1. Overview of Significant Issues and Identified Alternatives for Draft Environmental Impact Statement: Produce Safety Rule Michael Mahovic, Ph.D. Produce Safety Staff

2. Intro/Purpose Background on Proposed Rule Background on Scoping The NEPA Process Proposed Alternatives How to comment

3. Background FSMA – Jan 2011 Proposed Produce Rule – Jan 2013 –Published with categorical exclusion (Cat Ex) –Comment and outreach since publication suggested Cat Ex not appropriate –Re-evaluation based on newly available information led agency to conclude significant environmental impacts are likely

4. Standards for Produce Safety Focus on 5 identified routes of microbial contamination 1.Agricultural water 2.Biological soil amendments of animal origin 3.Worker health and hygiene 4.Equipment, tools, buildings and sanitation 5.Domesticated and wild animals Other Requirements Sprouts Growing, harvesting, packing and holding

5. Background on Scoping August 19, 2013 –FDA publishes Notice of Intent (NOI) to prepare the EIS –FDA concurrently opens the public scoping period

6. Background on Scoping March 11, 2014 – FDA announces public scoping meeting –FDA concurrently provides the list of identified alternatives it plans to consider in the EIS Public Scoping Comment Period Closes April 18, 2014

7. The National Environmental Policy Act (NEPA) Process 1.FDA publishes Notice of Intent to prepare an EIS 2.FDA opens public scoping period 3.FDA evaluates public comments and potential impacts of possible alternatives 4.FDA prepares a Draft EIS We Are Here

8. 5.Draft EIS released for public comment - Public has opportunity to comment on FDA’s analysis of potential significant environmental impacts for the proposed action and alternatives 6.FDA considers comments and the need to revise the EIS 7.FDA publishes final EIS and Record of Decision (ROD) The National Environmental Policy Act (NEPA) Process

9. The NEPA Process: Scoping Identify provisions considered likely to result in significant environmental impact Consider range of “Reasonable Alternatives” Consider “No Action” alternative as the assessment of the status quo

10. Areas of Potential Significant Environmental Impacts Microbial Standards for Ag Water Manure and Compost Application Intervals Animal Grazing and Intrusion Land Use and Management

11. Microbial Standard For Direct Application Water – Proposed Applies to Ag water used for direct application (i.e., intended/likely to contact produce) during growing of produce other than sprouts Other proposed provisions include testing requirements and corrective actions, as appropriate Thresholds are: –≤235 cfu (or MPN) generic E. coli/100 ml single sample –≤126 cfu (MPN) /100 ml (n=5) rolling geometric mean

12. Microbial Standard For Direct Application Water – Alternatives I No Action Proposed: –235 cfu (MPN)/100 ml; single sample –126 cfu (MPN)/100 ml; rolling geometric mean Detectable limit per 100 ml that is less stringent than proposed ( > 235/126)

13. Microbial Standard For Direct Application Water – Alternatives II Flexible standard Example may include WHO standard: ≤1,000cfu (MPN)/100ml on root crops ≤10,000cfu(MPN)/100ml on leaf crops –With up to 2-log die-off between irrigation and harvest; AND –1-log reduction during washing Definition of “Direct water application”: –Including root crops with drip irrigation; OR –Excluding root crops with drip irrigation

14. Areas of Potential Significant Environmental Impacts Microbial Standards for Ag Water Manure and Compost Application Intervals Animal Grazing and Intrusion Land Use and Management

15. Raw Manure Application Interval – Proposed ‘‘If the biological soil amendment of animal origin is untreated, then the biological soil amendment of animal origin must be applied in a manner that does not contact covered produce during application and minimizes the potential for contact with covered produce after application, and then the minimum application interval is 9 months’’

16. Raw Manure Application Interval – Alternatives I No action Proposed –Does not contact at application –Minimizes contact after application –9 month application interval As proposed, except with no application interval

17. Raw Manure Application Interval – Alternatives II National Organic Program standards: –90 day application interval for tree crops –120 day application interval for likely-to- contact crops (e.g., tomatoes, leafy greens) As proposed, except with 6 month application interval As proposed, except with 12 month application interval

18. Composted Manure Application Interval – Proposed “…applied in a manner that minimizes the potential for contact with covered produce during and after application, and then the minimum application interval is 45 days”

19. Composted Manure Application Interval – Alternatives No Action Proposed –Minimizes contact at application and after application –45 day application interval As proposed, except with 0 application interval As proposed, except with 90 day application interval

20. Areas of Potential Significant Environmental Impacts Microbial Standards for Ag Water Manure and Compost Application Intervals Animal Grazing and Intrusion Land Use and Management

21. Animal Grazing – Proposed “An adequate waiting period between grazing and harvesting for covered produce in any growing area that was grazed to ensure the safety of the harvested crop”

22. Animal Grazing – Alternatives No Action Proposed – Adequate waiting period between grazing and harvest As proposed, except with a minimum waiting period of 9 months As proposed, except with a minimum waiting period of 90/120 days

23. Animal Intrusion – Proposed “If animal intrusion, as made evident by observation of significant quantities of animals, animal excreta or crop destruction via grazing, occurs, you must evaluate whether the covered produce can be harvested”

24. Animal Intrusion – Alternatives No Action Proposed – Evaluate whether the covered produce can be harvested If animal intrusion is reasonably likely to occur, take measures to exclude animals from fields where covered produce is grown

25. Areas of Potential Significant Environmental Impacts Microbial Standards for Ag Water Manure and Compost Application Intervals Animal Grazing and Intrusion Land Use and Management

26. Land Use and Management – Proposed excludes farms with $25,000 or less of annual value of food sold

27. Land Use and Management – Alternatives No Action Proposed: Exclude ≤ $25,000 annual food sales Exclude ≤ $50,000 annual food sales Exclude ≤ $100,000 annual food sales Exclude ≤ $25,000 annual covered produce sales

28. How to Comment www.regulations.govwww.regulations.gov Docket No. FDA-2011-N-0921Docket No. FDA-2011-N-0921 Link to rules on www.fda.gov/fsmaLink to rules on www.fda.gov/fsma EIS Scoping Comments due April 18, 2014EIS Scoping Comments due April 18, 2014 Link also in today’s handoutLink also in today’s handout