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21 CFR Part 1
[Docket No. FDA-2013-N-0013]
RIN 0910-AG98
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• FAXJ301-827-6870
• 4G¯��}¯���R�¿|§B��SJDivision of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
��Jkµlj¹]|§>T\�qUHI�Uª«¬¤®No. FDA-2013-N-0013U
=>?zBMNY�pqBRIN 0910-AG98m� �¹qpiµ¹Ïijip~kµ
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]JDivision of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852~
��±²,-©J��±²,-©J��±²,-©J��±²,-©J
zBMNOYÈ}qJ Michael E. Kashtock, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,
240-402-2022.
±²ÆÇYÈ}qJDomini Bean, Office of Operations, Food and Drug Administration, 1350
Picard Dr., PI50-400T, Rockville, MD 20850, [email protected].
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V��ip~S
1. Hennessy T.W., Hedberg, C.W., Slutsker, L. et al., 1996, "A National Outbreak of
Salmonella Enteriditis Infections From Ice Cream," New England Journal of Medicine, Vol. 334,
No. 20, pp. 1281–1286, available at
http://www.nejm.org/doi/full/10.1056/NEJM199605163342001#t=articleTop, accessed and
printed on September 10, 2013.
2. FDA Memorandum, "Feed RFRs Related to Transportation Problems," 2012.
3. Wojtala, G., 2007, Interstate Food Transportation Assessment Project, presented at
the June 16 through 20, 2007, Conference of the Association of Food and Drug Officials,
available at http://www.michigan.gov/documents/mda/truckproj_224450_7.pdf, accessed and
printed on September 9, 2013.
4. Michigan Department of Agriculture, "Food Truck Assessment Project, April 18/19,
87
��� ����� ���� ��������� ��
2006."
5. The Indy Channel, "200 Pounds of Contaminated Food Headed to Central Indiana
Restaurants in Semi Destroyed, Police: Raw Chicken, Veggies Found Together,"
(http://www.theindychannel.com/news/local-news/200-pounds-of-contaminated-food-headed-to
central-indiana-restaurants-in-semi-destroyed ), 2013, accessed and printed on September 9,
2013.
6. Caledonia Record, "DMV Stops Truck, Finds Spoiled Food," August 18, 2012.
7. Courier Journal, "Overheated Transport Trucks Spark Concerns About Spoilage,"
August 10, 2012.
8. Motor Carrier Division, Michigan State Police, "Commercial Motor Vehicle
Enforcement Quarterly,"
(http://www.michigan.gov/documents/msp/CMV_Quarterly_January_2007_205099_7.pdf),
2007, accessed and printed on September 9, 2013.
9. Eastern Research Group, Inc., 2009, Characteristics of Current Food Transportation
and Holding Practices for Food Commodities, GSA MOBIS SIN 874-1, Contract No.
GS-10F-0125P, Order No.HHSF223200730236G, ERG Task No. 0193.16.001.001)
10. FDA, “Guidance for Industry: Sanitary Transportation of Food,”
(http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitati
ontransportation/ucm208199.htm), accessed and printed on January 28, 2014.
11. FSIS, "FSIS Safety and Security Guidelines for the Transportation and
Distribution of Meat, Poultry, and Egg Products,"
(http://www.fsis.usda.gov/shared/PDF/Transportation_Security_Guidelines.pdf ), 2005,
accessed and printed on September 9, 2013.
12. FDA, "Compliance Policy Guide Sec. 565.100 FDA Jurisdiction Over Meat and
88
��� ����� ���� ��������� ��
Poultry Products," 2005.
13. FSIS, "HACCP for Shelf Stable Processes,"
(http://www.fsis.usda.gov/shared/PDF/FSRE_SS_HACCP_Student.pdf), 2009, accessed and
printed on September 9, 2013.
14. Greater Pittsburgh Community Food Bank, "Shelf Life of Food Bank Products,"
(http://www.pittsburghfoodbank.org/pdf/shelflifeguide.pdf), 2012, accessed and printed on
September 9, 2013.
15. NSW Food Authority, "Shelf Stable Acid Preserved Foods,"
(http://www.foodauthority.nsw.gov.au/_Documents/science/shelf-stable-acid-preservedfoods.pd
f ), 2011, accessed and printed on September 10, 2013.
16. FSIS, "Shelf Stable Food Safety,"
(http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safetyf
act-sheets/safe-food-handling/shelf-stable-food-safety), 2013, accessed and printed on
September 9, 2013.
17. FDA, "Food Code 2009: Chapter 1 - Purpose and Definitions," 2009.
18. Compressed Gas Association, letter, "Docket No. FDA–2010–N–0013," 2010.
19. Airgas, Inc., letter, "Docket No. FDA–2010–N–0013," 2010.
20. North American Produce Transportation Working Group, "Produce Transportation
Best Practices,"
(http://www.hortcouncil.ca/uploads/file/naptwg_produce_trans_best_practices.pdf), 2012,
accessed and printed on September 9, 2013.
21. University of Florida IFAS Extension, "Sanitary Design and Construction of Food
Equipment," (http://edis.ifas.ufl.edu/fs119), 2011, accessed and printed on September 9, 2013.
22. Juice Products Association, "Model Tanker Wash Guidelines for the Fruit Juice
89
��� ����� ���� ��������� ��
Industry,"
(http://www.tankerwash.org/data/archive/JPA%20Model%20Tanker%20Wash%20Guidelines%
20November%202010(1).pdf), 2010, accessed and printed on September 9, 2013.
23. FSIS, "Kitchen Companion: Your Safe Food Handbook,"
(http://www.fsis.usda.gov/wps/wcm/connect/2bc7ada9-12a4-4b36-960c-3230904edcc2/Kitchen
_Companion.pdf?MOD=AJPERES&CACHEID=8bf06fa4-b0e7-488a-afff-22018c3bb075),
2008, accessed and printed on September 9, 2013.
24. FDA, "Food Code 2009: Annex 3 - Public Health Reasons / Administrative
Guidelines - Chapter 3, Food," 2009.
25. FDA, "Food Code 2009: Annex 3 - Public Health Reasons / Administrative
Guidelines - Chapter 1, Purpose and Definitions," 2009.
26. Institute of Food Technologists, "Evaluation and Definition of Potentially
Hazardous Foods – Chapter 2,"
(http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm094143.ht
m), 2001, accessed and printed on September 9, 2013.
27. Cornell University College of Agriculture and Life Sciences, "Paenibacillus and
Bacillus Are the Shelf-Life Limiting Microbes for Fluid Milk Products," 103
(http://impact.cals.cornell.edu/project/paenibacillus-and-bacillus-are-shelf-life-limitingmicrobes
-fluid-milk-products), accessed and printed on September 9, 2013.
28. University of Guelph, "Microorganisms in Milk,"
(http://www.uoguelph.ca/foodscience/dairy-science-and-technology/dairymicrobiology/microor
ganisms-milk), 2010, accessed and printed on September 9, 2013.
29. National Food Processors Association, letter, "Safeguarding Food From
Contamination During Transportation," 1991.
90
��� ����� ���� ��������� ��
30. FDA, "Grade 'A' Pasteurized Milk Ordinance (2011 Revision)," 2012.
31. FDA, "Food Code 2009: Chapter 8 – Compliance and Enforcement," 2009.
32. FDA, "Food Code 2009: Chapter 3 – Food," 2009.
33. FDA, "Preliminary Regulatory Impact Analysis," 2014.
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