1. Federal Produce Safety Regulations: Why do have them? What do they require? June 13, 2016June 13, 2016June 13, 2016 1 Steve Ingham Administrator Division of Food Safety

2.  48 million foodborne illnesses each year  128,000 hospitalizations  3,000 deaths  Economic loss of $5 billion dollars annually Cause of Illness# Cases# Deaths Bacteria 3.6 million 861 Parasites 232,705 333 Viruses 5.5 million 157 Unknown agent ~38.4 million 1,686 (56%) CDC, Dec. 2010 Annual Foodborne Illness Data

3. Outbreaks of Foodborne Illness 5,316 outbreaks of illness linked to specific foods occurred between 1990 and 2005 FOOD# OUTBREAKS# ILLNESSES Seafood1,05310,415 Produce71334,049 Poultry58017,661 Beef50613,873 Eggs35211,224 CDC, 2008

4. Ave. No. of Illnesses Per Outbreak 4 Center for Science and the Public Interest, 2008 The average number of illnesses in produce-related outbreaks is about 40; far greater than the average number for poultry, beef or seafood.

5. Top-10 Produce/Pathogen Combos ItemPathogenNo. of outbreaksNo. of cases Green-based salad Norovirus1966,772 Fruit, fruit saladNorovirus381,810 LettuceNorovirus321,106 Veg., veg. saladNorovirus27895 SproutsSalmonella19724 TomatoSalmonella171,694 MelonSalmonella15474 GreensE. coli13291 Green-based salad Salmonella12521 LettuceE. coli12361 source = Center for Science in the Public Interest database

6. What can make produce unsafe?  Biological, chemical and physical hazards  Bacteria, viruses, parasites  Natural and man-made contaminants  Foreign materials  Introduced during:  Pre-harvest  Harvest  Postharvest

7. Biological Hazards: Bacteria  Bacteria  CAN reproduce on produce and soiled equipment  Examples: Salmonella, Escherichia coli O157:H7, Listeria monocytogenes

8. Biological Hazards: Parasites  Parasites  Do NOT reproduce on produce or soiled equipment  Contaminate food via water, e.g. Cryptosporidium  Infect animal intestinal tract, contaminate food via feces, e.g. Cryptosporidium, Giardia

9. Biological Hazards: Viruses  Viruses  Simple life forms  Transferred to food by humans  Do NOT reproduce on produce or soiled equipment  Examples: hepatitis A, norovirus

10. Sources of microbes on produce  Water  Soil  Animals  Workers  Equipment  Air

11. Chemical Hazards 1. Naturally occurring compounds  Allergens – peanuts, tree nuts  Glycoalkaloids - potatoes 2. Man-made contaminants  Pesticide residues  Cleaning and sanitizing chemicals  Lubricants  Environmental contaminants 11 Technical and Business Services, LLC

12. Physical Hazards  Foreign Matter  Risk of cuts, broken teeth, choking  Controlled by sorting, screening, etc. 12 Technical and Business Services, LLC

13. Registration of Food Facilities w/ FDA: the FSMA starting point  NO FEE  Only facilities processing food for wholesale, or warehousing processed food  Processing plants  Includes farms where produce is “processed’  Warehouses  Biennial registration  Registration = consent to inspection June 13, 2016June 13, 2016June 13, 2016 13 http://www.fda.gov/food/guidancecomplianceregulatoryinformation/ registrationoffoodfacilities/default.htm

14. Exempt from registration  Farms  Includes on-farm packing if all produce is grown, raised or consumed on that farm or another farm under same ownership  Retail Food Establishments  Regulated by state and local jurisdictions  Restaurants  Grocery / Convenience stores  Direct sales to consumers  Roadside stands and farmers’ markets  Community-supported agriculture June 13, 2016June 13, 2016June 13, 2016 14

15. Examples  Farmer grows seed for other farmers: NO if planted, YES if fed to animals  Farmer washes lettuce with chlorinated water: NO if 200 ppm Cl  Farmer puts stickers on fruits: NO if all fruit is from his/her farm, YES if fruit brought in from other farms  Farm grows, harvests, packs its own crop and ships it elsewhere: NO  Produce grown and harvested, trimmed, and then packed at a packing shed at a different location from farm: NO for farm, YES for packing shed June 13, 2016June 13, 2016June 13, 2016 15

16. Produce Safety Regulations implementing FSMA  Published 10/30/2015  Mandatory for safe production and harvesting of “covered” produce  Virtually all fresh produce is “covered”  Several exemptions  Focus is on key GAPs  Only deals with biological hazards June 13, 2016June 13, 2016June 13, 2016 16

17. What do these regulations have to do with food service?  Restaurants and retail food establishments must use foods from sources that “comply with law” – WI regulations  Food processing plants must use ingredients that are “safe, wholesome, and unadulterated” – WI regulations  Food warehouse operators shall “promptly destroy, or shall exclude or promptly remove” any contaminated food – WI regulations  Meeting the produce safety regulations could be viewed as minimal requirements in a legal case  It is in your best interest to obtain produce from farmers who meet the standards June 13, 2016 17

18. Produce Safety Rule, Title 21 CFR, Part 112. Components:  Subpart A: What’s covered produce? Who’s exempt? Who has a qualified exemption?  Subpart B: General requirements  Growing, harvesting, packing  Subpart C: Personnel qualifications and training  Subpart D: Health and hygiene  Subpart E: Agricultural water

19. Produce Safety Rule Components, continued:  Subpart F: Biological soil amendments  Microbiological standards  Application intervals (application-to-harvest)  Subpart I: Domesticated and wild animals  Subpart K: Growing, harvesting, packing, holding  Subpart L: Equipment, tools, buildings, sanitation  Subpart M: Sprouts

20. Produce Safety Rule components, continued:  Subpart N: Analytical methods  Subpart O: Records  Generally 2-year retention  Subpart P: Variances  Could be requested by state, tribe, or foreign country  Scope can be expanded beyond requested  Subpart Q: Compliance and enforcement  Subpart R: Withdrawal of qualified exemption

21. What is covered? What is not covered?  Fruits and vegetables, peanuts, tree nuts, herbs, mushrooms, sprouts, mixes of intact fruits and vegetables  COVERED  Produce that is rarely consumed raw  NOT COVERED  Produce that is grown for personal or on-farm consumption  NOT COVERED  Produce that is grown for further processing that adequately reduces pathogens  NOT COVERED June 13, 2016June 13, 2016June 13, 2016 21

22. The Exemption and the Qualified Exemption  Very small businesses: <$25,000 per year over past 3 years  “Qualified Exemption”  > 50% of sales to “qualified end users”:  consumers, restaurants, retail  In same state OR within 275 miles of farm  Total food sales < $500,000  Packaging / placards indicate source June 13, 2016June 13, 2016June 13, 2016 22

23. What parts apply to qualified exemption farms?  Subpart A – General provisions  Subpart O – Records  Subpart Q – Compliance and Enforcement  Subpart R – Withdrawal of Qualified Exemption June 13, 2016 23

24. Training requirement (Subpart C)  All personnel who harvest or handle covered produce (or supervise these activities)  Supervisors – training at least equivalent to a standard curriculum recognized by FDA  Training must be understandable for audience, and documented  Training topics are listed in the regulation June 13, 2016June 13, 2016June 13, 2016 24

25. Worker health requirements (Subpart D)  Exclude ill workers who may contaminate produce or food- contact surfaces  Personnel must be trained to notify their supervisor when they are ill  Hand-washing at specified times  Basic hygiene June 13, 2016June 13, 2016June 13, 2016 25

26. Requirements for Agricultural Water (Subpart E)  Inspect water system at start of growing season, and at least annually  Maintain water sources and distribution systems that are under your control – prevent contamination  Use of untreated surface water is forbidden for certain activities, e.g. washing hands  Ensure water for harvest and post-harvest activities meets microbiological standard of no detectable generic E. coli in 100 ml June 13, 2016June 13, 2016June 13, 2016 26

27. Standards for water used for direct-application growing activities  Statistical threshold value not to exceed 410 CFU E. coli per 100 ml  Rolling geometric mean of no more than 126 CFU E. coli per 100 ml  Initial survey to develop “microbial water quality profile”  Annual updates to update the profile  Geometric mean, statistical threshold value  COMPLICATED! LOTS OF QUESTIONS! June 13, 2016June 13, 2016June 13, 2016 27

28. Biological Soil Amendment of Animal Origin (Subpart F)  Treatments must either result in  No L. monocytogenes in 5 g  < 3 MPN Salmonella in 4 g total solids  < 0.3 MPN E. coli O157:H7 in 1 g  OR  < 3 MPN Salmonella in 4 g total solids  < 1,000 MPN fecal coliforms per g June 13, 2016June 13, 2016June 13, 2016 28

29. Validated Critical Factors in Manure Composting  Static and aerobic  At least 131°F for 3 days, followed by adequate curing  Turned and aerobic  At least 131°F for 15 days, with at least 5 turnings, followed by adequate curing June 13, 2016June 13, 2016June 13, 2016 29

30. Minimum Application Intervals for manure  Untreated, no contact during application, minimal contact after application  Interval to be determined  Untreated, no contact with edible portion during or after application  0 days  Treated to meet microbial standards for Salm., E.c. O157:H7  0 days, no contact restrictions  Composted to meet microbial standards for Salm., fecal coliforms; no contact during and after application  0 days June 13, 2016June 13, 2016June 13, 2016 30

31. Animal Control Requirements (Subpart I)  If animals graze or work in produce fields, you must:  Ensure an “adequate waiting period between grazing and harvesting”  Take measures to prevent introduction by working animals of hazards into or onto produce  If animal intrusion is reasonably likely:  Monitor  Evaluate whether uncontaminated produce can be harvested June 13, 2016June 13, 2016June 13, 2016 31

32. “No Drops” Requirement  “You must not distribute dropped covered produce…”  Exemption for crops that will be processed to kill pathogenic bacteria  Exemption for root crops and crops that grow on ground, e.g. cantaloupe June 13, 2016June 13, 2016June 13, 2016 32

33. Equipment and Tools Requirements (Subpart L)  Equipment and tools for harvesting, packing, holding  Emphasis on cleanability and maintenance  Food-contact surfaces:  Inspect  maintain  clean and sanitize when appropriate  Non-food-contact surfaces:  Inspect  maintain  clean when appropriate June 13, 2016June 13, 2016June 13, 2016 33

34. Building Requirements (Subpart L)  Sufficient space for equipment and materials  Separation of operations in which contamination is likely to occur  Constructed so that cleaning and repair is possible  Floors, walls, ceilings, fixtures, ducts, pipes  Constructed so that contamination is unlikely  Produce, food-contact surfaces, pkg. materials June 13, 2016June 13, 2016June 13, 2016 34

35. Building / Facility Requirements (Subpart L)  Adequate:  Drainage  Pest control  Toilet and hand-washing facilities – readily accessible  Sewage disposal  Trash disposal June 13, 2016June 13, 2016June 13, 2016 35

36. Requirements for Sprout Production (Subpart M)  Done in a fully-enclosed building  Food-contact surfaces cleaned and sanitized before contact with seeds or sprouts  Seeds or beans must be treated in your facility before sprouting to reduce pathogens June 13, 2016June 13, 2016June 13, 2016 36

37. Requirements for Sprout Production  Environmental testing for Listeria spp. or L. monocytogenes  Written plan  At least monthly  Testing spent irrigation water or in-process sprouts for E. coli O157:H7 and Salmonella  Written plan  Every batch June 13, 2016June 13, 2016June 13, 2016 37

38. WI Licenses for Selling Produce and Related Items to Food Service  Unprocessed fruits and vegetables: NONE  Canned or Frozen produce: Food Processing Plant  Otherwise processed “fresh” produce: Food Processing Plant June 13, 2016June 13, 2016June 13, 2016 38

39. WI Licenses for Selling Produce and Related Items to Food Service  Maple Syrup: Food processing plant June 13, 2016June 13, 2016June 13, 2016 39

40. WI Licenses for Selling Produce and Related Items to Food Service  Apple Cider: Food Processing Plant that meets Juice HACCP and pathogen- reduction regulations June 13, 2016June 13, 2016June 13, 2016 40

41. WI Licenses for Selling Produce and Related Items to Food Service  Unprocessed Honey: NONE  Processed Honey: Food Processing Plant June 13, 2016June 13, 2016June 13, 2016 41

42. Coming July 1, 2016 TO WDATCP:  Division of Food and Recreational Safety  Bureau of Food and Recreational Businesses  Restaurants  Retail Food Establishments  Dairy and Food Processing Plants  Food warehouses  Dairy farms  Hotels, B + B’s, tourist rooming houses  Campgrounds, camps  Pools, water parks  Bureau of Meat and Poultry Businesses June 13, 2016 42

43. Questions? Steve Ingham 608-224-4701 Steve.Ingham@wi.gov June 13, 2016June 13, 2016June 13, 2016 43

44. When can alternatives to the regulations be used?  Water testing, and responding to test results  Composting of biological soil amendments of animal origin  Application intervals for untreated biological soil amendments of animal origin or compost agricultural tea  You must have adequate data to validate the process June 13, 2016June 13, 2016June 13, 2016 44

45. Other Water Requirements  Maintain adequate sanitary quality, incl. use of water- change schedules for re-circulating water  Visual monitoring for build-up of organic materials  Maintain and monitor temperature of water to minimize potential for infiltration of microorganisms June 13, 2016June 13, 2016June 13, 2016 45

46. Record-Retention Requirements (Subpart O)  At least 2 years for most records  Can be off-site after 6 mo.; retrieve within 24 h of request  Electronic records are acceptable  For records relating to adequacy of equipment or processes: at least 2 years after equipment or process use is discontinued June 13, 2016June 13, 2016June 13, 2016 46