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Results and Discussion - FY 2004

Regulatory Monitoring

Under regulatory monitoring, 7,905 samples were analyzed in FY 2004. Of these, 2,832 were of domestic foods and 5,073 were imported foods.

Figure 1 shows the percentage of the 2,832 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 formal FDA Action Level, or a residue at a level of regulatory significance for which no tolerance has been established in the sampled food.)

Figure 1 - Results of Domestic Samples by Commodity Group for FY 2004

Group Sample Totals: Grains & Grain Products, 326; Milk/Dairy/Eggs, 49; Fish/Shellfish, 123; Fruit, 868; Vegetables, 1383; Other Foods, 83.

As in earlier years, fruits and vegetables accounted for the largest proportion of the domestic commodities analyzed in 2004; these two commodity groups comprised 79.5 % of the total number of domestic samples.  In 2004, 98.2% of all domestic foods analyzed by FDA were in compliance with EPA's established residue tolerances and FDA formal  action levels.  The compliance rate for domestic foods for fiscal years 1996 to 2003 ranged from 97.6% to 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 2,832 domestic samples, 58.6% had no detectable residues and 1.8% had violative residues. In the largest commodity groups, fruits and vegetables, 42.9 % and 61.9 % of the samples, respectively, had no residues detected; 1.2% of the fruit samples and 1.5% of the vegetable samples contained violative residues (Figure 1). In the grains and grain products group, 67.8 % of the samples had no residues detected, and 1.2 % had violative residues. In the fish/shellfish/other aquatic products group, 89.4% had no detectable residues, and no violative residues were found. In the milk/dairy products/eggs group, 91.8% of the samples had no residues detected, and no violative residues were found. In the "Other" foods group that covers nuts, seeds, beverages, and honey among other foods, 66.3 % of the samples had no residues detected and 16 violations (19.3%) were detected; all 16 violations were detected in ginseng-based dietary supplements as part of a "focused sampling" effort.

Findings by commodity group for the 5,073 import samples are shown in Figure 2. Fruits and vegetables accounted for 87.4 % of these samples. Overall for all imported foods, 94.5% of the samples analyzed were in compliance with EPA tolerances and FDA formal action levels. This compares with a compliance rate for imported foods for fiscal years 1996 to 2003 of 94.0 % to 98.4 %.

Appendix B contains detailed data on the import samples. Of the 5,073 samples analyzed, 66.4 % had no residues detected, while 5.5 % had violative residues. Fruits and vegetables had 61.1% and 65.4 % of samples analyzed, respectively, with no residues detected, and 5.6% and 5.7% of the samples had violative residues. No residues were found in 77.8% of the milk/dairy products/eggs group and in 86.0% of the fish/shellfish group, and no violative residues were found in either of these groups. In the grains and grain products group, 83.8% had no detectable residues, and 0.8 % of the samples had violative residues. In the "Other" foods group 66.4 % of the samples had no residues and 25 (7.7 %) had violative residues; the majority of the violations were found on spices and ginseng supplement products.

Figure 2 - Results of Import Samples by Commodity Group for FY 2004

Group Sample Totals: Grains & Grain Products, 130; Milk/Dairy/Eggs, 18; Fish/Shellfish, 167; Fruit, 1613; Vegetables, 2819; Other Foods, 326.

Pesticide monitoring data collected under FDA's regulatory monitoring approach in 2004 are available to the public as a computer database. This database summarizes FDA 2004 regulatory monitoring coverage and findings by country/commodity/pesticide combination. The database also includes the monitoring data by individual sample from which the summary information was compiled. Information on how to obtain this database as well as those for 1992-2003 is provided in the "Acknowledgments" section.

Geographic Coverage

Domestic. A total of 2,832 domestic samples were collected in 2004 from 39 states. The largest numbers of samples were collected from those states that are the largest producers of fruits and vegetables. Table 1 lists numbers of domestic samples from each location, in descending order.

Note - for Table 1, domestic samples with no state recorded in the "Sample 2004" file were attributed through other documentation.

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Table 2A - Ten or Fewer Samples Collected and Analyzed from the Following Countries in FY 2004:

Algeria Armenia Austria Bangladesh Belize Bolivia Burkina Faso Cyprus Czech Republic Denmark Djibouti El Salvado Estonia Ethiopia Fiji French Polnesia Georgia Germany, Fed Republic Ghana

Hong Kong Hungary Iraq Ireland Jordan Kampuchea Kenya Liberia Macedonia Malaysia Malta & Gozo Morocco Namibia Nicaragua Panama Papua New Guinea Portugal Romania Sierra Leone

Singapore Somalia Sri Lanka Swaziland Sweden Switzerland Syria Tonga Tunisia Uganda Ukraine United Arab Emirates United Kingdom Uruguay Vanuatu (New Hebrides) Venezuela Western Sahara Yugoslavia Zimbabwe

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Domestic/Import Violation Rate Comparison for FY 2004

In FY 2004, 2,832 domestic and 5,073 import samples were collected and analyzed. Pesticide residues were detected in 41.4 % of the domestic samples and in 33.6 % of the import samples. The violation rate for domestic samples was 1.8% and 5.5 % for import samples. Among grains and grain products, the violation rate was 1.2 % for domestic samples and 0.8 % for imports. No violations were found in the milk/dairy products/eggs group or the fish/shellfish/other aquatic products group among either domestic or import samples. Of domestic fruit samples, 1.2% were violative; of imported fruit samples, 5.6% were violative. Of vegetables, 1.5% of domestic samples and 5.7% of import samples were violative. In the category "Other" (mostly nuts, edible seeds, honey, spices, and dietary supplements), the violation rates for domestic and import samples were 19.3 % and 7.7 %, respectively.

Of the domestic violative samples, eight of the 51 violations overall (15.7%) were for residues found to be over an established EPA tolerance or FDA formal action level.  The balance, 43 (84.3%), were for residues found in foods with no established EPA tolerance.  Of the import violative samples, 14 of 277 violations overall (5.1%), were for residues found to be over an established EPA tolerance or FDA formal action level.  The balance of import violations, 263 (94.9%), were for residues found in foods with no established EPA tolerance.

Pesticide Coverage

Table 3 lists the 403 pesticides that were detectable by the methods used in FY 2004; each of the 157 pesticides that were actually found is indicated by an asterisk (*).  Chemicals indicated by a (+) were not looked for by methods used in previous years, nor previously detected.

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Animal Feeds

In FY 2004, 578 feed samples (476 domestic surveillance and 102 import) were collected and analyzed for pesticides by the FDA (Table 4). Of the 476 domestic surveillance samples, 354 (74.4%) contained no detectable pesticide residues, 108 (22.7%) contained non-violative residues, and 14 (2.9%) contained residues which exceeded regulatory guidance. Of the 102 import samples, 80 (78.4%) contained no detectable pesticide residues, 20 (19.6%) contained non-violative residues, and 2 (2.0%) contained a residue which exceeded regulatory guidance.

Eight domestic surveillance samples of corn exceeded regulatory guidance.  Three corn samples from Ohio and one from Mississippi contained o-phenylphenol at levels ranging from .021 ppm to .105 ppm.  The EPA has not established a tolerance for o-phenylphenol on corn in 40 CFR 180.129 (title 40 of the Code of Federal Regulations, part 180, section 129).  Two corn samples from Kansas and one from Missouri contained methoxychlor at levels ranging from .035 ppm to .071 ppm.  All the tolerances for methoxychlor in 40 CFR 180.120 were revoked by the EPA effective October 15, 2002.  One corn sample from New York contained 0.224 ppm of chlorpyrifos-methyl.  The EPA has not established a tolerance for chlorpyrifos-methyl on corn in 40 CFR 180.419.

Six other domestic surveillance samples of animal feed exceeded regulatory guidance.  A sample of pistachio hulls from California contained 9.42 ppm of permethrin.  This level exceeded the 0.1 ppm tolerance the EPA established in 40 CFR 180.378 for permethrin on pistachios.  A soybean meal sample from Missouri contained gardona (tetrachlorvinphos) at 0.317 ppm.  The EPA has not established a tolerance for gardona on soybeans in 40 CFR 180.252.  A distiller's grain sample from Minnesota contained .043 ppm of biphenyl.  All the tolerances for biphenyl in 40 CFR 180.141 were revoked by the EPA effective October 19, 1999.  A sample of poultry litter from California contained .300 ppm of o-phenylphenol.  Although o-phenylphenol has tolerances that range from 5 to 125 ppm on 22 different fruits and vegetables in 40 CFR 180.129, none of these 22 commodities would be expected in poultry litter.  A sample of beet pulp pellets from Montana contained .101 ppm of CIPC (chlorpropham) and a sample of dry rendered tankage from Illinois contained .062 ppm of chlorpropham.  The only tolerance established by the EPA for chlorpropham in 40 CFR 180.181 is on potatoes.  The EPA established an interim tolerance for chlorpropham of 0.05 ppm in meat byproducts of cattle, hogs, horses, and sheep in 40 CFR 180.319.

Two import samples of animal feed exceeded regulatory guidance.  Pelleted canola fines from Canada contained 4.40 ppm of malathion.  The EPA has not established a tolerance for malathion on canola or rapeseed in 40 CFR 180.111.  A sample of pet bird food (chili peppers) that was manufactured in India and shipped from Canada contained 0.867 ppm of ethion.  The only tolerances established for ethion in 40 CFR 180.173 are on animal by-products and citrus fruit.

In the 122 domestic surveillance and 22 import samples of animal feed in which one or more pesticides were detected, there were 201 residues (165 quantifiable and 36 trace).  Malathion, chlorpyrifos-methyl, chlorpropham, DDE + TDE + DDT, and ethoxyquin were the most frequently found and accounted for 65.2% of all residues detected (Table 5).

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Focused Sampling

As previously described, FDA conducts "focused sampling" by means of short-term, regulatory based, field assignments.

In FY 2004 two field assignments for pesticide residues were issued. The first was "Sample Collection and Analysis of Dietary Supplement Ginseng for Pesticides," which was issued as regulatory follow-up for domestic marketed ginseng supplements suspected of pesticide residue violations. This assignment was related to an assignment issued in FY 2003, "Pesticides in Imported Bulk Ginseng and Domestic Ginseng Dietary Supplements." The FY 2003 assignment was noted in "FDA's Pesticide Program Residue Monitoring Report 2003."

The results of the combined FY 2003 and 2004 ginseng assignments are as follows:

Imports:

• Sixty-two import samples, largely bulk ginseng, collected and analyzed.
• Violative residues reported in 37 samples (60%) from these countries of origin: People's Republic of China (17); Canada (11); Hong Kong (6); and Republic of Korea (3).
• Twenty-three different violative residues reported
• Pentachloroaniline, quintozene, and pentachlorobenzene were the most common violative residues found.

Domestic:

• Seventy-nine domestic ginseng samples, largely dietary supplements, collected and analyzed
• Violative residues reported in 45 samples (57%)
• Twenty-three different violative residues reported
• Pentachloroaniline, quintozene, and pentachlorobenzene were the most common violative residues found.

The second field assignment was "Sample Collection and Analysis of Imported Dietary Supplements and Botanical Products for Pesticides and Toxic Elements" which included non-ginseng products Citrus aurantium, milk thistle, echinacea, and saw palmetto.

As a result of the second assignment, 21 samples were collected and analyzed, consisting of milk thistle (10 samples), Cirtus aurantium (6), echinacea (3), and saw palmetto (2). No violative residues were found in any of the samples. Some of these sample analyses carried over into FY 2005, but the results have been consolidated here.

Detailed results for samples for both assignments can be found in the Access database tables provided on FDA's internet website (see "Acknowledgments" section) .  The tables accompany this FY 2004 narrative report on the web.   The database tables for FY 2003 (ginseng) and 2005 (imported dietary supplements) are also available on that site. 

FDA Total Diet Study

Of the over 300 chemicals that can be determined for the analytical methods used, residues of 97 individual compounds were found in the foods analyzed in the four market baskets reported for FY 2004 (Market Baskets 03-4, 04-1, 04-2, and 04-3). The 97 individual compounds detected consisted of 71 parent pesticides of which 31 had one or more related compounds (e.g., isomers, metabolites) detected as well.

Table 6 lists the 25 most frequently found residues (i.e., those found in 2% or more of the samples) in the TDS foods other than infant and toddler foods, the total number of findings, and the percent occurrence in the four market baskets analyzed in 2004 (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.

The TDS program also collects and analyzes infant and toddler foods. Table 7 provides the frequency of occurrence in FY 2004 of the 23 pesticide residues (found in 2% or more of these samples in the four collections of these foods which totaled 228 samples), and the ranges of levels found.

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Summary

 Regulatory Monitoring FY 2004

A total of 7,905 samples of domestically produced food and imported food from 102 countries were analyzed for pesticide residues in FY 2004. No residues were found in 58.6 % of domestic and 66.4 % of import samples (Figure 3) analyzed under FDA's regulatory monitoring approach in 2004. Violative residue levels were found in 1.8 % of domestic and 5.5% of import samples. The findings for 2004 demonstrate that pesticide residue levels in foods are generally well below EPA tolerances, corroborating results presented in earlier reports .

FDA also collected and analyzed 476 domestic and 102 import animal feed samples for pesticides. No residues were found in 74.4 % of the domestic feed samples and 78.4 % of the import feed samples.

Figure 3 - Summary of Results of Domestic vs. Import Samples

Total Diet Study

In FY 2004, the types of pesticide residues found and their frequency of occurrence in the TDS were generally consistent with those in previous FDA reports. The pesticide residue levels found were well below regulatory standards. Results of baby foods tested in FY 2004 (and earlier years) also provide evidence of only small amounts of pesticide residues in these foods.

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FDA Pesticide Program Residue Monitoring 2004-2006 August 1, 2008