Technical Affairs Committee Report

1. Technical Affairs Committee Report Alexis Freier-Johnson, Dakota Growers Pasta Company TAC Chair

2. Committee Members

3. Science Based Microbial Prevention & Management Plan- How Did We Get Here? • Foodborne illness outbreaks led to regulatory action and the creation of the Food Safety Modernization Act of 2011 (FSMA) • With implementation of FSMA the FDA now requires comprehensive, science-based controls to mitigate potential health risks

4. Building a Defensible Position: Mitigation & Control of Salmonella in Dry Pasta Facilities (2016) • Released March 2016 • Tool to minimize pre & post process contamination • Aligned with and supported by the GMA • Available on NPA website

5. Building a Defensible Position: Salmonella Cooking Validation Study (2016) • In a partnership with Covance (formerly National Food Labs) NPA validated that the cooking of pasta will provide a >6 log reduction of Salmonella using the cook methods of stove top, microwave, and baking a no-boil lasagna • A cocktail of 4 Salmonella serotypes was used • Added to dough, extruded, dried, and cooked • Used worst case scenarios for cooking procedures

6. But What About E. coli, Listeria, and Others? • Do our results apply to other organisms of public health/FDA concern that may be associated with pasta? • Listeria monocytogenes • E. coli O157:H7 • E. coli O121

7. Heat Resistance Assessment (2018) • Commissioned Eurofins (formerly National Food Labs) to conduct a literature review to determine if further validation work is needed with other pathogens • Challenging since there is very little data on heat resistance and cooking in pasta • Instead examined heat resistance of Salmonella, E. coli, and Listeria in foods with similar properties (water activity, protein, pH) as pasta

8. Heat Resistance Assessment: Focus on Similar Water Activities • Water Activity (Aw) • Measures availability of water for chemical reactions and microbial growth in a food • Measured on a scale 0-1.0 • High Aw can support the growth of bacteria, low Aw can inhibit growth • Different from moisture which measures water content

9. Heat Resistance Assessment • Our results in the validation study showed an increase in water activity (Aw) as we cooked the pasta: • Dry: 0.54 – 0.65 • Cooked: 0.98->0.99 • As the Aw is changing, the organism’s resistance can change. • Literature review looked at data using low Aw and high pH (>4.6), high Aw matrixes

10. Heat Resistance Assessment Conclusions • It appears that at least one of the Salmonella serovars used in NPA’s validation study is more heat resistant than L. monocytogenes, E. coli O157:H7, and E. coli O121 • No projects or literature similar to validation study available for pasta • Utilizing data from scientific literature is difficult because heat resistance can be influenced by many variables, including product matrix

11. Hazard Analysis: Listeria monocytogenes • Thrives in refrigeration and wet environments • Can hide and survive well in floor drains • Killed at temperatures >50°C (122°F) • Major cause of USDA recalls • Sunopta sunflower seed recall Summer 2016 • $16 million half year loss (estimated they recouped $15.4 million from insurance) • No recalls or issues noted with pasta or flour • TAC discussion found Listeria sp. is typically part of our environmental monitoring programs

12. Hazard Analysis: E. Coli • General Mills Flour Recall: 05/31/18 • 9/29/16 the CDC reported 63 people infected with outbreak strains of E. coli O121 and O26 reported from 24 states. 17 hospitalized and 1 developed hemolytic-uremic syndrome • Flour from Kansas City, MO mill • Ardent Mills Flour Recall: 5/26/17 • Canadian Food Inspection Agency reported 30 ill with 8 hospitalized in 7 Canadian provinces • Flour from Saskatoon, SK and Brampton, ON facilities

13. Hazard Analysis: E. Coli • Food Safety Plans for flour suppliers note E. coli as biological hazard with no PC • NAMA Voluntary language: “SAFE HANDLING INSTRUCTIONS:  Raw flour is not ready-to-eat and must be thoroughly cooked before eating to prevent illness from bacteria in the flour.  Do not eat or play with raw dough; wash hands, utensils, and surfaces after handling.”

14. Study Design • Use equipment that replicates typical pressures, temperatures and humidity used by a majority of our membership • Use the same cooking methods as our consumers • Select the “worse case scenario” for each cooking method/product • Replicate product thickness and water activity typical of our membership’s finished products • Goal is >5 log reduction of E. coli after cooking

15. Study Design • Extruder obtained by Joe DeFrancisci, Demaco • Dies from DeMari • Dryer built by Al Lucia • Time, temperature, and humidity controls • Low drying temperature 38°C/ 100.4 ° F

18. Study Design 5 strain E. colicocktail: • E. coli 0104:H4 • E. coli 0111:H8 • E. coli O121 • E. coli O157:H7: Hamburger isolate-Jack in the box outbreak • E. coli O157:H7: Patient isolate- Lettuce outbreak

19. Study Design • 3 pasta/cooking method combinations • Elbow pasta: 2:30 min in 1100 W microwave • Flat noodle: 6 min in boiling water • No‐boil lasagna: in a covered dish at 204 °C/ 400 °F for 50 minutes • Microbial load measured before and after cooking to determine amount of reduction

20. Study Progress • Pasta was prepared the week of 2/18/19 • Al Lucia flew out to Eurofins in Livermore, CA to complete • Finished products have similar water activities as Salmonella study

21. Study Progress: Next Steps • Confirm that we have proper microbial load after drying • May need to make more pasta if drying reduced too much • Perform cooking validations • Results! • Assuming favorable results, our final step is to seek publication • Manuscript prepared by Eurofins • Peer reviewed journal • Food Protection Trends- International Association for Food Protection

22. Food Defense: More Than Fences • New Regulations - Both FDA and Global Food Safety Initiative • Current Food Defense Plans likely won’t comply • Intentional Adulteration

23. Intentional Adulteration In The News • Employee contamination of chicken • Gold N Plump Company-Cold Spring, MN factory • Recall of almost 28 tons of chicken products (June 2016) • Employee sentenced to 90 days in jail and ordered to pay $200,000 in restitution to the company • Employee tampering of strawberries • Australia/New Zealand -Sewing needles in strawberries -September 2018 • By the end of the month, more than 200 food tampering notifications had been made • Only a few were believed by authorities to be associated with the original incident with most hoax or copycat events. Social media had significant impact • Ex-farm worker was charged with six counts of contaminating goods and granted bail in November

24. Intentional Adulteration Rule • FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration • FDA focus is on motivated insider causing wide scale public health harm • FDA views processes as the driver of vulnerability, rather than specific foods • Rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

25. Intentional Adulteration Rule • Requires a written plan: • Vulnerability Assessment • Mitigation strategies including required explanations • Procedures for the food defense monitoring of the implementation of the mitigation strategies • Procedures for food defense corrective actions • Procedures for food defense verification

26. Vulnerability Assessment Methods • Key Activity Types • Bulk liquid receiving and loading • Liquid storage and handling • Secondary ingredient handling • Mixing and similar activities • Three Fundamental Element Evaluation • Potential Public Health Impact (severity and scale) if a contaminant were added • Degree of physical access to the product • Ability of attacker to successfully contaminate the product

27. NPA Resource- Vulnerability Assessment • NPA partnered with FDA CFSAN to conduct a table top vulnerability assessment of the pasta industry in August 2017 • Looked at both dry and fresh pasta processes • Considered both large scale and artisanal size factory set ups • Key conclusions report from this activity is available on the members only section of the NPA website

28. Mitigation Strategies to Protect Against Intentional Adulteration: Guidance for Industry (Draft Guidance) • Part 1- Released June 18, 2018 • Focused on components of food defense plan, conducting vulnerability assessments, using Key Activity Type Method, identifying and implementing mitigation strategies, and monitoring requirements • TAC submitted comments: • Concerns regarding level of detail of process step description in the example vulnerability assessment, need clarification that a single mitigation strategy is acceptable if it is effective, and that Key Activity Types may not be actionable process steps • Urged release of FSPCA training module and updated Food Defense Plan Builder

29. Mitigation Strategies to Protect Against Intentional Adulteration: Guidance for Industry (Draft Guidance) • Part 2- Released March 6, 2019 • Three Fundamental Element Evaluation • Employee education and training/Food Defense Qualified Individuals • Vulnerability Assessment examples using the Three Fundamental Elements and a Hybrid method of KATs/ Three Fundamental Elements • Third Guidance Document- Coming Soon • Corrective actions, verification, plan reanalysis requirements, recordkeeping, mitigation strategies database, calculating small and very small business sizes

30. FSMA Intentional Adulteration Rule Compliance Dates: • Businesses that do not comply for exceptions: July 26, 2019 • Small Businesses: July 27, 2020 • Very Small Businesses: July 26, 2021

31. TAC Funding Requests

32. Closing Comments • TAC volunteers are outstanding and truly dedicated to this team. • Our meetings are lively and full of commentary about challenges and issues facing the pasta industry. • It is a pleasure to serve as Chair for this group. Thank you for allowing your employees to participate!