Document ID: FDA-2009-D-0348-0003
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-08-06T04:00Z

DRAFT GUIDANCE FOR INDUSTRY:  gUIDE TO MINIMIZE MICROBIAL FOOD SAFETY
HAZARDS OF Leafy greens

DOCKET NO.  FDA-2009-D-0348

(FDA has verified the Web site addresses, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes in
the FEDERAL REGISTER.) 

DOCUMENTS LISTED IN “V. REFERENCES” OF FEDERAL REGISTER NOTICE

Gorny, J., et al., Eds., Commodity Specific Food Safety Guidelines for
the Lettuce and Leafy Greens Supply Chain (1st edition); International
Fresh-cut Produce Ass’n, Produce Marketing Ass’n, United Fresh Fruit
and Vegetable Ass’n, Western Growers Ass’n; April 25, 2006. 
Accessed online at   HYPERLINK
"http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVe
getablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm" 
http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVeg
etablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm . 
(See Reference 7 below.)

Commodity Specific Food Safety Guidelines for the Production and Harvest
of Lettuce and Leafy Greens; Produce Marketing Ass’n, United Fresh
Fruit and Vegetable Ass’n, and Western Growers Ass’n; last revised
June 13, 2008.  Accessed online at    HYPERLINK
"http://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.0
8.pdf" 
http://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.08
.pdf .  (See Reference 8 below.)

________________________

DOCUMENTS LISTED IN “X. REFERENCES” OF DRAFT GUIDANCE

1.         U.S. Food and Drug Administration (FDA), 1996-2008 Produce
Outbreaks (unpublished data). 

2.         Institute of Food Technologists and FDA.    HYPERLINK
"http://www.cfsan.fda.gov/~comm/ift3-toc.html"  Analysis and Evaluation
of Preventative Control Measures for the Control and
Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut
Produce . September 2001. (  HYPERLINK
"http://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforF
oodProcesses/ucm090977.htm" 
http://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFo
odProcesses/ucm090977.htm ) (accessed 7/14/09). 

3.         Mead, P.S., et al, Food-Related Illness and Death in the
United States. Journal of Environmental Health, 2000. 62: 9-18. 

4.         Allos, B.M., et al., Surveillance for Sporadic Foodborne
Disease in the 21st Century: The FoodNet Perspective. Clinical
Infectious Disease, 2004. 38(Suppl 3): S115-120. 

5.         Lampel, K.A., Orlandi, P.A., and Kornegay, L., Improved
Template Preparations for PCR-Based Assays for Detection of Food-Borne
Bacterial Pathogens. Applied and Environmental Microbiology, 2000.
66(10): 4539-4542. 

6.         Sivapalasingam, S., et al., Fresh Produce: A Growing Cause of
Outbreaks of Foodborne Illness in the United States, 1973 through 1997.
Journal of Food Protection, 2000. 67(10): 2342-2353. 

7.         Gorny, J., et al., Eds. Commodity Specific Food Safety
Guidelines for the Lettuce and Leafy Greens Supply Chain (1st edition);
International Fresh-cut Produce Ass’n, Produce Marketing Ass’n,
United Fresh Fruit and Vegetable Ass’n, Western Growers Ass’n; April
25, 2006.   Accessed online at   HYPERLINK
"http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVe
getablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm" 
http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVeg
etablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm .  

8.	Commodity Specific Food Safety Guidelines for the Production and
Harvest of Lettuce and Leafy Greens; Produce Marketing Ass’n, United
Fresh Fruit and Vegetable Ass’n, and Western Growers Ass’n; last
revised June 13, 2008.    Accessed online at    HYPERLINK
"http://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.0
8.pdf" 
http://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.08
.pdf .  

9.	Solomon, E.B., Pang, H.J., and Matthews, K.R., Persistence of
Escherichia coli O157:H7 on Lettuce Plants following Spray Irrigation
with Contaminated Water. Journal of Food Protection, 2003.
66(12):2198-2202. 

10.	Fukushima, H.K. Hoshina, and Goymoda, M., Long-term survival of
Shiga toxin-producing Eschericia coli O26, O111 and O157 in bovine
feces. Applied and Environmental Microbiology, 1999. 65:5177-5181.

11.	Gagliardi, J.V. and Karns, J.S., Leaching of Escherichia coli
O157:H7 in diverse soils under various agricultural management
practices. Applied and Environmental Microbiology, 2000. 66(3):877-883. 

12.       Jiang, X., Morgan, J., and Doyle, M.P., Fate of Escherichia
coli O157:H7 in manure-amended soil. Applied and Environmental
Microbiology, 2002. 71:2221-2225.

13.       Franz, E., et al., Effects of cattle feeding regimen and soil
management type on the fate of    Escherichia coli  O157:H7 and
Salmonella enterica serovar typhimurium in manure, manure-amended soil,
and lettuce.  Applied and Environmental Microbiology, 2005.
71:6165-6177.

14.       Kudva, I.T., Blanch, K. and Hovde, C.J., Analysis of
Escherichia coli  O157:H7 survival in ovine or bovine manure and manure
slurry. Applied and Environmental Microbiology, 1998. 64:3166-3174.

15.       Jiang, X., Morgan, J., and Doyle, M.P., Fate of Escherichia
coli O157:H7 during composting of bovine manure in a laboratory-scale
bioreactor. Journal of Food Protection, 2003. 66(1):25-30.

16.       Jiang, X., Morgan, J., and Doyle, M.P., Thermal Inactivation
of Escherichia coli O157:H7 in cow manure compost. Journal of Food
Protection, 2003. 66(10):1771–1777.  

17.       Islam, M., et al., 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.
Journal of Food Protection, 2004. 67(7):1365-1370. 

18.       Van Elsas, J.D., et al., Survival of genetically marked
Escherichia coli O157:H7 in soil as affected by soil microbial community
shifts. The ISME journal, 2007. 1:204-214.

19.       Suslow, T.V., Assessment of indicator bacteria in lettuce
production environments.  California Lettuce Research Board, Annual
Report 2004 – 2005. Salinas, CA. p. 235–249, 2005. 

20.       Suslow, T.V., et al., Production practices as risk factors in
microbial food safety of fresh  and fresh-cut produce.  Comprehensive
Reviews in Food Science and Food Safety.  2003. 2S:38-77. 

21.      Takeuchi, K. and Frank, J.F. Expression of Red-Shifted Green
Fluorescent Protein by Escherichia coli O157:H7 as a Marker for the
Detection of Cells on Fresh Produce. Journal of Food Protection, 2001.
64(3):298-304. 

22.       Wachtel, M.R., Whitehand, L.C., and Mandrell, R.E.,
Association of Escherichia coli O157:H7 with Preharvest Leaf Lettuce
upon Exposure to Contaminated Irrigation Water. Journal of Food
Protection, 2002. 65(1):18-25.

23.      Wachtel, M.R., Whitehand, L.C., and Mandrell, R.E., Prevalence
of Escherichia coli Associated with a Cabbage Crop Inadvertently
Irrigated with Partially Treated Sewage Wastewater. Journal of Food
Protection, 2002. 65(3)471-475. 

24.      Wells, J.M. and Butterfield, J.E., Salmonella contamination
associated with bacterial soft rot of fresh fruits and vegetables in the
marketplace. Plant Disease, 1997. 81:867-872. 

25.	Wachtel, M.R. and Charkowski, A.O., Cross-Contamination of Lettuce
with Escherichia coli O157:H7. Journal of Food Protection, 2002.
65(3)465-470.

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