289 



^\' i^u ^^' ^^^ generally bases its pesticide regulatory decisions upon data 

 generated by pesticide registrants. Under FIFRA, registration applications must be 

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

 the authority under Section 3(cK2XB), at least since its amendment in 197H. 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 standards 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 Registration." 



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 

 firm responsible for managing the conduct of the study. The EBDC Task Force who 

 contracted for this study brought to EPA's attention alleged improprieties at Craven 

 Laboratories, one of the laboratories performing residue analysis for the survey. A 

 joint investigation conducted by the Department of Justice, the U.S. Attorney's 

 office and the EPA led to the indictment by a Federal grand jury of Craven Labora- 

 tories, Inc., its President, and three employees on 20 felony counts in connection 

 with pesticide testing. Several Craven employees have admitted to wrong-doing and 

 the matter is nearing the trial stage. Where requested by EPA, the EBDC Task 

 Force replaced the data generated by Craven Laboratories for the EBDC survey. 



EPA's audits confirmed that the data used in the final results of the market 

 basket survey met scientific standards for integrity and quality. EPA was further 

 able to verify the market basket data by comparison with data available from other 

 sources. In addition to the registrant's market basket study, EPA reviewed monitor- 

 ing data from FDA and the States, and studies from other interested parties, such 

 as monitoring data from the National Food Processor's Association and commercial 

 processing studies. All supported the results of the market basket survey. 



Q. 31: C) Are there denciencies in the way the human health concerns about 

 EBDCs have been handled by EPA, and, if so, do these deficiencies apply to other 

 pesticides decisions EPA has made where concerns about human health or the en- 

 vironment were at stake? 



A. 31: C) No. The EBDC decision followed the most extensive review, analysis and 

 assessment of data ever undertaken on any pesticide or class of pesticides. Because 

 of this rigorous analysis, EPA is confident that the risk reduction measures imple- 

 mented— -decreased application rates, reduced number of applications on a crop, and 

 longer intervals between the last EBDC treatment and harvesting the crop, as well 

 as the cancellation of certain uses — are protective of public health. 



Q. 32: EPA has an important role, but no statutory authority, in setting stand- 

 ards for exposure to and cleanup of radionuclides. A process is actually now un- 

 derway (involving the Office of Radiation and Indoor Air) for EPA to be a major 

 player in this effort. Do you support this process and how can we be assured of its 

 completion? 



A. 32: EPA has statutory authority under a number of statutes to set exposure 

 standards for the cleanup of sites contaminated with radiation and the protection of 

 drinking water. The Atomic Energy Act, the Comprehensive Environmental Re- 

 sponse, Compensation,and Liability Act, the Toxic Substances Control Act, and the 

 Resource Conservation and Recovery Act each give the Agency authority, although 

 each statute excludes some radionuclides or some radioactively contaminated sites. 

 The Agency is currently considering which statute, or combination of statutes, can 

 best be applied to developmg cleanup regulations. The Office of Air and Radiation is 

 taking the lead in developing radiation cleanup standards, including: 



Regulatory Development Efforts , , , > . 



—Regulations are being developed which will set forth cleanup procedures and 

 criteria, including residual radioactivity levels. •„ ■• 



—Waste management regulations are also being developed and will address the 

 disposal and recycle of radioactively contaminated waste resulting from clean- 



— EPA is participating in the NRC's participatory rulemaking workshops for the 

 development of their Decommissioning rulemaking. NRC can be exenipted from 

 the EPA regulation if EPA concludes that the NRC regulation provides a sufTi- 

 cient level of protection for the public health and environment. 



—EPA is chairing a high-level Interagency Steering Committee to address coordi- 

 nation of effort in the cleanup of radioactively contaminated sites. This commit- 



