* U.S. ENVIRONMENTAL PROTECTION AGENCY
"V Itf OFFICE OF INSPECTOR GENERAL
^pRerf*^
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
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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)
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U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
10-P-0026
November 10, 2009
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.
EPA Needs to Comply with the Federal Insecticide,
Fungicide, and Rodenticide Act and Improve Its
Oversight of Exported Never-Registered Pesticides
For further information,
contact our Office of
Congressional, Public Affairs
I and Management at
(202)566-2391.
To view the full report,
click on the following link:
www.epa.qov/oiq/reports/2010/
20091110-10-P-0026.pdf
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.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MEMORANDUM
OFFICE OF
INSPECTOR GENERAL
November 10, 2009
SUBJECT:
FROM:
TO:
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 ,
cd&/..
Wade T. Najjum
Assistant Inspector General for Program Evaluation
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.ieffrev@epa.gov.
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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 -
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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
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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.
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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.
! Tolerances may be established for products or separate active ingredients within a product.
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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 Food-
Related Import Refusal Report., EIB-39. U.S. Department of Agriculture, Economic Research Service, September
2008.
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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
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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.
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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 forwardedCanada and
Mexicoare 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 2007s
FPAS Received
I |1-9
110-100
^100 +
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.
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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.
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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.
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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
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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
1 0
content, destination, and use of most exports are not monitored.
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
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10-P-0026
Table 3-1: Registration Status Definitions
Registration Status
Registered
Unregistered
Definition
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.
Cancelled
A pesticide product's
registration has been
removed due to any
variety of reasons.
Never-registered
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
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10-P-0026
Fiscal Year (FY) 2006 found no violations for these high-risk, imported pesticide-
food 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 never-
registered 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
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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 never-
registered 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
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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
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10-P-0026
Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
Rec.
No.
2-1
Page
No.
8
Planned
Completion
Subject
Comply with the FIFRA Section 1 7(a)
Status1
U
Action Official
Assistant Administrator for
Date
POTENTIAL MONETARY
BENEFITS (in SOOOs)
Claimed Agreed To
Amount Amount
forwarding requirement or seek official
relief.
Prevention, Pesticides and
Toxic Substances
2-2 8 Develop and implement management
controls to ensure EPA is receiving FPASs
from all manufacturers as required by
FIFRA Section 17(a).
2-3 8 Develop procedures for reporting FPAS
information, including intended use
information.
Assistant Administrator for
Prevention, Pesticides and
Toxic Substances
Assistant Administrator for
Prevention, Pesticides and
Toxic Substances
13 Establish criteria to govern when the
quantity and composition of a never-
registered pesticide for export could pose
an unreasonable dietary risk.
Assistant Administrator for
Prevention, Pesticides and
Toxic Substances
3-2 13 Establish procedures to mitigate risk from
never-registered pesticides, including
coordinating information with USDA and
FDA.
Assistant Administrator for
Prevention, Pesticides and
Toxic Substances
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
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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 USD A 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
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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 la and Ib pesticides were exported at an
average rate of greater than 16 tons/day. Pesticide exports included greater than 500,000 pounds
17
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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
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10-P-0026
Appendix B
FIFRA 17(a) Programmatic Logic Model
of Additional Controls
OPP FPAS
Statement Compliance Controls
FIFRA 17(a)
Program
Activities
Formal procedures for processing Indjsry
Ftaite* or sufimffled =PAS nolces for al
data reojlremenrx ~a KmdLct follow-up as
necessary to secure TiijJn; Irccrp e'e date
Complialon sf all Indusrry sjcrrirled data
Into a database Jr c>; rq arc analysis or
U.S. unregistered peslOde emxrlE
Wertfteallon :r IncLstrv complance annLallv
comparing =PAS daa 1o Sedtar Serai
TracBrq System ISSTSJ or other EPA
pesdcide rroiluCl OT2X"Cfl Frfcrrnalion
SIStEfTB
Outputs
Fonral (locumenlallon of importer
acknowledged potential rtslt
Reported daca or J.S. unregfetered
peeUctde expsrtE Ireiudlrg: producl name,
acOve Ingredient, Cnemteal AbEtracte
Service (CAS) registry number, and Mat
aesltnatlor, ilf known)
kiduEtn/ compliance veDncaflon reporlE
Immediate
Outcomes
Imprc'ied Importer awareness or paentlal
Hazards cf Lnrejstersd pesticides
Industry complance wftti FIFRA Section
t7fa)lnnxqh reparlfirj of unregistered
Intermediate/
Long-term
Outcomes
5=A assesErrerr: anrj Incsiporalon or eiporl
data -v ir r lt£ pes&adss - ; ; management
planrtng, (fedskn mattig, and related acttvUeK
OPP FIFRA International Export
Notifications
Export Notice Information
Exchange with FDA & USDA
=cfT5l pmcediires % prDcestinq and
rtcusrtlTj expcn noOces
For*arn all FPAS nollces to apqracriate
Torelqn rjowrnmen! offldas
Formal pracerlirss tor reporting of FPAS
Intormador and avalaBle SnrelqTi use
Hbraten
**crito(tiq iS US. unregistered pestlctde
ewer's B detect arry polerOal I6r dfetanc risk
and to loenrfy pesticides and corrmsdrles %r
regjar.3Ty monfnrlnj or rda det studes
Fnrnal tnormatloii esfianqe system ; snare
FPAS esport data *trti=Wand USQA
Paddcattsn In FCA and LSCrt requtemnf
and deary nsfc Tcrltomg plaining acd^rles
tor unregistered peEtldOe residues
Formal oltena ana procedures IDT
transrnrtltig eirparl rwOras 1o Toretgn
oTHdals
RficmSs cf -=AS ejporl nsdce rreTos
sent 1o mpartlng country' omclals
Intormador excnanQ3 on U.S. LnreolElered
pescode ej^Hfte Iwluilno^ pnxljanarne,
acttie rqrederr.. Chemical Abstract Senrtra
(CAS) registry number, and tlnal destnaUcn
lirirowTii
EPA Inpu: en regLlatory and dietary rlEt
TDTltrtig cf Lrveglslsred pesBSfle residues
on rrpcned foods
Irrpordng coLnrtes advseo' a aierrteal
Imped fe ccnsldEfed to be hazar-dcLE ID
nurrar heaffi and IK enf/lromert or 11
ras not ceen evaluated Cy EPA
IrKrease capacity -a Importing ccLrlnes :c
mate framed dEdSons regardhg
riazardsie chemical tiporis
Improved =DA and USDA
a*anress.'knGW«edgecru.S. Lnreg
pes:c*d5 ejccfis :: liTani regulatcry and
dea^Tst Tcritcr-q
EFA. prcmo-jeE TrernarCnal 'xopsrartofi to
reduce aoVefie rtst "en irterTalonal
peslddeE trade
EPA reduces rne AlnsraUlly o* the U.S. tcod
sa%ty syGtem a rlEte posed ;; urreglstenKl
peBBctie reclOjs on Imporlea foodB
EPA Strategic Goals
EPA Goals 4. 1.3 £ 4.1.4: Protect human rualtn
and trie snvlronmerst Tfom pesticide rlaK
Improved numan tieaJtn
and envtronment lecosystsma)
Source: OIG evaluation of OPP documents.
19
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10-P-0026
Appendix C
Map of 2007 Leading U.S. Agricultural Import Sources
European
Canada
United States ''"'
'?'.
Importer
Eun>pe3n Union
Canada
Mexico
China
Brazil
Australia
Indonesia
Chile
Hew Zealand
Colombia
Thailand
Costa Rica
India
Malaysia
Argentina
Brazil /
r
^ t
M
10,168,559,029
2,916,020,742
2,643,612,917
2,633,145,026
2,081,136,440
1,836,976,132
1,733,262,736
1,538,986.460
1,506,700,428
1^236,184,302
1,165,728,187
1,138,763,270
1,079,038,199
Desna*
p
** ;
- - %>-vr- V V> China
v- X-'7)^,
-
i y
V -5,;,;^,
'
2
; x I T; '~t*M* ^ V'>>^''
yv "*r,'-'i" "" j i v -u-^' *l&5t
^/r- '. i!"
i- v "> Malaria .',
"<'/:<|nd(Drie4^S'l. ^->,
'l \ J
. ""vrl'':/'
"" ---'""^1 \-'' "' /
, -/^ i,
^" <5/
Australia
Source: OIG review of USDA data.
20
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10-P-0026
Appendix D
FPASs Received and Forwarded by EPA
Initial Export
Destination Country
Listed on FPAS
Albania
Algeria
Argentina
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Bolivia
Brazil
Bulgaria
Cameroon
Canada
Cayman Island
Chile
China
Colombia
Congo
Congo, DRC
Costa Rica
Cote d'lvoire
Croatia
Cyprus
Czech Republic
Denmark
Dominican Republic
Ecuador
Egypt
El Salvador
Estonia
Ethiopia
Fiji
France
Georgia
Germany
Ghana
Greece
Guatemala
Guyana
Honduras
Hungary
India
Indonesia
Iraq
Ireland
FPAS
Received
By EPA
3
5
36
1
52
29
1
4
1
1
16
4
23
4
5
49
1
6
198
3
15
79
32
1
1
46
9
1
9
9
2
27
64
8
20
11
6
2
87
7
97
5
24
31
1
19
14
30
17
1
2
FPAS
Forwarded
By EPA21
2
0
0
0
1
3
0
0
0
0
0
0
1
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
1
6
0
0
0
0
0
4
0
1
2
1
1
0
1
2
0
0
0
0
Source: OIG analysis of 2007 FPASs received.
Initial Export
Destination Country
Listed on FPAS
Israel
Italy
Jamaica
Japan
Jordan
Kenya
Kuwait
Lebanon
Macedonia
Malaysia
Mexico
Morocco
Netherlands
Netherland Antilles
New Zealand
Nicaragua
Oman
Pakistan
Panama
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
Romania
Russia
Saudi Arabia
Senegal
Serbia & Montenegro
Singapore
South Africa
South Korea
Spain
Sri Lanka
Suriname
Sweden
Switzerland
Taiwan
Tanzania
Thailand
Trinidad & Tobago
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Venezuela
Vietnam
FPAS
Received
By EPA
13
43
5
53
2
16
1
10
2
11
101
14
57
2
23
13
7
12
113
2
19
11
12
14
2
5
1
12
2
8
17
18
29
25
3
1
3
139
26
1
19
15
5
11
20
8
172
11
44
5
FPAS
Forwarded
By EPA
0
0
0
0
0
1
0
2
0
0
4
3
4
0
0
0
1
0
2
0
0
0
0
1
0
0
0
1
0
0
0
1
0
3
0
0
0
1
0
0
0
1
1
0
0
0
0
0
0
0
All of the forwarded FPASs were for a particular pesticide: the granular formulations of carbofuran.
21
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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 Act22 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 EPA-
established 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
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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
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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"
(ProjectNo. 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
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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.
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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, USD A,
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
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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
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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)
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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.
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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
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