Produce Safety/Juice HACCP RegulationEmbassy Seminar

November 7, 2003

Michelle A. Smith, Ph.D.

Center for Food Safety and Applied Nutrition

Food and Drug Administration

michelle.smith@fda.gov

Outline• Fresh Produce – Microbial Food Safety

- Background/outbreaks- Guidance to minimize contamination- Implementation/Surveys

• Juice HACCP– The regulation– Implementation– Update

Fresh Produce - Concerns

• Grown in non-sterile environment

• Opportunities for contamination

• Likely to be consumed raw

(factors consistent w/ “high risk foods”)

US Produce Outbreaks: 1990-1998

Source: CDC Foodborne outbreak surveillance system

Salad BarSalad Bar35.4%35.4%

FruitFruit20.8%20.8%

LettuceLettuce16.7%16.7%

Unknown/Other7.3%

Cabbage5.2%

Carrots3.1%

Tomatoes2.1%

SproutsSprouts9.4%9.4%

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

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

Guide to Minimize Microbial Food Safety Hazards for Fresh

Fruits and Vegetables

Guidance for Industry

October 1998

The Guide

• Broadscope - practices common to the growing and packing of most fresh produce

• Guidance only - NO NEW REQUIREMENTS

• Risk reduction, not elimination

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

Table of Contents

• Water

• Manure and Municipal Biosolids

• Worker Health and Hygiene

• Sanitary Facilities

• Field/Packing Facility Sanitation

• Transportation

• Traceback

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

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

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

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”

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

Selection of Commodities

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

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

Imported Produce Survey

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

Domestic Produce Survey2000-2001

– 98.8% free of target pathogens – NO E. coli 0157:H7

– Salmonella – 35/1003 samples positive– Shigella – 9 samples positive

IMPORTED PRODUCE SURVEY

PRODUCT # sampled#

positive

Positive (%of #

sampled)

Positives(% oftotal)

broccoli 36 0 0.0 0.0cantaloupe 151 11 7.3 1.1

celery 84 3 3.6 0.3

cilantro 177 16 9.0 1.6

culantro 12 6 50.0 0.6

lettuce 116 2 1.7 0.2

parsley 84 2 2.4 0.2

scallions 180 3 1.7 0.3

strawberries 143 1 0.7 0.1

tomatoes 20 0 0.0 0.0

Totals 1003 44 ------ 4.4

IMPORTED PRODUCE SURVEY

Figure 1. Incidence by Pathogen on Imported Produceab

11

3

16

6

2 23

1

8

1

16

6

1 1 1 1

32

0 01 1

2

00

2

46

8

10

1214

16

18

Produce Item

Nu

mbe

r o

f S

amp

les

# of positives

Salmonella

Shigella

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%

Produce Food Safety!

www.fda.govwww.foodsafety.gov/~dms/fs-toc.html#prod

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”

Juice HACCP RegulationDefinition 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

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

Written Hazard AnalysisSection 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

HACCP PlanSection 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

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

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)

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

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

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

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

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

• 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:

• 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:

Recent additionsavailable 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.edu• Final bulk transport guidance for high brix

concentrates• Final Hazards and Controls Guide (soon)

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