Pesticide Monitoring Program FY 2007
- Regulatory Monitoring
- Analytical Methods
- FDA/State Cooperation
- Animal Feeds
- International Activities
- Focused Sampling
- Total Diet Study
- FDA Pesticide Program Sampling Design
- Identification of Imports (Products or Countries) Requiring Special Attention or Additional Studies
- Regulatory Monitoring
- Geographic Coverage
- Domestic/Import Violation Rate Comparison
- Pesticide Coverage
- Animal Feeds
- Focused Sampling
- Total Diet Study
- Regulatory Monitoring
- Total Diet Study
- Analysis of Domestic Samples by Commodity Group in 2007
- Analysis of Import Samples by Commodity Group in 2007
- Summary of 2007 Results of Domestic Samples by Commodity
- Summary of 2007 Results of Import Samples by Commodity
- Summary of 2007 Results of Domestic vs. Import Samples
- Domestic Samples Collected and Analyzed, by State, in 2007
- Foreign Countries and Number of Samples Collected and Analyzed in 2007 (Table 2A shows countries with Fewer Than Ten Samples)
- Pesticides Detectable and Found (*) by Methods Used in 2007 Regulatory Monitoring
- Summary of the 196 Domestic Surveillance and 96 Import Samples of Animal Feed That Were Analyzed for Pesticides by FDA in Fiscal Year 2007
- Summary of the Pesticides in the 51 Domestic Surveillance and 18 Import Samples of Animal Feed Analyzed by FDA in FY 2007 That Contained One or More Detectable Residues
- Frequency of Occurrence of Pesticide Residues in the Total Diet Study for Foods Other Than Infant and Toddler Foods in FY 2007
- Frequency of Occurrence of Pesticide Residues in Total Diet Study Infant and Toddler Foods in FY 2007
This document is the nineteenth report summarizing the results of the Food and Drug Administration's (FDA) pesticide residue monitoring program. Eight of the eighteen previous reports were published in the Journal of the Association of Official Analytical Chemists/Journal of AOAC International; these presented results from Fiscal Years (FY) 1987 through 1994. Results from FY 1995 through FY 2006 were published on FDA's Center for Food Safety and Applied Nutrition World Wide Web site. This report includes annual findings obtained during FY 2007 (October 1, 2006 through September 30, 2007) under regulatory monitoring along with selected Total Diet Study (TDS) findings.
In the early 1990s, FDA conducted comprehensive incidence and level monitoring studies of four major foods and published the results.  Due to resource constraints, incidence and level monitoring for pesticide residues conducted by FDA's field laboratories, which was typically non-regulatory in nature, has been replaced in recent years by regulatory based "focused sampling." Incidence and level pesticide residue data are however, provided by FDA's Total Diet Study program. The TDS program analyzes market baskets of about 300 foods four times per year.
Results in this and earlier reports continue to demonstrate that levels of pesticide residues in the U.S. food supply are overwhelmingly in compliance with EPA's permitted pesticide uses and tolerances.
Three federal government agencies share responsibility for the regulation of pesticides. The Environmental Protection Agency (EPA) registers (i.e., approves) the use of pesticides and establishes tolerances (the maximum amounts of residues that are permitted in or on a food) if use of a particular pesticide may result in residues in or on food. Except for meat, poultry, and certain egg products, for which the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) is responsible, FDA is charged with enforcing tolerances in both imported foods and in domestic foods shipped in interstate commerce. FDA also acquires data on particular commodity and pesticide combinations by carrying out market basket surveys under the Total Diet Study. Since 1991, USDA's Agricultural Marketing Service (AMS) has carried out a pesticide residue testing program, called the Pesticide Data Program (PDP), directed at raw agricultural products and various processed foods through contracts with states to perform the sampling and analyses. FSIS and AMS report their pesticide residue data independently. Information about the PDP is available at http://www.ams.usda.gov/science/pdp/index.htm.
FDA samples individual lots of domestically produced and imported foods and analyzes them for pesticide residues to enforce the tolerances established by EPA. Domestic samples are collected as close as possible to the point of production in the distribution system; import samples are collected at the point of entry into U.S. commerce. Emphasis is on the raw agricultural product, which is typically analyzed as the unwashed, whole (unpeeled), raw commodity. Processed foods are also included. If illegal residues are found at a level above an EPA tolerance or FDA enforcement level, or measurable levels of residues for which EPA has established no tolerance for a given food are found in domestic foods, the lot of food as available will be removed from commerce. FDA can also issue Warning Letters to the responsible growers and invoke other sanctions such as a seizure or injunction to correct the cause of the violation. For imports, shipments with illegal residues are refused entry into U.S. commerce. "Detention Without Physical Examination", or DWPE (previously called automatic detention), may be invoked for future imported lots of the commodity based on the finding of a single violative shipment. Congress has authorized FDA to refuse admission of regulated articles based on information, other than the results of examination of samples that causes an article to appear to violate the Food Drug and Cosmetic Act (FD&C Act). Imported foods containing illegal pesticide residues meet the criteria. DWPE can be applied to product from specific growers, manufacturers, or shippers, or to a geographic area or country if the problem is demonstrated to be sufficiently broad-based. FDA's Import Alerts, available at http://alpha.ora.fda.gov/fiars/fiars.html describe current DWPEs for pesticide residues and other food issues. There are currently four Import Alerts that address food products that are under DWPE for pesticides, and they are:
- Import Alert # 99-05 "Detention Without Physical Examination of Raw Agricultural Products for Pesticides"
- Import Alert # 99-08 "Detention Without Physical Examination of Processed Products for Pesticides"
- Import Alert # 99-14 " Countrywide Detention Without Physical Examination of Raw Agricultural Products for Pesticides"
- Import Alert # 99-15 "Countrywide Detention Without Physical Examination of Processed Products for Pesticides"
Growers, manufacturers, and shippers can have their product(s) removed from FDA DWPE by providing evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and that there is sufficient basis for the Agency to have confidence that future entries will be in compliance of the FD&C Act. A minimum of five consecutive non-violative commercial shipments, as demonstrated by providing FDA with acceptable reports of private lab analyses, can remove a grower's, manufacturer's, or shipper's product from DWPE. Removal of a countrywide or geographic area DWPE would typically require submission to FDA of an effective, detailed approach to correcting the problem, along with acceptable lab reports demonstrating compliance of the commodity(ies) in question.
Factors considered by FDA in planning the types and origin of commodities to sample include: analysis of past problem areas; commodity/pesticide coverage from recently generated state, USDA, and FDA residue data; regional intelligence on pesticide use; dietary significance of the food; volume of individual commodities of domestic food produced and entered into interstate commerce and of imported food offered for entry into the U.S.; the origin of imported food; and the chemical characteristics and toxicity of the pesticide(s) of concern.
Analytical Methods and Pesticide Coverage
To analyze the large numbers of samples whose pesticide treatment history is usually unknown, FDA uses analytical methods capable of simultaneously determining a number of pesticide residues. These multi-residue methods (MRMs) can determine about half of the approximately 400 pesticides with EPA tolerances, and many others that have no tolerances. The most commonly used MRMs can also detect many metabolites, impurities, and alteration products of pesticides.
Single residue methods (SRMs), or selective MRMs, are used to determine some pesticide residues in foods. An SRM usually determines one pesticide; a selective MRM measures a relatively small number of chemically related pesticides. SRMs and selective MRMs are more resource-intensive per residue and therefore employed more judiciously. A suspicion of a violation or a need to acquire residue data in select commodities will usually trigger use of these methods.
The lower limit of residue measurement in FDA's determination of a specific pesticide is usually well below tolerance levels. Tolerance levels generally range from 0.1 to 50 parts per million (ppm). Residues present at 0.01 ppm and above are usually measurable; however, for individual pesticides, this limit may range from 0.005 to 1 ppm. Trace levels of pesticide residues are also reported. The term "trace" is used to indicate residues that are detected but at levels below the residue's limit of quantitation (LOQ) for the method employed.
FDA conducts ongoing research to update its pesticide monitoring program. This research includes testing the behavior of new or previously untested pesticides through existing analytical methods, as well as development of new methods to improve efficiencies and detection capabilities. In recent years, newer extraction procedures and detection techniques have increasingly replaced older methods. As a result, the number of pesticides recorded in Table 3 in the yearly report as detectable in any single year will vary. Table 3 reflects the residues: (1) for which FDA has performed appropriate method validation to confirm the residue is adequately recovered in a variety of foods; or (2) that were detected in an FDA sample that year, but for which their recoveries may not have been appropriately validated. The latter can occur when unusual residue responses are detected and identified. Regarding criterion (2), a residue detected one year does not re-appear in Table 3 in succeeding years unless it is detected again, or the appropriate validation has subsequently been performed. The recovery of such pesticides is not assumed across a variety of foods until validated.
FDA field offices interact with their counterparts in many states to enhance the effectiveness of the Agency's pesticide monitoring program. Memoranda of Understanding and Partnership Agreements have been established between FDA and many state agencies. These agreements provide for more efficient residue monitoring by both parties by coordinating efforts, broadening coverage, and eliminating duplication of effort. The agreements vary from data sharing, joint planning, and state collection of samples for FDA examination, to FDA/state division of collection, analysis, and enforcement follow-up responsibilities for individual commodities or products of particular origin (i.e., imported vs. domestic products).
In addition to monitoring foods for human consumption, FDA also samples and analyzes domestic and imported animal feeds for pesticide residues. FDA's Center for Veterinary Medicine (CVM) directs this portion of the Agency's monitoring via its Feed Contaminants Compliance Program. Although animal feeds containing violative pesticide residues may present a potential hazard to a number of different categories of animals (e.g., laboratory animals, pets, wildlife, etc.), CVM's monitoring focuses on feeds for livestock and poultry - animals that ultimately become or produce foods for human consumption.
FDA Pesticide Residue monitoring activities are a part of the Agency's overall food safety programs. As such, they are subject to the responsibilities FDA has under international trade agreements to which the United States is signatory. The arrangements FDA makes with other countries with respect to food safety programs, and the activities that FDA carries out internationally with respect to food safety, can also affect how some of our monitoring is conducted.
FDA, as a part of the U.S. Government, is subject to the obligations placed on countries by the World Trade Organization's Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). Pesticide residue tolerances and monitoring activities are included as sanitary measures under the SPS Agreement. FDA's obligations under this Agreement include the requirement that standards are based on an assessment appropriate to the circumstances of the risk to human and animal health, and, on international standards except when a more stringent standard can be scientifically supported. The standards must also be applied equally to domestic and imported products unless there is scientifically based justification for doing otherwise.
Similarly, FDA, as part of the U.S. Government, is subject to obligations arising from several Free Trade Agreements, the most notable of which is the North America Free Trade Agreement (NAFTA). These bilateral or multilateral Free Trade Agreements contain provisions on sanitary measures that areconsistent with the provisions of the WTO SPS Agreement. As with the SPS Agreement, the sanitary provisions of these agreements include provisions relating to pesticide residues.
FDA maintains a number of arrangements with counterpart agencies in foreign governments. Such arrangements include Memoranda of Understanding, Confidentiality Agreements, and Exchanges of Letters. These arrangements most often contain information-sharing provisions that include the ability to share analytical findings about pesticide residues. Several of the MOUs have specific provisions relating to pesticide residue information sharing or cooperative efforts relating to pesticide residues.
FDA also participates in meetings with counterpart food safety agencies of foreign governments. For example, FDA participates in the work of the Quadrilateral Discussions on Food Safety comprised of senior food safety officials from Australia, Canada, New Zealand, and the United States. FDA also carries out bilateral discussions on food safety with several countries including Canada and Mexico, and meets regularly with the European Commission. Pesticide control programs and pesticide residue issues can be subjects for discussion at these meetings.
FDA participates in the work of international standards-setting organizations, particularly the work of the Codex Alimentarius Commission (Codex). Within Codex, FDA is an active participant in the work of the Codex Committee on Pesticide Residues.
FDA's pesticide monitoring program frequently includes what this report describes as "focused sampling." This approach is primarily regulatory in nature, with the necessary protocols followed to ensure enforcement action can be pursued if a violation is detected. Focused sampling is generally used to follow-up on suspected problem areas or to acquire residue data on select commodities not usually covered during regulatory monitoring. Focused sampling is carried out by short-term field assignments that require collection of specific commodities to be analyzed for the general classes of pesticide residues (e.g., organochlorine and organophosphate) or individual or unique classes of residues of interest.
Focused sampling differs from what was previously described in FDA's pesticide program as incidence and level monitoring. Incidence and level monitoring to obtain pesticide residue data was generally non-regulatory analyses of selected samples of commodities of interest, which at times was statistically based. Incidence and level monitoring typically required a follow-up collection and analysis of a regulatory sample to confirm a violation before an FDA enforcement action could ensue. However, due to resource constraints, incidence and level monitoring as done in the past by FDA has been replaced by focused sampling, except as considered below as part of FDA's Total Diet Study program.
The Total Diet Study (TDS) is distinct from regulatory monitoring in that it determines pesticide residues not in the raw commodity, but in foods that are prepared table-ready for consumption. The sampled foods are washed, peeled, and/or cooked before analysis, simulating typical consumer handling.
TDS foods are sampled as "market baskets," with each market basket comprising samples of about 300 different foods that represent the average U.S. consumer's diet. Four regional market baskets are planned for each year and for each market basket, samples are collected in three different cities within the region. The three samples of each food are combined to form a single composite prior to analysis. In addition to being analyzed for pesticide residues, TDS foods are also selectively analyzed for toxic and nutrient elements, industrial chemicals, and other chemical contaminants. Additional information about the history and design of the TDS as well as analytical results can be found in several FDA publications      and on CFSAN's website .
Another distinction from FDA's pesticide residue regulatory monitoring is that the TDS foods are analyzed using methods that are modified to permit enhanced measurement of residues, generally at levels up to 10-100 times more sensitive than regulatory monitoring procedures. TDS residue levels as low as 0.1 part per billion are routinely reported.
The TDS program is not regulatory in nature but considered incidence and level monitoring. However, when results are found that indicate a food contains a pesticide residue with no tolerance, or exceeds an existing tolerance or enforcement level, an investigation into the cause of the illegal residue will typically ensue. The investigation will be conducted of the responsible manufacturer or grower for a domestic food. For foods of foreign origin, the investigation can involve the importer and foreign grower and manufacturer. The investigation may include subsequent regulatory sampling and analysis of the food or suspect ingredients.
The goal of FDA's pesticide monitoring program is to carry out selective monitoring to achieve an adequate level of consumer protection. Most of the FDA samples are of the surveillance type; that is, there is no specific prior knowledge or evidence that a particular food shipment contains illegal residues. However, FDA's monitoring is not random because some bias is introduced primarily by emphasizing sampling of commodities and places of origin with a past history of violations, and to a lesser extent emphasizing larger-sized shipments.
For fiscal year 2007, the import violation rate was 4.2% and the domestic violation rate was 2.3%. Though the difference between the two rates narrowed in FY 2007 from previous years, they had been fairly consistent in the past 15 years or so, averaging about 2% for domestic samples and 6% for imports.
In FY 1991, FDA contracted with the Research Triangle Institute (RTI) to design a statistical approach to conduct a residue study. The resulting report was entitled "Monitoring Pesticide Residues in Fresh Produce: A Probabilistic Approach." The report acknowledged that FDA's then current program (which was similar to FDA's current program except that sample totals were two to three times higher) was not a probability-based approach since it was not free of selection bias. A probabilistic approach described in the report would need to account for, among other elements, a high degree of consumption coverage (coverage of a significant portion of the commodity population), and seasonal and geographical representation. Also, to achieve a meaningful certainty level of confidence of about 95%, 800 data points, i.e., samples, of each import or domestic commodity would be necessary.
In FY 1992-1994 FDA conducted "statistically-based" studies of four commodities  adhering to as many of the tenets of the RTI report as was practical within available resources. The commodities tested were apples, pears, rice, and tomatoes. Domestically grown and imported products were separately tested. The conclusions of the studies corroborated the premise that when compared to a statistically-based study, FDA's monitoring program provides a reasonably reliable estimate of pesticide residues in the U.S. food supply, especially when the data are viewed over many years; and that the levels of residues found are generally well below U.S. tolerances. FDA maintains this premise, but does not infer statistical significance to its results for any particular imported or domestic commodity within a fiscal year due to sampling bias and sampling levels which can vary significantly from year to year.
It should be noted that these studies were very expensive for FDA to conduct. For example, total costs exceeded 1 million dollars (in 1993-1994 dollars) for the import apple study and also for the domestic apple study. Costs included FDA personnel time, equipment and supplies.
An important complement to FDA's pesticide program is its Total Diet Study Program previously discussed in this report. By its design, the TDS serves as an early warning system, capable of detecting many more pesticide residues and at much greater sensitivity when compared to FDA's regulatory program (FDA's regulatory program is designed to detect residues in violation of EPA tolerances).
Considering the above and coupled with available Agency resources, FDA has, to date, not attempted to develop a monitoring program that would be statistically based. FDA is willing to investigate whether such a program might be developed and implemented in a cost-effective manner. However, it is FDA's opinion that the current sampling levels, coupled with broad-based enforcement strategies for imports, are sufficient for FDA to achieve the program's main objective, i.e., adequate consumer protection by selective enforcement. Import enforcement strategies that are available to the Agency are "Detention Without Physical Examination" (DWPE) for future entries of commodity/grower combinations that are found in violation of U.S pesticide tolerances, and country-wide DWPE of particular commodities if the violations are numerous and from multiple growers. Once a problem is identified, FDA can achieve broad enforcement by employing these strategies and detaining at their entry points the suspect imported foods as they would exhibit the appearance of a violation. This procedure places the burden of demonstrating product compliance with U.S. residue tolerances on the importer before the entry can be released into domestic commerce.
Addressing Products and Countries that Warrant Special Attention:
Addressing products and countries that warrant special attention is best carried out by providing specific guidance (e.g., increased surveillance, focused sampling by means of field assignments) to the Agency field offices and laboratories under FDA's "Pesticides and Industrial Chemicals in Domestic and Imported Foods Compliance Program." FDA's sampling strategy of focusing on products that have a history of recurring violations will continue to be applied to future program coverage. Though specifics are provided in this report regarding import commodities and countries of origin that, based on FY 2007 data, may warrant special attention, FDA's sampling guidance provided to its field districts is typically based on multi-year data. However, meaningful violative episodes that do occur are addressed in real time as much as possible through use of the Import Alert system or enhanced sampling.
When attempting to compare FDA's import pesticide residue data against its domestic data, by product or by country, several factors need to be kept in mind:
- The import violation rate has typically been three to four times that of domestic foods. Based on FY 2007 data, the import sample violation rate was about two times that of domestic foods, 4.2% compared to 2.3%. It is not unexpected that many imported food products in this or previous reports have a violation rate exceeding that of their domestic counterparts, or for many foreign countries to have a violation rate exceeding that of the U.S.
- The data analysis by commodity in this report was compiled by FDA product code (i.e., distinct commodities). For FY 2007, 704 different import food commodities and 173 different domestic food commodities were tested.
- FDA's pesticide residue monitoring program should not be viewed as random or statistical, rather it is influenced towards products and countries of origin that have a history of violations.
The criteria used for designating commodities and countries of origin that may warrant special attention were tightened from the 3-year FY 2004-FY 2006 report because the FY 2007 report covered a single year and comprised only about one third the sample count of the earlier report.
Review by Commodity:
Considering the above factors, the following criteria were applied to the FY 2007 data to select import commodities that may warrant special attention:
- Commodities with at least 20 samples analyzed or at least 3 violations, and a violation rate of 10% or higher.
The following table lists the import commodities that meet the criteria. The commodities are sorted by violation rate and include the total number of samples analyzed for FY 2007. Commodities reported under non-specific product codes (e.g., leaf and stem vegetables, not elsewhere classified) were excluded.
|Commodity||No. Samples Analyzed||Violation Rate (%)|
|Berries, dried or paste||8||62.5|
|Ginseng, herbal and botanical, other than tea *||35||40.0|
|Mango, dried or paste||13||23.1|
|Celery, dried or paste *||20||20.0|
|Chinese okra (luffa) *||21||19.0|
|Red beet *||27||18.5|
* Indicates commodity was on the FY 2004-FY 2006 table of import commodities warranting special attention.
Review by Country of Origin:
The table below lists countries of origin with a minimum of 50 samples analyzed and a 7% or greater violation rate for FY 2007.
|Country*||No. Samples Analyzed||Violation Rate (%)|
* All five countries listed were on the FY 2004-FY 2006 table of countries of origin warranting special attention.
Note: Samples from Mexico continue to comprise the greatest portion of FDA's import pesticide sampling. In FY 2007, 3091 samples from Mexico were analyzed. The violation rate for Mexican samples was 3.0%, somewhat below the 4.2% average for all import samples. Continued high coverage of Mexican foods is warranted due to the large volume of foods exported to the U.S. from Mexico.
This report was compiled through the efforts of the following FDA personnel: Center for Food Safety and Applied Nutrition, College Park Maryland, Office of Food Safety - Sara K. Egan and Ronald R. Roy; Office of Regulatory Science - Carolyn M. Makovi ; Office of the Center Director- Mark S. Wirtz; Office of Constituent Operations - Michael H. Wehr; Office of Compliance - Sharon A. Macuci; Center for Veterinary Medicine, Rockville, MD: Randall Lovell; Office of Regulatory Affairs, Kansas City District, Lenexa, KS - Chris A. Sack.
The database containing the FY 2007 data from which this report was derived is also available from FDA's World Wide Web site. The 1996 through 2006 reports and databases are available on the same website. FDA pesticide monitoring data collected under the regulatory monitoring approach in 1992, 1993, 1994, and 1995 are available for purchase on personal computer diskettes from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (telephone 1-800-553-6847); or from NTIS' website at http://www.ntis.gov. Order numbers are: 1992, PB94-500899; 1993, PB94-501681; 1994, PB95-503132; and 1995, PB96-503156.
 Roy, Ronald R., et al (1995) U.S. Food and Drug Administration Pesticide Program: Incidence/Level Monitoring of Domestic and Imported Pears and Tomatoes J. AOAC Int. 78, 930-940.
 Roy, Ronald, R., et al (1997) Monitoring of Domestic and Imported Apples and Rice by the U.S. Food and Drug Administration Pesticide Program J.AOAC Int, 80, 883-894.
 Code of Federal Regulations (2003) Title 40, U.S. Government Printing Office, Washington, DC, Parts 180, 185, and 186.
 Pesticide Analytical Manual Volume I (3rd Ed., 1994 and subsequent revisions), available from FDA's World Wide Web site at http://www.cfsan.fda.gov, and Volume II (1971 and subsequent revisions), available from National Technical Information Service, Springfield, VA 22161. Food and Drug Administration, Washington, DC.
 Pennington, J.A.T., Capar, S.G., Parfitt, C.H., & Edwards, C.W. (1996) History of the Food and Drug Administration's Total Diet Study (Part II), 1987-1993. J. AOAC Int. 79, 163-170.
 Food and Drug Administration (1996) Food and Drug Administration pesticide program - residue monitoring - 1995, 2003 (and earlier reports in the series). Available from FDA's World Wide Web site at http://www.cfsan.fda.gov.
 Gunderson, E.L. (1995) Dietary intakes of pesticides, selected elements, and other chemicals: FDA Total Diet Study, June 1984-April 1986. J. AOAC Int. 78, 910-921.
 Gunderson, E.L. (1995) FDA Total Diet Study, July 1986-April 1991, dietary intakes of pesticides, selected elements, and other chemicals. J. AOAC Int. 78, 1353-1363.
 Pennington, J.A.T. (1992) Total Diet Studies: the identification of core foods in the United States food supply. Food Addit. Contam. 9, 253-264.
 Pennington, J.A.T. (1992) The 1990 revision of the FDA Total Diet Study. J. Nutr. Educ. 24, 173-178.
 Pennington, J.A.T. (1992) Appendices for the 1990 revision of the Food and Drug Administration's Total Diet Study. PB92-176239/AS, National Technical Information Service, Springfield, VA 22161.
Under regulatory monitoring, 6,930 samples were analyzed. Of these, 1,317 were domestic foods and 5,613 were imported foods.
Figure 1 shows the percentage of the 1,317 domestic samples by commodity group with "No Residues Found," "Residues Found; No Violation," and "Violative" (a violative residue is defined in this report as a residue which exceeds an EPA tolerance or FDA enforcement level, or a residue at a level of regulatory significance for which no tolerance has been established in the sampled food.)
Group Sample Totals: Grains & Grain Products, 143; Milk/Dairy/Eggs, 28; Fish/Shellfish, 45; Fruit, 403; Vegetables, 672; Other Foods, 26.
As in earlier years, fruits and vegetables accounted for the largest proportion of the domestic commodities analyzed in FY 2007; these two commodity groups comprised 81.6 % of the total number of domestic samples. In FY 2007, 97.7 % of all domestic foods analyzed by FDA were in compliance with EPA's established residue tolerances and FDA formal enforcement levels. The compliance rate for domestic foods for FYs 1996 to 2006 was between 97.6% and 99.3%.
Appendix A contains more detailed data on domestic monitoring findings by commodity, including the total number of samples analyzed, the percent samples with no residues detected, and the percent violative samples including the nature of the violation (over-tolerance vs. no tolerance). Of the 1,317 domestic samples, 58.0 % had no detectable residues and 2.3 % had violative residues. In the largest commodity groups, fruits and vegetables, 36.7 % and 63.1 % of the samples, respectively, had no residues detected;
2.7 % of the fruit samples and 2.8 % of the vegetable samples contained violative residues (Figure 1). In the grains and grain products group, 71.3 % of the samples had no residues detected, and there were no samples with violative residues. In the fish/shellfish/other aquatic products group, 84.4 % had no detectable residues, and there were no samples with violative residues. In the milk/dairy products/eggs group, all 28 samples analyzed had no detectable residues. In the "Other" foods group that covers nuts, seeds, and snack foods among other foods, 92.3 % of the samples had no detectable residues and there were no samples with violative residues.
Findings by commodity group for the 5,613 import samples are shown in Figure 2. Fruits and vegetables accounted for 79.9 % of import samples. Overall for all imported foods, 95.8 % of the samples analyzed in FY 2007 were in compliance with EPA tolerances and FDA enforcement levels. This compares with a compliance rate for imported foods for FYs 1996 to 2006 of 93.8 % to 98.4 %.
Appendix B contains detailed data on import samples. Of the 5,613 import samples analyzed, 64.8 % had no residues detected, while 4.2 % had violative residues. Imported fruits had 64.2 % of samples with no residues detected and 4.0 % samples with violative residues. Imported vegetables had 58.2 % of samples with no residues detected and
4.5 % samples with violative residues. No residues were found in all 23 samples of the imported milk/dairy products/eggs group. No residues were found in 86.3 % of the imported fish/shellfish group and 1 violation (0.4 %) was found in this food group. In the imported grains and grain products group, 85.3 % had no detectable residues, and one sample (0.4 %) contained violative residues. In the "Other" foods group consisting largely of nuts, seeds, oils, spices, multiple food products, and dietary supplements, 82.5 % of the samples analyzed had no residues detected, while 6.0 % of the samples contained violative residues.
Group Sample Totals: Grains & Grain Products, 238; Milk/Dairy/Eggs, 23; Fish/Shellfish, 233; Fruit, 1282; Vegetables, 3203; Other Foods, 634.
Pesticide monitoring data collected under FDA's regulatory monitoring approach in FY 2007 are available to the public as a computer database. This database summarizes FDA 2007 regulatory monitoring coverage and findings by country/commodity/pesticide combination. The database also includes monitoring data by individual sample from which the summary information was compiled. Information on how to obtain this database as well as those for 1992-2006 is provided in the "Acknowledgements" section of this report.
Domestic: A total of 1,317 domestic samples were collected in FY 2007 from 41 states, Puerto Rico, and the District of Columbia. The largest numbers of samples are usually collected from those states that are the largest producers of fruits and vegetables. Table 1 lists the number of domestic samples from each state, in descending order.
Puerto Rico – 2 samples; District of Columbia – 1 sample. States of Alabama, Arkansas, New Mexico, Nevada, Oklahoma, Texas, Utah, West Virginia, and Wyoming – no samples collected.
Note – for Table 1, 73 domestic samples with no state recorded in "Sample 2007" file were attributed through other data as: Oregon 37; Idaho 15; Washington 6; Pennsylvania 4; Virginia 3; Florida 2; North Carolina 2; Ohio 2; California 1; and Wisconsin 1.
Imports: A total of 5,613 samples representing food shipments from 98 countries (excluding U.S. goods sampled in import status) were collected in FY 2007. Table 2 lists the number of samples collected from each country. Mexico, as in the past, was the source of the largest number of samples, reflecting the volume and diversity of commodities imported from that country, especially during the winter months. Table 2A lists the countries of origin that had ten or fewer samples collected in FY 2007.
* Note: Unspecified samples consisted primarily of foods reported sampled in import status but of U.S origin, including U.S. Goods Returned (U.S. products originally exported and subsequently returned). An additional 5 samples reported as unspecified in Table "Sample 2007" were attributed to individual countries and are reflected in the counts in Tables 2 and 2A.
Domestic/Import Violation Rate Comparison for FY 2007
In FY 2007, 1,317 domestic and 5,613 import samples were collected and analyzed. Pesticide residues were detected in 42.0 % of the domestic samples and in 35.2 % of the import samples. Violative residues were found in 2.3 % of the domestic samples and 4.2 % of the import samples. Among grains and grain products, the violation rate was zero for domestic samples and 0.4 % for imports. No violations were found in the milk/dairy products/eggs group for either domestic or import samples. No violations were found for the domestic fish/shellfish/other aquatic products group, and only 0.4 % for the import samples of this group. Of domestic fruit samples, 2.7 % contained violative residues while 4.0 % of imports did. For vegetables, 2.8% of domestic samples and 4.5 % of import samples contained violative residues. In the category "Other" (mostly nuts, edible seeds, honey, spices, and dietary supplements), the violation rates for domestic and import samples were zero and 6.0 %, respectively. As in FY 2005 and FY 2006, ginseng accounted for most of the samples with violative residues for the import "Other" foods group.
Of the domestic violative samples, five of the 30 violations (16.7 % of domestic violations) were for residues found to be over an established EPA tolerance or FDA enforcement level. The balance, 25 or 83.3 %, were for residues found in foods with no established EPA tolerance or formal FDA enforcement level. Of the import samples with violative residues, 6 of 234 violations (2.6% of import violations) were for samples that contained both residues found to be over an EPA tolerance or FDA enforcement level AND residues with no tolerance, 5 of 234 violations (2.1 %) were for residues found to be over an established EPA tolerance or FDA enforcement level, and 223 or 95.3 %, were for residues found in foods with no established EPA tolerance.
FDA enforcement actions for products found in violation of EPA tolerances are described in the "Regulatory Monitoring" section of this report.
Table 3 lists the 461 pesticides that were detectable or found by the methods used in FY 2007; each of the 156 pesticides that were actually found is indicated by an asterisk (*). Residues not previously looked for or detected, are noted by a "+".
1The list of pesticides detectable is expressed in terms of the parent pesticide. However, monitoring coverage and findings may have included metabolites, impurities, and alteration products.
2Some of these pesticides are no longer manufactured or registered for use in the United States.
3Chemicals indicated only by a (+) were not found nor documented as recovered in previous years.
In Fiscal Year (FY) 2007, 292 feed samples (196 domestic surveillance and 96 import) were analyzed for pesticides by the FDA (Table 4). Of the 196 domestic surveillance samples, 145 (74.0%) contained no detectable pesticide residues, 44 (22.4%) contained one or more detectable residues that did not exceed regulatory guidance, and 7 (3.6%) contained a residue which exceeded regulatory guidance. Of the 96 import samples, 78 (81.3%) contained no detectable pesticide residues, 18 (18.8%) contained one or more detectable residues that did not exceed regulatory guidance, and 0 (0.0%) contained a residue which exceeded regulatory guidance.
During FY 2007, 7 domestic surveillance samples of animal feed (3 grains and 4 plant by-products) contained 7 residues that exceeded regulatory guidance. Two corn samples from Ohio contained 0.110 and 0.143 ppm of chlorpyrifos, respectively. These levels exceed the 0.05 ppm tolerance for chlorpyrifos on field corn in 40 CFR 180.342. One corn sample from Missouri contained 0.030 ppm of chlorpyrifos-methyl. No tolerances have been established by the EPA for chlorpyrifos-methyl on corn in 40 CFR 180.419.
Two samples from Washington, one a soy hull pellet and the other canola meal, contained 0.037 ppm and 0.066 ppm of tris (chloropropyl) phosphate, respectively. No tolerances, action levels, or guidance has been established by the EPA or FDA for this fire retardant in animal feed so any quantifiable level is considered to have exceeded regulatory guidance. One sample of cotton burrs from Texas contained 14.8 ppm of malathion. This level exceeds the 2 ppm tolerance for malathion on delinted cotton seed in 40 CFR 180.111. One sample of peanut hulls from Texas contained 0.058 ppm of DEF (tribuphos). No tolerances have been established by the EPA for DEF on peanuts in 40 CFR 180.272.
In the 51 domestic surveillance and 18 import samples of animal feed in which one or more pesticides were detected, there were 99 residues (90 quantifiable and 9 trace). Malathion and ethoxyquin were the most frequently found and accounted for 54.5% of all residues detected (Table 5).
|Type of Feed||# of Samples||Samples with No Pesticide Residues||Samples Exceeding Regulatory Guidance|
|Mixed Feed Rations||59||34||57.6||0||0.0|
|Hay & Hay Products||13||10||76.9||0||0.0|
|Pesticide||# of Samples with|
|Trace1 Amounts||Quantifiable Levels||Range2
|malathion||1||32||0.011 - 14.8||0.111|
|ethoxyquin3||1||20||0.068 - 29.8||0.571|
|chlorpyrifos-methyl||0||6||0.011 - 0.175||0.028|
|dde + tde + ddt||0||6||0.002 - 0.046||0.014|
|def||0||6||0.056 - 1.82||0.253|
|chlorpyrifos||0||3||0.018 - 0.143||0.110|
|chlorpropham||0||2||0.070 - 0.073|
|fenpropathrin||0||2||0.210 - 0.600|
|myclobutanil||0||2||0.047 - 1.20|
|quinoxyfen||0||2||0.077 - 0.330|
|tris (chloropropyl) phosphate||0||2||0.037 - 0.066|
|all others4||4||6||0.025 - 2.10||0.134|
1 the residue found is below that normally quantifiable, but its presence and identity are known.
2 in samples containing quantifiable levels.
3 ethoxyquin is approved as a pesticide (plant regulator) at levels up to 3 ppm in 40 CFR 180.178. Ethoxyquin is also a feed additive (anti-oxidant) that is approved at levels up to 150 ppm in a finished article (21 CFR 573.380).
4 n=1 for boscalid (.300 ppm), cypermethrin (trace), diphenyl 2-ethylhexyl phosphate (trace), fenarimol (.067), lindane (.062), methoxychlor, p,p' (trace), mgk 264 (.025 ppm), o-phenylphenol (trace), piperonyl butoxide (.200 ppm), and propargite (2.10 ppm).
FDA conducts "focused sampling," typically by means of short-term, regulatory based field assignments. In FY 2007 an assignment issued mid-August 2007 to collect and analyze selected imported dietary supplements and botanical products for pesticides and toxic elements. As this assignment issued towards the very end of the fiscal year, few samples were completed in FY 2007. The pesticide residue results will be reported in the FY 2008 report of FDA's pesticide program residue monitoring. Data regarding pesticide residue findings on dietary supplements and botanicals that were analyzed by FDA under general monitoring in FY 2007 are contained in the downloadable database tables that accompany this report on FDA's internet website.
Of the over 300 chemicals that can be determined by the analytical methods used in FDA's Total Diet Study, residues of 102 individual compounds were found in the foods analyzed in the four market baskets reported for FY 2007 (Market Baskets 06-4, 07-1, 07-2, and 07-3). The 102 individual compounds consisted of 80 parent pesticides and 22 related compounds (e.g., isomers, metabolites, degradation products) that are added to the parent pesticide for reporting and enforcement purposes.
Table 6 lists the most frequently found residues in the TDS foods other than infant and toddler foods (those found in 2% or more of the samples), the total number of findings, and the percent occurrence in the four market baskets analyzed in FY 2007 (916 total samples). The five most frequently observed chemicals were: DDT, malathion, chlorpyrifos-methyl, endosulfan, and dieldrin, and are the same as those observed for the past several years. The levels of these and other residues listed in Table 6 were typically below regulatory limits.
|Pesticide2||Total No. of Findings||Occurance %||Range, ppm|
1 Based upon 4 market baskets consisting of 916 total items.
2 Isomers, metabolites, and related compounds are included with the 'parent' pesticide.
3 Reflects overall incidence; however, only 67 selected foods per market basket (268 items total) were analyzed for Benzimidazole fungicides.
4 Reflects overall incidence; however, only 82 selected foods per market basket (328 items total) were analyzed for N-methylcarbamates.
5 Reflects overall incidence; however, only 16 selected foods per market basket (64 items total) were analyzed for Chlorophenoxy acids.
The TDS program also collects and analyzes infant and toddler foods. Table 7 provides the frequency of occurrence of the pesticide residues that were found in 2% or more of these samples in the four collections of infant and toddler foods (212 samples total) in FY 2007 and the range of levels found.
|Pesticide2||Total No. of Findings||Occurence %||Range, ppm|
1Based upon 4 market baskets consisting of 212 total items.
2Isomers, metabolites, and related compounds are included with the 'parent' pesticide.
3Reflects overall incidence; however, only 34-36 selected foods per market basket (i.e.,140 items total) were analyzed for Benzimidazole fungicides.
4Reflects overall incidence; however, only 6-7 selected foods per market basket (27 items total) were analyzed for Chlorophenoxy acids.
A total of 6,930 samples of domestically produced food and imported food from 98 countries were analyzed for pesticide residues in FY 2007. No residues were found in 58.0 % of domestic and 64.8 % of import samples (Figure 3) analyzed under FDA's regulatory monitoring approach in FY 2007. Only 2.3 % of domestic and 4.2 % of import samples had residue levels that were violative. The findings for FY 2007 demonstrate that pesticide residue levels in foods are generally well below EPA tolerances, corroborating results presented in earlier reports (6).
FDA also collected and analyzed 196 domestic and 96 import animal feed samples for pesticides. No residues were found in 74.0 % of the domestic feed samples and in 81.3% of the import feed samples. Seven domestic samples (3.6%) had residue findings that either exceeded EPA tolerances, or for which no EPA or FDA acceptable levels have been established. All import animal feeds samples were in compliance with EPA and FDA pesticide residue requirements.
In FY 2007, the types of pesticide residues found and their frequency of occurrence in TDS were generally consistent with those given in previous FDA reports. The pesticide residue levels found were well below regulatory standards. Results of baby foods tested in FY 2007 (and earlier years) also provide evidence of only low levels of pesticide residues in these foods.
Tolerance Violations #
Tolerance Violations #
|A. Grains and
|Barley & barley products||3||100||0||0||0|
|Corn & corn products||14||100||0||0||0|
|Oats & oat products||3||100||0||0||0|
|Rice & rice products||5||100||0||0||0|
|Wheat & wheat products||91||58.2||0||0||0|
|Soybeans and soybean products||14||100||0||0||0|
|Other grains & grain products||6||66.7||0||0||0|
|Bakery products, crackers, etc.||2||100||0||0||0|
|Cheese & cheese products||7||100||0||0||0|
|Milk/cream & milk products||12||100||0||0||0|
|Fish and Fish Products||28||75.0||0||0||0|
|Shellfish & Crustaceans||12||100||0||0||0|
|Other Aquatic Animals & Products||1||100||0||0||0|
|Other citrus fruit||7||42.9||0||0||0|
|Other pome fruit||2||50.0||0||0||0|
|Other sub-tropical fruit||1||100||0||0||0|
|Other fruits/fruit products||1||100||0||0||0|
|Other fruit juices||9||55.5||0||0||0|
|Mung beans and bean sprouts||10||60.0||0||0||0|
|String beans (green/snap/pole/long)||21||38.1||4.8||0||1|
|Other beans & peas & products||48||72.9||2.1||1||0|
|Other fruiting vegetables||4||25.0||0||0||0|
|Other leaf & stem vegetables||19||42.1||10.5||1||1|
|Mushrooms and Truffles||16||68.8||0||0||0|
|Other root & tuber vegetables||13||46.2||0||0||0|
|Other vegetables/vegetable products||15||86.7||0||0||0|
|F. Other||Peanuts & peanut products||5||100||0||0||0|
|Other nuts & nut products||2||100||0||0||0|
|Edible seeds & seed products||1||100||0||0||0|
|Water & ice||3||100||0||0||0|
1Whole food commodities include dried, paste, pulp, and puree forms.
2One sample contained both no tolerance and over tolerance residues.
3Violations involved 2 episodes (same packer, same residues) of 4 and 3 samples.
4Violations involved single episodes of each commodity (same grower or packer, same violative residues).
Tolerance Violations #
Tolerance Violations #
|A. Grains and
|Barley & barley products||3||100||0||0||0|
|Corn & corn products||12||91.7||0||0||0|
|Oats & oat products||1||100||0||0||0|
|Rice & rice products||33||87.9||0||0||0|
|Soybeans & soy flour||13||100||0||0||0|
|Wheat & wheat products||37||75.7||0||0||0|
|Other grains & grain products||27||74.1||0||0||0|
|Bakery products, doughs, crackers, etc.||43||95.3||0||0||0|
|Macaroni and noodles||29||86.2||3.4||0||1|
|Cheese & cheese products||4||100||0||0||0|
|Eggs (includes duck & quail)||3||100||0||0||0|
|Milk/cream & milk products||16||100||0||0||0|
|Fish and Fish Products||131||87.0||0.8||0||1|
|Shellfish & Crustaceans||42||85.7||0||0||0|
|Other Aquatic Animals & Products||11||81.8||0||0||0|
|Other citrus fruit||4||50.0||25.0||0||1|
|Other pome fruit||21||90.5||0||0||0|
|Other pit fruit||6||66.7||0||0||0|
|Ackees, lychees, longans||8||87.5||12.5||0||1|
|Other sub-tropical fruit||30||86.7||0||0||0|
|Other fruit juices||44||75.0||2.3||0||1|
|Fruit butters, jams, jellies, preserves, syrups, toppings, etc.||69||94.2||0||0||0|
|Other fruits and fruit products||12||91.7||8.3||0||1|
|Bean sprouts and seeds||45||62.2||2.2||0||1|
|String beans (green/snap/pole/long)||98||53.1||4.1||0||4|
|Other beans & peas & products||129||82.9||3.1||1||3|
|Other fruiting vegetables||51||72.5||7.8||0||4|
|Bok choy & Chinese cabbage||21||47.6||0||0||0|
|Other leaf & stem vegetables||194||66.0||8.2||0||16|
|Mushrooms and Truffles||42||78.6||7.1||0||3|
|Other root & tuber vegetables||39||92.3||5.1||0||2|
|Vegetables with sauce||51||76.5||3.9||0||2|
|Other vegetables/vegetable products inc mixed vegetables||57||71.9||3.5||1(2)||1|
|Coconut & coconut products||2||100||0||0||0|
|Peanuts & peanut products||11||81.8||0||0||0|
|Other nuts & nut products||28||96.4||0||0||0|
|Other edible seeds & seed products||17||100||0||0||0|
|Vegetable oil, crude||2||50.0||0||0||0|
|Vegetable oil, refined||12||100||0||0||0|
|Oil Seed Stock||2||100||0||0||0|
|Other vegetable oil products||2||100||0||0||0|
|Spices, condiments & flavors||64||79.7||4.7||0||3|
|Beverages & water||16||93.8||0||0||0|
|Candy, chocolate, cocoa products||30||90.0||0||0||0|
|Honey & honey products||33||100||0||0||0|
|Sweeteners other than honey||9||88.9||0||0||0|
|Multiple food dinners, sauces, etc.||63||82.5||4.8||0||3|
|Ginseng (dietary supplement)||38||42.1||42.1||1(2)||15|
|Other dietary supplements||81||81.5||8.6||0||7|
|Other food products||38||92.1||0||0||0|
1whole food commodities include dried, paste, pulp, and puree forms, as well as foods similarly classified by EPA for residue tolerance enforcement (e.g., eggplant includes Chinese/Thai eggplant; radishes include daikon or Chinese/Oriental radishes)
2One sample contained both no tolerance and over tolerance residues