My name is Jean-Mari Peltier. I am the Chief Deputy Director of the Department of Pesticide Regulation (DPR) in the California Environmental Protection Agency. Since the Food Quality Protection Act (FQPA) was signed into law in August of 1996, DPR has been involved in the scientific and policy discussions surrounding the implementation of FQPA. As a part of my testimony, I am submitting a recent letter to Congressman Gary Condit that outlines a number of concerns that DPR has regarding FQPA implementation. I will focus my comments on some additional points that complement those issues.

The lack of transparency of U.S. EPA’s implementation of FQPA has been an area of continuing concern. Within the last several months, U.S. EPA has responded to this criticism by facilitating public discussions of some aspects of their implementation process. The new Tolerance Reassessment Advisory Committee on which I serve, and the Pesticide Program Dialogue Committee are two of the forums where U.S. EPA is presenting detailed descriptions of specific implementation approaches and decisionmaking. U.S. EPA has also presented several issue papers on a number of the scientific issues at numerous meetings of the Scientific Advisory Panel (SAP) over the 18 months since FQPA went into effect.

Despite these recent efforts to improve the transparency of the implementation process, DPR believes there are two fundamental policy decisions for which U.S. EPA has yet to provide a full explanation. The first is why U.S. EPA is not fully employing the data call-in provisions of FQPA and is instead employing default assumptions. The second related issue is how U.S. EPA is defining "reasonable certainty of no harm." I will discuss each of these issues.

One of the key issues with which U.S. EPA is struggling is how to assess the risk of pesticides in the diet with common mechanisms of toxicity. U.S. EPA’s determination of common mechanism of toxicity will lay the groundwork for determining the cumulative risk of pesticides in tolerance reassessment.

U.S. EPA solicited advice from the International Life Sciences Institute (ILSI) on how to group pesticides with a common mechanism of toxicity using Organophosphates (OPs) as a case study. ILSI tested several possible hypotheses on how to subgroup this class of pesticides but concluded that there was insufficient data on which to make determinations on subgroups of OPs.

U.S. EPA is using the report from ILSI as the basis for determining that OPs share a common mechanism of toxicity (i.e. cholinesterase depression). This is essentially the default position of ILSI in the absence of sufficient data to determine any appropriate subgroups of OPs. We have concerns about this decision as U.S. EPA pursues the reassessment of tolerances. The OPs vary in their level of assumption toxicity, in the target organ of the toxic effect, and whether their mutual effects are additive, synergistic, or antagonistic. By failing to gather additional data to more precisely categorize pesticides which share common mechanisms of toxicity, U.S. EPA could inappropriately include exposures in a single risk cup, which greatly overestimate risk. In our opinion, U.S. EPA should not proceed with regulatory decisions based on cumulative toxicity for OPs until meaningful subgroups are identified. U.S. EPA should instead use the data call-in authority in FQPA to require studies to elucidate appropriate subgroups.

U.S. EPA managers have indicated that they do not have a model for conducting cumulative risk assessments, yet they have declared that because OPs share a common mechanism of toxicity, they must account for cumulative risk in reassessing tolerances. It is our understanding that U.S. EPA has tasked ILSI with developing an approach to conducting a cumulative risk assessment. One of the key issues will be how to determine the "toxicity equivalents" for OPs in assessing cumulative risk, given their widely varying degrees of acute toxicity. Another underlying concern is the effect using multiple conservative default assumptions in the cumulative risk assessment.

The need to acquire additional data to make the safety determinations is not confined to requests of pesticide registrants. Accounting for drinking water residues is apart of the requirement for assessing the aggregate exposure to pesticides. Since implementation began, U.S. EPA has moved from a default assumption of assigning a portion of each pesticide’s risk cup to drinking water, to using any available data coupled with available models to predict drinking water concentrations. Some of the available data are of questionable value, and the current models to predict surface and ground water contamination are flawed. To her credit, Dr. Lynn Goldman, Assistant Administrator of U.S. EPA’s Office of Prevention, Pesticides, and Toxic Substances, has acknowledged a need to obtain as much water data as possible from both federal and state programs to improve decisionmaking in this critical area and has emphasized that the ecological model used for predicting surface water contamination will not be used for final decisions. We understand that U.S. EPA is working closely with the U.S. Geologic Survey (USGS) to utilize their extensive database on surface and ground water monitoring. However, we believe that U.S. EPA’s Office of Pesticide Programs (OPP) needs to move ahead in working through U.S. EPA’s Office of Water to request monitoring data collected by state agencies responsible for administering provisions of the Safe Water Drinking Act. These monitoring data are more directed to the issue of pesticide residues in drinking water. While we understand the OPP cannot require such data be submitted as it might from pesticide registrants, the requests need to be made in cooperation with the administering U.S. EPA program.

How U.S. EPA is defining the new safety standard of "reasonable certainty of no harm" is the second transparency issue that needs to be addressed. Particularly in the area of issuance of Section 18 emergency exemptions, U.S. EPA appears to have a standard that exceeds the expectations of Congress. An external proposal on streamlining the Section 18 approval process called the "Incremental Risk Assessment Proposal" uses one percent of the theoretical risk for three different risk parameters as a benchmark for determining whether a full risk assessment is needed. In the public discussions of this proposal, lawyers for U.S. EPA said that the one percent benchmark would not meet the definition of "reasonable certainty of no harm", and the proposal was, therefore, not acceptable as a means of expediting time-limited tolerances. DPR and its toxicologists do not see any scientific basis for U.S.EPA’s attorneys’ positions that one percent can be distinguished from "reasonable certainty of no harm."

As co-regulators with U.S. EPA, it is clear to us at DPR that there is a critical need for better data to improve the quality of risk assessments to meet the new safety standard. We believe that U.S. EPA needs to move forward with collecting existing data so that it can be used during the tolerance reassessment process. We are aware of U.S. EPA and the U.S. Department of Agriculture’s (USDA’s) effort to acquire use and usage information for the OP’s including more specifics on the role of specific OPs in addressing key pest issues for diverse crops. DPR is pleased that the pesticide use data uniquely collected in California will play an important part in U.S. EPA’s assessment of how OP pesticides are used. U.S. EPA needs to move quickly to develop the national residue database derive from data collected by the Food and Drug Administration, USDA, state residue monitoring programs, and others. Given our experience with monitoring residues on raw commodities, this database will be important in assessing realistic dietary exposure.

In conclusion, DPR believes that the implementation of FQPA could be improved with additional data to provide a sound scientific basis for decision-making. There is grave concern that large scale revocation of tolerances of OPs in a short time frame will have unintended adverse impacts on production agriculture. California’s farmers, encouraged by the work of the University of California Statewide Integrated Pest Management (IPM) program and various commodity groups, have worked diligently to develop pest management systems for a wide array of crops using the principles of IPM. Widescale losses of OPs and carbamates will disrupt many of these pest management systems. Because of crop diversity in California, there may not be suitable alternative pesticides or other technologies. We are also concerned that shifting to other materials may impact worker safety and have environmental and other consequences.

Thank you for the opportunity to provide comments on FQPA implementation issues.