Percent Crop Treated PCT Projected Percent Crop Treated PPCT: BEAD s Approach

1. Percent Crop Treated (PCT)& Projected Percent Crop Treated (PPCT):BEAD�s Approach Cynthia Doucoure, Quality Assurance Officer Biological and Economic Analysis Division (BEAD) Usage and Label Use Team (ULUT) May 15, 2007

2. 2 PCT Overview Percent Crop Treated (PCT) Market Share PCT Uses Elements of PCT Report PCT Approach Data Sources & Years Used

3. 3 Percent Crop Treated (PCT)(Registered Uses) Amount of a crop or site treated with an active ingredient The ratio of base acres treated to acres planted or grown, expressed as a percentage An estimate of pesticide usage on an agricultural crop on a state or national Level

4. 4 Base Acres Treated (BAT) Acres that receive one or more treatments annually --OR-- Acre treatments divided by the average number of treatments (applications) per acre

5. 5 Acre Treatments (AT) Each application of a pesticide to an acre is one acre treatment --OR-- Base acres treated multiplied by the average number of applications

6. 6 Market Share The ratio of acre treatments with a chemical or product to total acres treated with all chemicals or products of the same pesticide type, expressed as a percentage.

7. 7 Percent Crop Treated and Market Share: The Difference Percent Crop Treated Base acres treated / Total acres planted or grown x 100 = % crop treated. Market Share Acres treatments with a chemical or product/ Total acres treated with all chemicals or products of the same pesticide type x 100%

8. 8 PCT Uses Help refine exposure information used in risk assessment Assess chronic and acute dietary risk Component of Agency�s �reasonable certainty of no harm� determination Authority: FFDCA, as amended by FQPA, Section 408

9. 9 Elements of PCT Report Based on national use of an active ingredient For each crop or site and a.i., includes Average pounds of active ingredient Average PCT Maximum PCT Preliminary data for refined dietary exposure

10. 10 Average Poundage of Active Ingredient (A.I.) Applied Values are calculated by merging sources of available pesticide usage data within the most recent six (6) years Averaging by year Averaging across all years Rounding up to the nearest multiple of 5

11. 11 Average Percent Crop Treated Values are calculated by merging sources of available pesticide usage data within the most recent six (6) years Averaging by year Averaging across all years Rounding up to the nearest multiple of 5. Used in assessing chronic dietary risk

12. 12 Maximum Percent Crop Treated Value is the single maximum value reported Across available sources of pesticide usage data within the most recent six (6) years, Across all years Rounded up to the nearest multiple of 5. Used in assessing acute dietary risk

13. 13 Data Sources & Years Used United States Department of Agriculture � National Agricultural Statistics Service (USDA NASS), 2000 to 2005 Private Pesticide Market Research/Doane AgroTrak, 2000 to 2005 National Center for Food and Agricultural Policy/National Pesticide Use Database (NCFAP/NPUD), 1997/2002 California Department of Pesticide Regulation (CalDPR), 2000 to 2005

14. 14 USDA NASS Publicly available pesticide use information State level National level Based on surveys Data, including percent crop treated pounds of active ingredient used application rates numbers of applications Updated yearly for most field crops Updated alternate years for fruits and vegetables

15. 15 Doane AgroTrak Proprietary pesticide use information Based on surveys of growers Data, including: Percent crop treated Pounds of active ingredients used Acres treated Application rates Target pests Updated yearly data for most crops and for most states

16. 16 (NCFAP 97/NPUD 2002) Contains data, including: Percent crop treated Pounds of active ingredients used Application rates Crops that are not surveyed by either NASS or Doane Data Sources Publicly available data Grower surveys

17. 17 California DPR Based on a census; represents actual pesticide use in California Contains summary data Pounds of active ingredient by pesticide and crop Acre treatments Application rates Data are used when Most of the crop grown in the United States is grown in California, Data are not found in NASS or Doane

18. 18 Summary of PCT Approach Average PCT Based on available data from the past six years Using six years means at least three observations (from USDA NASS) are typically available for fruit and vegetables Maximum PCT highest observation over the six year time period data are not calculated

19. 19 PPCT Overview Projected Percent Crop Treated (PPCT) Market Leader PPCT Uses PPCT Approach Benefits of Approach

20. 20 The use of historical data from leading chemicals or market leaders to estimate the percent crop or site treated for a new chemical or new use(s) of an old chemical Projected Percent Crop Treated (PPCT)(New Uses)

21. 21 Market Leader The chemical with the highest PCT for a specific pesticide type (e.g., insecticide, fungicide, herbicide) and crop or site

22. 22 PPCT and PCT Uses To evaluate exposure to pesticide residues in: new food use crops (PPCT) existing or registered crops (PCT) A component of the Agency�s �reasonable certainty of no harm� determination. Authority: FFDCA, as amended by FQPA, Section 408

23. 23 PPCT Approach: Overview Market Leader Approach: Use of data on market leaders and other relevant factors to project the PCT of the new uses. Assumption The new chemical or use is not likely to overtake the market leader for that pesticide type and crop within the first five years following registration. The header change is suggested because the original question didn�t quite flow with the following question. I think you may want to be prepared to talk about why one approach is better than the other; perhaps in terms of added benefits of the new approach.The header change is suggested because the original question didn�t quite flow with the following question. I think you may want to be prepared to talk about why one approach is better than the other; perhaps in terms of added benefits of the new approach.

24. 24 Market Leader Approach Step 1: Derive PPCT based on publicly available data for market leaders Step 2: Examine other relevant factors to characterize the likelihood that the PPCT estimates can be exceeded Step 3: Provide details of our analysis for inclusion by the Registration Division (RD) in the Federal Register (FR) Notice

25. 25 Step 1: Derive PPCT Identify the max PCT of the market leaders for the crop & chemical type for the 3 most recent years Primary Source: USDA NASS Average the 3 yearly max PCTs to derive average PPCT Identify the max PCT of the 3 yearly max PCTs Uses for dietary risk assessment: Chronic: average PPCT Acute: the max (of 3 max�s) PPCT

26. 26

27. 27 Step 2: Examine Other Relevant Factors Section 18 Emergency Exemptions Pest resistance Pests controlled by new pesticide Alternatives to control pests Mode of action of pesticide Costs of pesticides Registrant data submissions

28. 28 Example of Relevant Factors: Biologist Review of PPCT Estimates for Use of Chemical D on Seven New Uses

29. 29 Step 3: Provide Details for Inclusion by RD in FR Notices Description of the methodology used for estimating PPCT Summary of review of relevant factors examined in developing estimates Have we already reaped benefits from the new process? Maybe you want to discuss them or add a slide.Have we already reaped benefits from the new process? Maybe you want to discuss them or add a slide.

30. 30 Example of PPCT Language for Inclusion in FR Notices

31. 31 Benefits of Current Approach Documented approach Based on an analysis of historical data Comprehensive approach Consists of estimates for chronic and acute risk assessment Considers relevant information Provides details for inclusion by RD in FR notice � transparent process Proactive Approach Involve OPP customers (HED/RD) upfront

32. 32 Summary PCT and PPCT Approaches Conservative Satisfy FQPA Requirements for �reasonable certainty of no harm� determination.

33. 33 BEAD Contact Cynthia Doucoure (703) 308-8133 doucoure.cynthia@epa.gov OPP/BEAD website: http://www.epa.gov/oppbead1/contacts_bead.htm