Protecting The Public From Pesticide Residues In Food

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As part of its program to regulate the use of pesticides, EPA is responsible for ensuring that the public is protected from unreasonable health risks posed by eating foods that have been treated with pesticides. An important component of that effort involves setting "tolerances," which are the maximum amount of pesticides that may legally remain in or on food and animal feed. This fact sheet provides a summary of EPA's process for protecting the public from pesticide residues in food, including the special efforts taken to protect infants and children.

On This Page:

Studies Required Regarding Pesticides in Food
Studies Required Regarding Pesticide Health Effects
Assessing Dietary Risks to Infants, Children and Others
Conclusion

Studies Required Regarding Pesticides in Food

In setting tolerances, EPA must determine the maximum levels of pesticides likely to be found in food. EPA accomplishes this by requiring pesticide manufacturers to submit data that answer basic questions about what residues are present in food and in what quantities. Among these are field trial data, which are studies of residues found on crops grown in the field when pesticides are applied using the highest rate allowed by the pesticide product label. Manufacturers must also provide information on residues found in many processed foods, such as apple juice or tomato paste. Data on residues in animal products, such as milk or meat, are also required if livestock are exposed to pesticides directly or through residues in their feed.

In re-evaluating the safety of existing pesticides, EPA also uses monitoring data that show the levels of pesticide residues actually occurring in foods as they are harvested, processed, marketed, and prepared to be served. EPA sometimes requires pesticide manufacturers to perform monitoring studies. Monitoring data often are also available from FDA, USDA, and state agencies.

Studies Required Regarding Pesticide Health Effects

EPA also requires a battery of toxicity tests in laboratory animals to determine a pesticide's potential for causing adverse health effects, such as cancer, birth defects, and adverse effects on the nervous system or other organs. Tests are conducted for both short-term (acute) and long-term (chronic) toxicity. For chronic effects other than cancer, laboratory animals are exposed to different doses of a pesticide to determine the level at which no adverse effects occur. This level is divided by an uncertainty or "safety" factor (usually 100) to account for the uncertainty of extrapolating from laboratory animals to humans and for individual human differences in sensitivity. The resulting figure, termed the Reference Dose, is the level of exposure that EPA judges an individual could be exposed to on a daily basis for a lifetime with minimal probability of experiencing any adverse effect. For cancer risks, EPA evaluates multi year tests of laboratory animals to estimate levels unlikely to pose more than a negligible risk. Tolerances are only approved if the expected exposure is below these health concern levels.

Several of the types of studies that EPA can require are designed specifically to assess risks to infants and children. These include developmental toxicity studies, which examine risks to developing fetuses that result from exposure of the mother to pesticides during pregnancy; developmental neurotoxicity studies, which specifically examine the risks to the developing nervous system; and two-generation reproduction studies, which provide information about the possible effects on the health of both the individual and its offspring resulting from pesticide exposure.

Assessing Dietary Risks to Infants, Children and Others

EPA recognizes that the diets of infants and children may differ substantially from those of adults and that they consume more food for their size than adults. As a result, they may be exposed to proportionately more pesticide residues. EPA addresses these differences by combining survey information on food consumption by nursing infants, non-nursing infants, and children with data on pesticide residues to estimate their dietary exposure. EPA also uses this process to estimate exposure for other age groups, as well as several different ethnic groups and regional populations.

Information about pesticide exposure to infants, children and other subgroups is then combined with toxicity information to determine the potential risks posed by pesticide residues. If risks are unacceptable, EPA will not approve the tolerances.

Some of EPA's recent important regulatory decisions were based on concerns about childhood or infant exposures, such as the elimination of the use of aldicarb on bananas EBDCs on a number of fruits and vegetables.

Conclusion

EPA believes that the tolerance process is protective of human health because it is based on extensive testing and on a combination of conservative assumptions and risk assessment practices developed using current scientific knowledge. At the same time, the Agency is working to make federal standards more protective of infants and children and to better understand the potential risks of pesticides. These efforts include addressing the recommendations of the National Academy of Sciences 1993 report entitled Pesticides in the Diets of Infants and Children.

EBDCs are fungicides containing chemicals known as dithiocarbamates.

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