1. Produce Safety/Juice HACCP Regulation Embassy Seminar November 7, 2003 Michelle A. Smith, Ph.D. Center for Food Safety and Applied Nutrition Food and Drug Administration michelle.smith@fda.gov

2. Outline Fresh Produce – Microbial Food Safety - Background/outbreaks - Guidance to minimize contamination -Implementation/Surveys Juice HACCP –The regulation –Implementation –Update

3. Fresh Produce - Concerns Grown in non-sterile environment Opportunities for contamination Likely to be consumed raw (factors consistent w/ “high risk foods”)

4. US Produce Outbreaks: 1990-1998

5. Produce Associated Outbreaks (1990-2002)  Pathogens  Salmonella spp., Shigella flexneri, E. coli O157:H7, Hepatitis A, Cyclospora, Cryptosporidium  Vehicles  Unpasteurized apple cider/juice, basil, cantaloupe, cole slaw, green onions, lettuce, frozen mamey, mesclun mix, unpasteurized orange juice, parsley, scallions, strawberries, tomatoes, raspberries, mango

6. The U.S. Produce Safety Initiative Announced October 1997 Goal: To reduce, to the greatest extent possible, foodborne illness associated with fresh produce consumed in the U.S., regardless of where the produce was grown

7. Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables Guidance for Industry October 1998

8. The Guide Broadscope - practices common to the growing and packing of most fresh produce Guidance only - NO NEW REQUIREMENTS Risk reduction, not elimination

9. Use of the Guide Increase awareness of common microbial hazards for fresh produce Useful when recommended practices are adapted to specific operations - Assess individual operations - Institute appropriate practices

10. Table of Contents Water Manure and Municipal Biosolids Worker Health and Hygiene Sanitary Facilities Field/Packing Facility Sanitation Transportation Traceback

11. Water Microbial hazards/quality –Agricultural water –Post harvest water uses Control of Potential Hazards –Know and protect water quality at source, during distribution, and at point of use –When and how water is used may impact water quality needs –Antimicrobials, monitoring, minimize water contact

12. Implementation Encourage adoption of guidance Training – GAPs, Farm Investigations, Laboratory Methods Microbial surveys of domestic and imported produce USDA/NASS survey of domestic agricultural and packing practices

13. Training Domestic and International – Extension Specialists, Growers, State and Federal Health and Agriculture Officials Areas covered – GAPs/GMPs, traceback, epidemiology, case studies, farm visits, investigation techniques, microbiology, sampling and analysis, participant presentations

14. Agricultural Practices Survey 30 commodities 10,000 growers and packers 14 States – 85% acreage Document current practices www.usda.gov/nass/pubs/rptscal. htmwww.usda.gov/nass/pubs/rptscal. htm, go to “June 2001”, select “13”, select “Fruits and Vegetables Ag Practices”

15. Microbiological Surveys Produce Obtain baseline data on incidence of contamination Identify vehicles and causes Focus Research aimed at reducing contamination Assess efforts to reduce foodborne illness Modify policy, fine tune GAPs and GMPs

16. Selection of Commodities Epidemiological Outbreak Data Commodity Characteristics Growing Conditions and practices Post-harvest handling Consumption

17. Imported Produce Survey 1999-2000 1000 samples - 125 each of 8 products –Broccoli, cantaloupe, celery, cilantro, loose- leaf lettuce, parsley, scallions, strawberries –Culantro, tomatoes –Pathogens tested: E. coli 0157:H7, Salmonella, Shigella www.foodsafety.gov/~dms/fs- toc.html#prod

18. Imported Produce Survey –95.6% free of target pathogens –NO E. coli 0157:H7 –Salmonella – 35/1003 samples positive –Shigella – 9/1003 samples positive

19. Domestic Produce Survey 2000-2001 –98.8% free of target pathogens –NO E. coli 0157:H7 –Salmonella – 35/1003 samples positive –Shigella – 9 samples positive

20. IMPORTED PRODUCE SURVEY

22. Domestic Produce Survey Results –Percentage of Samples Positive for Pathogen Cantaloupe5 of 1643.0% Celery0 of 1200.0% Cilantro2 of 852.4% Green onions3 of 933.2% Lettuce1 of 1420.8% Parsley1 of 901.1% Strawberries0 of 1360.0% Tomatoes0 of 1980.0%

23. Produce Food Safety! www.fda.gov www.foodsafety.gov/~dms/fs-toc.html#prod

24. The Juice HACCP Final Rule In the Federal Register of January 19, 2001, FDA published final regulations to ensure the safe and sanitary processing of fruit and vegetable juices. These regulations mandate the application of HACCP principles to the processing of juice (21 CFR part 120) Go to: www.cfsan.fda.gov, look under “HACCP”www.cfsan.fda.gov

25. Juice HACCP Regulation Definition of Juice: Aqueous liquid expressed or extracted from one or more fruits or vegetables Puree used in a beverage of the edible portion of one or more fruits or vegetables Concentrate of such liquid or puree Used in a beverage

26. Effective Dates Based on the size of the business: –January 22, 2002 - medium and large businesses –January 21, 2003 - small businesses –January 20, 2004 - very small businesses

27. Written Hazard Analysis Section 120.7: Identify food hazards Evaluate each hazard to determine if the hazard is reasonably likely to occur Identify control measures that can be applied Review current processes to determine if modifications are necessary Identify critical control points

28. HACCP Plan Section 120.8 Must be developed by a trained individual(s) and be written Specific to each location and to each type of juice processed, except: –may group types of juice together, and –may group types of production methods together, if the hazards and CCP controls, etc. are essentially the same

29. Contents of the HACCP Plan List all food hazards that are reasonably likely to occur List the CCPs List the critical limits that shall be met at each CCP List the monitoring procedures Include any corrective action plans List the validation and verification procedures Provide for a record keeping system

30. Juice HACCP Inspections Full coverage in effect Jan 2004 Initial domestic inspections, Oct 2002 Outcomes: NAI, VAI (Form 483), OAI (possibility of Warning Letter or Untitled Letter)

31. FY 04 HACCP Inspections 500 Planned for domestic firms Priority: Unpasteurized juice, follow-up of VAIs and OAIs, 1 st time inspections 200 Planned for importers

32. First Inspections - Educational 51% of Initial Inspections were No Action Indicated (NAI) 37% Voluntary Action Indicated (VAI) 4% Official Action Indicated (OAI) Very few Warning Letters

33. Requirements for Imported Products Every importer of juice shall: Obtain the juice from a country that has an active memorandum of understanding (MOU) or similar agreement with the U.S. FDA, OR

34. Requirements for Imported Products Have and implement written procedures for ensuring that the juice received for import into the United States was processed according to the requirements of the juice HACCP regulation. Section 120.14

35. These procedures shall provide, at a minimum: Product specifications that are designed to ensure that the juice is not adulterated, and Affirmative steps to ensure that the products being offered for entry were processed under controls that meet the requirements of the regulation

36. Obtaining from the foreign processor the HACCP plan and prerequisite program records of the lot being offered for import; Obtaining either a continuing or lot specific certificate from an appropriate foreign government inspection authority or competent third party; Regularly inspecting the foreign processor's facilities, Affirmative steps may include:

37. Maintaining on file a copy, in English, of the foreign processor's hazard analysis and HACCP plan and a written guarantee that the food was processed according to the requirements; Periodically testing the imported food, and maintaining on file a copy, in English, of a written guarantee that the food was processed in accordance with the rule; or Other verification measures that provide an equivalent level of compliance with the requirements Affirmative steps may include:

38. Recent additions available at www.cfsan.fda.gov Q and A’s Part 2 Final guidance on juice HACCP training curricula Juice HACCP Alliance Curriculum available at www.iit.ncfst.eduwww.iit.ncfst.edu Final bulk transport guidance for high brix concentrates Final Hazards and Controls Guide (soon)

39. Summary Active juice HACCP inspectional program Highest priority on unpasteurized juice Educational approach 1 st inspection only High priority on follow up of VAIs and OAIs Importers should have documentation for product specs and affirmative steps