Pesticide Residue Monitoring Program Results and Discussion FY 2006

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

Results and Discussion - FY 2006

Regulatory Monitoring

Under regulatory monitoring, 5,512 samples were analyzed. Of these, 1,260 were of domestic foods and 4,252 were imported foods.

Figure 1 shows the percentage of the 1,260 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.)

As in earlier years, fruits and vegetables accounted for the largest proportion of the domestic commodities analyzed in FY 2006; these two commodity groups comprised 80.6 % of the total number of domestic samples. In FY 2006, 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 FYs 1996 to 2005 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 1,260 domestic samples, 68.8 % had no detectable residues and 1.6% had violative residues. In the largest commodity groups, fruits and vegetables, 44.2 % and 73.8 % of the samples, respectively, had no residues detected; 0.9 % of the fruit samples and 2.4 % of the vegetable samples contained violative residues (Figure 1). In the grains and grain products group, 86.9 % of the samples had no residues detected, and there were no samples with violative residues. In the fish/shellfish/other aquatic products group, 94.1 % had no detectable residues, and there were no samples with violative residues. In the milk/dairy products/eggs group, all 21 samples analyzed had no detectable residues. In the "Other" foods group that covers nuts, seeds, honey, spices, and animal feeds among other foods, 93.1 % of the samples had no detectable residues and there were no samples with violative residues.

Findings by commodity group for the 4,252 import samples are shown in Figure 2. Fruits and vegetables accounted for 84.3 % of import samples. Overall for all imported foods, 94.9 % of the samples analyzed in FY 2005 were in compliance with EPA tolerances and FDA formal action levels. This compares with a compliance rate for imported foods for FYs 1996 to 2005 of 93.8 % to 98.4 %.

Appendix B contains detailed data on import samples. Of the 4,252 import samples analyzed, 66.6 % had no residues detected, while 5.1 % had violative residues. Imported fruits had 70.4% of samples with no residues detected and 3.6 % samples with violative residues. Imported vegetables had 60.4 % of samples with no residues detected and 5.4% samples with violative residues. No residues were found in 75.0 % of the imported milk/dairy products/eggs group and no violative residues were reported. No residues were found in 82.4 % of the imported fish/shellfish group and 3 violations (2.2 %) were found in this food group. In the imported grains and grain products group, 85.5% had no detectable residues, and 2.2 % of the samples had violative residues. In the "Other" foods group consisting largely of nuts, oils, spices, and dietary supplements, 82.4 % of the samples analyzed had no residues detected, while 10.1 % of the samples contained violative residues.

Pesticide monitoring data collected under FDA's regulatory monitoring approach in FY 2006 are available to the public as a computer database. This database summarizes FDA 2006 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 1992-2005 is provided in the "Acknowledgements" section of this report.

Geographic Coverage

Domestic:A total of 1,260 domestic samples were collected in FY 2006 from 41 states and Puerto Rico. The largest numbers of samples are usually collected from those states that are the largest producers of fruits and vegetables, although California, often the state with the greatest number of samples, dropped to ninth in FY 2006. This was believed to be due to the re-direction of local FDA resources to respond to the outbreaks that occurred that year. Table 1 lists the numbers of domestic samples from each state, in descending order.

Note - for Table 1, domestic samples with no state recorded in the "Sample 2006" file were attributed through other documentation.

Imports: A total of 4,252 samples representing food shipments from 85 countries (excluding U.S. goods sampled in import status) were collected in FY 2006. 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 2006.

Domestic/Import Violation Rate Comparison for FY 2006

In FY 2006, 1,260 domestic and 4,252 import samples were collected and analyzed. Pesticide residues were detected in 31.2 % of the domestic samples and in 33.4 % of the import samples. Just 1.6 % of the domestic samples and 5.1 % of the import samples were found to contain violative residues. Among grains and grain products, the violation rate was zero for domestic samples and 2.2 % 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 2.2 % for the import samples of this group. Of domestic fruit samples, 0.9 % contained violative residues while 3.6 % of imports did. For vegetables, 2.4% of domestic samples and 5.4 % 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 5.1 %, respectively. As in FY 2005, ginseng and spices accounted for most of the samples with violative residues for the import "Other" foods group.

Of the domestic violative samples, two of the 19 violations (10.5 %) were for residues found to be over an established EPA tolerance or FDA formal action level. The balance, 17 or 89.5 %, were for residues found in foods with no established EPA tolerance. Of the import samples with violative residues, 8 of 217 violations (3.7 %), were for residues found to be over an established EPA tolerance of FDA formal action level. The balance of import violations, 209 or 96.3 %, were for residues found in foods with no established EPA tolerance.

Pesticide Coverage

Table 3 lists the 279 pesticides that were detectable by the methods used in FY 2006; each of the 135 pesticides that were actually found is indicated by an asterisk (*). Residues not previously looked for, or detected, are noted by a "+".

Animal Feeds

In FY 2006, 335 feed samples (264 domestic surveillance and 71 import) were analyzed for pesticides by the FDA (Table 4). Of the 264 domestic surveillance samples, 196 (74.2 %) contained no detectable pesticide residues, 66 (25.0 %) contained residues at levels not exceeding regulatory guidance, and 2 (0.8%) contained residues which exceeded regulatory guidance. Of the 71 import samples, 68 (95.8 %) contained no detectable pesticide residues, 3 (4.2 %) contained residues at levels not exceeding regulatory guidance, and 0 (0.0 %) contained a residue which exceeded regulatory guidance.

During FY 2006, 2 domestic surveillance samples of animal feed contained 2 residues that likely exceeded regulatory guidance. A vitamin premix sample collected by the New England District Office and manufactured in Canada contained 82,070 ppm of ethoxyquin. If this domestic import sample were added at ≥ 3.66 pounds per ton of a complete ration, then the complete ration would be expected to contain > 150 ppm of ethoxyquin (82,070 ppm x 3.66/2000 = 150.2 ppm). Levels above 150 ppm would exceed the feed additive tolerance for ethoxyquin in animal feed that was established by the FDA in 21 CFR 573.380.

In addition, a sample of tallow collected by the Chicago District Office contained 0.069 ppm of o-phenylphenol. Although the EPA has established tolerances ranging from 5 to 125 ppm on 22 different commodities for this fungicide in 40 CFR 180.129, no tolerances have been established for o-phenylphenol in animal fat.

In the 68 domestic surveillance and 3 import samples of animal feed in which one or more pesticides were detected, there were 99 residues (82 quantifiable and 17 trace). Malathion and ethoxyquin were the most frequently found and accounted for 60.6% of all residues detected (Table 5).

Focused Sampling

As previously described, FDA conducts "focused sampling" by means of short-term, regulatory based, field assignments. In FY 2006, there was one pesticide-related field assignment issued and it was "Sample Collection and Analysis of Imported Dietary Supplement and Botanical Products for Pesticides and Toxic Elements." Samples of imported dietary supplement products, including Ginkgo, Garcinia cambogia, Angelica, Kava kava, and St John's wort were to be collected. Sampling districts were also asked to continue collection of Citrus aurantium, Milk thistle, Echinacea, and Saw palmetto from a FY 2004 assignment to obtain additional samples of these products. The supplement products to be collected were to be in bulk dried, powdered, or ground forms, or bulk finished dosage form supplements such as capsules and tablets.

Results: Eighty-seven samples were collected and analyzed and consisted of Angelica (19 samples), Milk thistle (18), St. John's wort (13, Ginkgo (13), Kava kava (10), Echinacea (7), Garcinia cambogia (4), Citrus aurantium (2), and Saw palmetto (1). Two samples were found to contain violative pesticide residues - a sample of St. John's wort extract from Canada for permethrin and a sample of Echinacea tablets from Australia for dieldrin and p,p' DDT. Detailed results for these samples can be found in the Access database tables provided on FDA's internet website (see "Acknowledgments" section). The tables accompany this FY 2006 narrative report on the web.

FDA Total Diet Study

Of the over 300 chemicals that can be determined for the analytical methods used, residues of 112 individual compounds were found in the foods analyzed in the four market baskets reported here for FY 2006 (Market Baskets 05-4, 06-1, 06-2, and 06-3). The 112 individual compounds detected consisted of 84 parent pesticides of which 32 had one or more related compounds (e.g., isomers, metabolites) detected as well.

Table 6 lists the 25 most frequently found residues in the TDS foods other than baby 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 2006 (916 total samples). The five most frequently observed chemicals were: DDT, malathion, endosulfan, chlorpyrifos-methyl, 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 of the 25 pesticide residues found in 2% or more of these samples in the four collections of these foods (215 samples total) in FY 2006 and the ranges of levels found.

Summary

Regulatory Monitoring - FY 2006

A total of 5,512 samples of domestically produced food and imported food from 85 countries were analyzed for pesticide residues in FY 2006. No residues were found in 68.8 % of domestic and in 66.6 % of import samples (Figure 3) analyzed under FDA's regulatory monitoring approach in FY 2006. Only 1.6 % of domestic and 5.1 % of import samples had residue levels that were violative. The findings for FY 2006 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 264 domestic and 71 import animal feed samples for pesticides. No residues were found in 74.2 % of the domestic feed samples and in 95.8 % of the import feed samples.

Total Diet Study

In FY 2006, 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 2006 (and earlier years) also provide evidence of only small amounts of pesticide residues in these foods.

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