLP standards that, in the opinion of the 
inspector, may have affected the validity and integrity of studies 
performed at the laboratory, the GLP Program Manager will refer this 
information to OPP for consideration in their decision-making process 
and, if appropriate, to OECA's Office of Civil Enforcement (OCE), 
which develops and prosecutes administrative civil and judicial cases 
and provides legal support for cases and investigations initiated in 
EPA regions. If the violation is criminal in nature, it will be 
referred to OECA's Office of Criminal Enforcement, Forensics and 
Training (OCEFT). The inspection will not be closed until OPP or OECA 
has made a final determination. Figure 2 summarizes the GLP inspection 
process. 

Figure 2: EPA Office of Enforcement and Compliance Assurance (OECA) 
GLP Compliance Monitoring Program's Inspection Process: 

[Refer to PDF for image: process illustration] 

1. Preinspection: 
Laboratories identified and prioritized for inspection: 
* OECA and OPP databases; 
* For cause (tip or complaint); 
* OPP (or other EPA office)/foreign government request. 

2. GLP inspection: 
* Study audit at EPA office; 
* On-site inspection of laboratory. 

3. Postinspection: 
* Inspection report prepared and reviewed. 

No deficiencies: Inspection closed; 
Minor deviations: Inspection closed; 
Major or significant violations: Inspection report sent to OPP, OCE, 
or OCEFT[A]. 

Abbreviations: 
GLP: Good Laboratory Practices; 
OCE: Office of Civil Enforcement; 
OCEFT: Office of Criminal Enforcement, Forensics and Training; 
OECA: Office of Enforcement and Compliance Assurance; 
OPP: Office of Pesticide Programs. 

Source: GAO analysis of EPA documents. 

[A] The GLP Program Manager will refer significant violations of the 
GLP standards to OPP and, if appropriate, to OECA's OCE. If a 
violation is criminal in nature, it will be referred to OECA's OCEFT. 

[End of figure] 

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. Because of resource limitations 
in the GLP Compliance Monitoring Program, OECA prioritizes 
laboratories for GLP inspections based on a set of criteria. 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. OECA officials said that budget cuts, among other 
things, have reduced the number of inspectors and the number of GLP 
inspections that can be performed. 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. 

OECA Inspects Few Laboratories Annually, but Most Laboratories Are Not 
Regularly Inspected for GLP Compliance: 

OECA inspected from 51 to 80 laboratories each year for GLP compliance 
in fiscal year 2009 to fiscal year 2013, but most laboratories were 
not regularly inspected for GLP compliance. During this period, OECA 
inspected about 4 to 6 percent of 1,400 eligible laboratories each 
year, according to EPA data and officials.[Footnote 21] In contrast, 
FDA's GLP compliance program guidance manual states that the program's 
objective is to inspect all eligible nonclinical laboratories 
conducting safety studies that are intended to support applications 
for research or marketing of regulated products approximately every 2 
years.[Footnote 22] Similarly, most member countries under OECD's 
Mutual Acceptance of Data (MAD) agreement conduct inspections of their 
laboratories for GLP compliance every 2 years, according to an OECD 
official we interviewed. 

Some laboratory representatives we surveyed stated that their 
laboratories were not inspected for GLP compliance by EPA from 2008 to 
2013. EPA officials told us they inspect as many laboratories as they 
can, given financial constraints. OECA officials explained that a 
limited number of inspectors and tight budgets have hindered their 
ability to perform more inspections. In fiscal year 2013, according to 
EPA officials, OECA had four GLP inspectors to inspect 1,400 eligible 
laboratories in the United States. OECA officials acknowledged that 
their four inspectors cannot inspect all 1,400 eligible laboratories 
for GLP compliance every 2 years. From fiscal year 2009 to fiscal year 
2013, EPA reduced its GLP Compliance Monitoring Program budget and the 
number of full-time equivalent staff by approximately 50 percent from 
eight to four inspectors. 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. During this same time 
period, the number of studies conducted by laboratories that were 
submitted to OPP has remained relatively constant, except for an 
increase in the number of studies submitted in fiscal year 2010. 
Estimates of the numbers of studies submitted, inspections conducted, 
inspection staff and GLP budget data are shown in table 1. 

Table 1: Number of Pesticide Studies Submitted, Inspections, Full-Time 
Equivalents, and Budget for EPA's Good Laboratory Practices (GLP) 
Compliance Monitoring Program from Fiscal Year 2009 to Fiscal Year 
2013: 

Number of pesticide studies submitted to EPA[A]; 
FY 2009: 7,791; 
FY 2010: 10,093; 
FY 2011: 8,715; 
FY 2012: 8,326; 
FY 2013: 7,123. 

Number of GLP inspections[B]; 
FY 2009: 64[C]; 
FY 2010: 71[C]; 
FY 2011: 51[C]; 
FY 2012: 80[C]; 
FY 2013: 79[C]. 

Number of GLP compliance monitoring program full-time equivalents; 
FY 2009: 8; 
FY 2010: 8; 
FY 2011: 5; 
FY 2012: 4; 
FY 2013: 4. 

GLP program budget; 
FY 2009: $1,415,000; 
FY 2010: $1,021,400; 
FY 2011: $959,500; 
FY 2012: $734,500; 
FY 2013: $702,000. 

Source: GAO analysis of EPA data. 

[A] Multiple studies can, and do, come from the same laboratory. 

[B] These numbers include inspections performed under the Federal 
Insecticide, Fungicide, and Rodenticide Act and exclude inspections 
conducted under the Toxic Substances Control Act. 

[C] Inspection data were taken from EPA's Integrated Compliance 
Information System database because of technical problems EPA has been 
experiencing with the Laboratory Information and Study Audit database 
since July 2011. 

[End of table] 

To increase efficiency and to respond to a reduced budget and 
workforce, as well as to address concerns from industry and the OECD, 
OECA implemented changes to its GLP inspection procedures in fiscal 
year 2012 to try to increase the number of GLP inspections from the 
low of 51 conducted in fiscal year 2011. Under its revised inspection 
procedures, agency officials consider laboratories' geographic 
proximity to each other, as well as other criteria, when selecting 
laboratories to inspect. For example, in February 2013, the agency 
inspected five laboratories located in Oregon and, in March 2013, the 
agency inspected two laboratories in Texas. OECA officials explained 
that grouping laboratory visits geographically saves travel money and 
staff time. In addition, they stated that a change in OECA's 
inspection procedures to allow inspectors to audit studies in EPA 
offices rather than on-site reduced the amount of time that inspectors 
spent at a laboratory. 

Nevertheless, some stakeholders and international officials we 
interviewed expressed concern about the infrequent GLP inspections by 
EPA. Pesticide manufacturers and industry associations told us that if 
laboratories cannot prove GLP compliance to potential clients or to 
countries where their products may be used, their business can be 
negatively affected. According to a senior staff person at one U.S. 
laboratory, in 2011, the Netherlands rejected a study from a U.S.-
based laboratory because the contractor laboratory that conducted the 
study had not been inspected by EPA. This same study had been 
previously submitted to EPA. Following the Netherlands' rejection of 
this study, the laboratory had to repeat the study and subsequently 
contracted with a European-based laboratory to do so. In addition, two 
stakeholders we interviewed said that such rejections by other 
countries could likely increase if U.S laboratories could not show 
that they had a recent GLP inspection. One laboratory representative 
said his laboratory may stop doing GLP testing since many registrants 
require proof of GLP inspections, and his laboratory had not been 
inspected by EPA. In addition, this laboratory representative said 
that if U.S. laboratories cannot show that they have had a GLP 
inspection, registrants may not hire them to conduct studies because 
of the possibility that those studies may be rejected. In our survey 
of laboratories, 5 of 14 respondents reported that EPA could improve 
its implementation of its GLP Compliance Monitoring Program by 
increasing the number and frequency of inspections to prevent these 
business consequences.[Footnote 23] Twelve of 15 respondents from 
laboratories with study data submitted to OPP since fiscal year 2008 
reported that EPA's GLP inspections had a positive effect on their 
business. Nine of the 12 respondents who reported positive effects of 
a GLP inspection indicated that the inspections enabled them to prove 
GLP compliance to their customers, such as U.S. and international 
pesticide manufacturing companies, as well as to other countries' 
governments. 

OECA Prioritizes Laboratories for GLP Inspections, but Data Challenges 
May Negatively Affect Its Targeting Process: 

OECA prioritizes laboratories for GLP inspections, but challenges with 
some of the data used to determine those priorities may negatively 
affect its targeting process. GLP Compliance Monitoring Program 
inspectors use the OPPIN and LISA databases to develop a list of the 
highest priority laboratories to inspect for GLP compliance in a given 
year. Once a list is generated using the Neutral Scheme Targeting 
Module located in the LISA database, OECA officials said they try to 
select laboratories that are geographically near to one another to 
inspect. The information used to develop this priority list is based 
on data transferred from OPPIN to LISA. However, our analysis showed 
that the laboratories' information in these databases was sometimes 
incomplete or inaccurate.[Footnote 24] 

We found that the OPPIN system currently has three categories to 
classify an entity's role in a study: sponsor, performing laboratory, 
or both. These categories do not allow EPA staff to differentiate 
between GLP laboratories and other entities involved in a study. As a 
result, we found some entities were identified in the OPPIN database 
as "performing laboratories," which EPA defines as facilities where a 
study or part of a study is conducted, when in fact they were 
not.[Footnote 25] For example, of the respondents to our survey of 
performing laboratories found in the OPPIN database, six reported that 
they were not a laboratory and did not conduct GLP testing.[Footnote 
26] Of these six, three said they were consultants, two said they 
contract with an outside source for laboratory testing, and one was a 
pesticide manufacturer. We were not able to determine how or why these 
entities were identified as performing laboratories in OPPIN. EPA 
officials told us that if the entity that submits the study puts 
inaccurate information on a study's title page concerning who 
performed the study and where the study was performed, the information 
entered by EPA's contractors into OPPIN will also be inaccurate. EPA's 
documentation describing the Neutral Scheme Targeting of laboratories 
states that the entity's role in a pesticide study determines whether 
it is a candidate for inspection. If entities are inaccurately 
identified in OPPIN as performing laboratories, the Neutral Scheme 
Targeting Module will not consider the correct universe of 
laboratories to inspect and, as a result, inspectors need to do 
additional manual research to verify that the laboratory selected for 
an inspection is indeed an entity eligible for a GLP inspection. 

We also found that address information for some laboratories was 
missing or inaccurate in OPPIN. For example, we found missing address 
information for 23 percent of laboratories listed in OPPIN.[Footnote 
27] In 2008, EPA updated its 1991 guidance to the contractors 
responsible for entering data into OPPIN.[Footnote 28] The updated 
guidance states that the agency wants to capture the physical address 
for each laboratory because OECA uses this information to select 
laboratories for inspection. The guidance acknowledges that 
determining the performing laboratory in published studies is 
challenging, but the goal is to identify where the actual location of 
the research was done. Without accurate address information, there 
could be problems determining where the testing was actually conducted. 

In addition, we found that some laboratory identification numbers were 
not reliable. In its November 1991 guidance, OPP states that 
laboratories should be assigned a unique laboratory identification 
number.[Footnote 29] For example, we found that one laboratory that 
was given a ranking in fiscal year 2013 as second highest priority for 
a GLP inspection had an identification number that was the same as 
four other laboratories in four different states, making it unclear 
which of those five laboratories was actually the one selected for 
inspection. 

The agency maintains two different databases to track GLP inspections, 
ICIS and LISA. The LISA database is used by the GLP Compliance 
Monitoring Program, while the ICIS database is used EPA-wide, 
according to officials. Because of technical problems EPA has been 
experiencing with the LISA database, inspection data have been entered 
only into ICIS since July 2011, according to officials. We reviewed 
inspection data contained in both databases for fiscal year 2008 to 
fiscal year 2013 in an effort to determine the total number of GLP 
inspections OECA conducted, but we were not able to match the 
inspection information contained in the two databases. While LISA uses 
laboratory identification numbers, ICIS does not. As a result, OECA 
may not be able to track if, or when, a specific laboratory had been 
inspected because the systems do not both use identification numbers. 
In addition, the laboratory names are not always the same in the two 
databases. We were also unable to match up the inspections in the two 
databases. Without accurate data on which laboratories have been 
inspected, OECA's Neutral Scheme Targeting Module scoring of 
laboratories most in need of inspection may be inaccurate and, 
therefore, manual research is required to ensure that OECA is 
targeting the laboratories most in need of inspection. 

Based on the incomplete or inaccurate data in ICIS, LISA, and OPPIN, 
it is not always possible for GLP Compliance Monitoring inspectors to 
identify where the testing was conducted without making telephone 
calls to individual laboratories. The data issues also impede the 
agency's ability to efficiently track which laboratories need 
inspecting. The officials said GLP inspectors must spend time manually 
verifying laboratory data before deciding which laboratories to 
inspect. In the absence of reliable data, EPA may not have the data it 
needs to prioritize laboratories to inspect efficiently or effectively. 

OECA Is Considering Other Implementation Approaches to Increase 
Inspections: 

OECA is considering other approaches to address laboratory 
representatives' and others' concerns about infrequent GLP 
inspections, such as using third parties or charging fees 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. In its Budget Adjustment 
Plan, EPA states that OECA will evaluate other implementation 
approaches, such as the use of a third party to conduct GLP 
inspections. 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. 

In 2012, we concluded that federal user fees and charges are generally 
related to some voluntary transaction or request for government goods 
or services beyond what is normally available to the public, such as 
fees for patent applications and customs inspections.[Footnote 30] In 
2012, the federal government collected nearly $300 billion in user 
fees from the public.[Footnote 31] In 2008, we found that well-
designed user fees can reduce the burden on taxpayers to finance those 
portions of activities that provide benefits to identifiable users. 
[Footnote 32] As we mentioned earlier, FDA charges user fees for 
medical and animal product application reviews, and these fees, 
together with appropriated funds, provide resources that FDA uses for 
conducting GLP inspections related to such products. In addition, some 
other countries, such as some that are members of the OECD, fund their 
GLP inspections through fee-based systems, whereby the registrant or 
laboratory pays a portion or all of the inspection costs. 

According to Office of Management and Budget (OMB) Circular A-25, 
every 2 years, agencies should review programs that are not currently 
funded by user fees (such as the GLP program) to determine whether 
fees should in fact be assessed for government services.[Footnote 33] 
Once user fees are implemented, revenue from the fees will be credited 
to the general fund of the U.S. Treasury as miscellaneous receipts 
unless otherwise specified by law.[Footnote 34] Circular A-25 also 
states that it may be appropriate for an agency to request authority 
to retain the fee revenue if the user fees offset the expenses of a 
service that is intended to be self-sustaining. The OMB guidance 
states that agencies are to discuss the results of the biennial fee 
reviews and any resulting proposals in their Chief Financial Officers 
(CFO) Annual Report required by the Chief Financial Officers Act of 
1990.[Footnote 35] In its most recent CFO Annual Report (EPA Agency 
Financial Report) EPA discussed its biennial review of its existing 
user fee programs. However, it did not discuss reviewing the GLP 
program--or any of its other programs that are not currently funded by 
fees--to determine whether fees should be assessed.[Footnote 36] 
Moreover, in March 2014, the EPA Office of Inspector General (OIG) 
reported that EPA did not conduct thorough biennial user fee reviews 
for fiscal year 2008 to fiscal year 2009 and for fiscal years 2010 to 
2011, and it did not review all agency programs to determine whether 
they should assess fees for government services they provided. 
[Footnote 37] Among the OIG's recommendations were that the EPA CFO 
discuss biennial user fee results in the EPA Agency Financial Report, 
coordinate with programs that claimed an exception to charging fees 
and costs and help determine whether fees should be assessed. Without 
assessing the need for user fees, EPA cannot determine whether fees 
could help make the laboratory inspection program self-sustaining. 
[Footnote 38] 

When asked about user fees, representatives of 8 of 12 laboratories 
and pesticide manufacturers told us they would support EPA user fees 
for GLP inspections, and they cited more frequent GLP inspections as a 
possible benefit of such user fees. Representatives from the remaining 
4 laboratories did not support user fees, and some of these expressed 
concern that a user fee system might be burdensome to smaller 
laboratories. However, as we previously reported, the amount of a user 
fee reflects the cost of providing the service, which may differ among 
users.[Footnote 39] 

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 an OPP official, pesticide registration decisions are required by 
statute to be made within 3 to 24 months of receipt of the pesticide 
application. For example, new pesticide products that are identical in 
their uses and formulation to one or more products already registered 
usually require a registration decision within 3 months.[Footnote 40] 
However, the official stated that the GLP Monitoring Program staff 
cannot set up and conduct inspections of many of the laboratories 
involved within those time frames. 

OPP and OECA officials told us that they have historically 
communicated on an informal basis about OPP's inspection priorities 
before a pesticide registration has taken place. These priorities are 
usually based on OPP's review of studies and the concerns that may 
arise from these reviews or about the sponsor or study performer. This 
informal communication generally involves OPP contacting OECA by 
telephone or e-mail to request that certain laboratories be inspected. 
An OPP official told us that the two offices have recently tried to 
make better use of the GLP inspection program in OPP's decision 
making. For example, according to EPA officials, in September 2012, a 
senior OPP official hand-delivered a document to her OECA counterpart 
requesting that (1) several laboratories be considered as priorities 
for GLP inspections in fiscal year 2013; (2) OECA focus its audit of 
studies on those submitted within the last 6 to 12 months when 
performing inspections under the Neutral Scheme Targeting Module in 
fiscal year 2013; and (3) OECA audit specific categories of studies 
that OPP officials considered critical to their pesticide approval 
decisions. An OECA official told us that as of March 2014, OECA 
inspectors had completed all of the eight OPP-requested inspections. 
An OPP official told us that OPP would like to continue to provide 
input to OECA prior to the beginning of each fiscal year to increase 
the opportunity for OPP to react to findings before a product is 
registered. The two offices appear to be communicating and 
prioritizing laboratories for GLP inspections informally, but 
according to an EPA official, there are no documented procedures that 
define the responsibilities of each office in coordinating and 
prioritizing GLP inspections. EPA has stated that formal procedures 
are not needed and that the current method of communication and 
coordination is satisfactory. However, by relying on informal 
coordination mechanisms, OECA and OPP are depending on relationships 
with individual officials to ensure effective coordination, and these 
informal relationships could end once personnel turnover occurs. 
Without documented procedures for effective coordination between the 
two offices, there is no assurance that the two offices will 
consistently coordinate on GLP inspections in the future. Under 
federal standards for internal control, agencies are to clearly 
document internal controls, and the documentation is to appear in 
management directives, administrative policies, or operating manuals. 
[Footnote 41] 

When OECA's GLP inspectors find deficiencies at a laboratory, they 
share the inspection reports with major or significant violations with 
OPP. According to OPP officials, once OPP receives the OECA inspection 
report, it sends it to the OPP registration division responsible for 
the registration (or pending registration) of products being supported 
by the studies audited. The OPP registration division then reviews the 
report and conducts a scientific reexamination of the studies that the 
laboratory in question conducted and that were submitted in support of 
the pesticide registration. Once OPP finishes its reexamination, if it 
finds that deficiencies affect a study's findings, OPP is to reject 
the study and may request that the registrant repeat the study, submit 
other materials that support that aspect of the registration, or 
perform other corrective action deemed satisfactory to OPP. After the 
reexamination is complete, OPP informs both OECA's GLP Compliance 
Monitoring Program and the registrant of the outcome. 

We found that, from fiscal year 2008 to fiscal year 2012, OECA GLP 
inspectors referred for reexamination the inspection results from 26 
laboratories and 73 studies to OPP. Table 2 lists the action taken by 
OPP as a result of its reexamination of studies, as of March 2014. 

Table 2: Actions by EPA's Office of Pesticide Programs Based on Good 
Laboratory Practices (GLP) Inspection Results, Fiscal Year 2008 to 
Fiscal Year 2012: 

Action: Requested study be repeated; 
Number of Studies: 26. 

Action: Rejected study and sponsor voluntarily canceled or voluntarily 
suspended registration; 
Number of Studies: 4. 

Action: No action needed; 
Number of Studies: 20. 

Action: Review of study still pending; 
Number of Studies: 23. 

Action: Total; 
Number of Studies: 73. 

Source: GAO analysis of EPA data. 

[End of table] 

Our analysis of EPA data shows that this review process, from the 
initial OECA GLP inspection to completion of OPP's reexamination, 
takes on average about 2 years (see table 3). 

Table 3: Average Time from EPA's Office of Compliance and Assurance's 
(OECA) Good Laboratory Practices (GLP) Inspection of Laboratory to 
EPA's Office of Pesticide Program's (OPP) Review of Inspection's 
Impact on Laboratory's Study, Fiscal Year 2008 to Fiscal Year 2012: 

Completed reviews (of 50 studies): 
Average time from start date of OECA's GLP inspection of a laboratory 
to referral of inspection results to OPP; 
Average days: 352; 
Average months[A]: 11. 

Completed reviews (of 50 studies): 
Average time from date OECA referred inspection results to OPP to when 
OPP completed its review of inspection results' impact on laboratory's 
study; 
Average days: 446; 
Average months[A]: 14. 

Completed reviews (of 50 studies): 
Reviews still pending (of 23 studies): Average time from start date of 
OECA's inspection to date OPP completed review of study; 
Average days: 798; 
Average months[A]: 26. 

Reviews still pending (of 23 studies); 
For those reviews that are still pending, average time from date of 
OECA GLP inspection to March 24, 2014; 
Average days: 1,066; 
Average months[A]: 34. 

Source: GAO analysis of EPA data. 

Note: Totals may not sum due to rounding. 

[A] Average months were determined by dividing the average days by 31. 

[End of table] 

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. For example, according to data 
provided by an OPP official, in fiscal year 2012, 15 studies 
associated with an already registered pesticide product were found to 
be "unacceptable" based on OECA inspection information. For 10 of 
these studies, EPA informed the registrants that they needed to repeat 
the study. For the 5 others, the registrant voluntarily canceled or 
suspended its registration associated with the study, or the study was 
not a deciding factor in the products registration and therefore EPA 
took no further action. In addition, OPP has required that an efficacy 
claim be removed from the label of a registered product based on a 
study submitted by a laboratory not meeting GLP standards. 

OPP officials explained that a single study is not likely to affect 
the denial or approval of a pesticide registration because OPP usually 
bases its registration decisions on more than one study (although OPP 
officials noted their decision depends on, among other things, the 
type of study). For example, according to OPP officials, some 
pesticides are the subject of more than 30 different studies before a 
decision is made on registration. However, these same officials stated 
that OPP believes that the GLP inspections are valuable not only to 
alert OPP to issues with study data and laboratories but to act as a 
deterrent to guard against the improper conduct of studies and 
submission of fraudulent or incorrect study data. According to OECA 
officials, GLP inspections often lead to positive action being taken 
by laboratories and pesticide registrants. They said that registrants 
have voluntarily withdrawn studies from OPP as a direct result of 
inspection notifications and inspection findings. 

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. 
[Footnote 42] In 1984, EPA and FDA entered into an interagency 
agreement to collaborate on GLP inspections that was last renewed in 
2004. Under the agreement, the two agencies agreed to collaborate in 
monitoring testing laboratories' adherence to GLP regulations, as well 
as in auditing of health-related toxicological test reports and 
related laboratory records. The agencies also agreed to exchange 
information and coordinate actions concerning active investigations, 
regulation correspondence, and legal or administrative action being 
considered against any laboratory covered under the agreement. Among 
FDA's responsibilities under the agreement was to conduct a certain 
number of on-site inspections of laboratories identified by EPA. From 
2000 to 2007, FDA conducted a total of nine inspections identified by 
EPA (three in 2000; three in 2001; and one each in 2002, 2005, and 
2007).[Footnote 43] 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. FDA also 
shifted from having its Office of Regulatory Affairs select 
laboratories for inspection to a more decentralized system, whereby 
its centers select laboratories for inspection, which made it more 
difficult for EPA to learn which laboratories FDA plans to inspect 
because it has to coordinate with multiple centers instead of the 
Office of Regulatory Affairs, according to EPA officials.[Footnote 44] 
EPA officials also said the last year FDA sent EPA a list of 
laboratories it planned to inspect was in 2007. They explained that, 
in the past, when EPA knew which laboratories FDA was going to 
inspect, it would ask FDA to audit a study for them and would avoid 
going to the same laboratory in the same year as FDA. However, since 
these meetings ended, EPA officials said that they do not always know 
if a laboratory was already inspected by FDA until they arrive on-
site. If EPA knew in advance that a laboratory was inspected by FDA 
recently, EPA inspectors could use FDA's inspection results to inform 
their decision regarding whether conducting their own inspection was 
necessary. If FDA's inspection results were sufficient for EPA's 
purposes, EPA inspectors could potentially select a different 
laboratory to inspect in place of the one recently inspected by FDA, 
thereby extending limited resources. It is important to note, however, 
that, in some circumstances, it may be necessary for both agencies to 
inspect the same laboratory. 

EPA officials stated that they occasionally coordinate with one of 
FDA's centers on GLP inspections and stated that the two agencies 
performed a joint GLP inspection in 2013. In addition, EPA and FDA 
officials also said that both agencies participate in an FDA-led work 
group focusing on the modernization of laboratories. 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. This coordination also could increase the 
number of laboratories that are inspected for GLP compliance, which in 
turn would help ensure that the study data submitted for pesticide 
registrations were generated in accordance with GLP regulations. 
However, the agencies do not regularly collaborate on or communicate 
about future inspections or share results from completed inspections. 

FDA conducts two types of laboratory inspections, surveillance 
inspections, which are periodic, routine determinations of a 
laboratory's compliance with GLP regulations and include a facility 
inspection and study audit, and directed inspections, which are 
inspections assigned to achieve a specific purpose, such as verifying 
the reliability, integrity, and compliance of critical safety studies. 
Because the two agencies do not regularly share GLP inspection-related 
information, we found that EPA and FDA may be duplicating each other's 
work in some of their GLP inspections. For fiscal year 2005 to fiscal 
year 2012, EPA and FDA conducted a total of 170 GLP inspections of the 
same 37 laboratories.[Footnote 45] In 38 of the 170 inspections, the 
agencies inspected the same laboratory during the same fiscal year 
(see appendix III). For example, EPA inspected a Colorado laboratory 
in November 2011, and FDA conducted a surveillance inspection of this 
same laboratory 7 months later in June 2012. Similarly, although EPA 
inspected a Utah laboratory in January 2012, FDA conducted a 
surveillance inspection of this same laboratory 5 months later, in 
June 2012. According to EPA and FDA officials, the GLP standards of 
the two agencies upon which these inspections are based are largely 
similar. Moreover, a senior official in OECA's GLP Compliance 
Monitoring Program and representatives from three laboratories that 
were inspected by both EPA and FDA told us that the inspections were 
comparable. 

We also found that there is some degree of overlap in the laboratories 
that are eligible for inspection by the two agencies.[Footnote 46] 
Some laboratories covered by GLP regulations conduct tests yielding 
data that will be submitted to only EPA, but we found that other 
laboratories conduct tests for review by both EPA and FDA and are, 
therefore, eligible for inspection by both agencies. FDA officials 
told us 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 we interviewed, however, told us 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 us 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. In addition, in our survey, 5 of 19 respondents 
indicated that their facility conducted tests or studies intended for 
review by both EPA and FDA. FDA officials told us that there has been 
no recent communication between the two agencies on which laboratories 
they plan to inspect and what they may have found at inspections that 
were conducted, although they have communicated this information in 
the past. FDA officials said they would welcome a list of inspections 
planned and conducted by EPA. 

EPA and FDA officials said that, at present, they do not share the 
results of completed inspections at facilities that do both EPA and 
FDA-related studies, and they do not have a process in place to 
collaborate on future GLP inspections. As a result, EPA is not 
learning about laboratories that FDA has inspected and at which it may 
have found deficiencies. Similarly, FDA is not learning about the 
results of EPA laboratory inspections. In addition to potentially 
duplicating each others' work, by not collaborating, the two agencies 
are missing opportunities to leverage each other's resources and 
expand their inspection coverage. FDA officials told us it would be 
helpful to know if EPA had inspected a laboratory and that it would be 
particularly useful if EPA shared information if the agency had found 
problems during its inspection. EPA officials also said collaborating 
and communicating on inspections would be helpful. 

In April 2013, we concluded that when executive branch agencies carry 
out activities in a fragmented and uncoordinated way, the resulting 
patchwork of programs can waste scarce funds, confuse and frustrate 
program customers, and limit the overall effectiveness of the federal 
effort.[Footnote 47] The federal government uses a range of mechanisms 
to implement interagency collaboration, such as interagency groups, 
and interagency agreements and memorandums of understanding.[Footnote 
48] Key practices state that agencies that articulate their agreements 
in formal documents can strengthen their commitment to working 
collaboratively.[Footnote 49] Written agreements are most effective 
when they are regularly updated and monitored. As we concluded in 
April 2013, where federal programs or activities are fragmented, 
overlapping, or duplicative, there are opportunities for agencies to 
improve the efficiency and effectiveness of government programs and 
activities.[Footnote 50] Moreover, without leveraging its inspection 
resources with FDA, EPA may continue to have difficulty increasing 
annual GLP inspections of laboratories. 

Conclusions: 

OECA has taken some steps to increase the number of GLP compliance 
inspections of laboratories conducting studies submitted to EPA for 
pesticide registration. However, OECA officials acknowledge that their 
four inspectors cannot inspect all 1,400 eligible laboratories for GLP 
compliance every 2 years, a time frame used by many of the countries 
that are members of OECD's MAD agreement. Because some laboratories 
have never had a GLP inspection, laboratory and industry 
representatives expressed concern that if OECA continues to inspect so 
few laboratories for GLP compliance, U.S. laboratories and 
manufacturers will be less competitive with foreign laboratories and 
manufacturers. In addition, with so many laboratories going 
uninspected, EPA may not have full assurance of the quality and 
integrity of data used to make pesticide registration decisions. 

OECA officials told us that they have informally discussed the 
possibility of instituting user fees for the GLP program, but EPA has 
not conducted a formal evaluation of GLP user fees as directed by OMB 
guidance for programs not currently funded by such fees and, as 
recommended by EPA's OIG. OECA might be able to increase the number of 
inspections it conducts if it were to charge a fee, which may be used 
to fund GLP inspections, as FDA does, and as do 17 European countries. 
Without assessing its authority and need for user fees, EPA cannot 
determine whether fees could make the laboratory inspection program 
self-sustaining. In addition, we found that the information in EPA 
databases used by OECA to set priorities for laboratory inspection is 
sometimes incomplete or inaccurate. In the absence of reliable data, 
EPA may not have the data it needs to prioritize laboratories to 
inspect efficiently or effectively. 

We commend OECA and OPP staff for communicating with each other on GLP 
inspection matters, including OECA consideration of OPP's recent steps 
to identify laboratories that OPP considers to be priorities for GLP 
inspections. Considering OPP's request is important because most OECA 
inspections currently take place after OPP has made its registration 
decisions. However, EPA does not have documented procedures that 
define the responsibilities of each office in coordinating and 
prioritizing laboratories for GLP inspections consistent with federal 
standards of internal control. Without such procedures, there is no 
assurance that the two offices will consistently coordinate on GLP 
inspections in the future. 

Furthermore, because EPA and FDA do not regularly share inspection-
related information, as they did when they had an agreement to 
collaborate on GLP inspections, the agencies have inspected some of 
the same laboratories since 2007, while other laboratories may have 
gone without needed inspections. 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. Officials from both agencies said that collaborating and 
communicating on inspections would be helpful. However, 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. 

Recommendations for Executive Action: 

We are making four recommendations in this report. 

To improve the OECA GLP inspection process, we recommend that the EPA 
Administrator take the following three steps: 

1. Assess the authority and need for a fee-based inspection system, 
and if such a system is warranted, establish a user fee system, 
seeking additional legislative authority, if necessary, to make the 
laboratory inspection program self-sustaining. 

2. Direct OECA and OPP to ascertain the exact causes of inaccurate and 
incomplete data in its databases and take action to ensure that the 
data, such as identification of performing laboratories and inspection 
history, are accurately recorded. 

3. Direct OECA and OPP to develop documented procedures to coordinate 
and prioritize laboratories for inspections. 

In addition, we recommend that the EPA Administrator and the FDA 
Commissioner develop a formal written agreement, such as a memorandum 
of understanding, that 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. 

Agency Comments and Our Evaluation: 

We provided EPA and HHS with a draft of this report for their review 
and comment; EPA provided written comments, which are reproduced in 
appendix IV, and HHS provided written comments, which are reproduced 
in appendix V. 

In its written comments, EPA stated that it agreed with our findings, 
conclusions, and all four of our recommendations. 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. 

In response to our fourth recommendation, EPA agreed to develop 
written procedures that outline how EPA and FDA will collaborate and 
share information on GLP inspections. EPA stated that it did not agree 
that a formal memorandum of understanding between the two agencies was 
necessary. Our recommendation did not prescribe the type of agreement 
the agencies should undertake and offered a memorandum of 
understanding as one example. We agree that written procedures 
developed and agreed to by both EPA and FDA will address the 
recommendation. 

In its technical comments, EPA noted that, while EPA and FDA have 
similar GLP regulations, and in a small number of cases both agencies 
may inspect the same laboratory, EPA does not believe the work is 
duplicative. However, we define duplication in this report as 
occurring when two or more agencies or programs engaged in the same 
activities or provided the same services to the same beneficiaries. We 
continue to believe that there is a possibility of duplication when 
both EPA and FDA are inspecting the same laboratories within a short 
period of time because both agencies provide a similar service to the 
same beneficiaries (ensuring laboratory compliance with GLP through 
facility inspections and study audits). Also in its technical 
comments, EPA acknowledged the problems we found with the databases 
used for targeting GLP inspections but stated that it does not believe 
these problems negatively affect targeting for inspection because OECA 
is able to gather the necessary information manually. While we agree 
that, ultimately, EPA may target the appropriate laboratories for 
inspection through its manual research when the databases are 
inaccurate or incomplete, we believe that the agency's reliance on 
manual research is not as efficient or effective as using databases 
containing accurate information. 

In its written comments, HHS also agreed with our fourth 
recommendation. HHS also reiterated the point that there are 
legitimate reasons why GLP inspections may be conducted by both EPA 
and FDA at a single laboratory within a relatively short period of 
time. For example, when FDA observes significant violations during for 
cause or surveillance inspections, follow-up inspections may be 
required to verify corrective actions. HHS also provided technical 
comments on our report, which we incorporated as appropriate. 

As agreed with your office, unless you publicly announce the contents 
of this report earlier, we plan no further distribution until 30 days 
from the report date. At that time we will send copies to the EPA 
Administrator and the FDA Commissioner, the appropriate congressional 
committees, and other interested parties. In addition, the report will 
be available at no charge on the GAO website at [hyperlink, 
http://www.gao.gov]. 

If you or your staff members have any questions about this report, 
please contact me at (202) 512-3841 or neumannj@gao.gov. Contact 
points for our Offices of Congressional Relations and Public Affairs 
may be found on the last page of this report. GAO staff who made key 
contributions to this report are listed in appendix VI. 

Sincerely yours, 

Signed by: 

John Neumann: 
Acting Director, Natural Resources and Environment: 

[End of section] 

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. To address these 
objectives, we reviewed relevant federal statutes and 
regulations,[Footnote 51] EPA program and guidance documents,[Footnote 
52] federal internal control standards,[Footnote 53] Office of 
Management and Budget circulars[Footnote 54], and previous GAO and EPA 
Inspector General reports.[Footnote 55] We also reviewed EPA's fiscal 
year 2011-2015 strategic plan; EPA's fiscal year 2011, 2012, and 2013 
annual agency financial reports; and EPA Office of Enforcement and 
Compliance Assurance (OECA) fiscal year 2012 Budget Adjustment Plan. 
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. Furthermore, we reviewed recent literature related to GLP, 
including information and documents found on the websites of a variety 
of industry, international, environment, and academia organizations, 
and foreign government GLP inspection programs. We interviewed about 
25 representatives from these organizations. We selected these 
individuals based on referrals from EPA, and industry and 
environmental stakeholders. 

To examine to what extent EPA inspects for GLP compliance laboratories 
that test pesticides; and the challenges, if any, EPA faces in doing 
so, we collected and analyzed documentation from OECA officials on its 
GLP inspection process and analyzed EPA laboratory and inspection 
data, the agency's use of this data , and the accuracy and 
completeness of the data. Specifically, we obtained information on how 
OECA determines which laboratories to inspect and how EPA's Office of 
Pesticide Programs Information Network (OPPIN), Laboratory Information 
and Study Audit (LISA), and Integrated Compliance Information System 
(ICIS) databases are used to assist inspectors in making these 
decisions, as well as the type of inspection data that are entered 
into these databases. Regarding inspection data, we requested OECA to 
provide us with several data elements contained in its LISA database 
for the years 2000 to 2013, including name and location of laboratory 
inspected, reason for inspection, number and type of inspections 
conducted, and number and name of studies associated with the 
laboratory inspected. We determined that inspection data were 
sufficiently reliable to present results on the number of inspections 
from fiscal year 2009 to fiscal year 2013 as a range. Since data, such 
as laboratories names and addresses, as well as information on studies 
contained in OECA's LISA database are transferred from OPP's OPPIN, we 
also requested OPP provide information from OPPIN on the number of 
studies associated with performing GLP laboratories from fiscal year 
2008 to fiscal year 2012. We analyzed this study data for accuracy and 
completeness. However, we determined that data for "performing 
laboratories," identification numbers, and addresses were not 
sufficiently reliable to assess the number and location of 
laboratories that had submitted studies to EPA. As a result, we were 
not able to define the universe of laboratories subject to a GLP 
inspection. However, EPA did provide estimates of the number and 
percentage of eligible laboratories that were inspected each year, and 
we used that information in this report. 

To determine the views on EPA's GLP Compliance Monitoring Program, we 
interviewed individuals representing 25 entities, including 
laboratories, pesticide manufacturers, international organizations, 
environmental and health organizations, national and trade 
associations and foreign government GLP programs, which we selected 
based on referrals from various stakeholders and EPA officials. 
Specifically, we spoke with representatives of nine laboratories and 
conducted site visits to four of these laboratories located in 
Maryland and Illinois. We also conducted a Web-based survey of 
performing laboratories. For our survey, we drew a randomly selected 
sample of 80 performing laboratories included in the OPPIN database 
that sent study data to OPP from fiscal year 2010 to fiscal year 2012. 
Because OPPIN does not contain e-mail addresses, we searched for 
laboratories' e-mail addresses and found them for 53 of the 80 
laboratories that we sampled. We sent the Web-based survey to these 53 
laboratories. We obtained responses from 26 laboratories and other 
entities. However, 6 of these 26 respondents stated that they were not 
a laboratory and did not conduct GLP testing. Therefore, we received 
usable survey responses from 20 laboratories. Not all respondents to 
our survey, however, answered every question. Our survey asked if the 
laboratory had conducted GLP testing for EPA or FDA, experienced a GLP 
inspection by EPA, what was the effect of having an inspection, and 
what improvements they thought could be made to EPA's GLP Inspection 
Monitoring Program. The survey results are not generalizeable to all 
laboratories that are covered by the GLP program, but they were 
randomly selected, and the results can provide examples of such 
laboratories' experiences and challenges with GLP inspections. We were 
not able to select a representative sample because some data in the 
OPPIN database was not sufficiently reliable. 

To assess the extent to which OPP uses the information obtained 
through GLP laboratory inspections in its pesticide decision-making 
process, we analyzed relevant documents and databases to determine the 
number of OECA's GLP inspections that produced results that were 
referred to OPP for reexamination, the time it took to conduct these 
reexaminations, and any impact the inspections had on OPP's pesticide 
registration decisions. 

To determine the extent to which EPA and FDA collaborate on 
inspections, we analyzed EPA and FDA GLP laboratory inspection data 
and determined that the inspection data were sufficiently reliable for 
our purposes. We also analyzed the 20 laboratory survey responses to 
determine if they had conducted GLP tests or studies for submission to 
both EPA and FDA since 2008. We reviewed agency documents, such as a 
1984 agreement entered into by EPA and FDA to cooperate on GLP 
inspections and FDA's Compliance Program Guidance Manual. We 
interviewed EPA and FDA officials, laboratory representatives and 
other stakeholders about the potential for the two agencies to 
collaborate. 

We conducted this performance audit from November 2012 to May 2014 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

[End of section] 

Appendix II: Web-Based Survey to Laboratories: 

GAO Survey on EPA's Good Laboratory Practices Monitoring Program: 

United States Government Accountability Office: 

Background: 

As you may know, EPA relies on data submitted by pesticide registrants 
as the basis for the agency's regulatory decisions involving pesticide 
product registrations and tolerances. EPA and the Food and Drug 
Administration (FDA) have promulgated Good Laboratory Practices (GLP) 
regulations to assure the quality of data. EPA relies on data 
submitted by registrants as the basis for the agency's regulatory
decisions involving pesticide product registrations and tolerances.

By "your facility," we are referring to the following lab: (Name of 
lab was pre-entered here). 

Lab number: (Lab number was pre-entered here). 

which we understand to be located at: (Lab address was pre-entered 
here). 

1. Since January 2008, has your facility conducted testing or studies 
in accordance with GLP? 
Yes: 
No: 
Don't Know: 

If you selected "Don't know," please explain. 

2. Since January 2008, has EPA performed a GLP inspection of your 
facility? 
Yes: 
No: 
Don't Know: 

2a. If Yes, what effect, if any, did the GLP inspection have on your 
business?
Mostly positive effect: 
Mostly negative effect: 
Neutral effect: 
No effect: 

What were these effects? 

2b. If NO, what effect, if any, did not having a GLP inspection have 
on your business?
Mostly positive effect: 
Mostly negative effect: 
Neutral effect: 
No effect: 

2c. What were these effects? 

If you selected "Don't know," please explain. 

3. In what ways, if at all, do you think EPA could improve its 
implementation of its GLP Compliance Monitoring Program? 

4. Since 2008, were the GLP tests or studies your facility conducted 
intended for review by EPA, FDA or both agencies?
EPA: 
FDA: 
Both agencies: 
Don't Know: 

If you selected "Don't know," please explain. 

5. Which of the following best describes your facility? 
An indoor laboratory: 
An outdoor field site: 
Both an indoor laboratory and an outdoor field site: 
Neither an indoor laboratory nor an outdoor field site: 
Don't Know: 

If you selected "Neither an indoor laboratory nor an outdoor field 
site," please explain. 

If you selected "Don't know," please explain. 

6. Are you ready to submit your final completed survey to GAO?
(This is equivalent to mailing a completed paper survey to us. It 
tells us that your answers are official and final.) 

Yes, my survey is complete - To submit your final responses, please 
click on "Submit" below. 

No, my survey is not yet complete - To save your responses for later, 
please click on "Submit" below. 

You may view and print your completed survey by clicking on the 
Summary link in the menu to the left. 

Thank you very much for your assistance. 

Print: 
Submit: 

[End of section] 

Appendix III: Laboratories Inspected for GLP Compliance by EPA and 
FDA, FY 2005-2012: 

Our analysis of Environmental Protection Agency (EPA) and U.S. Food 
and Drug Administration (FDA) Good Laboratory Practices (GLP) 
inspections data identified the following instances where laboratories 
were inspected by both agencies (see figure 3). We do not know the 
reason for every inspection. In some instances, EPA and FDA may have 
needed to conduct their own inspection. 

Figure 3: Laboratories Inspected for GLP Compliance by EPA and FDA, FY 
2005-2012: 

[Refer to PDF for image: illustrated table] 

Laboratory location: 1. Laboratory in Alabama; 
Fiscal year 2005: FDA, September; 
Fiscal year 2006: EPA, January; 
Fiscal year 2007: FDA,February; 
Fiscal year 2008: None; 
Fiscal year 2009: FDA, August; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: FDA, September. 

Laboratory location: 2. Laboratory in Arkansas; 
Fiscal year 2005: None; 
Fiscal year 2006: FDA, August; 
Fiscal year 2007: None; 
Fiscal year 2008: None; 
Fiscal year 2009: FDA, March; 
Fiscal year 2010: EOA, May; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 3. Laboratory in California; 
Fiscal year 2005: FDA, June
Fiscal year 2006: None; 
Fiscal year 2007: FDA, March; EPA, August; 
Fiscal year 2008: None; 
Fiscal year 2009: FDA, June; 
Fiscal year 2010: EPA, February; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 4. Laboratory in Colorado; 
Fiscal year 2005: EPA, April; 
Fiscal year 2006: None; 
Fiscal year 2007: FDA, March; 
Fiscal year 2008: None; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 5. Laboratory in Colorado; 
Fiscal year 2005: FDA, July; 
Fiscal year 2006: EPA, February; FDA, July; 
Fiscal year 2007: None; 
Fiscal year 2008: None; 
Fiscal year 2009: EPA, December 2008; FDA, September; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 6. Laboratory in Colorado; 
Fiscal year 2005: None; 
Fiscal year 2006: None; 
Fiscal year 2007: None; 
Fiscal year 2008: None; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: EPA, November 2011; FDA, June. 

Laboratory location: 7. Laboratory in Georgia; 
Fiscal year 2005: None; 
Fiscal year 2006: None; 
Fiscal year 2007: None; 
Fiscal year 2008: None; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: EPA, September; 
Fiscal year 2012: FDA, June. 

Laboratory location: 8. Laboratory in Illinois; 
Fiscal year 2005: EPA, October; 
Fiscal year 2006: FDA, November; 
Fiscal year 2007: None; 
Fiscal year 2008: FDA, March and September; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: FDA, February; 
Fiscal year 2012: EPA, June. 

Laboratory location: 9. Laboratory in Illinois; 
Fiscal year 2005: FDA, January; 
Fiscal year 2006: EPA, November; 
Fiscal year 2007: FDA, February; 
Fiscal year 2008: EPA, August; 
Fiscal year 2009: None; 
Fiscal year 2010: FDA, September; 
Fiscal year 2011: EPA, May; 
Fiscal year 2012: None. 

Laboratory location: 10. Laboratory in Kansas; 
Fiscal year 2005: EPA, April; FDA, April; 
Fiscal year 2006: EPA, September; FDA, September; 
Fiscal year 2007: None; 
Fiscal year 2008: EPA, March and April; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 11. Laboratory in Kansas; 
Fiscal year 2005: None; 
Fiscal year 2006: None; 
Fiscal year 2007: None; 
Fiscal year 2008: None; 
Fiscal year 2009: None; 
Fiscal year 2010: EPA, September; 
Fiscal year 2011: FDA, June; 
Fiscal year 2012: None. 

Laboratory location: 12. Laboratory in Maryland; 
Fiscal year 2005: EPA, July; 
Fiscal year 2006: None; 
Fiscal year 2007: None; 
Fiscal year 2008: EAO, June; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: FDA, September; 

Laboratory location: 13. Laboratory in Maryland; 
Fiscal year 2005: FDA, September; 
Fiscal year 2006: None; 
Fiscal year 2007: EPA, February; FDA inspected this lab in September 
2007 on behalf of EPA; 
Fiscal year 2008: FDA, September; 
Fiscal year 2009: None; 
Fiscal year 2010: EPA, July; FDA, August; 
Fiscal year 2011: FDA, January; 
Fiscal year 2012: EPA, September. 

Laboratory location: 14. Laboratory in Massachusetts; 
Fiscal year 2005: FDA, March; 
Fiscal year 2006: EPA, June; 
Fiscal year 2007: None; 
Fiscal year 2008: FDA, December; 
Fiscal year 2009: FDA, April; 
Fiscal year 2010: None; 
Fiscal year 2011: FDA, September; 
Fiscal year 2012: None. 

Laboratory location: 15. Laboratory in Massachusetts; 
Fiscal year 2005: FDA, September; 
Fiscal year 2006: None; 
Fiscal year 2007: None; 
Fiscal year 2008: EPA, August; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 16. Laboratory in Michigan; 
Fiscal year 2005: FDA, August; 
Fiscal year 2006: FDA, May; 
Fiscal year 2007: FDA, April; 
Fiscal year 2008: EPA, May; FDA, September; 
Fiscal year 2009: FDA, November; 
Fiscal year 2010: FDA, June; 
Fiscal year 2011: EPA, December; 
Fiscal year 2012: FDA, August. 

Laboratory location: 17. Laboratory in Missouri; 
Fiscal year 2005: None; 
Fiscal year 2006: EPA, June; FDA, June; 
Fiscal year 2007: None; 
Fiscal year 2008: None; 
Fiscal year 2009: EPA, May; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: FDA, July. 

Laboratory location: 18. Laboratory in Missouri; 
Fiscal year 2005: None; 
Fiscal year 2006: FDA, November; 
Fiscal year 2007: None; 
Fiscal year 2008: FDA, June and August; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: EPA, August; 
Fiscal year 2012: None. 

Laboratory location: 19. Laboratory in Missouri; 
Fiscal year 2005: None; 
Fiscal year 2006: FDA, January; 
Fiscal year 2007: None; 
Fiscal year 2008: None; 
Fiscal year 2009: EPA, September; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 20. Laboratory in New Jersey; 
Fiscal year 2005: EPA, November; 
Fiscal year 2006: FDA, April; 
Fiscal year 2007: EPA, February; 
Fiscal year 2008: None; 
Fiscal year 2009: EPA, January; FDA, September; 
Fiscal year 2010: None; 
Fiscal year 2011: FDA, July; 
Fiscal year 2012: None. 

Laboratory location: 21. Laboratory in New Jersey; 
Fiscal year 2005: FDA, January; 
Fiscal year 2006: FDA, August; 
Fiscal year 2007: None; 
Fiscal year 2008: None; 
Fiscal year 2009: FDA, December; 
Fiscal year 2010: EPA, December; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 22. Laboratory in New Mexico; 
Fiscal year 2005: FDA, February; 
Fiscal year 2006: None; 
Fiscal year 2007: EPA, August; 
Fiscal year 2008: None; 
Fiscal year 2009: FDA, August; 
Fiscal year 2010: EPA, March; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 23. Laboratory in New Mexico; 
Fiscal year 2005: EPA, May; 
Fiscal year 2006: None; 
Fiscal year 2007: FDA, December; 
Fiscal year 2008: None; 
Fiscal year 2009: FDA, August; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 24. Laboratory in North Carolina; 
Fiscal year 2005: FDA, November; 
Fiscal year 2006: EPA, March; 
Fiscal year 2007: FDA, September; 
Fiscal year 2008: None; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: FDA, August. 

Laboratory location: 25. Laboratory in North Carolina; 
Fiscal year 2005: FDA, January; 
Fiscal year 2006: None; 
Fiscal year 2007: FDA, June; 
Fiscal year 2008: EPA, August; 
Fiscal year 2009: None; 
Fiscal year 2010: EPA, September; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 26. Laboratory in Ohio; 
Fiscal year 2005: FDA, March; 
Fiscal year 2006: None; 
Fiscal year 2007: FDA, June; 
Fiscal year 2008: EPA, August; 
Fiscal year 2009: None; 
Fiscal year 2010: EPA, September; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 27. Laboratory in Ohio; 
Fiscal year 2005: None; 
Fiscal year 2006: EPA, September; FDA, February; 
Fiscal year 2007: None; 
Fiscal year 2008: FDA, September; 
Fiscal year 2009: EPA, April; FDA, August (2); 
Fiscal year 2010: FDA, January; 
Fiscal year 2011: None; 
Fiscal year 2012: FDA, April. 

Laboratory location: 28. Laboratory in Ohio; 
Fiscal year 2005: None; 
Fiscal year 2006: None; 
Fiscal year 2007: EPA, August; FDA, March; 
Fiscal year 2008: None; 
Fiscal year 2009: FDA, September; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 29. Laboratory in Ohio; 
Fiscal year 2005: None; 
Fiscal year 2006: None; 
Fiscal year 2007: FDA, October; 
Fiscal year 2008: None; 
Fiscal year 2009: EPA, May; FDA, July; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: EPA, January. 

Laboratory location: 30. Laboratory in Pennsylvania; 
Fiscal year 2005: FDA, December; 
Fiscal year 2006: None; 
Fiscal year 2007: EPA, June; 
Fiscal year 2008: FDA, October; 
Fiscal year 2009: EPA, February; 
Fiscal year 2010: FDA, May; 
Fiscal year 2011: None; 
Fiscal year 2012: EPA, June. 

Laboratory location: 31. Laboratory in Pennsylvania; 
Fiscal year 2005: EPA, August; 
Fiscal year 2006: None; 
Fiscal year 2007: FDA, October; 
Fiscal year 2008: EPA, April; 
Fiscal year 2009: FDA, May; 
Fiscal year 2010: FDA, June; 
Fiscal year 2011: None; 
Fiscal year 2012: None. 

Laboratory location: 32. Laboratory in Pennsylvania; 
Fiscal year 2005: None; 
Fiscal year 2006: FDA, February; 
Fiscal year 2007: EPA, November; 
Fiscal year 2008: None; 
Fiscal year 2009: FDA, June; 
Fiscal year 2010: FDA, August; 
Fiscal year 2011: None; 
Fiscal year 2012: FDA, July. 

Laboratory location: 33. Laboratory in Texas; 
Fiscal year 2005: FDA, September; 
Fiscal year 2006: EPA, December; 
Fiscal year 2007: FDA, January; 
Fiscal year 2008: None; 
Fiscal year 2009: None; 
Fiscal year 2010: EPA, April; FSA, April; 
Fiscal year 2011: None; 
Fiscal year 2012: EPA, September. 

Laboratory location: 34. Laboratory in Utah; 
Fiscal year 2005: FDA, August; 
Fiscal year 2006: None; 
Fiscal year 2007: None; 
Fiscal year 2008: None; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: None; 
Fiscal year 2012: EPA, January; FDA, June. 

Laboratory location: 35. Laboratory in Virginia; 
Fiscal year 2005: FDA, May; 
Fiscal year 2006: EPA, August; 
Fiscal year 2007: FDA, July; 
Fiscal year 2008: FDA, May; 
Fiscal year 2009: EPA, October; FDA, July (2); 
Fiscal year 2010: None; 
Fiscal year 2011: FDA, August; 
Fiscal year 2012: None. 

Laboratory location: 36. Laboratory in Wisconsin; 
Fiscal year 2005: EPA, August; FDA, January; 
Fiscal year 2006: None; 
Fiscal year 2007: FDA, May; 
Fiscal year 2008: FDA, June; 
Fiscal year 2009: None; 
Fiscal year 2010: FDA, August; 
Fiscal year 2011: None; 
Fiscal year 2012: EPA, September. 

Laboratory location: 37. Laboratory in Wisconsin; 
Fiscal year 2005: None; 
Fiscal year 2006: FDA, July; 
Fiscal year 2007: EPA, June; 
Fiscal year 2008: FDA, September; 
Fiscal year 2009: None; 
Fiscal year 2010: None; 
Fiscal year 2011: FDA, May. 
Fiscal year 2012: None. 

Sources: GAO analysis of EPA and FDA data. 

[End of figure] 

[End of section] 

Appendix IV: Comments from the Environmental Protection Agency: 

United States Environmental Protection Agency: 
Washington, DC 20450: 

May 5, 2014: 

Anne Johnson, Assistant Director: 
Natural Resources and Environment: 
U.S. Government Accountability Office: 
Washington. D.C. 20548: 

Re: Comments on draft GAO Report "Pesticide Safety - Improvements 
Needed in EPA's Good Laboratory Practice Inspection Program," GAO-14-
289. 

Dear Ms. Johnson: 

Thank you for the opportunity to review and comment on GAO's draft 
Report "Pesticide Safety: Improvements Needed in EPA's Good Laboratory 
Practice Inspection Program," GAO-14-289. The purpose of this letter 
is to provide EPA's response to your recommendations. This response 
reflects consolidated comments received from the Office of the Chief 
Financial Officer, the Office of Pesticide Programs, the Office of 
General Counsel as well as the Office of Enforcement and Compliance 
Assurance. 

The EPA appreciates GAO's feedback on opportunities to improve the 
Good Laboratory Practice (GLP) inspection program. We generally agree 
with the GAO's findings, conclusions, and recommendations and are 
committed to acting on those recommendations as described below. A
number of detailed technical and editorial comments on various aspects 
of the draft report are also noted in the enclosure. 

GAO Recommendation #1: 

Assess the need for a fee-based inspection system, and if such a 
system is warranted, establish a user fee system. Seeking additional 
legislative authority, if necessary to make the laboratory inspection 
program self-sustaining. 

EPA Response #1: 

EPA agrees to assess the authority and the need for a fee-based GLP 
inspection system. The Office of Enforcement and Compliance Assurance 
(OECA), the Office of Pesticide Programs (OPP), Office of General 
Counsel (OGC) and the Office of the Chief Financial Officer (OCFO)
will assess the authority and the need and feasibility of a fee-based 
inspection system, and, if warranted. begin taking the steps necessary 
to establish such a user fee system. 

GAO Recommendation #2: 

Direct OECA and OPP to ascertain the exact causes of inaccurate and 
incomplete data in the data bases and take action to ensure that the 
data, such as identification of performing laboratories and inspection 
history, are accurately recorded. 

EPA Response #2: 

EPA agrees to ascertain the exact causes of inaccurate and incomplete 
data and to take action to ensure that the data are accurately 
recorded. 

GAO Recommendation #3: 

Direct OECA and OPP to develop documented procedures to coordinate and 
prioritize laboratories for inspections. 

EPA Response #3: 

EPA agrees that OECA and OPP should develop written procedures in the 
coordination and prioritization of GLP inspections. 

GAO Recommendation #4: 

The EPA Administrator and the FDA Commissioner should develop a formal 
written agreement, such as a memorandum of understanding that outlines 
how the two agencies plan to regularly collaborate and share 
information of GLP inspections. EPA does not agree that a formal 
Memorandum of Understanding at the Administrator/FDA Commissioner 
level is necessary. EPA will work with FDA to develop written standard 
operating procedures for collaboration on the GLP program. 

Again, we appreciate the opportunity to review the draft report. 
Please direct any questions regarding our response to Gwendolyn 
Spriggs, at (202) 564·2439. 

Sincerely, 

Signed by: 

Cynthia Giles: 
Assistant Administrator: 

Enclosure: 

[End of section] 

Appendix V: Comments from the Department of Health and Human Services: 

Department of Health And Human Services: 
Office of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

April 30, 2014: 

John Neumann, Acting Director: 
Natural Resources Environment: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, DC 20548: 

Dear Mr. Neumann: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) report entitled, "Pesticide Safety: Improvements Needed in EPA's 
Good Laboratory Practices Inspection Program" (GAO-14-289). 

The Department appreciates the opportunity to review this report prior 
to publication. 

Sincerely, 

Signed by: 

Jim A. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

The Department Of Health And Human Services' (HHS) General Comments To 
GAO's Draft Report "Pesticide Safety: Improvements Needed In EPA's 
Good Laboratory Practices Inspection" (GAO-14-289): 

The Department appreciates the opportunity to review and comment on 
this draft report. 

GAO Recommendation: 

We recommend that the EPA Administrator and the FDA Commissioner 
develop a formal written agreement, such as a memorandum of 
understanding, that 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. 

HHS Response: 

HHS agrees with GAO's recommendation that EPA and FDA develop an 
agreement that could help the two agencies better collaborate and 
share information on GLP inspections and minimize unnecessary GLP 
inspection duplication. HHS recognizes the value of this information-
sharing, is examining how the two agencies can better communicate on 
GLP inspections, and looks forward to collaborating with EPA in the 
future. 

While HHS concurs with GAO's recommendation and recognizes that GAO 
found that EPA and FDA may be duplicating work in some good laboratory 
practices (GLP) inspections, it is important to note that there are 
also legitimate reasons why GLP inspections may be conducted by both 
agencies at a single laboratory within a relatively short period of 
time. FDA and EPA are at times engaged in very different activities 
for unrelated beneficiaries. Although the work to support these 
services may be performed at the same facility, there may be little or 
no overlap of resources. FDA inspections of GLP laboratories may also 
be either surveillance-based or for cause. For-cause inspections focus 
on specific product applications or complaints received by the agency 
and may be limited to a single study or to other limiting factors. 
When a for-cause GLP inspection has been conducted for a specific 
product application and new applications are subsequently received, it 
may be necessary to conduct another inspection within a relatively
short timeframe. In addition, when significant violations are observed 
during surveillance-based or for-cause inspections, follow-up 
inspections may be required to verify corrective actions. Finally, GLP 
inspections are not solely systems type inspections. A major aspect of 
GLP inspections is data validation, which may necessitate multiple 
inspections of laboratories within a relatively short period of time. 

[End of section] 

Appendix VI: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

John Neumann, (202) 512-3841 or neumannj@gao.gov: 

Staff Acknowledgments: 

In addition to the individual named above, Anne K. Johnson, Assistant 
Director; Cheryl Arvidson; Mark Braza; Greg Carroll; Cynthia Grant; 
Angela Miles; and Patricia Moye made key contributions to this report. 
Richard Johnson, Stuart Kaufmann, Anna Maria Ortiz, and Dan Royer also 
made important contributions. 

[End of section] 

Footnotes: 

[1] Act of June 25, 1947, ch. 125, 61 Stat. 163 (codified as amended 
at 7 U.S.C. §§ 136-136y). 

[2] 7 U.S.C. § 136a(a). 

[3] 40 C.F.R. pts. 152-180. 

[4] EPA implements two sets of regulations setting forth GLP standards-
-one under FIFRA, see 40 C.F.R. pt. 160, and one under the Toxic 
Substances Control Act (TSCA), Pub. L. No. 94-469, 90 Stat. 2003 
(1976) (codified as amended at 15 U.S.C. §§ 2601-2697), see 40 C.F.R. 
pt. 792. According to EPA officials, most of its GLP inspections are 
conducted under FIFRA. For that reason, we have focused on GLP 
standards under FIFRA in this report. 

[5] A "laboratory" in this report is defined as a facility where a 
study or part of a study is conducted. A laboratory can conduct its 
testing either indoors or outdoors at a field site. 

[6] EPA regulations define a sponsor as (1) a person who initiates and 
supports, by the provision of financial or other resources, a study; 
(2) a person who submits a study to EPA in support of an application 
for a research or marketing permit; or (3) a testing facility, if it 
both initiates and actually conducts the study. 40 C.F.R. § 160.3. 

[7] We are using the term "audit" to refer to the OECA inspectors' 
examination of studies. 

[8] Act of June 25, 1938, ch. 675, 52 Stat.1040 (codified as amended 
at 21 U.S.C. §§ 301-399f). 

[9] 21 C.F.R. pt. 58. 

[10] 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. We recommended, in part, that EPA consider and 
implement options for an automated system to better track conditional 
registrations. See GAO, Pesticides: EPA Should Take Steps to Improve 
Its Oversight of Conditional Registrations, [hyperlink, 
http://www.gao.gov/products/GAO-13-145] (Washington, D.C.: Aug. 8, 
2013). 

[11] While we received a total of 26 survey responses from our sample 
of laboratories, 6 of the 26 reported that they were not a laboratory 
and did not conduct GLP testing. Therefore, these 6 are considered out-
of-scope for reporting our survey results. See appendix I for more 
detail. 

[12] The phrase "unreasonable adverse effects on the environment" is 
defined in FIFRA, in part, to mean (1) any unreasonable risk to man or 
the environment, taking into account the economic, social, and 
environmental costs and benefits of the use of any pesticide or (2) a 
human dietary risk from residues that result from a use of a pesticide 
in or on any food inconsistent with the standard for tolerance under 
section 408 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 
346a. This standard requires EPA to consider both the benefits and 
risks of using a pesticide. 7 U.S.C. § 136(bb). 

[13] Under section 408 of the 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. 21 U.S.C. § 346a(b)(2)(A)(ii). 

[14] According to OPP officials, applicants for pesticide 
registrations are usually pesticide product manufacturers. When EPA 
registers an applicant's pesticide product, the applicant is then 
called a registrant. For the purposes of this report, we refer to both 
applicants and registrants as registrants. 

[15] 40 C.F.R. § 160.12. 

[16] 43 Fed. Reg. 59,986 (Dec. 22, 1978) (codified as amended at 21 
C.F.R. pt. 58). 

[17] OECD is an organization of 34 industrialized countries, operating 
by consensus, that fosters dialogue among members to discuss, develop, 
and refine economic and social policies and provides an arena for 
establishing multilateral agreements. 

[18] EPA has signed a memorandum of understanding with Canada, 
Germany, Israel, Japan, the Netherlands, Switzerland, and the United 
Kingdom. In addition, EPA has signed a Letter of Intent with China to 
mutually accept each other's GLP Program upon completion of certain 
criteria, and the U.S. Ambassador signed a bilateral agreement with 
Taiwan. 

[19] When pesticide registration application or tolerance level 
petitions are submitted to OPP, contractors enter laboratory data, 
such as laboratory name and address, as well as information on the 
studies submitted with the application, into the Office of Pesticide 
Program Information Network (OPPIN) database. At any given time, LISA 
only contains data submitted to OPP for the previous 5 years. The data 
are transferred to LISA from OPPIN. In contrast to EPA's process, 
officials from other countries told us that their GLP compliance 
monitoring programs select laboratories for inspection before these 
laboratories begin GLP testing. 

[20] Some laboratories are identified for inspection through other 
means, such as complaints submitted. 

[21] According to EPA officials, approximately 1,400 laboratories 
conducted studies that were submitted to EPA over a 5-year time frame 
and are thus eligible for inspection. 

[22] FDA Compliance Program Guidance Manual 7348.808. 

[23] Not all respondents to our survey answered every question. We 
obtained survey responses from 20 laboratories from a 
nongeneralizable, random sample of 53 laboratories, and other entities 
that had sent supporting studies to OPP for a pesticide registration 
application for fiscal year 2010 to 2012 to ask them questions about 
EPA's GLP inspections. Please see appendix I for details. 

[24] We have previously reported issues with inaccurate data in OPPIN. 
In August 2013, we reported that, according to OPP officials, 
following an internal review of its conditional pesticide registration 
program that it completed in March 2011, OPP concluded that the OPPIN 
data on the number of conditional pesticide registrations were 
inaccurate. See [hyperlink, http://www.gao.gov/products/GAO-13-145]. 

[25] In the Pesticide Registration (PR) Notice 2011-3 Standard Format 
for Data Submitted Under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, 
Drug, and Cosmetic Act (FFDCA) published on November 30, 2011, EPA 
instructs study submitters to clearly identify on each study's title 
page the name of the performing laboratory. The guidance does not 
specify that a laboratory's identification number be included on the 
title page but does specify inclusion of a laboratory project 
identifier. 

[26] We received a total of 26 survey responses from our sample of 
laboratories, but 6 of the 26 reported that they were not a laboratory 
and did not conduct GLP testing. Therefore, these 6 are considered out-
of-scope for reporting our survey results. 

[27] Missing address information could include missing data for any of 
the following: street address, city, state, or zip code. 

[28] EPA, Technical Guidance for Citation Building: Extra Hints for 
Coding Laboratories and Sponsors. Apr. 1, 2008. 

[29] EPA, Revised Technical Direction for PDMS Laboratory Indexing. 
Nov. 1991. 

[30] GAO, 2012 Annual Report: Opportunities to Reduce Duplication, 
Overlap and Fragmentation, Achieve Savings, and Enhance Revenue, 
[hyperlink, http://www.gao.gov/products/GAO-12-342SP] (Washington, 
D.C.: February 2012). 

[31] GAO, Federal User Fees: Fee Design Options and Implications for 
Managing Revenue Instability, [hyperlink, 
http://www.gao.gov/products/GAO-13-820] (Washington, D.C.: Sept. 30, 
2013). 

[32] In May 2008, we issued a User Fee Design Guide, which examined 
how the four key design and implementation characteristics--how fees 
are set, collected, used, and reviewed--may affect the economic 
efficiency, equity, revenue adequacy, and administrative burden of the 
fees. GAO, Federal User Fees: A Design Guide, [hyperlink, 
http://www.gao.gov/products/GAO-08-386SP] (Washington, D.C.: May 2008). 

[33] Office of Mgmt. & Budget, Circular No. A-25 Revised, Memorandum 
for Heads of Executive Departments and Establishments (July 8, 1993). 

[34] The rule governing the accounting and disposition of receipts, 
including user fees, states that they must be deposited in the general 
fund of the Treasury as miscellaneous receipts unless the agency has 
statutory authority to do otherwise. 31 U.S.C. § 3302. 

[35] Pub. L. No. 101-576, 104 Stat. 2838 (1990). 

[36] EPA, Fiscal Year 2013 Agency Financial Report. 

[37] EPA Office of Inspector General, EPA Did Not Conduct Thorough 
Biennial User Fee Reviews, 14-P-0129 (Washington, D.C.: Mar. 4, 2014). 

[38] EPA acknowledges that improvements were needed to ensure that all 
agency programs were reviewed, in accordance with OMB Circular A-25, 
"User Charges, Revised," and the Chief Financial Officers Act of 1990. 
According to EPA officials, the agency took actions in Fiscal Year 
2013 to improve its user fee review efforts by issuing a biennial user 
fee review guide, conducting training for its user fee programs, and 
established fee review procedures. 

[39] [hyperlink, http://www.gao.gov/products/GAO-08-386SP]. 

[40] The Pesticide Registration Improvement Act of 2003 (PRIA) 
provides a schedule of covered applications and registration service 
fees, including the category or type of application, the amount of the 
pesticide registration service fee, and the corresponding decision 
review timeframe in which the agency is to make a decision. There are 
189 fee categories or types of applications, each with a fee and 
decision review time frame. Pub. L. No. 108-199, div. G, tit. V, § 
501(f)(2), 118 Stat. 419, 422 (2004) (codified as amended at 7 U.S.C. 
§ 136w-8). 

[41] GAO, Standards for Internal Control in the Federal Government, 
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1] 
(Washington, D.C.: November 1999). 

[42] We have defined duplication as occurring when two or more 
agencies or programs engaged in the same activities or provided the 
same services to the same beneficiaries. 

[43] FDA continued to perform inspections for EPA until 2007, although 
the agreement was not renewed after 2004. 

[44] FDA consists of nine centers and offices. According to FDA 
officials, five of these centers conduct GLP inspections: the Center 
for Biologics Evaluation and Research, the Center for Devices and 
Radiological Health, the Center for Drug Evaluation and Research, the 
Center for Food Safety and Applied Nutrition, and the Center for 
Veterinary Medicine. 

[45] EPA officials provided us with an analysis that identified GLP 
inspections conducted by EPA and FDA at 31 laboratories. We compared 
these 31 laboratories with our analysis that identified 37 
laboratories. We found that EPA's analysis included some additional 
laboratories that we could not find in our analysis. Conversely, EPA's 
analysis excluded some laboratories that were included in our 
analysis, which was based on a review of inspection data provided to 
us by EPA and FDA. 

[46] We have defined overlap as two or more agencies or programs 
engaging in similar activities or providing similar services to 
similar beneficiaries. 

[47] GAO, 2013 Annual Report: Actions Needed to Reduce Fragmentation, 
Overlap, and Duplication and Achieve Financial Benefits, [hyperlink, 
http://www.gao.gov/products/GAO-13-279SP] (Washington, D.C.: April 
2013). 

[48] GAO, Managing for Results: Key Considerations for Implementing 
Interagency Collaborative Mechanisms, [hyperlink, 
http://www.gao.gov/products/GAO-12-1022] (Washington, D.C.: Sept. 27, 
2012). 

[49] GAO, Results-Oriented Government: Practices That Can Help Enhance 
and Sustain Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21, 
2005). 

[50] [hyperlink, http://www.gao.gov/products/GAO-13-279SP]. 

[51] These statutes and regulations include Federal Insecticide, 
Fungicide, and Rodenticide Act, Act of June 25, 1947, ch. 125, 61 
Stat. 163 (codified as amended at 7 U.S.C. §§ 136-136y); Federal, 
Food, Drug, and Cosmetic Act, Act of June 25, 1938, ch. 675, 52 Stat. 
1040 (codified as amended at 21 U.S.C. §§ 301-399f); 21 C.F.R. pt. 58; 
40 C.F.R. pts. 152-180. 

[52] These program and guidance documents included EPA, Good 
Laboratory Practice Standards, Inspection Manual, (Washington, D.C.: 
Sept. 1993); Enforcement Response Policy for the Federal Insecticide, 
Fungicide, and Rodenticide Act, Good Laboratory Practices (GLP) 
Regulations, Sept. 1991. 

[53] [hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1]. 

[54] Office of Mgmt. & Budget, Circular No. A-25 Revised, Memorandum 
for Heads of Executive Departments and Establishments (July 8, 1993). 

[55] [hyperlink, http://www.gao.gov/products/GAO-06-15]; EPA Office of 
Inspector General, EPA Did Not Conduct Thorough Biennial User Fee 
Reviews, 14-P-0129 (Washington, D.C.: Mar. 4, 2014). 

[End of section] 

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