Tài liệu Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain ppt

Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain TM 25 APRIL 2006 COMMODITY SPECIFIC FOOD SAFETY GUIDELINES FOR THE LETTUCE AND LEAFY GREENS SUPPLY CHAIN • 1ST Edition This document was prepared by members of the lettuce/leafy greens industry from farm to table For more information contact: International Fresh-cut Produce Association Attn: David Gombas, Ph.D., Vice President Technical Services 1600 Duke Street Suite 440 Alexandria, VA 22314 Tel: 703.299.6282 Email: DGombas@fresh-cuts.org Produce Marketing Association Attn: Kathy Means, CAE, Vice President, Government Relations PO Box 6036 Newark, DE 19714-6036 Tel: 302.738.7100 Email: KMeans@pma.com United Fresh Fruit and Vegetable Association Attn: James Gorny, Ph.D., Vice President Quality Assurance & Technology 1901 Pennsylvania Avenue, NW, Suite 1100 Washington, DC 20006 Tel: 202.303.3400 Email: JGorny@uffva.org Western Growers Attn: Hank Giclas, Vice President, Science and Technology P.O Box 2130 Newport Beach, CA 92658 Tel: 949.885.2205 Email: HGiclas@wga.com i Special thanks to all of the trade associations and individuals who helped in developing this guidance Acknowledgements Greatest appreciation is expressed to the people who have contributed to this first edition These guidelines in their 1st edition were developed under the coordination and leadership of: James R Gorny, Ph.D., UFFVA , Editor-In-Chief 1st Edition Hank Giclas, WGA, Co-Editor 1st Edition David Gombas, Ph.D., IFPA, Co-Editor 1st Edition Kathy Means, PMA, Co-Editor 1st Edition 1st Edition Contributors and Reviewers: Roger Becker, Gold Coast Packing Inc Jim Brennan, Alliance of Technical Professionals Patrick Collins, Dole Fresh Vegetables Will Daniels, Earthbound Farm Donna Garren, Ph.D., National Restaurant Assoc Zizi Gibbs, Mann Packing Phil Gilardi, Freshway Foods Amy Green, U.S FDA CFSAN James Gorny, Ph.D UFFVA Wendell Hahn, Four Seasons Produce, Inc Brett Harrell, The Nunes Company, Inc Gene Harris, Denny's Toni Hofer, Raleys Merry Holliday-Hanson, Ph.D CA Dept Health Services Jill Hollingsworth, DVM Food Marketing Institute Dan Ivory, Minyard Food Stores Michele Jay-Russell, DVM, MPVM, CA Dept Health Services John Jackson, Beachside Produce Joe Jordan, Publix Patrick Kelly, Grimmway Farms Bruce Knobeloch, River Ranch Fresh Foods Mahipal Kunduru, Ph.D., Dole Fresh Vegetables Tom Lovelace, R.C McEntire Drew McDonald, Taylor Farms Kate McDonald, Bonipak/ Betteravia Farms Kay Mercer, S SLO & SB Co Ag Watershed Coalition Gurmail Mudahar, Ph.D., Tanimura & Antle Carol Myers, CA Dept Health Services Jerry Noland, Safeway Mary Palumbo, Ph.D CA Dept Health Services Chad Parker, Condies Foods, Inc Anne Pauly, River Ranch Fresh Foods Bill Pool, Wegmans Ed Pohlman, Schnuck Markets, Inc Roger Roeth, Freshway Foods Joan Rosen, Fresh Express Todd Rossow, Publix Colby Rubbo, Costa Farms Bill Scepansky, Four Seasons Produce, Inc Vicki Scott, Amigo Farms Michelle Smith, Ph.D U.S FDA CFSAN Trevor Suslow, Ph.D University of California Alan Temple, B & W Quality Growers, Inc Jennifer Tong, UFFVA (Emeritus) Maurice W Totty, Foodbuy Robert Whitaker, Ph.D NewStar Fresh Foods Benson Yee, CA Dept Health Services Devon Zagory, Ph.D., Davis Fresh Technologies Brian Zomorodi, Ready Pac Produce, Inc Layout: Angela Bezon, UFFVA Gladys Hunt, PMA The aforementioned acknowledgments of individual persons and the organizations that these individual are currently affiliated with does not imply endorsement nor approval of this document in its entirely or in part by these individual persons or the organizations listed The document is a publication of the IFPA, PMA, UFFVA and WGA, who bear sole responsibility for its contents ii User's Note This document provides voluntary recommended guidelines on food safety practices that are intended to minimize the microbiological hazards associated with fresh and fresh-cut lettuce/leafy greens products The intent of drafting this document is to provide currently available information on food safety and handling in a manner consistent with existing applicable regulations, standards and guidelines The information provided herein is offered in good faith and believed to be reliable, but is made without warranty, express or implied, as to merchantability, fitness for a particular purpose, or any other matter These recommended guidelines were not designed to apply to any specific operation It is the responsibility of the user of this document to verify that these guidelines are appropriate for its operation The publishing trade associations, their members and contributors not assume any responsibility for compliance with applicable laws and regulations, and recommend that users consult with their own legal and technical advisers to be sure that their own procedures meet with applicable requirements iii Foreword The diversity of production and processing methods in the lettuce/leafy greens industry makes a single, universally applicable approach to food safety planning complicated It is important that each firm assess its operations and implement methods that meet its individual needs What is most important is that basic food safety program components are implemented by producers to ensure lettuce/leafy greens product safety for consumers Whatever the preferred production and processing method may be for a single producer, the lettuce/leafy greens industry recognizes the following basic principles that serve as the foundation for all food safety programs found within the industry: • The lettuce/leafy greens industry recognizes that once lettuce/leafy greens are contaminated, removing or killing pathogens is difficult Therefore, prevention of microbial contamination at all steps from production to distribution is strongly favored over treatments to eliminate contamination after it has occurred • The lettuce/leafy greens industry supports implementation and documentation of food safety programs that utilize risk assessment techniques that identify significant risks and use a preventive approach to ensure safe food products • The lettuce/leafy greens industry also supports and encourages routine and regularly scheduled food safety awareness training for all persons who grow, handle, distribute, process, prepare and/or serve lettuce/leafy greens products • The human pathogens most often associated with produce (Salmonella and E coli O157:H7) cause infection and illness by the fecal-oral route of food contamination Therefore, lettuce/leafy greens food safety programs should pay special attention to controlling, reducing and eliminating potential fecal contamination from people and domestic and wild animals through the most likely conduits, that being human hands, water and soil In the sections that follow, the lettuce/leafy greens field to fork supply chain has been broken down into the following unit operations: production and harvesting, postharvest handling, fresh-cut/value-added operations, distribution and end-user handling (retail, foodservice and consumer) Experts from industry and academia were solicited to identify, in the unit operations that they were intimately familiar with, microbial food safety issues that are found to be common to but not necessarily exclusive to lettuce/leafy greens For each identified potential food safety issue, a list of "things to consider" about the issue was developed to raise awareness and offer possible mitigation steps or practices as means to address the issue However, it is the responsibility of individuals and companies involved in the field to fork lettuce/leafy greens supply chain to determine what actions are appropriate in their individual operations The potential food safety issues identified in each unit operation section are focused only on lettuce/leafy greens and may or may not apply to other specialty crops Particular recommendations put forward to address any identified issue are not the only means by which the issue may be addressed Individuals and companies are encouraged to use this document to evaluate, develop and enhance their own food safety programs At the end of each section and this document there are lists of required reference documents that offer detailed and important background information for individuals and companies that are engaged in the various aspects of the lettuce/leafy greens field to fork supply chain These required reference documents provide detailed information regarding how to develop food safety programs for specific segments of the fresh produce industry from field to fork supply chain Each company's comprehensive food safety program and its various components (e.g employee training, sanitation, etc.) must be developed based upon an analysis of the potential hazards in that specific company's operations This guidance document, as presented, is not sufficient to serve as an action plan for any specific operation but should be viewed as a starting point This guidance document is intended to supplement, not replace, already established food safety program components such as Good Agricultural Practices (GAPs), current Good Manufacturing Practices (cGMPs), Hazard Analysis Critical Control Point (HACCP), etc., for the fresh fruit and vegetable industry iv Table of Contents Foreword iv Introduction Section I Production and Harvesting Unit Operations Water Soil Amendments Machine Harvest Hand Harvest - Direct Contact with Soil During Harvest Hand Harvest - Transfer of Human Pathogens by Field Workers Equipment Facilitated Cross Contamination Flooding Water Usage to Prevent Product Dehydration Production Locations - Climatic Conditions and Environment Production Locations - Encroachment by Animals and Urban Settings Section II Postharvest Unit Operations 11 Cooling Water Re-use of Field Containers Bulk Bin Modified Atmosphere Process Condition and Sanitation of Transportation Vehicles Employee Hygiene Section III Fresh-cut / Value Added Unit Operations 14 Wash Water Labeling of Raw Agricultural Commodity (RAC) versus Ready-To-Eat (RTE) Products New Technologies Finished Product Packaging Section IV Distribution Unit Operations 16 Condition and Sanitation of Transportation Vehicles Condition and Sanitation of Distribution/Cooler Facilities Techniques for Temperature Measurement of Product Section V End-user Handling (Retail, Foodservice and Consumer) Unit Operations 18 Retail and Foodservice Handling Raw Agricultural Commodity (RAC) versus Ready-To-Eat (RTE) Product Labeling Lettuce Re-Crisping Cross Contamination Consumer Handling Information and Resources 22 Websites 25 References 26 Glossary & Acronyms 35-38 Required Reference Documents 39 Introduction In 1998, the U.S Food and Drug Administration (FDA) issued its “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables.” The practices outlined in this and other industry documents are collectively known as Good Agricultural Practices or GAPs GAPs provide general food safety guidance on critical production steps where food safety might be compromised during the growing, harvesting, transportation, cooling, packing and storage of fresh produce More specifically, GAP guidance alerts fruit and vegetable growers, shippers, packers and processors to the potential microbiological hazards associated with various aspects of the production chain including: land history, adjacent land use, water quality, worker hygiene, pesticide and fertilizer use, equipment sanitation and product transportation The vast majority of the lettuce/leafy greens industry has adopted GAPs as part of normal production operations Indeed the majority of lettuce/leafy greens producers undergo either internal or external third-party GAP audits on a regular basis to monitor and verify adherence to their GAPs programs These audit results are often shared with customers as verification of the producer’s commitment to food safety and GAPs While the produce industry has an admirable record of providing the general public with safe, nutritious fruits and vegetables, it remains committed to continuous improvement with regard to food safety In 2004, the FDA published a food safety action plan that specifically requested produce industry leadership in developing the next generation of food safety guidance for fruit and vegetable production These new commodity-specific guidelines focus on providing guidance that enhances the safe growing, processing, distribution and handling of commodities from the field to the end user In the last 10 years, the focus of food safety efforts has been on the farm, initial cooling and distribution points and value-added processing operations Fruit and vegetable processing operations have developed sophisticated food safety programs largely centered on current Good Manufacturing Practices (cGMPs) and the principles of Hazard Analysis Critical Control Point (HACCP) programs As we develop a greater understanding of food safety issues relative to the full spectrum of supply and distribution channels for fruits and vegetables it has become clear that the next generation of food safety guidance needs to encompass the entire supply chain Scope The scope of this document pertains only to fresh and fresh-cut lettuce and leafy greens products, and does not include products commingled with non-produce ingredients (e.g salad kits which may contains meat, cheese, and/or dressings) Examples of “lettuce/leafy greens” include, but are not limited to, iceberg lettuce, romaine lettuce, green leaf lettuce, red leaf lettuce, butter lettuce, baby leaf lettuce (i.e., immature lettuce or leafy greens), escarole, endive, spring mix and spinach These crops are typically considered lettuce and leafy greens by FDA but may not be similarly defined by other state or federal regulatory bodies This document is also limited to offering food safety guidance for crops grown under outdoor field growing practices and may not address food safety issues related to hydroponic and/or soil-less media production techniques for lettuce/leafy greens Lettuce/leafy greens may be harvested mechanically or by hand and are almost always consumed uncooked or raw Because lettuce/leafy greens may be hand-harvested and hand-sorted for quality, there are numerous “touch points” early in the supply chain and a similar number of “touch points” later in the supply chain as the products are used in foodservice or retail operations Each of these “touch points” represents a potential opportunity for cross-contamination For purposes of this document, a “touch point” is any occasion when the food is handled by a worker or contacts an equipment food contact surface Lettuce/leafy greens present multiple opportunities to employ food safety risk management practices to enhance the safety of lettuce/leafy greens It should be noted that processed or value-added versions of lettuce/leafy greens packaged products are also commonly found in the marketplace in both retail and food- service stores These products are generally considered to be “ready-to-eat” (RTE) owing to the wash process used in their manufacturing and protective packaging employed in their distribution and marketing In a processing operation, the basic principles of cGMPs, HACCP sanitation and documented operating pro, cedures are commonly employed to ensure production of the safest products possible Lettuce/leafy greens raw agricultural commodities and fresh-cut/value added products are highly perishable and it is (strongly) recommended that they be distributed, stored and displayed under refrigeration to maintain product quality Further, it should be understood that this recommendation is for product quality reasons only, and not for food safety reasons Raw agricultural commodities not require refrigeration for food safety Safe production, packing, processing, distribution and handling of lettuce/leafy greens depends upon a myriad of factors and the diligent efforts and food safety commitment of many parties throughout the distribution chain No single resource document can anticipate every food safety issue or provide answers to all food safety questions These guidelines focus on minimizing only the microbial food safety hazards by providing suggested potential actions to reduce, control or eliminate microbial contamination of lettuce/leafy greens in the field to fork distribution supply chain It is suggested that all companies involved in the lettuce/leafy greens farm to table supply chain consider the recommendations contained within these guidelines to ensure the safe production and handling of lettuce/leafy greens products from field to fork Every effort to provide food safety education to supply chain partners should be made as well Together with the commitment of each party along the supply chain to review and implement these guidelines, the fresh produce industry is doing its part to provide a consistent, safe supply of produce to the market Figure General Supply Chain Flow for Lettuce/Leafy Greens Figure Lettuce/ Leafy Greens Unit Operations Lettuce/Leafy Greens Commodity Specific Guidance I Production & Harvest Unit Operations Issue: Water Water used for in production and harvest operations may contaminate lettuce and leafy greens if there is direct contact of water containing human pathogens with edible portions of lettuce/leafy greens or by means of water-to-soil and soil-to-lettuce/leafy greens contact (Solomon et al., 2003) In addition, irrigation methods vary and each may have varying potential to introduce human pathogens or promote human pathogen growth on lettuce and leafy greens Things to Consider: • Assuring that irrigation water and water used in harvest operations is of appropriate microbial quality for its intended use • Reducing human pathogen contamination of soil which may in turn contaminate water and/or edible portions of lettuce and leafy greens (e.g., solarization, fumigation, etc.) • Evaluating irrigation methods (drip irrigation, overhead sprinkler, furrow, etc.) for their potential to introduce, support or promote the growth of human pathogens on lettuce and leafy greens Considerations include the potential for depositing soil on the crop, pooled or standing water that attracts animals, etc • Evaluating irrigation water reservoir conditions and means of reducing, controlling or eliminating potential contamination with human pathogens • Evaluating risks of using tail water and/or reclaimed (primary or secondary) water, including use in operations such as road dust abatement • When waters from various sources are combined, consider the potential for pathogen growth • Using procedures for storing irrigation pipes and drip tape that reduce potential pest infestations Developing procedures to assure safe use of irrigation pipes and drip tape if a pest infestation does occur • Water used for direct or indirect application to edible portions of lettuce/leafy greens such as spraying and mixing pesticides should be of appropriate microbial quality for its intended purpose Water may be tested on a regular basis, treated or drawn from an appropriate source as a means of assuring it is appropriate for its intended purpose • Water used on harvesting equipment or during harvesting should be of appropriate microbial quality for its intended use (e.g., meets U.S EPA or WHO microbial standards for drinking water) The water source should be tested periodically to assure that it is of appropriate microbial quality for its intended purpose Issue: Soil Amendments Soil amendments are commonly but not always incorporated into agricultural soils used for lettuce/leafy greens production to add organic and inorganic nutrients to the soil as well as to reduce soil compaction Human pathogens may persist in animal manures for weeks or even months (Fukushima et al., 1999; Websites Gateway to Government Food Safety Information www.foodsafety.gov/ Partnership for Food Safety Information Fight BAC! www.fightbac.org Produce Education Handling Campaign http://portal.fightbac.org/pfse/toolsyoucanuse/phec/ BAC Down! http://portal.fightbac.org/pfse/toolsyoucanuse/BACDown/ U.S Code of Federal Regulations (CFR) All www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1 U.S Code of Federal Regulations (CFR) 21CFR 100-169 cGMPs and other Food Regulations www.access.gpo.gov/nara/cfr/waisidx_04/21cfrv2_04.html U.S Code of Federal Regulations (CFR) Food Labeling www.access.gpo.gov/nara/cfr/waisidx_00/21cfr101_00.html USDA, ARS Agriculture Handbook Number 66 The Commercial Storage of Fruits, Vegetables, and Florist and Nursery Stocks: Produce Food Safety www.ba.ars.usda.gov/hb66/024foodsafety.pdf U.S Environmental Protection Agency (EPA) Drinking Water Standards: www.epa.gov/safewater/standards.html U.S Food and Drug Administration www.fda.gov World Health Organization (WHO) Drinking Water Standards www.wca-infonet.org/servlet/BinaryDownloaderServlet?filename=1063379476163_1.pdf&refID=110012 25 References Abdul-Raouf UM, Beuchat LR, Ammar MS 1993 Survival and growth of Escherichia coli O157:H7 on salad vegetables Appl Environ Microbiol.59(7):1999-2006 Adams MR, and Hartley AD 1989 Factors affecting the efficacy of washing procedures used in the production of prepared salads Food Microbiol 6:69-77 Albrecht JA, Hamouz FL, Sumner SS, Melch V 1995 Microbial evaluation of vegetable ingredients in salad bars J Food Prot 58(6):683-685 Allwood PB, Malik YS, Hedberg CW, Goyal SM 2004 Effect of Temperature and Sanitizers on the Survival of Feline Calicivirus, Escherichia coli, and F-Specific Coliphage MS2 on Leafy Salad Vegetables J Food Prot 67(7):1451-1456 Anonymous 1991 Listeria monocytogenes in vegetables, fruits and dairy products Int J Food Microbiol 14:220-225 Austin JW, Dodds KL, Blanchfield B, Farber JM 1998 Growth and toxin production by Clostridium botulinum on inoculated fresh-cut packaged vegetables J Food Prot 61(3):324-328 Badawy AS, Gerba CP, Kelley LM 1985 Survival of rotavirus SA-11 on vegetables Food Microbiol 2:199-205 Barriga MI, Trachy G, Willemot C, Simard RE 1991 Microbial changes in shredded iceberg lettuce stored under controlled atmospheres J Food Sci 56(6):1586-1599 Beuchat LR 1996 Listeria monocytogenes: incidence on vegetables Food Control 7(4/5):223-228 Beuchat LR 1996 Pathogenic microorganisms associated with fresh produce J Food Protect 59(2):204-216 Beuchat LR 1998 Surface decontamination of fruits and vegetables eaten raw: A review Food Safety Issues World Health Organization Beuchat LR 1992 Surface disinfection of raw produce Dairy Food Environ Sanit 12(1):6-9 Beuchat LR 1999 Survival of enterohemorrhagic Escherichia coli O157:H7 in bovine feces applied to lettuce and the effictiveness of chlorinated water as a disinfectant Journal of Food Protection 62(8):845-849 Beuchat LR, Adler BB, Lang MM 2004 Efficacy of Chlorine and a Peroxyacetic Acid Sanitizer in Killing Listeria monocytogenes on Iceberg and Romaine Lettuce Using Simulated Commercial Processing Conditions J Food Prot 67(6):12381242 Beuchat LR, Brackett RE 1990 Survival and growth of Listeria monocytogenes on lettuce as influenced by shredding, chlorine treatment, modified atmosphere packaging and temperature J Food Sci 55(3):755-758, 870 Beuchat LR, Nail BV, Adler BB, Clavero MRS 1998 Efficacy of spray application of chlorinated water in killing pathogenic bacteria on raw apples, tomatoes, and lettuce J Food Prot 61(10):1305-1311 Beuchat LR, Ryu J-H 1997 Produce handling and processing practices Emerging Infectious Diseases 3(4):459-465 Bidawid S, Malik N, Adegbunrin O, Sattar SA, Farber JM 2004 Norovirus Cross-Contamination during Food Handling and Interruption of Virus Transfer by Hand Antisepsis: Experiments with Feline Calicivirus as a Surrogate J Food Prot 67(1):103-109 26 Bolin HR, Stafford AE, King J, A.D., Huxsoll CC 1977 Factors affecting the storage stability of shredded lettuce J Food Sci 42(5):1319-1321 Burnett AB, Iturriaga MH, Escartin EF Pettigrew CA, Beuchat LR 2004 Influence of Variations in Methodology on , Populations of Listeria monocytogenes Recovered from Lettuce Treated with Sanitizers J Food Prot 67(4):742-750 Brackett RE 1987 Antimicrobial effect of chlorine on Listeria monocytogenes J Food Prot 50(12):999-1003 Brackett RE 1999 Incidence and behavior of Listeria monocytogenes in products of plant origin Ryser ET, Marth EH Marcel Dekker New York Brackett RE 1999 Incidence, contributing factors, and control of bacterial pathogens in produce Postharvest Biol Technol 15:305-311 Brackett RE 1987 Microbiological consequences of minimally processed fruits and vegetables J Food Qual 10:195-206 Brackett RE 1992 Microbiological safety of chilled foods: current issues Tr Food Sci Technol 3(4):81-85 Brackett RE 1992 Shelf stability and safety of fresh produce as influenced by sanitation and disinfection J Food Prot 55(10):804-814 Carlin F Nguyen-The C 1994 Fate of Listeria monocytogenes on four types of minimally processed green salads Let Appl , Microbiol 18:222-226 Chen Y, Jackson KM, Chea FP, Schaffner DW 2001 Quantification and Variability Analysis of Bacterial CrossContamination Rates in Common Food Service Tasks J Food Prot 64(1):72-80 Davis H, Taylor JP, Perdue JN, Stelma J, G.N., Humphreys J, J.M., Rowntree III R, Greene KD 1988 A shigellosis outbreak traced to commercially distributed shredded lettuce Am J Epidm 128(6):1312-1321 Delaquis PJ, Stewart S, Cazaux S, Toivonen P 2002 Survival and Growth of Listeria monocytogenes and Escherichia coli O157:H7 in Ready-to-Eat Iceberg Lettuce Washed in Warm Chlorinated Water J Food Prot 65(3):459-464 Delaquis PJ, Stewart S, Toivonen PMA, Moyls AL 1999 Effect of warm chlorinated water on the microbial flora of shredded iceberg Food Res Int 32:1999 Diaz C, Hotchkiss JH 1996 Comparative growth of Escherichia coli O157:H7, spoilage organisms and shelf-life of shredded iceberg lettuce stored under modified atmospheres J Sci Food Agric 70:433-438 Ercolani GL 1997 Note: occurrence and persistence of culturable clostridial spores on the leaves of horticultural plants J Appl Microbiol 82:137-140 Ercolani GL 1976 Bacteriological quality assessment of fresh marketed lettuce and fennel Appl Environ Microbiol 31(6):847-852 Escudero ME, Velázquez LD María SDG 1999 Effectiveness of Various Disinfectants in the Elimination of Yersinia enterocolitica on Fresh Lettuce J Food Prot 62(6):665-669 Fain J, A.R 1994 A review of the microbiological safety of fresh salads SCOPE 9(3):1-4 Fan X, Sokorai KJB 2002 Sensorial and Chemical Quality of Gamma-Irradiated Fresh-Cut Iceberg Lettuce in Modified Atmosphere Packages J Food Prot 65(11):1760-1765 27 Farber JM, Sanders GW, Johnston MA 1989 A survey of various foods for the presence of Listeria species J Food Prot 52(7):456-458 Farber JM, Wang SL, Cai Y, Zhang S 1998 Changes in populations of Listeria monocytogenes inoculated on packaged fresh-cut vegetables J Food Prot 61(2):192FDA (U.S Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition [CFSAN]) 1998 Guide to minimize microbial food safety hazards for fresh fruits and vegetables Washington, DC: 40 FDA (U.S FDA/CFSAN) 1999 Potential for infiltration, survival and growth of human pathogens within fruits and vegetables Washington, DC: 20 Fenlon DR 1985 Wild birds and silage as reservoiors of Listeria in the agricultural environment J Appl Bacteriol 59:537543 Fonseca, J.M 2006 Postharvest quality and microbial population of head lettuce as affected by moisture at harvest Journal of Food Science 71(2): M45-M49 Francis GA, O'Beirne D 1997 Effects of gas atmosphere, antimicrobial dip and temperature on the fate of L innocua and L monocytogenes on minimally processed lettuce Int J Food Sci and Technol 32:141-151 Francis GA, O'Bierne D 1998 Effects of the indigenous microflora of minimally processed lettuce on the survival and growth of Listeria innocua Int J Food Sci Technol 33:477-488 Francis GA, O'Bierne D 1998 Effects of the indigenous microflora of minimally processed lettuce on the survival and growth of Listeria innocua Int J Food Sci Technol 33:477-488 Francis GA, Thomas C, O'Beirne D 1999 The microbial safety of minimally processed vegetables Intl J Food Sci.Technol 34:1-22 Fukushima, H.K Hoshina and M Goymoda 1999 Long-term survival of Shiga toxin-producing Eschericia coli O26, O111 and O157 in bovine feces Appl Environ Microbiol 65:5177-5181 Gagliardi JV, Karns JS 2000 Leaching of Escherichia coli O157:H7 in diverse soils under various agricultural management practices App Environ Microbiol 66(3):877-883 Garcia-Gimeno RM, Zuera-Cosano G, Amaro-Lopez M 1996 Incidence, survival and growth of Listeria monocytogenes in ready-to-use mixed vegetable salads in Spain J Food Safety 16:75-86 Garcia-Gimeno RM, Sanchez-Pozo MD, Amaro-Lopez MA, Zurera-Cosano G 1996 Behaviour of Aeromonas hydrophila in vegetable salads stored under modified atmosphere at and 15 Degrees C Food Microbiol 13:369-374 Garcia-Villanova Ruiz B, Galvez Vargas R, Garcia-Villanova R 1987 Contamination on fresh vegetables during cultivation and marketing Intl J Food Microbiol 4:285-291 Gulati BR, Allwood PB, Hedberg CW, Goyal SM 2001 Efficacy of Commonly Used Disinfectants for the Inactivation of Calicivirus on Strawberry, Lettuce, and a Food-Contact Surface J Food Prot 64(10):1430-1434 Hernandez F Monge R, Jimenez C, Taylor L 1997 Rotavirus and hepatitis A virus in market lettuce [Latuca sativa] in , Costa Rica Intl J Food Microbiol 37:221-223 28 Hines E 2000 The microbiology of fresh and fresh-cut produce Food Quality 7(1):18-20, 22-25 Hurme EU, Kinnunen A, Heinio R-L, Ahvenainen R, Jokinen K 1999 The storage life of packed shredded iceberg lettuce dipped in glycine betaine solutions J Food Prot 62(4):363-367 Ingham SC, Fanslau MA, Engel RA, Breuer JR, Breuer JE, Wright TH, Reith-Rozelle JK, Zhu J 2005 Evaluation of Fertilization-to-Planting and Fertilization-to-Harvest Intervals for Safe Use of Noncomposted Bovine Manure in Wisconsin Vegetable Production J Food Prot 68(6):1134-1142 Islam M, Doyle MP, Phatak SC, Millner P, Jiang X 2004 Persistence of Enterohemorrhagic Escherichia coli O157:H7 in Soil and on Leaf Lettuce and Parsley Grown in Fields Treated with Contaminated Manure Composts or Irrigation Water J Food Prot 67(7): 1365-1370 Jacxsens L, Devlieghere F Falcato P, DeBevere J 1999 Behavior of Listeria monocytogenes and Aeromonas spp on fresh-cut , produce packaged under equilibrium-modified atmosphere J Food Protect 62(10):1128-1135 Jiang, X., J Morgan and M P Doyle 2003a Fate of Escherichia coli O157:H7 during composting of bovine manure in a laboratory-scale bioreactor Journal of Food Protection 66 (1): 25-30 Jiang, X., J Morgan and M P Doyle 2003b Thermal Inactivation of Escherichia coli O157:H7 in cow manure compost Journal of Food Protection 66 (10) 1771 – 1777 Johnsen K., G, Leitao J, Herikstad H, Andersson Y, Langeland G, Gondrosen B, Lassen J 1995 Outbreak of Shigella sonnei infection traced to imported iceberg lettuce J Clin Microbiol 33(3):609-614 Kakiomenou K, Tassou C, Nychas G-J 1998 Survival of Salmonella enteritidis and Listeria monocytogenes on salad vegetables World J Microbiol Biotechnol 14:383-387 Kim J-G, Yousef AE, Chism GW 1999 Use of ozone to inactivate microorganisms on lettuce J Food Safety 19:17-34 Koseki S, Fujiwara K, Itoh K 2002 Decontaminative Effect of Frozen Acidic Electrolyzed Water on Lettuce J Food Prot 65(2):411-414 Koseki S, Itoh K 2002 Effect of Nitrogen Gas Packaging on the Quality and Microbial Growth of Fresh-Cut Vegetables under Low Temperatures J Food Prot 65(2):326-332 Koseki S, Itoh K 2001 Prediction of Microbial Growth in Fresh-Cut Vegetables Treated with Acidic Electrolyzed Water during Storage under Various Temperature Conditions J Food Prot 64(12):1935-1942 Koseki S, Yoshida K, Isobe S, Itoh K 2001 Decontamination of Lettuce Using Acidic Electrolyzed Water J Food Prot 64(5):652-658 Koseki S, Yoshida K, Kamitani Y, Itoh K 2003 Influence of Inoculation Method, Spot Inoculation Site, and Inoculation Size on the Efficacy of Acidic Electrolyzed Water against Pathogens on Lettuce J Food Prot 66(11):2010-2016 Kurdziel AS, Wilkinson N, Langton S, Cook N 2001 Survival of Poliovirus on Soft Fruit and Salad Vegetables J Food Prot 64(5):706-709 Lang MM, Harris LJ, Beuchat LR 2004 Survival and Recovery of Escherichia coli O157:H7, Salmonella, and Listeria monocytogenes on Lettuce and Parsley as Affected by Method of Inoculation, Time between Inoculation and Analysis, and Treatment with Chlorinated Water J Food Prot 67(6):1092-1103 29 Larson AE, Johnson EA, Barmore CR, Hughes MD 1997 Evaluation of the botulism hazard from vegetables in modified atmosphere packaging J Food Prot 60(10):1208-1214 Lee SY, Costello M, Kang, DH 2004 Efficacy of Chlorine Dioxide Gas as a Sanitizer of Lettuce Leaves J Food Prot 67(7):1371-137 Lilly T, Solomon HM, Rhodehamel EJ 1996 Incidence of Clostridium botulinum in vegetables packaged under vacuum or modified atmosphere J Food Prot 59(1):59-61 Leggitt PR, Jaykus LA 2000 Detection Methods for Human Enteric Viruses in Representative Foods J Food Prot 63(12):1738-1744 Liao CH, Fett WF 2001 Analysis of Native Microflora and Selection of Strains Antagonistic to Human Pathogens on Fresh Produce J Food Prot 64(8):1110-1115 Little C, Roberts DY 1999 Microbiological Quality of Retail Imported Unprepared Whole Lettuces: A PHLS Food Working Group Study J Food Prot 62(4):325-328 Little C, Roberts D, Youngs E, deLouvois J 1999 Microbiological quality of retail imported unprepared whole lettuces: a PHLS Food Working Group Study J Food Prot 62:325-328 Li Y, Brackett RE, Chen J, Beuchat LR 2001 Survival and Growth of Escherichia coli O157:H7 Inoculated onto Cut Lettuce Before or After Heating in Chlorinated Water, Followed by Storage at or 15°C J Food Prot 64(3):305-309 Lin CK, Jeongmok D, Wen-Xian Wei C 2000 Bactericidal Activity of Isothiocyanate against Pathogens on Fresh Produce J Food Prot 63(1):25-30 Lin CM, Moon SS Doyle MP, McWatters KH 2002 Inactivation of Escherichia coli O157:H7, Salmonella enterica Serotype Enteritidis, and Listeria monocytogenes on Lettuce by Hydrogen Peroxide and Lactic Acid and by Hydrogen Peroxide with Mild Heat J Food Prot 65(8):1215-1220 Liu Y,Ye J, Li Y 2003 Rapid Detection of Escherichia coli O157:H7 Inoculated in Ground Beef, Chicken Carcass, and Lettuce Samples with an Immunomagnetic Chemiluminescence Fiber-Optic Biosensor J Food Prot 66(3):512-517 Lund BM 1993 The microbial safety of prepared salad vegetables Food Technol Int Eur :196-200 Martinez-Tome M, Vera AM, Murcia MA 2000 Improving the control of food production in catering establishments with particular reference to the safety of salads Food Control 11:437-455 Martinez JA, Artes F 1999 Effect of packaging treatments and vacuum-cooling on quality of winter harvested iceberg let tuce Food Res Int 32:621-627 McWatters KH, Chinnan MS, Walker SL, Doyle MP, Lin CM 2002 Consumer Acceptance of Fresh-Cut Iceberg Lettuce Treated with 2% Hydrogen Peroxide and Mild Heat J Food Prot 65(8):1221-1226 Montville R Chen Y Schaffner DW 2001 Glove Barriers to Bacterial Cross-Contamination between Hands to Food J Food Prot 64(6):845-849 Moore CM, Sheldon BW, Jaykus LA 2003 Transfer of Salmonella and Campylobacter from Stainless Steel to Romaine Lettuce J Food Prot 66(12):2231-2236 30 Mukherjee A, Speh D, Dyck E, Diez-Gonzalez F 2004 Preharvest Evaluation of Coliforms, Escherichia coli, Salmonella, and Escherichia coli O157:H7 in Organic and Conventional Produce Grown by Minnesota Farmers J Food Prot 67(5):894-900 Nascimento MS, Silva N, Catanozi MP, Silva KC 2003 Effects of Different Disinfection Treatments on the Natural Microbiota of Lettuce J Food Prot 66(10):1697-1700 National Advisory Committee on Microbiological Criteria for Food 1999 Microbiological safety evaluations and recommendations on fresh produce Food Control 10:117-143 Nguyen-the C, Carlin F 2000 Fresh and processed vegetables In: Lund BM, Baird-Parker TC, Gould GW, Editors The microbiological safety and quality of food Gaithersburg, MA: Aspen Publishers P 620-684 Nguyen-the C, Carlin F 1994 The microbiology of minimally processed fresh fruits and vegetables Crit Rev Food Sci Nutr 34(4):371-401 Niemira BA, Sommers CH, Fan X 2002 Suspending Lettuce Type Influences Recoverability and Radiation Sensitivity of Escherichia coli O157:H7 J Food Prot 65(9):1388-1393 Odumeru JA, Mitchell SJ, Alves DM, Lynch JA, Yee AJ, Wang SL, Styliiadis S, Farber JM 1997 Assessment of the microbiological quality of ready-to-use vegetables for health-care food services J Food Prot 60(8):954-960 Oh S, Dancer G, Iris K, Dong-Hyun 2005 Efficacy of Aerosolized Peroxyacetic Acid as a Sanitizer of Lettuce Leaves J Food Prot 68(8): 1743-1747 Ohsone M, Kaneko K, Hayashidani H, Takahashi T, Ogawa M 1999 Growth and inhibition by acids of five species of pathogenic bacteria inoculated in salad vegetables Food Hyg Soc Jpn 40(4):297-303 Priepke PE, Wei LS, Nelson Al 1976 Refrigerated storage of prepackaged salad vegetables J Food Sci 41:379-382 Rafii F Lunsford P 1997 Survival and detection of Shigella flexneri in vegetables and commercially prepared salads J , AOAC Int 80(6):1191-1197 Raiden RM, Sumner SS, Eifert JD, Pierson MD 2003 Efficacy of Detergents in Removing Salmonella and Shigella spp from the Surface of Fresh Produce J Food Prot 66(12):2210-2215 Rodgers SL, Cash JN, Siddiq M, Ryser ET 2004 A Comparison of Different Chemical Sanitizers for Inactivating Escherichia coli O157:H7 and Listeria monocytogenes in Solution and on Apples, Lettuce, Strawberries, and Cantaloupe J Food Prot 67(4):721-731 Robertson LJ, Gjerde B 2001 Occurrence of Parasites on Fruits and Vegetables in Norway J Food Prot 64(11):17931798 Robertson LJ, Gjerde B, Campbell AT 2000 Isolation of Cyclospora Oocysts from Fruits and Vegetables Using LectinCoated Paramagnetic Beads J Food Prot 63(10): 1410-1414 Robertson LJ, Gjerde B 2000 Isolation and Enumeration of Giardia Cysts, Cryptosporidium Oocysts, and Ascaris Eggs from Fruits and Vegetables J Food Prot 63(6):775-778 Rosenblum LS, Mirkin IR, Allen DT, Safford S, Hadler SC 1990 A multifocal outbreak of hepatitis A traced to commercially distributed lettuce AJPH 80(9):1075-1079 31 Ryu JH, Kim H, Beuchat LR 2004 Attachment and Biofilm Formation by Escherichia coli O157:H7 on Stainless Steel as Influenced by Exopolysaccharide Production, Nutrient Availability, and Temperature J Food Prot Volume 67(10): 21232131 Schuenzel KM Harrison MA 2002 Microbial Antagonists of Foodborne Pathogens on Fresh, Minimally Processed Vegetables J Food Prot 65(12):1909-1915 Schulbach, K 1998 Assessing the impact of manure application on the presence of microbial contamination of lettuce at harvest California Lettuce Research Board, Annual Report 1997 – 1998 Salinas, CA p.229 - 233 Seo KH, Frank JF 1999 Attachment of Escherichia coli O157:H7 to lettuce leaf surface and bacterial viability in response to chlorine treatment as demonstrated by using confocal scanning laser microscopy J Food Prot 62(1):3-9 Shearer AEH, Strapp CM, Joerger RD 2001 Evaluation of a Polymerase Chain Reaction-Based System for Detection of Salmonella Enteritidis, Escherichia coli O157:H7, Listeria spp., and Listeria monocytogenes on Fresh Fruits and Vegetables J Food Prot 64(6):788-795 Sivapalasingam S, Friedman CR, Cohen L, Tauxe RV 2004 Fresh Produce: A Growing Cause of Outbreaks of Foodborne Illness in the United States, 1973 through 1997 J Food Prot Volume 67 (10): 2342-2353 Smith S, Dunbar M, Tucker D, Schaffner DW 2003 Efficacy of a Commercial Produce Wash on Bacterial Contamination of Lettuce in a Food Service Setting J Food Prot 66 (12):2359-2361 Smith, R, Schulbach K 1999 Assessing the impact of manure application on the presence of microbial contamination of lettuce at harvest California Lettuce Research Board, Annual Report 1998 – 1999 Salinas, CA p 247-251 Solomon EB, Matthews KR 2005 Use of Fluorescent Microspheres as a Tool To Investigate Bacterial Interactions with Growing Plants J Food Prot 68(4): 870-873 Solomon EB, Pang HJ, Matthews KR 2003 Persistence of Escherichia coli O157:H7 on Lettuce Plants following Spray Irrigation with Contaminated Water J Food Prot 66(12):2198-2202 Solomon EB, Potenski C, Matthews KR 2002 Effect of Irrigation Method on Transmission to and Persistence of Escherichia coli O157:H7 on Lettuce J Food Prot 65(4)673-676 Soriano JM, Rico H, Moltó JC, Mes J 2001 Listeria Species in Raw and Ready-to-Eat Foods from Restaurants J Food Prot 64(4):551-553 Stine SW, Song I, Choi C, Gerba CP 2005 Effect of Relative Humidity on Preharvest Survival of Bacterial and Viral Pathogens on the Surface of Cantaloupe, Lettuce, and Bell Peppers J Food Prot 68(7):1352-1358 Stine SW, Song IC, Christopher Y, Gerba CP, 2005 Application of Microbial Risk Assessment to the Development of Standards for Enteric Pathogens in Water Used To Irrigate Fresh Produce J Food Prot Volume 68(5): 913-918 Steinbruegge EG, Maxcy RB, Liewen MB 1988 Fate of Listeria monocytogenes on ready to serve lettuce J Food Prot 51(8):596-599 Suslow TV 2001 Pre-incorporation transfer of indicator bacteria from stacked manure to existing letttuce California Lettuce Research Board, Annual Report 2000 – 2001 Salinas, CA p 251-262 Suslow TV 2004 Assessment of indicator bacteria from reservoir irrigation water and on lettuce California Lettuce Research Board, Annual Report 2003 – 2004 Salinas, CA p 229 – 259 32 Suslow TV 2005a Assessment of indicator bacteria in lettuce production environments California Lettuce Research Board, Annual Report 2004 – 2005 Salinas, CA p 235 –249 Suslow TV 2005b Development of food safety BMP’s for lettuce California Lettuce Research Board, Mid-year Report, Oct 11, 2005 Sy KV, Murray MB, Harrison MD, Beuchat LR 2005 Evaluation of Gaseous Chlorine Dioxide as a Sanitizer for Killing Salmonella, Escherichia coli O157:H7, Listeria monocytogenes, and Yeasts and Molds on Fresh and Fresh-Cut Produce J Food Prot 68(6): 1176-1187 Szabo EA, Scurrah KJ, Burrows JM 2000 Survey for Psychrotrophic bacterial pathogens in minimally processed lettuce Let Appl Microbiol 30:456-460 Szabo EA, Simons L, Coventry MJ, Cole MB 2003 Assessment of Control Measures To Achieve a Food Safety Objective of Less than 100 CFU of Listeria monocytogenes per Gram at the Point of Consumption for Fresh Precut Iceberg Lettuce J Food Prot 66(2):256-264 Takeuchi K, Frank JF 2001a Expression of Red-Shifted Green Fluorescent Protein by Escherichia coli O157:H7 as a Marker for the Detection of Cells on Fresh Produce J Food Prot 64(3):298-304 Takeuchi K, Frank JF 2001b Direct Microscopic Observation of Lettuce Leaf Decontamination with a Prototype Fruit and Vegetable Washing Solution and 1% NaCl-NaHCO3 J Food Prot 64(8):1235-1239 Takeuchi K, Frank JF 2000 Penetration of Escherichia coli O157:H7 into lettuce tissues as affected by inoculum size and temperature and the effect of chlorine treatment on cell viability J Food Prot 63(4):434-440 Takeuchi K, Frank JF 2001 Quantitative Determination of the Role of Lettuce Leaf Structures in Protecting Escherichia coli O157:H7 from Chlorine Disinfection J Food Prot 64(2):147-151 Takeuchi K, Hassan AN, Frank JF 2001 Penetration of Escherichia coli O157:H7 into Lettuce as Influenced by Modified Atmosphere and Temperature J Food Prot 64(11):1820-1823 Takeuchi K, Matute CM, Hassan, AN Frank JF 2000 Comparison of the Attachment of Escherichia coli O157:H7, Listeria monocytogenes, Salmonella Typhimurium, and Pseudomonas fluorescens to Lettuce Leaves J Food Prot 63(10):1433-1437 Thunberg RL, Tran TT, Bennett RW, Matthews R, Belay N 2002 Microbial Evaluation of Selected Fresh Produce Obtained at Retail Markets J Food Prot 65(4):677-682 U.S EPA Water Standards: www.epa.gov/safewater/standards.html Vega E, Smith J, Garland J, Matos A, Pillai S 2005 Variability of Virus Attachment Patterns to Butterhead Lettuce J Food Prot 68(10) 2112-2117 Vijayakumar C, Wolf-Hall CE 2002 Evaluation of Household Sanitizers for Reducing Levels of Escherichia coli on Iceberg Lettuce J Food Prot 65(10):1646-1650 Villari P, Crispino M, Montuori P, Stanzione S 2000 Prevalence and Molecular Characterization of Aeromonas spp in Ready-to-Eat Foods in Italy J Food Prot 63(12):1754-1757 Wachtel MR, McEvoy JL, Luo Y Williams-Campbell AM Solomon MB 2003 Cross-Contamination of Lettuce (Lactuca sativa L.) with Escherichia coli O157:H7 via Contaminated Ground Beef J Food Prot 66(7):1176-1183 33 Wachtel MR, Charkowski AO 2002 Cross-Contamination of Lettuce with Escherichia coli O157:H7 J Food Prot 65(3)465-470 Wachtel MR, Whitehand LC,Mandrell RE 2002a Association of Escherichia coli O157:H7 with Preharvest Leaf Lettuce upon Exposure to Contaminated Irrigation Water J Food Prot 65(1):18-25 Wachtel M, Whitehand LC, Mandrell RE 2002b Prevalence of Escherichia coli Associated with a Cabbage Crop Inadvertently Irrigated with Partially Treated Sewage Wastewater J Food Prot 65(3)471-475 Wallace JS, Cheasty T, Jones K 1997 Isolation of Vero cytotoxin-producing Escherichia coli O157:H7 from wild birds J Appl Microbiol 82:399-404 Wang G, Zhao T, Doyle MP 1996 Fate of Enterohemorrhagic Escherichia coli O157:H7 in bovine feces Appl Environ Microbiol 62(7):2567-2570 Wells JM, Butterfield JE 1997 Salmonella contamination associated with bacterial soft rot of fresh fruits and vegetables in the marketplace Plant Disease (81):867-872 WHO Water Standards: http://www.wca-infonet.org/servlet/BinaryDownloaderServlet?filename=1063379476163_1.pdf&refID=110012 Zhang S, Farber JM 1996 The effects of various disinfectants against Listeria monocytogenes on fresh-cut vegetables Food Microbiol 13:311-321 Zhao T, Doyle MP 2001 Evaluation of Universal Preenrichment Broth for Growth of Heat-Injured Pathogens J Food Prot 64(11):1751-1755 34 Glossary This glossary of definitions have been obtained from Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, October 1998 (www.foodsafety.gov/~dms/prodguid.html) and the definitions describing risk are those adopted on an interim basis at the 22nd Session of the Codex Alimentarius Commission Agricultural Water: refers to water used in the growing environment (for example, field, vineyard, or orchard) for agronomic reasons It includes water used for irrigation, transpiration control (cooling), frost protection, or as a carrier for fertilizers and pesticides Occasionally a more specific term may be used, such as “irrigation water.” Typical sources of agricultural water include flowing surface waters from rivers, streams, irrigation ditches, open canals, impoundments (such as ponds, reservoirs, and lakes), wells, and municipal supplies Adequate: means that which is needed to accomplish the intended purpose in keeping with good practice Clean: means that food or food-contact surfaces are washed and rinsed and are visually free of dust, dirt, food residues, and other debris Control: (a) to manage the conditions of an operation in order to be consistent with established criteria, and (b) to follow correct procedures and meet established criteria Control Measure: any action or activity that can be used to prevent, reduce, or eliminate a microbiological hazard Facility: the buildings and other physical structures used for or in connection with the harvesting, washing, sorting, storage, packaging, labeling, holding, or transport of fresh produce Field Packed: means that grading, sorting, sizing, packing, and palletizing are carried out in the field Food-contact Surfaces: are those surfaces that contact fresh produce and those surfaces from which drainage onto the produce or onto surfaces that contact the produce may occur during the normal course of operations “Food-contact surfaces” includes equipment, such as containers and conveyor belts, which contact fresh produce, whether used in harvesting, postharvesting, or packaging operations It would not include tractors, forklifts, handtrucks, pallets, etc., that are used for handling or storing large quantities of contained or packed fresh produce and that not come into actual contact with the food Good Agricultural Practices: refer to the guidelines set forth in the “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,” which was published by the U.S Food and Drug Administration in 1998 (www.foodsafety.gov/~dms/prodguid.html) cGMPs (current Good Manufacturing Practices): Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Human Food (21 CFR 110) Hazard: any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control Human Pathogen: means a microorganism capable of causing disease or injury to people This is different from a plant pathogen which may cause disease to plants 35 Microorganisms: include yeasts, molds, bacteria, protozoa, helminths (worms), and viruses Occasionally, the term “microbe” or “microbial” is used instead of the term “microorganism.” Microbial Hazard: means occurrence of a microorganism that has the potential to cause illness or injury Operator: means the person or persons who have day-to-day responsibility for the production, harvesting, washing, sorting, cooling, packaging, shipping, or transportation of fresh fruits and vegetables, and responsibility for management of all employees who are involved in each of these activities Packing Shed/Packinghouse: means a facility where raw agricultural commodities are washed, trimmed or sorted and packed in commercial containers, e.g cartons or totes Pest: refers to any animal or insect of public health importance including, but not limited to, birds, rodents, cockroaches, flies, and larvae that may carry pathogens that can contaminate food Raw Agricultural Commodity: any fruit or vegetable in its raw or natural state, including all fruits and vegetable that are washed, colored, or otherwise treated in the unpeeled natural form prior to marketing Risk: is a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food Sanitize: means to treat produce by a process that is effective in destroying or substantially reducing the numbers of microorganisms of public health concern, as well as other undesirable microorganisms, without adversely affecting the quality of the product or its safety for the consumer Sanitize (food contact surfaces): means to adequately treat clean food-contact surfaces by a process that is effective in destroying or substantially reducing the numbers of microorganisms of public health concern, as well as other undesirable microorganisms, without adversely affecting the quality of the involved product or its safety for the consumer It means the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to reduce populations of representative microorganisms by log or 99.999% Shed Packed: means grading, sorting, sizing, packing, and palletizing are carried out in a packing shed/packinghouse Spring Mix: a blend of baby lettuces, mustards, chards, spinach and chicories that will vary based on availability of supply Value-Added or Fresh-cut Produce: refers to fruits or vegetables that have been trimmed and/or peeled and/or cut into 100% usable product that is bagged or pre-packaged These products are very often packed in protective plastic films and are typically "ready-to-eat" food products, if they are labeled as "washed,” "triple washed" or "ready-to-eat" as they have gone through a vigorous washing process before being packaged and sold Products that are not labeled as such are raw agricultural commodities and should be considered raw agricultural commodities even if they are packaged in a plastic overwrap or polyfilm 36 FDA Jurisdiction Over Fresh Fruits and Vegetables FDA’s regulations regarding current good manufacturing practices (cGMPs) exclude from their purview the following: Establishments engaged solely in the harvesting, storage, or distribution of one or more “raw agricultural commodities,” as defined in section 201(r) of the act, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public 21 C.F § 110.19(a) Section 201(r) of the Food, Drug, and Cosmetic Act defines “raw agricultural R commodities” as any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing 21 U.S.C § 321(r) It is this regulatory language that is usually regarded as the fresh fruit and vegetable “exemption” from FDA regulation The same regulation, however, goes on to provide as follows: FDA, however, will issue special regulations if it is necessary to cover these excluded operations 21 C.F § 110.19(b) The agricultural commodity exemption from cGMPs exists by regulation; it can be R revoked by regulation It is important to note that despite the regulatory exclusion from the specific requirements of the cGMP regulations, FDA still has jurisdiction over raw agricultural commodities as food Fresh fruits and vegetables are “food” within the meaning of the FD&C Act, and, as such, subject to adulteration and misbranding provisions of the Act A food shall be deemed to be adulterated – Poisonous, insanitary, etc., ingredients (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a) of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title 37 FD&C Act § 402(a), 21 U.S.C § 342(a) FDA has long used subsection (a)(4) of the adulteration provisions to take enforcement action against food facilities that have insanitary conditions Importantly, it is not necessary for FDA to demonstrate that the food at issue is actually contaminated, only that the food was held under such conditions that it may have become contaminated Agriculture’s regulatory “exemption” from the GMP regulations – which also address sanitation – not alter the statutory provisions regarding adulteration FDA could, at any time, take enforcement action against an agricultural producer FDA has the statutory authority to institute court proceedings to restrain violations of the Act (FD&C Act § 302, 21 U.S.C § 332), criminally prosecute responsible persons for violations of the Act (FD&C Act § 303, 21 U.S.C § 333), and seize adulterated or misbranded product (FD&C Act § 304, 21 U.S.C § 334) Under section 303 of the Bioterrorism Act, FDA now has the authority to administratively detain adulterated food that presents a threat of serious adverse health consequences or death FD&C Act § 403(h), 21 U.S.C § 334(h) Under section 304 of the Bioterrorism Act, FDA now also has the authority to debar persons from importing adulterated food into the United States FD&C Act § 306, 21 U.S.C § 335a These guidelines are recommendations only, and the International Fresh-cut Produce Association, the Produce Marketing Association, the United Fresh Fruit and Vegetable Association and Western Growers and all other contributors and reviewers, not make any claims or warranties about any specific actions contained herein It is the responsibility of any purveyor of food to maintain strict compliance with all local, state and federal laws, rules and regulations These guidelines are designed to direct inquiries and develop information that must be independently evaluated by all parties with regard to compliance with legal and regulatory requirements The providers of this document not certify compliance with these guidelines and not endorse companies or products based upon their use of these guidelines Differences between products, production processes, distribution and consumption, and the ever-changing state of knowledge regarding food safety make it impossible for any single document to be comprehensive and absolutely authoritative Users of these guidelines should be aware that scientific and regulatory authorities are periodically revising information regarding best practices in food handling, as well as information regarding potential food safety management issues Users of this document must bear in mind that as knowledge regarding food safety changes, so will measures to address those changes, as will the emphasis on particular issues by regulators, as well as regulations themselves Neither this document, nor how food producers and distributors should address food safety are set in stone Users are strongly urged to maintain regular contact and utilize information available through their trade associations, the U.S Food and Drug Administration, U.S Department of Agriculture, U.S Environmental Protection Agency, the Centers for Disease Control and Prevention, as well as state agricultural, environmental, academic, and public health authorities Acronyms CCP: A point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level CP: This stands for control point which is a step in a process where control my be applied to manage a food safety risk FDA: This acronym stands for the U.S Food and Drug Administration GAPs: This acronym stands for Good Agricultural Practices and synonymously refers to the “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” published by the U.S Food and Drug Administration www.foodsafety.gov/~dms/prodguid.html cGMPs: current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Human Food (21 CFR 110) www.access.gpo.gov/nara/cfr/waisidx_04/21cfr110_04.html 38 Required Reference Documents 1.FDA Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (www.foodsafety.gov/~dms/prodguid.html) 2.UFFVA Food Safety Auditing Guidelines: Core Elements of Good Agricultural Practices for Fresh Fruits and Vegetables (www.uffva.org/training/) 3.UFFVA Food Safety Questionnaire for Fresh Fruits and Vegetables (www.uffva.org/training/) 4.National GAPs Program Cornell University: Food Safety Begins on the Farm: A Grower Self Assessment of Food Safety Risks (www.gaps.cornell.edu/pubs_fsbf_ws.html) 5.IFPA/NFPA/UFFVA Field Cored Lettuce Best Practices (www.uffva.org/news/fccbest8_3a.pdf) 6.IFPA Food Safety Guidelines for the Fresh-Cut Produce Industry (www.fresh-cuts.org/index.php?page=37) 7.Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Human Food (21 CFR 110) (www.access.gpo.gov/nara/cfr/waisidx_04/21cfr110_04.html) 8.DRAFT Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (www.cfsan.fda.gov/~dms/prodgui2.html) 9.IFPA/PMA Fresh-cut Produce Handling Guidelines (www.fresh-cuts.org/index.php?page=37) 10.FMI Total Food Safety Management Guide: A Model Program for Raw Ready-To-Eat Fresh-cut Produce (www.fmi.org/forms/store/ProductFormPublic/search?action=1&Product_productNumber=2014) 11.AFDO Guidance for Processing Fresh-cut Produce in Retail Operations (www.afdo.org/afdo/upload/Fresh-cutProduce.pdf) 12.FMI SuperSafeMark: Retail Best Practices and Guide to Food Safety and Sanitation (www.fmi.org/supersafemark/) 13.NRA Education Foundation ServSafe Coursebook (www.nraef.org/servsafe) 39 .. .COMMODITY SPECIFIC FOOD SAFETY GUIDELINES FOR THE LETTUCE AND LEAFY GREENS SUPPLY CHAIN • 1ST Edition This document was prepared by members of the lettuce/ leafy greens industry... involved in the lettuce/ leafy greens farm to table supply chain consider the recommendations contained within these guidelines to ensure the safe production and handling of lettuce/ leafy greens products... of the lettuce/ leafy greens field to fork supply chain These required reference documents provide detailed information regarding how to develop food safety programs for specific segments of the