300 



The career staff of the Agency have proposed a series of "pilot projects" for assist- 

 ing in implementing these new regflex guidelines. There are two especially impor- 

 tant objectives of the pilot effort: (1) demonstrate efficient means of developing regu- 

 latory alternatives which minimize adverse economic impacts on small entities 

 while accomplishing environmental goals and objectives; and, (2) identify innovative 

 ways to effectively involve small entities in the rulemakings which affect them. I 

 strongly agree with these objectives. Additionally, I support the pilot project effort 

 because I believe it will help illuminate how we can be even more effective in 

 achieving the spirit and intent of the Regflex Act. 



Q. 30: C) Will you build on them? How? 



A. 30: C) In coming weeks, I will be reviewing issues related to both regulatory 

 flexibility and our relations with small governments. And as indicated above, I will 

 carefully follow the progress of the Regflex Pilot Projects. These reviews will enable 

 me to formulate long term policies and programs for ensuring successful environ- 

 mental programs in partnership with state and local governments and the private 

 sector. 



Q. 31: A) Is this [the use of the industry market-basket survey in determining 

 the extent of dietary health risk and therefore in deciding which uses could be re- 

 tained] the way that EPA normally makes such decisions? 



A. 31: A) Yes, the EBDC decision is wholly consistent with the manner in which 

 EPA makes its regulatory decisions regarding pesticides. EPA bases its decisions on 

 the best scientific evidence available to the Agency, considering both the risks and 

 the benefits of a pesticide, as mandated by the Federal Insecticide, Fungicide and 

 Rodenticide Act (FIFRA). ^^ 



By way of background, under FIFRA, EPA registers pesticides on the basis of data 

 adequate to demonstrate that their use will not pose unreasonable risks to public 

 health or the environment. When evidence is raised which calls into question the 

 safety of a registered pesticide, EPA may initiate a process to determine if cancella- 

 tion or some other regulatory action is warranted. FIFRA requires that the Agen- 

 cy's regulatory decision be based upon a consideration of both the potential risks 

 and the benefits of a pesticide's use. The Agency's action on the EBDCs, therefore, 

 came after careful consideration of both the risks and the benefits of these pesti- 

 cides. 



To arrive at its final decision on the EBDCs, EPA conducted a Special Review of 

 these pesticides. Special Review is a public administrative review process by which 

 the risks of a pesticide are weighed against its benefits to determine the appropriate 

 regulatory action. 



As part of a Special Review, a Preliminary Determination is often issued long 

 before issuance of a Final Determination. The intent of a Preliminary Determina- 

 tion is to publicly announce the Agency's position, based upon available data. At 

 this stage, among other actions the Agency may take, EPA may do the following: 1) 

 describe the available data and the conclusions it would reach based upon those 

 data alone; 2) identify additional data needed to refine the assessment; 3) request 

 comment. Comments can often be accompanied by additional data. A Final Determi- 

 nation can differ significantly from a Preliminary Determination if data received in 

 the interim substantially alters the balance of the pesticide's risks and benefits. 



EPA's Final Determination on the EBDCs in 1992 differed significantly from the 

 action proposed in the Preliminary Determination in 1989, because the final action 

 was beised upon additional data submitted in response to the Preliminary Determi- 

 nation, as well as a revised estimate of the toxicity of the EBDCs. Changes in infor- 

 mation between the Preliminary Determination and the Final Determination in- 

 cluded the following: 



• "Market Basket Survey" data, indicating the concentrations of EBDCs that are 

 found in food in the grocery store, rather than at the time of harvest. 



• A revised cancer potency factor, as recommended by the Scientific Advisory Panel 

 (SAP), EPA's panel of independent scientific experts. 



• Additional benefits and residue data from grower groups. 



• Additional data on worker exposure, including data submitted by the registrant 

 on dermal exposure and dermal absorption. 



Following is a more detailed discussion of each of these areas in which data were 

 improved: 



Market Basket Survey. At the time of the Preliminary Determination, the 

 Agency indicated that actual residues of the EBDCs might be significantly lower if 

 the food samples for residue studies were taken closer to the "dinner plate" than 

 the "farm gate." Therefore, pursuant to its authority imder Federal Insecticide, 

 Fungicide and Rodenticide Act (FIFRA) the Agency required the r^istrants to gen- 



