Vol. 04 Issue 1, Winter 1999
Food Quality Protection Act: Putting Kids First
The Ribbon
Susan H. Wayland, Acting Assistant Administrator
Office of Prevention, Pesticides and Toxic Substances, US Environmental Protection Agency
The FQPA Provides Special Protections for Children
There is growing recognition with public health protection that one size does not fit all. Children may be especially sensitive to their environments, and that sensitivity needs to be considered in public policy. The Food Quality Protection Act (FQPA), passed unanimously by both Houses of Congress and signed into law on August 3, 1996, is noteworthy because of its explicit protection of children. The Act amended the two primary statutes governing pesticide use in the United States, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act. Within this statutory framework, the Environmental Protection Agency's (EPA) Office of Prevention, Pesticides, and Toxic Substances is responsible for granting market approval for new pesticides, reviewing older pesticides to ensure that they meet current health and safety standards, and establishing maximum allowable levels of residues for food and feed (tolerances).
The genesis for many of FQPA's provisions was the National Academy of Sciences' 1993 report entitled, " Pesticides in the Diets of Infants and Children." That report concluded that the federal government was not differentiating clearly enough between pesticide risks for children and adults. FQPA mandates that the EPA make a specific determination that tolerances are safe for children, and significantly amends the risk assessment process to provide greater confidence in those determinations. Specifically, FQPA requires consideration of the aggregate risk from dietary and non-occupational sources of exposure to a particular pesticide, the cumulative risk of pesticides with similar modes of action, and the use of an additional safety factor to account for toxicity to children or for incompleteness of the data. These requirements not only apply to post-FQPA registrations, but to all tolerances established prior to the law's enactment.
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The FQPA requires EPA to reassess within 10 years all existing tolerances to ensure that they meet the tougher new safety standard. In developing the tolerance reassessment schedule, EPA is placing a priority on pesticides (including organophosphates, carbamates, probable and possible carcinogens, organochlorine pesticides, and high-hazard inert ingredients) that appear to pose the greatest risk to the public. |
Pesticide Exposures Should be Aggregated
While EPA traditionally assessed pesticide risk to a number of human subpopulations, including infants and children, FQPA challenges the Agency to refine risk assessments and employ new areas of science in those assessments. One new area is the aggregation of pesticide exposures, not just from the diet but from other non-occupational sources such as home and garden use, and from drinking water. EPA has been working internally, and with scientific organizations such as our Scientific Advisory Panel and the International Life Sciences Institute (ILSI), to develop an effective approach to aggregate risk. Building on recommendations resulting from an ILSI workshop, the Agency anticipates publishing a final aggregate risk policy in the Spring of 1999.
Pesticide Risks Should be Considered Cumulatively
FQPA also requires that risks from pesticides with a common mechanism of toxicity be considered cumulatively. For example, since all the organophosphate insecticides inhibit a key enzyme responsible for nerve transmission, they share a common mechanism of toxicity and need to be considered collectively. While the Agency is developing a methodology for cumulative risk assessment, we are conducting individual risk assessments for each organophosphate.
Safety Factor for Infants and Children
To ensure that we are providing adequate protection, EPA applies safety factors during its assessments. The Agency has customarily applied a 100-fold safety factor; 10-fold for the extrapolation of animal data to human effects and 10-fold for the differences in sensitivity among humans. In cases where the Agency has concerns over the adequacy of a pesticide's data base, it uses additional factors. FQPA mandates that every decision is protective of infants and children. The law specifies that an additional factor of ten shall be applied, unless another factor is shown to be protective based on reliable data, evaluating pre- and post-natal toxicity as well as the adequacy of the data available on toxicity and exposure. EPA is actively reviewing its use of the additional safety factors and evaluating the current data requirements to determine what additional information should be gathered to assist in evaluating toxicity unique to infants and children.
Reassessment of Established Tolerances
FQPA not only changed the process of reviewing new pesticides, but required EPA to review established tolerances. Presently there are 9728 tolerances subject to reassessment, with the first third scheduled for completion by August 3, 1999. All existing tolerances will be reassessed by August 3, 2006. FQPA requires that the Agency give priority consideration to the reassessment of tolerances for pesticides which appear to pose the greatest risk to human health. In response to this provision, EPA has been devoting a great deal of resources to reassessing the tolerances for the organophosphates. While reassessment of all organophosphate tolerances may not be accomplished by August 3, the Agency will meet its statutory requirement to review one-third of pre-FQPA tolerances and will be in position to move forward with cumulative assessment of organophosphate risk.
USDA Involvement
Vice President Gore has asked EPA and USDA to work closely in implementing FQPA, and specifically charged the agencies to use sound science, to consult with stakeholders, to ensure openness and transparency in everything we do, and provide for a reasonable transition for agriculture. USDA is playing a vital role by collecting improved data on foods consumed by infants and children as well as providing critical information to refine our preliminary risk assessments. To assist with transition away from potentially risky pesticides and uses, USDA and EPA will be working together to identify risk mitigation and transition opportunities, which will also involve all affected stakeholders. In addition, EPA has established a program to bring safer pesticides to the market faster. Many components of that program are reflected in FQPA, and around half of new registrations in the last two years have been for reduced risk pesticides.
There is Widespread Consensus That Kids Deserve Special Protections
The Clinton Administration places a high priority on the protection of children. The tools FQPA provides are essential in ensuring that protection. Under the new law, EPA will enhance its scientific approaches, give greater attention to the differences between children and adults, and improve consumer confidence in the safety of the food supply.
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