301 



erate market basket data to determine the levels of EBDC residues in marketplace 

 produce. 



Before the market basket survey data were available, EPA based its risk assess- 

 ment upon residue levels found in field residue trials. Field residue trials are de- 

 signed to measure the highest residue resulting from the most extreme use pattern 

 on the label. Their primary function is for use in setting tolerances (maximum legal 

 pesticide residue levels). Most pesticide residues resulting from registered uses will 

 be well below the tolerance level. 



The market basket survey was the largest of its kind ever conducted, reflecting 

 analysis of almost 6,000 food samples. In fact, the number of analyses performed in 

 the survey rivals the FDA and CDFA (California Department of Food and Agricul- 

 ture) surveillance monitoring programs. The survey cost the registrants about $10 

 million. As expected, the market-basket findings indicated that, in general, the 

 EBDC residues in foods on the grocery shelves were much lower than the field trial 

 data indicated. These new residue data were used to refine the preliminary residue 

 estimates. 



Cancer Potency Factor, In addition to updating the dietary and occupational/res- 

 idential exposure estimates, the Agency reevaluated the cancer potency factor (re- 

 ferred to as the Qi*— read "Q Star") for the Final Determination, based on further 

 analysis of animal laboratory data on ETU, the breakdown product of the EBDCs. 

 The cancer potency factor is a measure of a chemical's potential to induce cancer 

 and is used in conjunction with the dietary and worker exposure to estimate risk. 



Because the Qi* resulting from EPA's reevaluation would have been significantly 

 lower than the preliminary Qi * used in the Preliminary Determination, and because 

 Agency scientists were divided on the scientific issues, EPA returned to the SAP in 

 September 1991. As a result of OPP's Health Effects Division Peer Review Commit- 

 tee decisions and the recommendations of the SAP, the Agency included in its anal- 

 ysis data from a low-dose group that had been analyzed previously. This low-dose 

 group of animals were fed ETU levels closer to those that might actually be con- 

 sumed by people. The effect of including these data was to lower the cancer potency 

 factor for the Final Determination from 0.60 (mg/kg/day)' ^ to 0.11 (mg/kg/day)"^ 



Data from Growers. Grower groups also played an important role in providing 

 information for the Final Determination for the EBDCs. By the fall of 1990, more 

 than 300 comments had been received including benefits information and residue 

 data from various grower organizations. For example, Hawaiian papaya growers de- 

 scribed the limitations of chlorothsdonil (the EBDC alternative for papayas) on pa- 

 payas grown in Hawaii. Without such information, the Agency could have underes- 

 timated the benefits of EBDCs for papaya cultivation in Hawaii. The residue infor- 

 mation provided by the growers was mainly used to corroborate the results of the 

 market basket survey. The International Apple Institute however, provided residue 

 data from an altered use pattern that was used as a primary source of data. With- 

 out these data, it is likely that the Agency would have pursued cancellation of the 

 use of EBDCs on apples. Instead, the use of EBDCs on apples was retained, with an 

 altered use pattern. 



Worker Exposure. The Agency also revised its exposure estimates for people who 

 handle EBDC products in a number of occupational or residential settings involving: 

 agricultural and industrial applications, tank-mixing, commercial lawn applications, 

 and homegardening. The new data for the revised worker exposure estimates in- 

 clude information received from commenters and data that were submitted by the 

 registrants on dermal absorption and dermal exposure. 



Q. 31: B) Do you consider EPA's reliance on the industry that they are responsi- 

 ble for regulating proper and objective? 



A. 31: B) Yes. EPA generally bases its pesticide regulatory decisions upon data 

 generated by pesticide r^istrants. Under FIFRA, registration applications must be 

 accompanied by certain data submitted by registrants. Also, FIFRA has given EPA 

 the authority under Section 3(cX2XB), at least since its amendment in 1978, to re- 

 quire pesticide registrants to generate and submit data in support of existing pesti- 

 cide registrations. 



It is clearly critical that the studies submitted in support of pesticide registrations 

 be conducted in accordance with current scientific staoidards for integrity and qual- 

 ity. EPA has implemented a number of measures to assure the quality of pesticide 

 data used by the Agency, including Good Laboratory Practice standards, the data 

 review process, EPA's inspection and audit programs, and EPA's enforcement op- 

 tions. These are all described in the informational bulletin titled, "Ensuring the 

 Quality of Studies Submitted to EPA in Support of Pesticide R^:istration." 



EPA's Office of Compliance Monitoring audited every one of the four laboratories 

 that generated data for the EBDC market basket survey, as well as the contracting 



