1. Regulatory Impact Assessment of the Proposed RTE Rule Dr. Felix Spinelli Economist Regulations and Directives Development Staff USDA - Food Safety and Inspection Service

2. Today’s Presentation Brief over-view of Regulatory Impact Assessment Framework Preliminary Estimate of Industry Costs –Impact of Higher Performance Standards –Impact of Mandatory Testing for L. spp. Cost Impact on Small Entities Preliminary Estimate of Social Benefits Comparison of Industry Costs and Possible Social Benefits

3. The Purpose of Regulatory Impact Assessments Estimate potential social benefits and costs of proposed actions. Identify and assess regulatory alternatives. Provide framework for public comment and further improvement.

4. The “Nuts and Bolts” Establish a Baseline. Forecast regulatory-induced changes in industry practices. Create a scenario which incorporates the impact of the above changes. Compare the regulatory-induced scenario to baseline.

5. Impact of Performance Standards Direct Costs –One-time, initial costs Validation costs Equipment costs –Recurring costs Additional processing, i.e. longer times/higher temperatures, other processes.

6. Estimates of Direct Costs First-year, one-time costs –545 products need validation at $5000/each. –No data on needed equipment, etc, so subsumed into recurring cost estimate. First-year and recurring costs –75 firms producing 441 million pounds/year incur an additional 1 cent/pound cost.

7. Indirect Impacts of Performance Standards –Short and long-term rejection rates –Line speeds –Recalls –Product Quality –Product Shrinkage –No estimate on indirect impacts on costs at this time.

8. Summary of Direct Cost Impact of Performance Standards First-year, one-time costs…. $2.72 million Annually recurring costs …. + $4.41 million Total first year impact ……. $7.13 million

9. Impact of Mandatory Environmental Testing for Listeria species Direct Costs –One-time, initial costs Incorporation of Critical Control Point addressing LM contamination into HACCP plan OR First-year and recurring costs Actual testing of product-contact surfaces for Sanitation SOP verification

10. Direct Cost Calculations HACCP Modification (Addition of CCP) –Large: 50 %  100 % –Small: 33 %  50 % –Very Small: 10 %  20 % 257 establishments* $5000/Plan = $1.29 million * Size based on employment figures.

11. Direct Cost Calculations (cont’d) Actual testing of product-contact surfaces for Sanitation SOP verification Large: $10,080/establishment Small: $ 3,360/establishment Very Small: $ 840/establishment 825 establishments for a total of $1.75 million.

12. Impact of Testing (cont’d) - Indirect Impacts Similar Indirect Impacts as described for performance standards are possible. Rejection rates, Recalls, Product Quality May not affect line speeds, shrinkage, but: Test and Hold Occurrences Disposal of Product Storage Capacity Needed Production Adjustments to remedy Listeria spp. contamination

13. Impact of Testing (cont’d) - Indirect Impacts Production Adjustments –Most establishments will not incur any additional cost (find they do not have a serious LM problem) –Other establishments likely will need to adjust production 7% incur “$2000 per line” cost 7% incur “1/10 of 1% of gross sales” cost 1% elect to drop RTE production

14. Total Direct and Indirect Costs of Testing (in million $) One-time cost, HACCP mod.….…. 1.29 One-time production adj. costs ….. + 2.49 Sub-total of one-time costs ………. 3.78 Recurring testing costs …..…...…... +1.75 Total first-year impact...…….……. 5.53

15. Total Impact of Performance Standards and Testing Provisions One-time costs (million $) –Validate Performance Standards.. 2.72 –Modify HACCP (Testing)……… + 1.29 –Adjustment (Testing) …………... + 2.49 Sub-total, one-time.....………..… 6.50 Performance Std (42%) and Testing (58%)

16. Total Impact of Performance Standards and Testing Provisions (cont’d) Recurring costs (million $) –Increased processing (Performance Std)...... 4.41 –Testing costs (Testing) ……...…………...… + 1.75 –Sub-total ….…………………………… 6.16 Performance Std (72%) and Testing (28%) Total Cost Impact, First-Year……….... 12.66 –Performance Std (56%) and Testing (44%)

17. Summary of Cost Impacts

18. Impact Across the RTE Industry

19. Estimate of Social Benefits All benefits derived from improved food safety spurred on by verification testing. Benefits from higher performance standards not quantified at this time. Increased testing  decreased probability of contaminated product. Less contaminated product  Fewer sicknesses and deaths.

20. Ready-to-eat Meat and Poultry Products and Listeriosis 2540 Listeriosis Cases and 508 Deaths from all sources in the US per year. Important Questions: –What is attributable to meat and poultry products? –What is attributable to establishments? –Impact of other measures? –Effectiveness of measures? –Rate of beneficial impacts? –How to monetarize benefits?

21. Two Estimates Linking Meat and Poultry Products and Listeriosis: FDA-FSIS Risk Assessment –DRAFT Recently Published –Ranked Relative Risk across Many Foods Mead-Olsen Studies –A Combination of Two Independent CDC Studies –Requires making some tenuous assumptions –Probably gives lower bound of cases and deaths attributable to meat and poultry products

22. DRAFT FDA-FSIS Risk Assessment –Suggests that over 65 percent of cases and deaths are attributable to ready-to-eat meat and poultry products. –Almost 90 percent of those are attributable to deli-meats. –Remainder attributable to deli salads, hot dogs, pate, and dry fermented sausages. –Estimated 1660 cases and 331 deaths per year attributable to meat and poultry products.

23. Mead-Olsen Studies Olsen estimates 8% of total food borne diseases attributable to meat and poultry products. Mead provides annual case and deaths estimates (above). The combination of these studies indicates that 167 cases and 35 deaths per year are attributable to meat and poultry products.

24. Average annual case and death reductions over 10 years Un-adjusted Mead-Olsen and Draft FDA-FSIS Study –Possible Case Reductions: 87 to 863 –Possible Deaths Reductions: 18 to 173 Adjusted for what can be controlled by Plant –Possible Case Reductions: 50 to 496 –Possible Deaths Reductions: 10 to 99 Adjusted for Program Effectiveness –Possible Case Reductions: 25 to 248 –Possible Deaths Reductions: 5 to 50

25. Summary of Major Costs/Benefits Nominal Costs (million $) –First-year costs ………….…… $12.66 million –Recurring costs..……...….….. $ 6.16 million –Costs over 10 years.………… $68.10 million Benefits in Lives Saved (5 to 50/year) –Highly Dependent on Assumptions of: Percentage attributable to meat and poultry products Percentage attributable to plants Other regulatory actions Effectiveness of measures

26. Summary of Major Costs/Benefits Preliminary data suggest that Benefits exceed Costs FSIS seeks additional data and comments on costs and benefits to inform any final action

27. COMMENTS