In doing so, EPA is required to (1) apply an additional 10-fold safety factor in setting tolerances to ensure the safety of foods for children, unless reliable data support a different factor; (2) ensure that there is reasonable certainty that no harm will result to children from aggregate exposure to a pesticide from food, drinking water, and residential sources; and (3) consider available information concerning the cumulative effects on children of pesticides that act in a similar harmful way (known as a common mechanism of toxicity). Approach for Considering Additional Safety Factor Has Evolved Since 1996

EPA began to consider the additional safety factor in its pesticide reviews and tolerance reassessments soon after FQPA was passed. No Additional Safety Factor Has Been Applied in Half of Decisions

OPP senior managers make the final decisions about whether to apply the additional safety factor for children, based on the Safety Factor Committee’s recommendations and other considerations. OPP determined that a safety factor to protect children, in addition to the routinely applied 100-fold safety factor, was necessary in 49 cases and that available evidence was sufficient to show that an additional safety factor was not required in 56 cases (see table 3). In the case of the organophosphates—and chlorpyrifos in particular—the potential effects of aggregate exposure and cumulative assessments, in terms of needed mitigation steps, are beginning to emerge. Interim Procedures for Aggregate Exposure Assessments Are in Place

Although formal policy guidance for performing aggregate exposure assessments has not yet been issued in final form, EPA has interim procedures in place for considering aggregate exposure using available data and methods.Traditionally, EPA has assessed the risk of food use pesticides on the basis of estimated exposure from all foods containing residues of the pesticide. Because of its traditional focus on pesticide exposures from foods, EPA’s data and methods for estimating food exposures are relatively highly developed, but for most pesticides the agency has lacked the data and methods to estimate nonfood exposures from drinking water and residential uses. EPA Has Made Some Progress in Reassessing Tolerances to Date

EPA has made some progress in reassessing existing tolerances, as required by FQPA, but relatively few of these allowable limits for pesticide residues have changed as a result of considering the law’s new requirements. As of April 2000, EPA reported that it had reassessed nearly 3,500 tolerances for about 300 pesticides.However, nearly half of these tolerance reassessments did not require consideration of the additional safety factor for children or aggregate exposure, because the manufacturer agreed with EPA to voluntarily eliminate the tolerances and withdraw the pesticides from those uses. Although EPA has given priority to reassessing tolerances for high-risk pesticides, reassessments for the high-risk organophosphate pesticides cannot be completed until a cumulative assessment has been done for the group. Most of these tolerance reassessments—1,421 tolerances, or 77.5 percent—resulted in no change (see table 4). This group accounts for the largest proportion, about 57 percent, of all tolerances that need to be reassessed. Did the committee adequately justify its decisions on (1) data completeness and reliability (data gaps) and (2) evidence of increased susceptibility in children? EPA was not prepared to consider cumulative effects at that time.
Why GAO Did This Study

Pursuant to a congressional request, GAO provided information on the Environmental Protection Agency's (EPA) efforts to reduce children's exposure to pesticides by implementing the requirements of the Food Quality Protection Act (FQPA), focusing on the: (1) approach EPA has developed for making decisions about applying the new safety factor; (2) progress that has been made in considering aggregate exposure and cumulative effects; and (3) progress that has been made in reassessing tolerances for pesticide residues.

What GAO Found

GAO noted that: (1) when FQPA became law in 1996, EPA immediately began efforts to consider the additional safety factors for children, using available methods and data in an interim approach that has evolved over time; (2) an internal committee now recommends whether to apply the additional safety factor in pesticide reviews, based on data completeness and evidence of increased susceptibility in children; (3) using this approach, EPA has made decisions about applying the additional safety factor for 105 of the more than 450 pesticides to be reassessed; (4) it determined that an additional safety factor was necessary in 49 cases and not necessary in the remaining 56 cases; (5) EPA also had interim procedures in place for considering aggregate exposure, which incorporate available data on exposures from food, drinking water, and residential uses; (6) data on nonfood exposures have been lacking for most pesticides, however, and methods for estimating and combining such exposures are still being developed; (7) EPA has not yet begun to consider cumulative effects in the regulatory process; (8) it has determined that one group of pesticides that is considered to be high-risk, called the organophosphates, will need to be assessed for cumulative effect, but methods for doing so are still under development; (9) potential effects of considering aggregate exposure and cumulative effects are beginning to emerge; (10) on June 8, 2000, after applying the additional safety factor and conducting an aggregate exposure assessment for chlorpyrifos, EPA announced a need to substantially reduce children's exposure to this pesticide by reducing its use on foods frequently eaten by children and by eliminating nearly all household uses; (11) EPA has reported progress in reassessing existing tolerances for pesticide residues on foods, but relatively few of these allowable limits have changed as a result of considering FQPA's new requirements; (12) FQPA called for reassessing one-third of all existing tolerances by August 1999--a goal EPA met; (13) GAO analyzed a larger group, those counted as reassessed through April 2000; (14) for about 47 percent of these tolerances, the manufacturer agreed with EPA to eliminate the tolerances and withdraw the pesticides from those uses, before the additional safety factor or aggregate exposures were considered; (15) in most of these cases the pesticide was no longer being used on a particular food crop or the manufacturer decided not to maintain the ability to use it on a particular food crop; (16) most of the remaining reassessments in the group GAO analyzed resulted in no change; and (17) in reassessing tolerances, EPA has given priority to high-risk chemicals.