Putting Children First
Making Pesticide Levels In Food Safer For Infants and Children


This is the Executive Summary of NRDC's April 1998 report reviewing the adequacy of data typically available to EPA in setting child-protective levels of allowable pesticide residues in or on food, as required by the Food Quality Protection Act of 1996.


Pesticides are designed to be poisonous. Yet pesticides are found almost everywhere -- in households and schools, in drinking water, even in baby food. Pesticide metabolites are also found consistently in children's urine, when such testing is performed.

Mounting evidence shows that children have daily exposure to pesticides. The Scientific Advisory Panel to EPA's Office of Pesticide Programs recently reviewed a study concluding that every day, nine out of ten American children age six months through 5 years ingest organophosphate insecticides in their food. Organophosphates kill pests by poisoning the brain and nervous system. Yet the study further estimated that more than a million children each day eat an amount of these chemicals that exceeds the safe adult daily dose set by EPA.

Children are not simply little adults. A child's potential susceptibility to the toxic effects of pesticides, including effects on the developing brain, nervous, immune and reproductive systems, is often greater than an adult's. This vulnerability may not extend to all pesticides. But specific data are often lacking to distinguish individual pesticides that are particularly toxic to children.

Food Quality Protection Act And The Protection Of Children

The Food Quality Protection Act (FQPA) of 1996 aims to assure for all pesticides used on food that EPA's tolerances -- the pesticide levels legally allowed to remain in or on raw or processed foods -- would protect infants and children, taking into account their potentially greater susceptibility, as well as their unique patterns of exposure. In particular, the FQPA directs EPA to use an additional, tenfold (10X) safety factor in its tolerance risk assessments, unless there are "reliable data" on children's toxicity and exposure that support the use of some other safety factor. This means that under the FQPA, the amount of pesticide residue legally allowed to remain in or on foods will be set ten times lower then it would have been previously, until reliable data is generated describing both children's exposure to that pesticide and its toxicity to infants and children.

This report reviews the information on children's exposure to pesticides typically available to EPA in determining whether there are reliable data to justify alteration of the children's tenfold safety factor. This includes data on dietary exposures through contaminated food and drinking water, exposure through contaminated air, soil, and surface water, and exposure through other non-dietary sources. We also scrutinize EPA's testing requirements, and the most up-to-date testing guidelines used to guide the generation of toxicity data on which the Agency bases its tolerance-setting decisions for infants and children under the new law.

Do these tests and data typically provide EPA with sufficiently "reliable data" to depart from use of the child-protective FQPA safety factor? We find, in most cases, they do not.


Data On Children's Exposures To Pesticides

For some pesticides, such as the organophosphate insecticides, existing data on children's exposure through contaminated food alone should cause concern. Evidence suggests that these nervous system poisons are present in food at levels that can drive many children eating a normal diet to exceed EPA's safe daily dose (set for adults) - even without using additional safety factors.

For other pesticides, however, EPA's Office of Pesticide Programs (OPP) usually lacks the comprehensive and reliable data on children's exposure needed to alter the tenfold FQPA safety factor. For example:

  • Water may well be the single item most consumed by children. EPA admits that it does not have sufficient monitoring data on pesticide contamination of drinking water to include in its tolerance-setting decisions. For pesticides like organophosphates, where known exposures through contaminated food are already worrisome, a child's additional exposure through pesticide-laced tap water will only drive the level of concern higher, making the need for stringent tolerances even greater. Yet contamination of drinking water is common, often with multiple pesticides.

  • For individual pesticides, EPA typically lacks much (if any) data on children's non-dietary exposures. Pesticides used on foods may have other non-food uses, on gardens or in homes, for example. Pesticides used for agricultural or other purposes may also contaminate the surrounding environment, including the air, soil and water. Under the FQPA, children's exposure via these other sources must be taken into account in setting a tolerance. Studies confirm that children are exposed to multiple pesticides in the household carpets, on countertops, even in their toys. Pesticides are used frequently in schools, often without notifying parents or teachers. Pesticide contaminants have also been found frequently in soil, rainwater, fog and air -- all of which a child can inhale or ingest.


Data On Pesticide Toxicity To Children

The toxicity testing that EPA requires of pesticide manufacturers, which is largely performed in laboratory animals and then used in setting tolerances, is often inadequate to protect children as well. Our analysis of EPA guidelines used by manufacturers to complete these tests reveals data gaps falling into three categories.

  • Failure to expose animals during all critical periods of development corresponding to ages when children are known to have the greatest potential susceptibility to the toxic effects of chemicals. Most toxicity testing for food-use pesticides uses only adult animals. Of the two tests required for food-use pesticides which actually do expose developing animals, one fails to continue dosing the animal after birth, when many organ systems are still developing. How can pesticide tolerances based upon these tests be said to carry a reasonable certainty of no harm to infants and children?

  • Failure to assess all endpoints, or toxic effects, of critical concern to the fetus, infant or child. None of the tests EPA typically requires of food-use pesticides will assess their toxicity to the developing brain - including effects on learning and memory, toxicity to the immune system, or their potential for disrupting the endocrine (hormonal) system. In fact, specific testing for toxicity to the immune system has been requested for only two chemical pesticides; developmental neurotoxicity testing has only been completed for six pesticides. How can pesticide tolerances be said to have a reasonable certainty of no harm to infants and children without these tests? Children depend on healthy brains, nervous and immune systems to become learning, productive, healthy adults.

    In compliance with the FQPA, EPA is still developing guidelines for testing a chemical's potential for disrupting normal function of the endocrine (hormonal) system. Normal development of the fetus, infant and child depends upon the timely release of low levels of various hormones from endocrine organs and their action on different organs. Until guidelines and testing are implemented, a pesticide's untested potential for endocrine disruption should be reflected in the tolerance for that chemical.

  • Failure to monitor test animals for a lifetime to allow all adverse or toxic effects which might occur to become evident. The only two toxicity tests required for food-use pesticides which employ developing animals, tests for developmental and reproductive toxicity, fail to follow the dosed animals to their natural death. These tests therefore cannot reflect what will happen to exposed children as they mature, accumulate exposure to other toxic chemicals, and as their organs lose their full capacity to function.


Recommendations For Protecting Children Under The FQPA

Despite the data gaps described above, many in the agribusiness and pesticide industries have recently suggested that EPA back away from routine use of the additional FQPA safety factor to protect infants and children. For its part, the Office of Pesticide Programs recently issued a draft policy on use of this child-protective tenfold factor that falls short of articulating a strong and presumptive use.

In addition, some industry members have suggested that EPA should wait to make decisions until more complete data are collected. It is important to emphasize that despite certain data gaps for children's exposure and toxicity, the Agency generally has more than enough data for many pesticides (such as organophosphates and carbamates) to necessitate immediate serious reductions in, or revocations of their tolerances. More data on children's toxicity and exposure to these pesticides could only add to the reasons for reducing or revoking these tolerances. Thus, there is absolutely no reason for EPA to wait to make these decisions. The agency should use the best data available, and where there are data gaps for fetuses', infants', or children's toxicity or exposure, EPA should retain the presumptive tenfold safety factor.

Even without generating new data on infants and children, OPP has ample data on pesticide toxicity and exposures, generally, to justify concern about their long-term effects on infants and children. In 1993, a National Academy of Sciences panel presented a compelling summary of this data in its report, Pesticides in the Diet of Infants and Children. Building on the NAS panel's recommendations, Congress made strong presumptive use of an additional tenfold safety factor central to the FQPA.

Nevertheless, the most recently available information from EPA indicates that it has retained the tenfold children's safety factor in less than 10 percent of the initial tolerances issued under the FQPA. We believe our children deserve better. NRDC therefore makes the following recommendations:

  1. Strong Presumptive use of the 10X Safety Factor. In its tolerance decisions, EPA must make strong, presumptive use of the additional tenfold children's safety factor, as is required by law in the Food Quality Protection Act, pursuant to the National Academy of Sciences report in 1993.

  2. Convene a Panel of Children's Experts. The FQPA allows departure from use of this child-protective 10X safety factor only if there are reliable, chemical-specific data to use some other factor. EPA should immediately convene a blue ribbon panel, comprised of independent pediatricians, pediatric neurologists, pediatric immunologists, pediatric endocrinologists, and developmental or other biologists with expertise in effects of in utero or early childhood exposure to toxic chemicals. This panel should be augmented with EPA developmental toxicologists and pediatric exposure assessors. It should be charged with reviewing the state of the science on what complete and reliable set of toxicity and exposure data would be sufficient to warrant departure from use of the tenfold FQPA children's safety factor. EPA should:

    • Convene these experts under the Children's Health Protection Advisory Committee, whose charter is to assist EPA in the development of regulations, guidance and policies to address children's health. This group, currently formed and functioning, already includes many of the pediatric experts needed to answer the charge above.

    • Make the panel's deliberations transparent and public, and its members free of conflicts of interest.


  3. Finalize Revised Data Requirements and Testing Guidelines. EPA should immediately finalize its revised pesticide data requirements and its most up-to-date toxicity testing guidelines. Though imperfect, and typically drafted prior to passage of the FQPA, these revisions are more stringent and better reflective of the state of the science than are existing requirements and guidelines.

  4. Review Guidelines. On receiving the determination of the blue ribbon panel, the EPA should again review its toxicity testing guidelines to ensure that they reliably assess -- individually and collectively -- the full range of toxic effects most relevant to the health of fetuses, infants, and other children, including effects on the developing brain and nervous, immune, endocrine and reproductive systems, and revise the guidelines accordingly. Special attention should be paid to the number and adequacy of existing criteria, or triggers, by which EPA scientists determine when to request testing of a pesticide's effect on the developing brain and nervous system, and other critical organs.

  5. Review Exposure Databases. On receiving the blue ribbon panel's determination, EPA should also review existing EPA, FDA, and USDA exposure data in terms of their reliability in describing the exposure of fetuses, infants and other children to potentially toxic pesticides.

  6. Use of the 10X Safety Factor Pending Reliable Data. EPA must not depart from use of the additional, child-protective 10X factor in setting tolerances until the Agency has collected a body of toxicity and exposure data for that pesticide that meets the standard of reliability determined by the blue ribbon panel.


Awareness of the lack of child-specific data for individual pesticides dates back to before the National Academy of Sciences first convened its expert panel in 1988. In the ensuing decade, OPP's pesticide data requirements and testing guidelines have remained largely unchanged; gaps in the data provided by pesticide manufacturers have also remained largely the same. The biggest change has come with the increasing recognition that large numbers of children are exposed to these pesticides each day.

Given this history, suggestions by agribusiness, the pesticide industry and others that EPA should wait for additional data before implementing the FQPA's child-protective uncertainty factor are self-serving. Strong and immediate presumptive use of this tenfold safety factor is necessary not only to protect infants and children, but also ensures that ten years from now we are not still waiting for data to show, with reasonable certainty, that pesticides pose no harm to our children. In other words, strong presumptive use of the FQPA safety factor is needed to finally generate the data to overcome the uncertainty that made the FQPA necessary in the first place.

Any delay in implementing the new child-protective provisions of the FQPA should be viewed, at best, as bare-knuckle politics. At worst, it amounts to a massive experiment on large numbers of fetuses, infants and children, an experiment where we knowingly expose them on a daily basis to pesticides -- chemicals designed to be poisonous in small amounts.


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