Produce Safety/Juice HACCP Regulation Embassy Seminar November 7, 2003

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Produce Safety/Juice HACCP RegulationEmbassy
SeminarNovember 7, 2003

• Michelle A. Smith, Ph.D.
• Center for Food Safety and Applied Nutrition
• Food and Drug Administration
• michelle.smith_at_fda.gov

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Outline

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

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Fresh Produce - Concerns

• Grown in non-sterile environment
• Opportunities for contamination
• Likely to be consumed raw

(factors consistent w/ high risk foods)
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US Produce Outbreaks 1990-1998
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Produce Associated Outbreaks (1990-2002)

• Pathogens
• Salmonella spp., Shigella flexneri, E. coli
  O157H7, 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

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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

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Guide to Minimize Microbial Food Safety Hazards
for Fresh Fruits and Vegetables

• Guidance for Industry
• October 1998

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The Guide

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

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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

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Table of Contents

• Water
• Manure and Municipal Biosolids
• Worker Health and Hygiene
• Sanitary Facilities
• Field/Packing Facility Sanitation
• Transportation
• Traceback

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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

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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

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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

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Agricultural Practices Survey

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

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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

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Selection of Commodities

• Epidemiological Outbreak Data
• Commodity Characteristics
• Growing Conditions and practices
• Post-harvest handling
• Consumption

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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 0157H7, Salmonella,
  Shigella
• www.foodsafety.gov/dms/fs-toc.htmlprod

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Imported Produce Survey

• 95.6 free of target pathogens
• NO E. coli 0157H7
• Salmonella 35/1003 samples positive
• Shigella 9/1003 samples positive

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Domestic Produce Survey2000-2001

• 98.8 free of target pathogens
• NO E. coli 0157H7
• Salmonella 35/1003 samples positive
• Shigella 9 samples positive

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IMPORTED PRODUCE SURVEY
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IMPORTED PRODUCE SURVEY
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Domestic Produce Survey

• Results
• Percentage of Samples Positive for Pathogen
• Cantaloupe 5 of 164 3.0
• Celery 0 of 120 0.0
• Cilantro 2 of 85 2.4
• Green onions 3 of 93 3.2
• Lettuce 1 of 142 0.8
• Parsley 1 of 90 1.1
• Strawberries 0 of 136 0.0
• Tomatoes 0 of 198 0.0

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Produce Food Safety!
www.fda.govwww.foodsafety.gov/dms/fs-toc.htmlpr
od
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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

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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

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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

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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

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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

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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

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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)

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FY 04 HACCP Inspections

• 500 Planned for domestic firms
• Priority Unpasteurized juice, follow-up of VAIs
  and OAIs, 1st time inspections
• 200 Planned for importers

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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

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• 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

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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

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• 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

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Affirmative steps may include

• 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,

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Affirmative steps may include

• 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

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Recent additionsavailable at www.cfsan.fda.gov

• Q and As Part 2
• Final guidance on juice HACCP training curricula
• Juice HACCP Alliance Curriculum available at
  www.iit.ncfst.edu
• Final bulk transport guidance for high brix
  concentrates
• Final Hazards and Controls Guide (soon)

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Summary

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