EPA opens public comment period on uncertainty factor in pesticide risk analyses

Following news that the Environmental Protection Agency (EPA) is considering a higher uncertainty factor in all pesticide risk determinations, the agency is making available for comment a policy paper entitled “Revised Risk Assessment Methods for Workers, Children of Workers in Agricultural Fields, and Pesticides with No Food Uses.” The paper describes how EPA will assess pesticide risks not governed by Food Quality Protection Act (FQPA) amendments to the Federal Food, Drug and Cosmetic Act (FFDCA). EPA describes its proposal as incluing a more thorough assessment of risks to workers, including farmworkers and farm children, as well as risks posed by pesticides that are not used on food. The agency is asking the public to comment on the new approach and how best to implement the improvements.

"Better information and applying these tools will strengthen EPA’s protections for farm workers exposed to these chemicals, and children living in and around the areas of highest possible exposure,” says EPA Administrator Lisa P. Jackson. “It’s essential we have the tools to keep everyone, especially vulnerable populations like children, safe from the serious health consequences of pesticide exposure.”

EPA licenses or registers pesticides for sale and distribution under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The agency establishes tolerances, limits for pesticide residues in or on food, under section 408 of FFDCA. In contrast to the risk/benefit standard for registration under FIFRA, FFDCA applies a risk-only standard for tolerances and explicitly sets certain approaches for assessing risks and establishes acceptable rates of harm. Critics of the risk assessment approach (as opposed to the precautionary approach) to toxics regulation have maintained that the methodology ignores data gaps on important health outcomes not evaluated (e.g. endocrine disruption), possible interactions, additive and synergistic effects resulting from chemical mixtures permitted to be released in the environment, effects of all the contaminants associated with a pesticide, and the availability of less or non-toxic approaches and products to the pesticide under evaluation. Health advocates have said that multiplying an uncertainty factor (called a safety factor by EPA) of ten times an unknown outcome (equivalent to zerio) does not necessarily improve the protection of children or others exposed. In simple math terms, ten times zero (knowledge) equals zero (knowledge). The best example of this are endocrine disruptors and sublethal effects associated with low dose exposure, where miniscule amounts of a chemical can induce serious health outcomes for a spectrum of disorders throughout ones life.

Under the policy, EPA risk assessments for children, farmworkers and others would consider aggregate pesticide exposures from all sources (which is currently done when there is a non-occupational food-related exposure) in addition to the cumulative effects from multiple pesticides that have similar toxicity (also done currently when there is food-related non-occupational exposure). The risk-only standard and the mandated risk assessment approaches were added to FFDCA by the Food Quality Protection Act of 1996 (FQPA). However, FQPA explicitly did not require EPA to use these risk assessment approaches in assessing worker risks or non-food use pesticides that do not have any food uses. Also, historically, EPA has not considered children in assessing worker risks.

Specifically, the policy will include using an additional uncertainty factor for children, considering aggregate exposures to pesticides from multiple sources, and considering cumulative effects which may occur from exposure to multiple pesticides with a common mechanism of toxicity. Moreover, risks will be explicitly reported for individuals who had not been explicitly considered, specifically workers age 12 to 17 and children taken into agricultural fields. EPA also would apply the additional uncertainty factor for infants and children in cases where the agency has incomplete data.

This “safety” factor, as EPA refers to it, however, is merely the allowable margin of error or the uncertainty factor in risk determinations. FQPA mandates that an additional 10X safety factor be applied to protect infants and children “to take into account potential pre- and postnatal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.” This additional factor can only be reduced or removed if there are reliable and sufficient data on effects in infants and children.

Beyond Pesticides has historically criticized the agency for what appears to be an arbitrary application of the FQPA 10X “safety” factor, for manipulating safety data and allowing hazardous pesticide uses to remain on the market. Despite these concerns, Beyond Pesticides believes that, in principle, expanding and increasing the uncertainty factor for some chemicals to protect sensitive populations will help reduce the hazards posed by pesticide use, but not eliminate the use of toxic pesticides that are not necessary given the availability of less and non-toxic methods and products. However, taking this step to eliminate the disproportionate risk to farmworkers and their children by equalizing protections across the population under risk calculations has important environmental justice ramifications, especially since occupational exposures were excluded from FQPA when it was passed in 1996. Additionally, advocates are asking EPA to evaluate the reasonableness of of any pesticide-related risks (especially given the unknowns) to children and workers when less and non-toxic approaches to agricultural land management are available and profitable.

TAKE ACTION! Tell EPA that you support their efforts for a more thorough assessment of risks to workers, including farmworkers and farm children, but that more needs to be done to restrict the availability of toxic pesticides on the market. Comments can be submitted to www.regulations.gov, docket number EPA-HQ-OPP-2009-0889 on or before February 8, 2010.