U.S. ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF INSPECTOR GENERAL 

Catalyst for Improving the Environment 

Evaluation Report 

EPA Needs to Comply with the 

Federal Insecticide, Fungicide, 

and Rodenticide Act and 

Improve Its Oversight of Exported 

Never-Registered Pesticides 

Report No. 10-P-0026 

November 10, 2009 
Report Contributors:	 Laurie Adams 

Ganesa Curley 

Jerri Dorsey

 Gabrielle Fekete 

Jeffrey Harris 

Lauretta Joseph 

 Kalpana Ramakrishnan 

Abbreviations 

EPA U.S. Environmental Protection Agency 

FDA Food and Drug Administration 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FPAS Foreign Purchaser Acknowledgement Statement 

FQPA Food Quality Protection Act 

FY Fiscal Year 

GAO Government Accountability Office 

OIG Office of Inspector General 

OPP Office of Pesticide Programs 

USDA U.S. Department of Agriculture 

Cover photo: Ripe tomato on vine. (EPA OIG photo) 
U.S. Environmental Protection Agency 10-P-0026 

November 10, 2009 Office of Inspector General 

At a Glance
 

Catalyst for Improving the Environment 

Why We Did This Review 

We initiated this review to 

evaluate whether the U.S. 

Environmental Protection 

Agency (EPA) has properly 

implemented Federal 

Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) 

Section 17(a) with respect to 

the Foreign Purchaser 

Acknowledgement Statements 

(FPASs), and whether 

controls are in place to ensure 

the safety of imported foods. 

Background 

Pesticides not registered for 

use in the United States may 

be manufactured domestically 

and exported abroad. FIFRA 

Section 17(a) requires that 

before an unregistered 

pesticide is exported, the 

foreign purchaser must sign 

an FPAS acknowledging 

awareness that the pesticide is 

not registered and cannot be 

sold for use in the United 

States. 

For further information, 

contact our Office of 

Congressional, Public Affairs 

and Management at 

(202) 566-2391. 

To view the full report, 

click on the following link: 

www.epa.gov/oig/reports/2010/ 

20091110-10-P-0026.pdf 

EPA Needs to Comply with the Federal Insecticide, 

Fungicide, and Rodenticide Act and Improve Its 

Oversight of Exported Never-Registered Pesticides 

 What We Found 

EPA is not complying with FIFRA Section 17(a) which is, in part, intended to 

notify the government of an importing country that a potentially hazardous 

pesticide was imported into that country. Specifically, EPA does not comply 

with requirements to provide notice to all countries importing unregistered 

pesticides. EPA does not ensure manufacturer compliance with FIFRA Section 

17(a) notification requirements. Consequently, there is no assurance EPA is 

receiving the entire universe of export notifications in any given year. Finally, 

export data on unregistered pesticides are insufficient for tracking and analysis. 

Export notification practices and data requirements are insufficient to monitor for 

the potential re-entry of never-registered pesticides on imported foods or to 

determine whether a dietary risk to U.S. consumers exists. The safety of 

unregistered pesticides intended solely for export is not evaluated by EPA. 

Therefore, the risk associated with never-registered pesticides is unknown. EPA 

does not know the pesticide class, volume, use, or final destination of 

unregistered U.S. pesticide exports. EPA also cannot provide the Food and Drug 

Administration and the U.S. Department of Agriculture with information needed 

to monitor and detect pesticide residues from pesticides that have never been 

registered for use in the United States. Therefore, the extent of dietary risk from 

never-registered pesticide residues on imported foods is unknown. 

 What We Recommend 

We recommend that EPA comply with statutory mandates, implement 

management controls, and establish procedures for identifying and mitigating any 

dietary risk to consumers from never-registered pesticides. 

The Agency stated that it had now checked the specific subset of FPASs 

highlighted in the report. The Agency concluded that since it did not find a 

problem after reviewing these Fiscal Year 2007 FPASs, there is no basis for 

change in procedures or further analysis. The Agency comments were 

nonresponsive to the findings and recommendations. The Agency addressed 

neither its compliance with FIFRA Section 17(a) requirements nor the 

insufficient control process to monitor for potential re-entry of never-registered 

pesticides. All recommendations are undecided. 
 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

INSPECTOR GENERAL 

November 10, 2009 

MEMORANDUM 

SUBJECT: EPA Needs to Comply with the Federal Insecticide, Fungicide, 

and Rodenticide Act and Improve Its Oversight of Exported 

Never-Registered Pesticides 

Report No. 10-P-0026 

FROM: Wade T. Najjum 

TO: Stephen A. Owens 

Assistant Administrator for Prevention, Pesticides and 

Toxic Substances 

This is our report on the subject of the pesticide export evaluation conducted by the 

Office of Inspector General (OIG) of the U.S. Environmental Protection Agency (EPA). 

This report contains findings that describe the problems the OIG has identified and 

corrective actions the OIG recommends. This report represents the opinion of the OIG 

and does not necessarily represent the final EPA position. Final determinations on 

matters in this report will be made by EPA managers in accordance with established 

resolution procedures. 

The estimated cost of this report – calculated by multiplying the project’s staff days by 

the applicable daily full cost billing rates in effect at the time – is $736,223. 

Action Required 

In accordance with EPA Manual 2750, you are required to provide a written response to 

this report within 90 calendar days. You should include a corrective action plan for 

agreed-upon actions, including milestone dates. We have no objections to the further 

release of this report to the public. This report will be available at http://www.epa.gov/oig. 

If you or your staff have any questions regarding this report, please contact me at 

(202) 566-0827; or Jeffrey Harris, Director of Cross-Media Issues, at (202) 566-0831 or 

harris.jeffrey@epa.gov. 

Assistant Inspector General for Program Evaluation 
EPA Needs to Comply with the Federal Insecticide, 10-P-0026 

Fungicide, and Rodenticide Act and Improve Its 

Oversight of Exported Never-Registered Pesticides 

Table of Contents 

Chapters 

1 Introduction ....................................................................................................... 1

 Purpose ....................................................................................................... 1 

Background ................................................................................................ 1 

 Noteworthy Achievements........................................................................... 3 

Scope and Methodology.............................................................................. 3 

2 EPA Is Not Complying With FIFRA Section 17(a) Requirements...................... 4 

Regulation on Exporting Unregistered Pesticides .......................................... 4 

EPA Does Not Determine Manufacturer Compliance with 

 Notification Requirements ....................................................................... 4 

Lack of Compliance with FIFRA Section 17(a) Requirements 

 for Forwarding FPASs ............................................................................. 5 

EPA Has Insufficient Data on U.S. Exports of Unregistered 

 Pesticides ................................................................................................ 6 

Conclusion...................................................................................................... 8 

Recommendations.......................................................................................... 8 

Agency Comments and OIG Evaluation ........................................................ 8 

3 Extent of Risk from Never-Registered Pesticide Residues on 

U.S. Food Imports Is Unknown ............................................................................. 9 

Never-Registered Pesticide Exports May Pose a Potential Risk 

 on Imported Foods .................................................................................. 9 

Federal Monitoring Can Mitigate Risks from Registered and 

 Cancelled Pesticide Residues ................................................................. 10 

FDA and USDA Lack Necessary Information from EPA to Detect 

 Never-Registered Pesticide Residues on Imported Foods...................... 12 

 Conclusion...................................................................................................... 13

 Recommendations.......................................................................................... 13 

Agency Comments and OIG Evaluation ........................................................ 13 

Status of Recommendations and Potential Monetary Benefits................................. 15 

- continued -
EPA Needs to Comply with the Federal Insecticide, 10-P-0026 

Fungicide, and Rodenticide Act and Improve Its 

Oversight of Exported Never-Registered Pesticides 

Appendices 

A Detailed Scope and Methodology........................................................................ 16 

B FIFRA 17(a) Programmatic Logic Model of Additional Controls....................... 19 

C Map of 2007 Leading U.S. Agricultural Import Sources..................................... 20 

D FPASs Received and Forwarded by EPA............................................................ 21 

E Dietary Risk Case Study ....................................................................................... 22 

F Agency Comments................................................................................................ 24 

G Agency Comments and OIG Evaluation.............................................................. 26 

H Distribution ............................................................................................................ 30 
10-P-0026 

Chapter 1

Introduction 

Purpose 

The overall objective of this evaluation was to determine how well the current 

systems of the U.S. Environmental Protection Agency (EPA) assist in preventing 

the entry of unregistered pesticide residues on imported food.1 Specifically, we 

sought to evaluate: 

•	 Has EPA properly implemented the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) Section 17(a) with respect to the 

Foreign Purchaser Acknowledgement Statement (FPAS) requirement? 

•	 Are controls in place to ensure that the imported food supply is not 

vulnerable to unregistered pesticides? 

Background 

On September 30, 1978, Congress amended FIFRA to include export notification 

provisions for pesticides intended solely for export. Pesticides not registered for 

use in the United States may still be manufactured domestically and exported 

abroad, as long as the exporters comply with labeling and notification 

requirements defined under FIFRA Section 17(a). FIFRA Section 17(a) requires 

that before an unregistered pesticide is exported from the United States, the 

foreign purchaser must sign a statement acknowledging an awareness that the 

pesticide is not registered and cannot be sold for use in the United States. The 

pesticide exporter is then required to transmit an FPAS for the pesticide product 

to EPA certifying that the FPAS preceded the initial shipment. FIFRA Section 

17(a) requires EPA to forward copies of all FPASs received to the appropriate 

government officials of the importing countries. 

EPA’s Pesticide Registration Process 

EPA must evaluate any pesticides before they can be marketed and used in the 

United States to ensure that they will meet federal safety standards. EPA must 

also ensure that pesticides registered for use in the United States will not have 

unreasonable adverse effects on humans and the environment. As part of the 

registration process, EPA examines: 

1

 EPA defines a pesticide as any substance intended to destroy, prevent, or repel pests such as insects, weeds, fungi, 

and rodents. This term applies to insecticides, herbicides, fungicides, and various other substances used to control 

pests. 

1 
10-P-0026 

• the active and inert ingredients of a pesticide; 

• the site or crop on which it is to be used; 

• the amount, frequency, and timing of its use; and 

• storage and disposal practices. 

EPA registers pesticide products and their uses on specific pests and under 

specific circumstances. For example, EPA may determine that “Pesticide A,” 

registered for use on apples, may not be used legally on grapes. The safety of 

unregistered pesticides intended solely for export is not evaluated by EPA. 

Before allowing the use of a registered pesticide on a food crop, EPA sets a 

tolerance for that food-pesticide combination. A tolerance is the amount of 

pesticide residue allowed to remain in or on a food commodity.2 Tolerances 

apply to both imported and domestic commodities. Import tolerances may be 

established for pesticides that are not registered for use in the United States but 

are commonly used on foreign commodities. Import tolerances allow pesticide 

residues for pesticides otherwise unregistered for use in the United States to be on 

imported foods destined for domestic consumption. Food commodities with 

pesticide residues that exceed tolerance levels or have residues that are not 

registered for use on that specific commodity are subject to enforcement actions 

by the Food and Drug Administration (FDA). 

Federal Pesticide Monitoring 

Three federal agencies share responsibility for preventing unsafe levels of 

pesticide residues in the Nation’s food supply. EPA determines the safety of new 

pesticides, sets tolerance levels for pesticide residues on foods, and administers 

FIFRA requirements for exporting unregistered pesticides. Except for meat, 

poultry, and certain egg products, for which the U.S. Department of Agriculture 

(USDA) is responsible, FDA enforces tolerances for both imported and domestic 

foods shipped in interstate commerce. FDA’s Pesticide Residue Monitoring 

Program enforces EPA tolerances through selective regulatory pesticide residue 

monitoring. 

FDA enforces EPA-established tolerances through focused regulatory monitoring 

of pesticide residues on food commodities. According to FDA, the goal of FDA’s 

monitoring program is to carry out selective monitoring to achieve an adequate 

level of consumer protection. If residues are found at a level above an EPA 

tolerance, or measurable levels of residues are found on imported foods for which 

EPA has no established tolerance, shipments are refused entry into U.S. 

commerce. 

2

 Tolerances may be established for products or separate active ingredients within a product. 

2 
10-P-0026 

A 2008 report from USDA reviewed FDA’s Import Retrieval Refusal system 

results from 1998-2004.3 USDA reported that vegetables and vegetable products 

had the largest total number of violations. The most frequently cited violation 

was unsafe residue levels. These violations include pesticide residues not 

registered in the United States and residues that exceeded tolerance levels set by 

EPA. In 2002 and 2003, more violations occurred on imported produce for 

unregistered pesticide residues than for residues that exceeded U.S. tolerance 

levels. 

Noteworthy Achievements 

Under FIFRA, EPA is required to cooperate and participate in international efforts 

on pesticide research and regulations. We found that the Office of Pesticide 

Programs (OPP) is engaging in ongoing international efforts contributing to 

developing improved pesticide research and regulations, including: 

•	 Work Sharing and Information Exchange: Collaboration with other 

governments and stakeholders for reviews of new pesticide registrations 

or re-assessments. 

•	 Harmonization of Regulations and Tolerances: Activities to facilitate 

harmonized regulations and tolerances improving the efficiency of 

pesticide evaluation, risk assessment, and managing and regulating new 

and existing pesticides. 

Scope and Methodology 

We conducted this performance evaluation in accordance with generally accepted 

government auditing standards. Those standards require that we plan and perform 

the evaluation to obtain sufficient, appropriate evidence to provide a reasonable 

basis for our findings and conclusions based on our objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based upon our objectives. We performed our evaluation from 

October 2008 through August 2009. 

Our review included examining applicable laws, regulations, and Agency 

guidance. We also reviewed internal controls relevant to our objectives. We 

reviewed the universe of FPASs received for 2007. We met with Agency staff 

and with officials from both the USDA and the FDA, along with other interested 

stakeholders. 

Appendix A provides further details on our scope and methodology. 

3

 Jean C. Buzby, Laurian J. Unnevehr, and Donna Roberts. Food Safety and Imports: An Analysis of FDA FoodRelated Import Refusal Report., EIB-39. U.S. Department of Agriculture, Economic Research Service, September 

2008. 

3 
10-P-0026 

Chapter 2

EPA Is Not Complying with FIFRA Section 17(a) 

Requirements 

EPA is not complying with FIFRA 17(a), which is, in part, intended to notify the 

government of an importing country that a potentially hazardous pesticide has 

been exported and is not registered and cannot be sold for use in the United 

States. EPA does not determine manufacturer compliance with FIFRA Section 

17(a) notification requirements. Consequently, EPA may not be receiving the 

entire universe of export notifications in any given year. EPA has decided not to 

comply with statutory requirements to provide notice to all countries importing 

unregistered pesticides. Export data on unregistered pesticides are insufficient for 

tracking and analysis. 

Regulation on Exporting Unregistered Pesticides 

As discussed in Chapter 1, FIFRA Section 17 addresses exporting unregistered 

pesticides from the United States. FIFRA requires prior notification from the 

manufacturer or exporter to the importer of these pesticides’ unregistered status. 

The pesticide exporter or manufacturer is then required to transmit the FPAS to 

EPA and certify to EPA that the shipment did not occur prior to EPA receiving 

the FPAS. 

FIFRA Section 17(a) requires that EPA forward copies of all FPASs received to 

the appropriate government officials of the importing countries. The intent of this 

section is to notify the government of the importing country that a pesticide 

judged hazardous to human health or the environment, or for which no such 

hazard assessment has been made, was imported into that country. Appendix B 

outlines a logic model that describes these processes and additional controls EPA 

could use to ensure compliance with statutory mandates. 

EPA Does Not Determine Manufacturer Compliance with Notification 

Requirements 

We reviewed EPA’s existing processes governing the receipt of FPASs. Based on 

our review, we found that EPA lacks reasonable assurance that it is receiving the 

universe of FPAS notices in a given year. EPA has a processing guide that 

documents receiving and safeguarding FPASs. However, no procedures are in 

place to determine if manufacturers are submitting all FPASs for unregistered 

pesticide exports as required. According to OPP staff, when OPP receives 

FPASs, it documents receipt and conducts no follow-up. OPP received 2,291 

4 
10-P-0026 

FPASs in 2007. Since OPP does not take any action to verify this information or 

ensure that the filings are comprehensive, this figure could be understated. 

OPP conducts no analysis on the FPASs received from manufacturers because it 

does not believe this exercise would hold sufficient value. EPA has an internal, 

automated system that tracks pesticide-producing establishments and the amount 

of pesticides manufacturers produce on an annual basis. FIFRA requires facilities 

that produce pesticides to register their establishments with EPA and to report 

annually the amount and types of pesticides produced and distributed, including 

the volume and type of all pesticides exported. While EPA could use the export 

production information contained in this system to determine whether OPP is 

receiving all necessary manufacturer data, we found OPP has chosen not to 

conduct any such reconciliation. If OPP conducted such an analysis, it would 

determine whether manufactures are complying with the FIFRA Section 17(a) 

requirement. 

Lack of Compliance with FIFRA Section 17(a) Requirements for 

Forwarding FPASs 

A copy of each FPAS received by EPA is required by statute to be transmitted to 

an appropriate official of the importing country. We found EPA does not forward 

most FPASs received. Rather than comply with the statutory mandate, OPP 

adopted a less rigorous practice. We reviewed the 2007 universe of 2,291 FPASs 

received. We found that only 55 of these FPASs, or less than 3 percent, were 

forwarded to foreign officials. All of the forwarded FPASs were for a particular 

pesticide: the granular formulations of carbofuran. OPP determined that only 

FPASs for these formulations of carbofuran should be forwarded to importing 

countries. 

EPA proposed alternative criteria as substitutes to the FIFRA 17(a) statutory 

mandate in a 1995 white paper, publishing a Notice of Availability for public 

comment in the Federal Register.4 According to this white paper, FIFRA Section 

17(a)’s requirements resulted in too many export notices that “trivialized the 

effect of its export notification system” and cited that the current mandate may be 

of little or no concern to other governments. Despite its concerns with the 

inefficiencies created by compliance with the statute, we found that OPP has not 

directly sought to have Congress amend or modify FIFRA Section 17(a). While 

OPP proposed draft modifications to EPA’s pesticide export notification policies, 

the current practice for forwarding FPASs has never been formalized as an 

Agency policy or criterion. 

In reviewing the FPASs for 2007, we found that EPA did not forward 2,236 

FPASs. Consequently, foreign governments are not receiving all information as 

4

 “Reinventing EPA’s Pesticide Export Notification Program,” September 20, 1995. The intent of this document 

was to improve the system for notifying foreign governments of unregistered pesticide exports from the United 

States. This document was designed as a preliminary proposal to reinvent FPAS procedures. It remains in draft 

form. 

5 
10-P-0026 

required under FIFRA 17(a), leaving them potentially unaware of any hazards 

associated with pesticides imported into their countries. EPA did not forward 

between 1 and nearly 200 FPASs to the appropriate countries. For example, 

while EPA forwarded 4 FPAS notifications on exporting carbofuran to Mexico, 

EPA did not forward 97 other FPASs for 89 pesticide products that were exported 

to Mexico in 2007. Although EPA received 79 and 198 FPASs that identified 

China and Canada as the respective destinations, EPA did not forward any of 

these notifications. 

Figure 2-1 illustrates the relative numbers of FPASs that EPA received and should 

have forwarded to the importing countries. We noted that two of the top six 

importing countries in 2007 where FPASs were not forwarded—Canada and 

Mexico—are also two of the top three sources of U.S. food imports (measured by 

value) in 2007.5 

Figure 2-1: FPASs Received by EPA by Importing Countries in 20076 

Source: OIG analysis of 2007 FPASs received. 

EPA Has Insufficient Data on U.S. Exports of Unregistered Pesticides 

EPA lacks sufficient data on U.S. exports of unregistered pesticide products for 

tracking and analysis. FPASs are required to include the following information: 

5

 See Appendix C for an illustration of the top sources of U.S. food imports in 2007. 

6

 See Appendix D for specific details regarding receipt and forwarding of the 2007 FPASs. 

6 
10-P-0026 

•	 Name, address, and EPA identification number of the exporter; 

•	 Name and address of the foreign purchaser; 

•	 Identity of the product and the active ingredient(s); 

•	 The country or countries of final destination7 (if known) for the export 

shipment; 

•	 A statement that indicates that the foreign purchaser understands that 

the product is not registered for use in the United States and cannot be 

sold in the United States; 

•	 The signature of the foreign purchaser; and 

•	 The date of the foreign purchaser’s signature. 

However, FPASs do not provide the following: 

•	 Quantity or volume, 

•	 Foreign commodity usage, 

•	 Safety procedures, 

•	 Pesticide class, or 

•	 Analytical methods and reference standards for residue detection that 

would be required for regulatory monitoring. 

FPASs are submitted on an annual or first shipment basis. EPA has no means to 

determine the amount of unregistered and never-registered pesticides being 

exported. Pesticides have a variety of potential uses, one of which is to prevent or 

eliminate pests on food crops. However, U.S. exporters do not declare on FPASs 

the intended use of the pesticide product in the importing countries. Therefore, 

EPA lacks the ability to identify food-use pesticides and their usage on foreign 

commodities that may be imported to the United States.8 If FPASs contained 

additional information, EPA could more accurately track and monitor where the 

pesticides are ultimately going, what commodities they are being used for or on, 

and the quantities of unregistered and never-registered pesticides exported. 

In EPA’s 1995 white paper, the Agency documented the consideration of the 

development of a standardized form to both “ease EPA’s data entry and tracking 

burden,” and “improve recipient countries ability to process the information” 

provided on the FPAS. Furthermore, the document discussed expanding the 

information provided on FPASs to include additional information such as: 

•	 Health and safety data; 

•	 Tolerance status, if applicable; 

•	 Hazard classification; and 

•	 Available use information. 

7

 According to OPP, the destination listed on FPASs does not mean that the pesticide product will remain in that 

country because it is possible that the pesticide may be further shipped to other destinations. 8

 See Appendix E for an analysis of EPA’s risk reduction activities for registered food-use pesticides. 

7 
10-P-0026 

However, EPA has not taken necessary steps to collect additional information or 

seek amendment of FPAS data requirements. 

Conclusion 

EPA does not have procedures in place to determine manufacturer compliance 

with FIFRA Section 17(a) notification requirements. Consequently, there is no 

assurance EPA is receiving the entire universe of export notifications in any given 

year. Furthermore, we found that EPA does not comply with FIFRA Section 

17(a) requirements to forward FPASs to all foreign government officials. 

Therefore, the importing countries are not being notified of pesticides not 

registered for use in the United States entering their country. Additionally, EPA 

obtains limited data on U.S. exports of unregistered pesticide products, which 

hinders its ability to track and monitor the export of unregistered pesticides. 

Recommendations 

We recommend that the Acting Assistant Administrator of the Office of 

Prevention, Pesticides and Toxic Substances: 

2-1 Comply with FIFRA Section 17(a) forwarding requirement or seek official 

relief. 

2-2 Develop and implement management controls to ensure EPA is receiving 

FPASs from all manufacturers as required by FIFRA Section 17(a). 

2-3 Develop procedures for reporting FPAS information, including intended 

use information. 

Agency Comments and OIG Evaluation 

The Agency was nonresponsive to the findings and recommendations in this 

chapter. The Agency did not address its noncompliance with FIFRA Section 

17(a) requirements, or the insufficient management control process to monitor the 

export of unregistered pesticides. All recommendations are undecided. The 

Agency’s complete written response is presented in Appendix F. The OIG’s 

evaluation of Agency comments is presented in Appendix G. 

8 
10-P-0026 

Chapter 3

Extent of Risk from Never-Registered Pesticide 

Residues on U.S. Food Imports Is Unknown 

EPA’s current practices are insufficient to monitor for the potential re-entry of 

never-registered pesticides on imported foods or to determine whether a dietary 

risk to U.S. consumers exists. The safety of unregistered pesticides intended 

solely for export is not evaluated by EPA. Therefore, the risk associated with 

never-registered pesticides is unknown. As reported in Chapter 2, EPA does not 

know the pesticide class, volume, use, or final destination for all unregistered U.S. 

pesticide exports. EPA also cannot provide FDA and USDA with information 

needed to monitor and detect pesticide residues from never-registered pesticides. 

Therefore, the extent of dietary risk from never-registered pesticide residues on 

imported foods is unknown. 

Never-Registered Pesticide Exports May Pose a Potential Risk on 

Imported Foods 

Pesticide manufacturers must satisfy a series of EPA data requirements to register 

products for domestic use. However, manufacturers exporting unregistered 

pesticides are not required to provide EPA data regarding product hazard or risk. 

With the globalization of the world’s food supply, some of the produce 

Americans consume comes from foreign sources.9 A potential vulnerability exists 

that imported produce may contain residues of these unregistered pesticide 

exports. However, the degree of the vulnerability due to never-registered 

pesticide exports is unknown. OPP does not receive information such as where 

the pesticide will be used and on what commodity. 

We analyzed the 2,291 FPASs received by the EPA in 2007 and found that nearly 

half (46 percent) were for pesticide products that were never registered for use in 

the United States. For never-registered pesticide products that consist of active 

ingredients contained in registered products but in different formulations, EPA 

may have some human health and environmental hazard data. However, the 

chemical content for some of these pesticides may be unknown because they have 

not been reviewed by EPA. Based on our review of EPA’s FPAS files and 

available product data, we determined that 182 FPASs received by EPA were for 

pesticides with chemical components that were never registered for use in the 

United States.10 

9

 See Appendix C for a map of import sources. 

10 The Agency conducted its own analysis of the 182 FPASs. According to the Agency, while most of these 

chemicals were not registered for use in the United States, they do not constitute an area of concern because the 

FPASs were for products that contained active ingredients that had either been registered by EPA in a different 

9 
10-P-0026 

As described in Chapter 2, manufacturers are not required to provide pesticide 

class, final destination,11 foreign commodity usage, or health and environmental 

risks from never-registered pesticide exports from the data collected on the 

FPASs. These unknowns create gaps in the overall federal pesticide monitoring 

regime. Thirty years ago, the Government Accountability Office (GAO) reported 

on the need to monitor pesticide exports. Specifically, the report concluded: 

The uncontrolled export of hazardous pesticides poses 

dangers to U.S. citizens, as well as to people in other nations. 

The extent of danger, however, is not known, because the 

content, destination, and use of most exports are not monitored.12 

Based on our review, the extent of risk still remains unknown due to the lack of 

information on pesticides that have never been registered for use in the United 

States. An analysis such as the one conducted for the 182 FPASs should be 

conducted for the remaining universe FPASs to fully determine where a risk 

exists. 

Federal Monitoring Can Mitigate Risks from Registered and Cancelled 

Pesticide Residues 

Over time, registered pesticide active ingredients, pesticide products, or certain 

uses of a registered pesticide have been cancelled. These cancellations occurred 

for various reasons, including: 

•	 voluntary cancellation by the registrant, 

•	 cancellation by EPA because required fees were not paid, or 

•	 cancellation by EPA because an unacceptable risk could not be reduced by 

another action.13 

Pesticides that have been cancelled for use cannot be used domestically or on 

imported foods. In addition, pesticides for which EPA has received no data 

regarding hazard or risk (never-registered pesticides) cannot be used in the United 

States but can be manufactured for export.14 Table 3-1 defines the various 

registration statuses for pesticides. 

product formulation and/or had tolerances or specific exemptions from tolerance requirements for residues in food, 

pesticides still in the research and development stage, or products that were not pesticides. Two of the pesticide 

products, while not registered for use in the United States, have active ingredients that have tolerances and have 

been registered for use in the European Union. Our analysis of the Agency’s response is in Appendix G. 11 EPA requests that the final destination be provided, if known. 12 Government Accountability Office. Pesticides: Better Regulation of Pesticide Exports and Pesticide Residues in 

Imported Foods is Essential. GAO/RCED-79-43, June 1979. 13 For example, a large number agricultural, residential, and commercial uses of organophosphate pesticides were 

cancelled by EPA for this reason under the Food Quality Protection Act of 1996 (FQPA). 

14 U.S. pesticide manufacturers may choose not to seek EPA registration for many reasons, including cases where 

the pesticide is used on crops not grown or not commonly grown in the United States, the cost and resources needed 

10 
10-P-0026 

Table 3-1: Registration Status Definitions 

Registration Status Definition 

Registered 

EPA has evaluated the pesticide to ensure that it will 

not have unreasonable adverse effects on humans, 

the environment, and nontarget species. For 

pesticides that may be used on food or feed crops, 

EPA also sets tolerances (maximum pesticide residue 

levels) for the amount of the pesticide that can legally 

remain in or on foods. 

Unregistered 

Cancelled Never-registered 

A pesticide product’s 

registration has been 

removed due to any 

variety of reasons. 

Never-registered 

pesticides have not 

completed EPA’s 

registration process.15 

Source: OIG evaluation of OPP documents. 

EPA cancellations of pesticide products of high risk to infants and children have 

reduced their dietary risk. These EPA regulatory actions have been associated 

with the reduction in cancelled pesticide residues returning to the United States 

from abroad captured through USDA and FDA’s monitoring programs. The 

effectiveness of the federal regulatory systems requires that EPA has sufficient 

product chemistry data to calculate risk and that FDA and USDA have data to 

detect and measure residues. 

In 2006, OIG conducted an analysis of the dietary pesticide residue exposure data 

in the USDA’s Pesticide Data Program. OIG evaluated the impact of the Food 

Quality Protection Act (FQPA) on dietary pesticide exposure risk for children.16 

We found that EPA’s cancellation of the pesticides chlorpyrifos and methyl 

parathion under FQPA reduced 98 percent of the total pesticide dietary risk posed 

by high risk domestic commodities among infants and children in the United 

States.17 

EPA actions on pesticide tolerances under FQPA reduced total pesticide dietary 

risk posed by cancelled pesticides on domestic foods. Primary imported food 

“risk drivers”18 posing the highest dietary risk to infants and children included 

chlorpyrifos on apples, tomatoes, or sweet bell peppers, and methyl parathion 

present on processed green beans. Our review of chlorpyrifos and methyl 

parathion violations cited in FDA’s Pesticide Residue Monitoring Program in 

to complete the registration process are onerous, or the lack of harmonization among different countries’ registration 

processes is confusing or burdensome. 

15 For most never-registered pesticides, EPA lacks information regarding these products’ potential hazard. 

However, never-registered pesticides may share a common active ingredient with other registered pesticide 

products. In this case, EPA would have some information regarding the parent chemical’s toxicity. 

16EPA–OIG. Measuring the Impact of the Food Quality Protection Act: Challenges and Opportunities. Report No.
 

2006-P-00028, August 1, 2006. 

17 Appendix E provides additional details on the case study. 

18 Risk drivers are the pesticide-food combinations of highest risk for consumers. Risk drivers account for the 

majority of dietary exposure risk from a given pesticide. 

11 
10-P-0026 

Fiscal Year (FY) 2006 found no violations for these high-risk, imported pesticidefood combinations. When there is sufficient pesticide product knowledge, EPA 

regulatory actions and the federal residue monitoring system work to capture and 

mitigate risks. 

FDA and USDA Lack Necessary Information from EPA to Detect 

Never-Registered Pesticide Residues on Imported Foods 

EPA lacks sufficient information to inform other federal agencies responsible for 

identifying pesticide residues on imported foods. Specifically, FDA would need 

information such as intended foreign use to determine which imported crops to 

test for pesticide residues. In the case of pesticides that have never been 

registered for use in the United States, FDA would need reference standards19 and 

testing methodologies to determine the presence of these residues. For registered 

products under FIFRA, the manufacturer is required to provide EPA with 

pesticide residue chemistry data. Manufacturers are not required to submit data 

for unregistered pesticides under FIFRA, which prevents FDA from developing 

tests for these residues. 

According to OPP, FDA is responsible for assuring imported foods are free of 

pesticide residues in excess of established tolerances, including those for which 

there are no tolerances. OPP stated that the absence of violations found by FDA 

on imported food validated that the system was working and no problem existed. 

However, FDA does not have the capabilities to detect pesticide residues from 

pesticides that have never been registered for use in the United States. FDA and 

USDA testing has detected unidentifiable residues on imported foods. These 

detections, called unknown analytical responses, may potentially be active 

ingredients from unregistered or never-registered pesticides. The frequency and 

occurrence of these unknown residues on imported foods is not currently tracked 

by these agencies. According to FDA, detection of these responses as neverregistered pesticide residues would require information about the chemical 

content.20 

EPA has not provided necessary guidance and information to FDA and USDA to 

conduct regulatory and dietary risk monitoring for never-registered pesticide 

residues. At a minimum, EPA would need to provide: 

•	 Criteria for when the quantity and composition of a never-registered 

pesticide for export could pose an unreasonable dietary risk, 

•	 The export destination countries and intended foreign pesticide use, and 

19 A reference standard is a pure pesticide sample used for calibrating test equipment for detecting pesticide residue. 20 FDA Pesticide Residue Monitoring Program staff said they would require “firm intelligence” from EPA on the 

never-registered pesticides to be monitored. This intelligence would include the class of pesticide and reference 

standards for residue detection, foreign crop usage, and countries of origin for targeted sampling of imports. 

Additionally, FDA program staff stated that confirmation from EPA that never-registered pesticide residues pose a 

dietary risk would be necessary prior to regulatory monitoring for this specific subset of pesticides. 

12 
10-P-0026 

•	 Analytical testing methods and reference standards for residue 

identification. 

Conclusion 

The extent of danger posed by never-registered pesticides in the food supply 

remains unknown due to the lack of information on their export. Risks posed to 

the U.S. food supply from registered and cancelled pesticides are mitigated 

through EPA tolerance actions and FDA regulatory enforcement. EPA relies on 

FDA to assure that imported foods are free of pesticide residues in excess of 

established tolerances, including those for which there are no tolerances. 

However, EPA lacks sufficient information needed by other federal agencies to 

identify some exported unregistered pesticide residues on imported foods. FDA 

does not have the capabilities to detect pesticide residues from pesticides that 

have never been registered for use in the United States. Manufacturer export data 

submitted to EPA is insufficient to assess human health and environmental 

hazards posed to importing countries or dietary risk posed to the U.S. food supply. 

Limited export notification data fail to capture the quantity, foreign commodity 

usage, and residue detection standards necessary for EPA, FDA, and USDA to 

monitor U.S. never-registered pesticide exports and their potential re-entry on 

imported foods. Consequently, EPA does not know the extent of the associated 

risk. 

Recommendations 

We recommend that the Acting Assistant Administrator of the Office of 

Prevention, Pesticides and Toxic Substances: 

3-1: Establish criteria to govern when the quantity and composition of a neverregistered pesticide for export could pose an unreasonable dietary risk. 

3-2 Establish procedures to mitigate risk from never-registered pesticides, 

including coordinating information with USDA and FDA. 

Agency Comments and OIG Evaluation 

The Agency was nonresponsive to the findings and recommendations in this 

chapter. The Agency questioned the analysis of the 182 FPASs determined to be 

never registered. The Agency conducted a subsequent analysis and concluded 

that while many of these chemicals were not registered for use in the United 

States, they did not constitute a concern because only two were for products that 

did not have a U.S. registration, tolerance, or exemption. The Agency’s analysis 

illustrates our conclusion that the Agency control process does not provide 

assurance that FDA can detect potentially significant risks from unknown 

pesticides that EPA has not evaluated on imported foods. Our conclusion that the 

extent of dietary risk from never-registered pesticide residues on imported foods 

13 
10-P-0026 

is unknown is based on several factors: (1) EPA’s current practices are 

insufficient to monitor for the potential re-entry of never-registered pesticides on 

imported foods or to determine whether a dietary risk to U.S. consumers exists; 

(2) the safety of unregistered pesticides intended solely for export is not evaluated 

by EPA; (3) EPA does not know the pesticide class, volume, use, or final 

destination of all unregistered U.S. pesticide exports; and, (4) EPA cannot provide 

FDA and USDA with information needed to monitor and detect pesticide residues 

from never-registered pesticides. See Appendix F for the Agency’s complete 

written response. The OIG’s evaluation of the Agency comments is presented in 

Appendix G. 

14 
10-P-0026 

Status of Recommendations and 

Potential Monetary Benefits 

POTENTIAL MONETARY 

RECOMMENDATIONS BENEFITS (in $000s) 

Planned 

Rec. 

No. 

Page 

No. Subject Status1 Action Official 

Completion 

Date 

Claimed 

Amount 

Agreed To 

Amount 

2-1 8 Comply with the FIFRA Section 17(a) U Assistant Administrator for 

forwarding requirement or seek official Prevention, Pesticides and 

relief. Toxic Substances 

2-2 8 Develop and implement management U Assistant Administrator for 

controls to ensure EPA is receiving FPASs Prevention, Pesticides and 

from all manufacturers as required by Toxic Substances 

FIFRA Section 17(a). 

2-3 8 Develop procedures for reporting FPAS U Assistant Administrator for 

information, including intended use Prevention, Pesticides and 

information. Toxic Substances 

3-1 13 Establish criteria to govern when the U Assistant Administrator for 

quantity and composition of a never- Prevention, Pesticides and 

registered pesticide for export could pose Toxic Substances 

an unreasonable dietary risk. 

3-2 13 Establish procedures to mitigate risk from U Assistant Administrator for 

never-registered pesticides, including Prevention, Pesticides and 

coordinating information with USDA and Toxic Substances 

FDA. 

1 O = recommendation is open with agreed-to corrective actions pending 

C = recommendation is closed with all agreed-to actions completed 

U = recommendation is undecided with resolution efforts in progress 

15 
10-P-0026 

Appendix A 

Detailed Scope and Methodology 

We conducted this evaluation from October 2008 through August 2009. To address our overall 

objective, we met with Office of Pesticides Programs (OPP) program staff at headquarters, and 

reviewed FIFRA Section 17 policies and procedures currently in place. We reviewed the 

legislative history for FIFRA Section 17(a), as well as proposed changes and amendments to this 

legislation over time, including the Rotterdam Convention. Interviews with staff of an external 

environmental and public health organization and other advocates helped to identify pesticide 

residue concerns from a public perspective. We also met with an industry advocacy group to 

ascertain its opinions on FIFRA Section 17 requirements. We also reviewed past GAO reports 

and publicly available reports and Websites. 

To determine whether controls were in place to ensure the safety of imported foods from 

unregistered pesticide residues, we reviewed FDA food-related import refusals and FDA 

regulatory monitoring violations data for cancelled pesticide residues. We interviewed FDA 

program staff and a USDA program official to determine the role of these federal agencies in 

monitoring pesticide residues on U.S. food commodities and FDA and USDA’s policies and 

practices regarding monitoring unregistered pesticides. 

To identify the universe of FPASs received, we obtained the FPASs held in hardcopy by OPP 

from 2007. We reviewed the hardcopy files as well as an electronic database file of 2007 FPAS 

information. We eliminated any duplicate data. With these documents, we created a searchable 

database of all FY 2007 FPASs to analyze trends, registration statuses, and destinations. We also 

used these data to determine the number of FPASs not transmitted to foreign government 

officials as required under EPA’s current procedures and as required by FIFRA. 

We used Microsoft Excel for all figures and maps. We created maps using the ArcMap 

component of ArcGIS. 

Prior Reports 

The OIG has not published work on exporting unregistered pesticides; international notifications 

of restricted, banned, or suspended pesticides; or EPA’s international efforts on pesticide 

research and regulations. However, the OIG has conducted previous work in pesticide 

regulation, the most recent of which is a series of three reports on EPA's implementation of 

FQPA. A 2006 OIG report using USDA’s Pesticide Data Program data found that risks 

associated with 16 foods commonly eaten by children declined by almost 50 percent due to 

cancellation actions taken by EPA under FQPA. We found risks declined by about two-thirds in 

domestically grown foods in 16 important children’s foods included in our analysis. Between 

FQPA implementation in 1996 and 2003, the average Dietary Risk Index values across the 16 

domestically produced foods declined from 175 to 65, or about 63 percent. 

The GAO issued three reports on exporting unregistered pesticides between 1979 and 1993. The 

following summarizes the major findings from these GAO reports, as well as one by Carl Smith, 

16 
10-P-0026 

Kathleen Kerr, and Ava Sadripour, which focused on U.S. Customs Service data used to track 

pesticide product exports, and a USDA report on violations. 

Government Accountability Office. Pesticides: Limited Testing Finds Few Exported 

Unregistered Pesticide Violations on Imported Foods. GAO/RCED-94-1, October 1993. 

GAO identified 27 unregistered food-use pesticides manufactured in the United States for export 

and linked four unregistered pesticides to FDA-cited tolerance violations. GAO found that it 

was not possible to determine whether all four pesticides responsible for these violations 

originated from U.S. exports due to difficulties in tracking the use and destination of U.S.-

unregistered pesticide exports and foreign production of unregistered pesticides. GAO 

concluded that information gaps and minimal legislative requirements prevent FDA from testing 

for residues from U.S. exports of unregistered pesticides that might be returning to this country 

on imported foods. FIFRA does not require U.S. manufacturers to provide EPA or FDA with 

samples, test methods, or pesticide-use information for unregistered pesticides. 

Government Accountability Office. Pesticides: Exports of Unregistered Pesticides is Not 

Adequately Monitored by EPA. GAO/RCED-89-128, April 1989. 

GAO found that EPA has yet to establish an effective program to determine whether pesticide 

manufacturers are complying with the export notification requirements. EPA does not know 

whether export notices are being submitted as required under FIFRA. EPA does not have 

internal procedures for preparing and issuing notices to foreign countries and international 

organizations when it has taken significant action on a pesticide because of a serious health or 

environmental concern. GAO found that foreign governments may not be alerted to 

unreasonable hazards associated with using particular pesticides. 

Government Accountability Office. Pesticides: Better Regulation of Pesticide Exports and 

Pesticide Residues in Imported Foods is Essential. GAO/RCED-79-43, June 1979. 

Pesticides suspended, cancelled, or never registered for use in the United States because of 

hazards associated with their use or unknown health and environmental risks are exported 

routinely. The EPA in many cases has neither informed other governments of pesticide 

suspensions, cancellations, and restrictions in the United States nor revoked tolerances for 

residues of these pesticides on imported food. The safety and appropriateness of some residues 

allowed on imported food has not been determined. 

Smith, Carl, Kathleen Kerr, MD, and Ava Sadripour. “Pesticide Exports from U.S. Ports, 

2001–2003.” International Journal of Occupational Health 14, No 3:176–86, 

July/September 2008. 

Smith et al.’s analysis of U.S. Customs Service records for 2001-2003 indicates that nearly 1.7 

billion pounds of pesticide products were exported from U.S. ports, a rate of greater than 32 

tons/hour. Exports included greater than 27 million pounds of pesticides whose use is cancelled 

in the United States. World Health Organization Class 1a and 1b pesticides were exported at an 

average rate of greater than 16 tons/day. Pesticide exports included greater than 500,000 pounds 

17 
10-P-0026 

of known or suspected carcinogens, with most going to developing countries; pesticides 

associated with endocrine disruption were exported at an average rate of greater than 100 

tons/day. Although the rate of export of banned products declined, as did exports of pesticides 

included in global conventions on Prior Informed Consent and Persistent Organic Pollutions, 

substantial quantities of hazardous products remain in trade. These products pose unacceptable 

risks in countries where unsafe use and storage practices are prevalent. 

Jean C. Buzby, Laurian J. Unnevehr, and Donna Roberts. Food Safety and Imports: An 

Analysis of FDA Food-Related Import Refusal Reports. EIB-39. U.S. Department of 

Agriculture, Economic Research Service, September 2008. 

This report examines FDA data on refusals of food offered for importation into the United States 

from 1998 to 2004. Although the data do not necessarily reflect the distribution of risk in foods, 

the study found that import refusals highlight food safety problems that appear to recur in trade 

and where the FDA has focused its import alerts, examinations (e.g., sampling), and other 

monitoring efforts. The data show some food industries and types of violations are consistent 

sources of problems, both over time and in comparison with previous studies of more limited 

data. The three food industry groups with the most violations were vegetables (20.6 percent of 

total violations), fishery and seafood (20.1 percent), and fruits (11.7 percent). Violations 

observed over the entire time period include sanitary issues in seafood and fruit products, unsafe 

pesticide residues in vegetables, and unregistered processes for canned food products in all three 

industries. 

18 
10-P-0026 

Appendix B 

FIFRA 17(a) Programmatic Logic Model 

of Additional Controls 

Source: OIG evaluation of OPP documents. 

19 
10-P-0026 

Appendix C 

Map of 2007 Leading U.S. Agricultural Import Sources 

Source: OIG review of USDA data. 

20 
10-P-0026 

Appendix D 

FPASs Received and Forwarded by EPA 

Initial Export FPAS FPAS Initial Export FPAS FPAS 

Destination Country Received Forwarded Destination Country Received Forwarded 

By EPA21 Listed on FPAS By EPA Listed on FPAS By EPA By EPA 

Albania 3 2 Israel 13 0 

Algeria 5 0 Italy 43 0 

Argentina 36 0 Jamaica 5 0 

Aruba 1 0 Japan 53 0 

Australia 52 1 Jordan 2 0 

Austria 29 3 Kenya 16 1 

Azerbaijan 1 0 Kuwait 1 0 

Bahamas 4 0 Lebanon 10 2 

Bahrain 1 0 Macedonia 2 0 

Bangladesh 1 0 Malaysia 11 0 

Barbados 16 0 Mexico 101 4 

Belarus 4 0 Morocco 14 3 

Belgium 23 1 Netherlands 57 4 

Belize 4 1 Netherland Antilles 2 0 

Bolivia 5 0 New Zealand 23 0 Brazil 49 0 Nicaragua 13 0 Bulgaria 1 0 Oman 7 1 Cameroon 6 0 Pakistan 12 0 Canada 198 0 Panama 113 2 Cayman Island 3 0 Paraguay 2 0 Chile 15 0 Peru 19 0 China 79 0 

Colombia Philippines 11 0 32 0 

Congo Poland 12 0 1 0 

Congo, DRC 1 0 Portugal 14 1 

Costa Rica 46 0 Qatar 2 0 

Cote d’Ivoire 9 0 Romania 5 0 

Croatia 1 0 Russia 1 0 

Cyprus 9 2 Saudi Arabia 12 1 

Czech Republic 9 0 Senegal 2 0 

Denmark 2 0 Serbia & Montenegro 8 0 

Dominican Republic 27 1 Singapore 17 0 

Ecuador 64 6 South Africa 18 1

Egypt 8 0 South Korea 29 0

El Salvador 20 0 Spain 25 3 Estonia 11 0 Sri Lanka 3 0 Ethiopia 6 0 Suriname 1 0 Fiji 2 0 Sweden 3 0 France 87 4 Switzerland 139 1 Georgia 7 0 Taiwan 26 0 Germany 97 1 

Ghana Tanzania 1 0 5 2 

Greece 24 1 Thailand 19 0

Guatemala 31 1 Trinidad & Tobago 15 1

Guyana 1 0 Tunisia 5 1 

Honduras 19 1 Turkey 11 0 

Hungary 14 2 Ukraine 20 0 

India 30 0 United Arab Emirates 8 0 

Indonesia 17 0 United Kingdom 172 0 

Iraq 1 0 Uruguay 11 0 

Ireland 2 0 Venezuela 44 0 

Vietnam 5 0 Source: OIG analysis of 2007 FPASs received. 

21 All of the forwarded FPASs were for a particular pesticide: the granular formulations of carbofuran. 

21 
10-P-0026 

Appendix E 

Dietary Risk Case Study 

To demonstrate the potential threat from an unregistered pesticide and the possible vulnerability 

of the U.S. food safety system, we developed a case study based on the previous OIG report, 

Measuring the Impact of the Food Quality Protection Act.

22 We compared 2006 FDA violations 

data to data obtained from the 2007 FPASs to identify U.S. pesticide exports for these pesticide 

products with corresponding FDA import residue violations. We focused on the pesticides 

chlorpyrifos and methyl parathion. 

Toxicity of Chlorpyrifos and Methyl Parathion 

Chlorpyrifos was one of the most widely used insecticides in the United States and was 

commonly found in many home-and-garden insecticides. In June 2000, EPA released a revised 

risk assessment and announced an agreement with registrants to phase out and eliminate certain 

uses of chlorpyrifos. This action eliminated home, lawn, and garden uses by the end of 2000. 

EPA also cancelled the use of chlorpyrifos on tomatoes and restricted its use on apples. 

Methyl parathion is one of the most toxic organophosphate pesticides. EPA’s risk assessment 

showed that methyl parathion posed an unacceptable risk to infants and children. To mitigate the 

high dietary risk to children, EPA accepted voluntary cancellation of the use of this pesticide on 

those crops that contribute most to children’s diets. These cancelled uses represented 90 percent 

of the dietary risk to children, dramatically reducing the estimated dietary risk and thus making 

the risk acceptable for children and all others in the U.S. population. 

Federal Monitoring Can Capture Risks from Cancelled Pesticide 

Residues 

EPA’s cancellation of the organophosphate pesticides chlorpyrifos and methyl parathion under 

FQPA reduced 98 percent of the total pesticide dietary risk among U.S. infants and children. 

Revocation of pesticide tolerances under FQPA shifted risk from domestic to imported foods. 

Our limited analysis of 2006 FDA-reported tolerance violations for chlorpyrifos and methyl 

parathion indicates EPA actions on pesticide tolerances under FQPA are also reducing total 

pesticide dietary risk posed by cancelled pesticide residues on imported foods. 

Chlorpyrifos and methyl parathion violative residues together composed 8 percent (18) of the 

total import violations (217) cited by FDA Pesticide Residue Monitoring Program in FY 2006. 

Twelve of the 14 violative chlorpyrifos residues found were cited for residues with no EPAestablished tolerances for the commodity tested, with the remaining violations for exceeding or 

meeting the level of current EPA tolerances or FDA formal action levels. FDA cited no EPA 

22 EPA–OIG. Details on Dietary Risk Data in Support of Report No. 2006-P-00028, “Measuring the Impact of the 

Food Quality Protection Act: Challenges and Opportunities.” Supplemental Report, August 1, 2006. 

22 
10-P-0026 

established tolerance on the commodity tested for 100 percent of the four violative methyl 

parathion residues detected. 

Primary imported food risk drivers or pesticide-food combinations posing the highest dietary risk 

to infants and children identified under FQPA include chlorpyrifos on apples, tomatoes, or sweet 

bell peppers, and methyl parathion on processed green beans. No FDA violations were cited in 

FY 2006 for these imported pesticide-food combinations. Imported commodities such as spices, 

exotic fruits, and rice not frequently consumed by infants and children were cited by FDA for 

lack of EPA established tolerances. 

Origins of Chlorpyrifos and Methyl Parathion Pesticide Residues on 

Imported Foods Difficult to Trace 

The 1993 GAO report Pesticides: Limited Testing Finds Few Exported Unregistered Pesticide 

Violations on Imported Foods (see Appendix B) identified 27 unregistered food-use pesticides 

manufactured in the United States for export in 1990. In those instances in which FDA Pesticide 

Residue Monitoring Program data cited corresponding violative residues, GAO concluded it was 

not possible to definitively determine whether the United States was the unregistered pesticides’ 

country of origin from available federal records. 

Our review of FPAS export notices submitted to EPA in 2007 identified 13 incidents of U.S. 

exports of chlorpyrifos with reported destinations of Argentina, Canada, Costa Rica, France, 

Germany, South Africa, Taiwan, and the United Kingdom. FDA Pesticide Residue Monitoring 

Program FY 2006 data cited tolerance violations for chlorpyrifos residues on imported 

commodities originating from mainland China, Chile, Colombia, Ecuador, India, Mexico, and 

Pakistan. No U.S. exports of methyl parathion were reported to OPP in 2007. 

Our analysis found that no 2007 U.S.-produced exports of chlorpyrifos correspond with violative 

residues on imported foods. Concurring with previous GAO conclusions, we found that 

establishing the origins of unregistered pesticide residues on imported foods proves difficult for 

two reasons: 

1.	 It is not possible to track the definitive destinations and use (lifecycle) of all U.S.-

produced unregistered exports from available federal records; and 

2.	 Unregistered and never-registered pesticides may be produced in countries other than 

the United States. 

23 
10-P-0026 

Appendix F 

Agency Comments 

MEMORANDUM 

SUBJECT:	 OPPTS' Comments on the OIG's Draft Evaluation Report "EPA Needs to Assess 

the Risk from Never-Registered Pesticides on Imported Foods" 

(Project No. 2008-601) 

FROM: Stephen A. Owens, Assistant Administrator 

Office for Prevention Pesticides and Toxic Substances 

TO: Bill A. Roderick, Acting Inspector General 

Office of Inspector General 

Thank you for the opportunity to comment on the draft evaluation report, dated August 

10, 2009, by the Office of Inspector General (OIG) entitled "EPA Needs to Assess the Risk from 

Never-Registered Pesticides on Imported Foods," Project No. 2008-601. 

From our review of the draft report, it appears that the OIG's conclusions regarding 

possible risks to consumers from imported foods flow from the OIG's analysis of the 2,281 

Foreign Purchaser Acknowledgement Statements (FPASs) of exports filed with OPP in 2007. 

The Federal Insecticide, Fungicide, and Rodenticide Act requires industry to submit FPASs to 

EPA for all exports of pesticide products/formulations not registered for use in the U.S. The 

OIG draft report asserts that of these 2,281 FPASs "182 FPAS received by EPA were for 

pesticides with chemical components that were never registered in the United States. The risk 

associated with these products is unknown because the human and environmental hazards have 

not been evaluated by EPA." 

To verify the accuracy of OIG's data review, OPP conducted a detailed evaluation of the 

182 FPASs in question. OPP's analysis shows a very different factual situation. We share a 

common interest in the report's conclusions being based upon the most accurate information 

available. Therefore, we share the following analysis. OPP found that 180 of these FPASs: 

1.	 were for products containing active ingredients that had either been registered by EPA 

(often of a different product formulation) and/or had tolerances or specific exemptions 

from tolerance requirements for residues in food, or 

2.	 were for pesticides still in the research and development stage, or 

3.	 were not pesticides. 

FPASs are not required for these last two categories. Therefore, of the 182 FPASs cited 

in the draft report, only two were for products with active ingredients that do not have a U.S. 

registration, tolerance, or exemption. These two pesticide products have active ingredients that 

have maximum residue limits (tolerances) and have been registered for use in the European 

24 
10-P-0026 

Union based on an evaluation of the human and environmental hazards. Thus, the OIG's 

conclusion about potentially significant unknown risks from pesticides which EPA has not 

evaluated, and FDA cannot detect on imported foods, is not supported by the available 

information on these exports. 

With regard to the case study in Appendix F, the authors write that they developed this 

case study to "demonstrate the potential threat from an unregistered pesticide and the possible 

vulnerability of the U.S. food supply." OPPTS notes that both pesticides (active ingredients) 

used in this scenario have EPA registrations and tolerances for which we have completed risk 

assessments. Our assessments include consideration of consuming domestic and imported foods 

with residues of these pesticides. 

We believe it would be useful to come to a common understanding of the facts before 

proceeding further with consideration of next steps and determining the most promising way 

forward in terms of enhancing our pesticide/food safety programs. We would be happy to meet 

again with your staff to review our analyses of the data in greater detail together, with the goal of 

reaching agreement on the baseline for future improvements. 

25 
10-P-0026 

Appendix G 

Agency Comments and OIG Evaluation 

MEMORANDUM 

SUBJECT: OPPTS' Comments on the OIG's Draft Evaluation Report "EPA Needs to Assess 

the Risk from Never-Registered Pesticides on Imported Foods" (Project No. 2008-

601) 

FROM: Stephen A. Owens, Assistant Administrator 

Office for Prevention Pesticides and Toxic Substances 

TO: Bill A. Roderick, Acting Inspector General 

Office of Inspector General 

Thank you for the opportunity to comment on the draft evaluation report, dated August 

10, 2009, by the Office of Inspector General (OIG) entitled "EPA Needs to Assess the Risk from 

Never-Registered Pesticides on Imported Foods," Project No. 2008-601. 

OIG Response: The Agency’s comments on the draft report are nonresponsive. The Agency’s 

response does not address the findings and recommendations presented in this report. We 

concluded that EPA is not complying with FIFRA 17(a) which is, in part, intended to notify the 

government of an importing country that a potentially hazardous pesticide has been exported and 

is not registered and cannot be sold for use in the United States. We found EPA does not 

determine manufacturer compliance with FIFRA Section 17(a) notification requirements. 

Furthermore, EPA has decided not to comply with statutory requirements to provide notice to all 

countries importing unregistered pesticides. The Agency’s response does not address these 

findings or the related recommendations. 

From our review of the draft report, it appears that the OIG's conclusions regarding 

possible risks to consumers from imported foods flow from the OIG's analysis of the 2,281 

Foreign Purchaser Acknowledgement Statements (FPASs) of exports filed with OPP in 2007. 

OIG Response: Only a portion of Chapter 3, not the whole report, addresses the possible risks 

to consumers based on the FPAS analysis. The conclusion regarding possible risks to consumers 

from imported foods was based on an analysis of the roles and responsibilities of EPA in 

ensuring the safety of imported foods, as described in Appendix B. Our analysis included a 

review of the universe of the 2,291 FPASs received by EPA for 2007; mining of an internal and 

external database; a review of the federal monitoring program; meetings with FDA, USDA, 

agency staff; and a review of Agency policies and practices. Moreover, Chapter 2 of the report 

addresses Agency noncompliance with the requirements of FIFRA. 

The Federal Insecticide, Fungicide, and Rodenticide Act requires industry to submit 

FPASs to EPA for all exports of pesticide products/formulations not registered for use in the 

26 
10-P-0026 

U.S. The OIG draft report asserts that of these 2,281 FPASs "182 FPAS received by EPA were 

for pesticides with chemical components that were never registered in the United States. The 

risk associated with these products is unknown because the human and environmental hazards 

have not been evaluated by EPA." 

To verify the accuracy of OIG's data review, OPP conducted a detailed evaluation of the 

182 FPASs in question. OPP's analysis shows a very different factual situation. We share a 

common interest in the report's conclusions being based upon the most accurate information 

available. 

OIG Response: OPP’s need to conduct a detailed evaluation to address the 182 FPAS in this 

report illustrates our conclusion that the Agency’s control processes are inadequate. The fact 

that OPP’s subsequent review did not disclose a serious risk is not proof that a risk will never 

exist or that a control process is unnecessary. It only demonstrates that EPA would have been 

unaware if one of the 182 had posed a major risk because of these insufficient control 

mechanisms. 

The assessment the OIG performed on the FPAS universe was completed with information 

available at the time of our review. In assessing product status, we checked OPP's internal 

Office of Pesticide Programs Information Network (OPPIN) database using a variety of different 

search parameters. We also used the external Pesticide Action Network database to confirm our 

results. OPP’s lack of quality assurance and quality control mechanisms for FPAS data caused a 

number of problems in accurately assessing the status for each product. For example, OPP 

reports that some of the 182 FPASs were for nonpesticide products. There apparently were no 

control mechanisms in place to reject FPASs received for nonpesticides. In addition, FPAS 

information lacks data integrity controls to ensure that product names are spelled correctly and 

active ingredients are properly listed. These two data items are imperative to accurately 

assessing product status, and therefore resulted in disparities between our results and OPP’s. 

Therefore, we share the following analysis. OPP found that 180 of these FPASs: 

1.	 were for products containing active ingredients that had either been registered by 

EPA (often of a different product formulation) and/or had tolerances or specific 

exemptions from tolerance requirements for residues in food, or 

2.	 were for pesticides still in the research and development stage, or 

3.	 were not pesticides. 

FPASs are not required for these last two categories. 

OIG Response: The 182 FPASs that OPP refers to are a subset of the 2,291 FPASs received by 

EPA during the calendar year 2007. If many of the 182 FPASs OPP reviewed in response to our 

draft report have now been identified as nonpesticides, that is an indication that the overall 

system is flawed. FIFRA Section 17(a) requires that before an unregistered pesticide is exported 

from the United States, the foreign purchaser must sign a statement acknowledging an awareness 

that the pesticide is not registered and cannot be sold for use in the United States. The pesticide 

exporter is then required to transmit an FPAS for the pesticide product to EPA certifying that the 

27 
10-P-0026 

FPAS preceded the initial shipment. According to OPP, it appears that some of the FPASs may 

be for chemicals that are not pesticides and therefore should not require an FPAS. OPP needs to 

take steps to ensure the process used by manufacturers is meeting the intent of FIFRA, which is 

to notify the government of importing countries that a potentially hazardous pesticide has been 

exported and is not registered and cannot be sold for use in the United States. 

OPP’s analysis further supports our finding that EPA does not determine manufacturer 

compliance with FIFRA Section 17(a) notification requirements. Not only may EPA not be 

receiving FPASs for unregistered pesticides, but some FPASs may be issued for nonpesticides. 

Therefore, the true universe of unregistered pesticides being exported, along with the associated 

risk, is unknown. In addition, EPA is creating an additional burden for itself and foreign 

governments by receiving, cataloging, and potentially forwarding unnecessary FPASs. The 

Agency’s analysis provides significant evidence that an internal review of FPAS data would 

provide both the Agency and external stakeholders with a more accurate depiction of pesticide 

exports. 

Therefore, of the 182 FPASs cited in the draft report, only two were for products with active 

ingredients that do not have a U.S. registration, tolerance, or exemption. These two pesticide 

products have active ingredients that have maximum residue limits (tolerances) and have been 

registered for use in the European Union based on an evaluation of the human and environmental 

hazards. 

OIG Response: As we stated in Chapter 3, the extent of dietary risk from never-registered 

pesticide residues on imported foods is unknown. The unknown risk is due in part to the 

unknown nature of the universe of never-registered pesticides. This type of belated review 

conducted by OPP in response to our draft report is the analysis that would be required for all 

FPASs received in order to fully address the intent of the recommendations in Chapter 3. At the 

time of our evaluation, OPP did not have information on the risk associated with the chemicals 

on the FPASs because reviews such as this were not being conducted. 

Thus, the OIG's conclusion about potentially significant unknown risks from pesticides which 

EPA has not evaluated, and FDA cannot detect on imported foods, is not supported by the 

available information on these exports. 

OIG Response: As discussed previously, OPP’s retrospective evaluation of the 182 FPAS 

demonstrates our conclusion that the Agency’s control processes and environment are deficient. 

We concluded that EPA’s current practices are insufficient to monitor for the potential re-entry 

of never-registered pesticides on imported foods or to determine whether a dietary risk to U.S. 

consumers exists. The safety of unregistered pesticides intended solely for export is not 

evaluated by EPA, and EPA does not know the pesticide class, volume, use, or final destination 

of unregistered U.S. pesticide exports. Consequently, EPA cannot provide FDA and USDA with 

information needed to monitor and detect pesticide residues from never-registered pesticides. 

With regard to the case study in Appendix F, the authors write that they developed this 

case study to "demonstrate the potential threat from an unregistered pesticide and the possible 

vulnerability of the U.S. food supply." OPPTS notes that both pesticides (active ingredients) 

28 
10-P-0026 

used in this scenario have EPA registrations and tolerances for which we have completed risk 

assessments. Our assessments include consideration of consuming domestic and imported foods 

with residues of these pesticides. 

OIG Response: As explained in Appendix E (Appendix F in an earlier version of this report), 

we compared 2006 FDA violations data to data obtained from the 2007 FPASs in order to 

identify U.S. pesticide exports for these pesticide products with corresponding FDA import 

residue violations. As highlighted in the report, the Federal Government does not have the 

capability to detect pesticides that have never been registered in the United States. Therefore, in 

order to conduct this analysis, we had to choose pesticides that are monitored and can be 

detected by FDA. 

According to the Agency, unregistered pesticides include pesticides that have been registered 

and are now cancelled. We chose to focus on two cancelled pesticides, chlorpyrifos and methyl 

parathion, because of the information OPP has on those pesticides. The intent of the analysis 

was to explain how well OPP’s system of regulating dietary risk works when the Office has 

complete information regarding a pesticide product or active ingredient. In order to conduct 

such an analysis, we used pesticides for which EPA has complete regulatory data and extensively 

reviewed. Our analysis showed the reduction in dietary and nondietary risk from regulatory 

actions taken by OPP for the active ingredients we assessed. The last section on tracking simply 

highlights the difficulties faced by OPP in correlated dietary exposure on imported foods. It does 

not dispute our findings regarding the reductions in dietary risk from OPP regulatory actions. 

We believe it would be useful to come to a common understanding of the facts before 

proceeding further with consideration of next steps and determining the most promising way 

forward in terms of enhancing our pesticide/food safety programs. We would be happy to meet 

again with your staff to review our analyses of the data in greater detail together, with the goal of 

reaching agreement on the baseline for future improvements. 

29 
10-P-0026 

Appendix H 

Distribution 

Office of the Administrator 

Assistant Administrator for Prevention, Pesticides and Toxic Substances 

Agency Follow-up Official (the CFO) 

Agency Follow-up Coordinator 

General Counsel 

Associate Administrator for Congressional and Intergovernmental Relations 

Associate Administrator for Public Affairs 

Audit Follow-up Coordinator, Office of Prevention, Pesticides and Toxic Substances 

Acting Inspector General 

30