FDA 2011 N 0920 0001 - Attachment - 1

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Docket No. FDA-2011-N-0920

References

The following references have been placed on display in the Division of Dockets

Management (see ADDRESSES) and may be seen by interested persons between 9 a.m.

and 4 p.m., Monday through Friday. (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.)

1. FDA, "Food CGMP Modernization — A Focus on Food Safety,"

(http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/CurrentG

oodManufacturingPracticesCGMPs/ucm207458.htm), November 2, 2005.

Accessed and printed on October 14, 2011.

2. Shapiro, R. L., C. Hatheway, and D. L. Swerdlow, "Botulism in the United States:

A Clinical and Epidemiologic Review," Annals of Internal Medicine, 129:221-

228, 1998.

3. FDA, "Fish and Fishery Products Hazards and Controls Guidance, Fourth

Edition," 2011.

4. FDA, "Guidance for Industry: Juice HACCP Hazards and Controls Guidance First

Edition; Final Guidance," 2004.

5. FDA, "Guidance for Industry: Lead in Candy Likely To Be Consumed Frequently

by Small Children: Recommended Maximum Level and Enforcement Policy,"

2006.
2

6. FDA, "Guidance for Industry: Measures to Address the Risk for Contamination

by Salmonella Species in Food Containing a Peanut-Derived Product as an

Ingredient," 2009.

7. FDA, "Compliance Policy Guide Sec. 527.300 Dairy Products - Microbial

Contaminants and Alkaline Phosphatase Activity," 2010.

8. FDA, "Compliance Policy Guide Sec. 555.300 Foods, Except Dairy Products -

Adulteration with Salmonella," 1995.

9. FDA, "Establishment Inspection Report (EIR),"

(http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061430.

htm), June 7, 2007. Accessed and printed on October 17, 2011.

10. FDA, "Regulatory Procedures Manual, Chapter 4. Advisory Actions," 2010.

11. FDA, "Regulatory Procedures Manual, Chapter 5. Adminstrative Actions," 2011.

12. FDA, "Regulatory Procedures Manual, Chapter 6. Judicial Actions," 2011.

13. CDC, "Foodborne Disease Outbreak Surveillance,"

(http://www.cdc.gov/outbreaknet/surveillance_data.html), September, 2011.

Accessed and printed on July 19, 2012.

14. CDC, "Frequently Asked Questions About CDC's Foodborne Outbreak Online

Database," (http://www.cdc.gov/outbreaknet/pdf/FAQsonFOOD.pdf), December,

2009. Accessed and printed on October 14, 2011.

15. CDC, "FoodNet - Foodborne Diseases Active Surveillance Network,"

(http://www.cdc.gov/foodnet/), 2012. Accessed and printed on July 27, 2012.


3

16. CDC, "Questions and Answers About Vital Signs: FoodNet MMWR, 2010,"

(http://www.cdc.gov/foodsafety/vitalsigns_questions.html), June 8, 2011.

Accessed and printed on October 17, 201.

17. "Food Emergency Response Network," (http://www.fernlab.org/), 2012.

Accessed and printed on July 27, 2012.

18. Electronic Laboratory Exchange Network, "Welcome to ELEXNET,"

(https://www.elexnet.com/portal/server.pt), 2012. Accessed and printed on July

27, 2012.

19. FDA, "Peanut Products Recall,"

(http://www.fda.gov/Safety/Recalls/MajorProductRecalls/Peanut/default.htm),

June 18, 2009. Accessed and printed on September 9, 2011.

20. FDA, "Peanut Butter and Other Peanut Containing Products Recall List,"

(http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm), October 28,

2009. Accessed and printed on September 9, 2011.

21. FDA, "Plainview Milk Cooperative Ingredient Recall,"

(http://www.fda.gov/Safety/Recalls/MajorProductRecalls/Milk/default.htm), July

23, 2009. Accessed and printed on September 9, 2011.

22. FDA, "Plainview Milk Cooperative Ingredient Recall Product List,"

(http://www.accessdata.fda.gov/scripts/Milk/), July 28, 2009. Accessed and

printed on September 9, 2011.

23. FDA, "Hydrolyzed Vegetable Protein Product Recalls,"

(http://www.fda.gov/Safety/Recalls/MajorProductRecalls/HVP/default.htm),

December 21, 2011. Accessed and printed on July 27, 2012.


4

24. FDA, "Recall: Products Containing Hydrolyzed Vegetable Protein,"

(http://www.accessdata.fda.gov/scripts/HVPCP/), April 1, 2010. Accessed and

printed on September 9, 2011.

25. Council to Improve Foodborne Outbreak Response, "Guidelines for Foodborne

Disease Outbreak Response," 2009.

26. FDA, "State Contracts,"

(http://www.fda.gov/ForFederalStateandLocalOfficials/PartnershipsContracts/Stat

eContracts/default.htm), 2012. Accessed and printed on July 27, 2012.

27. "FoodSafety.Gov," (http://www.foodsafety.gov/index.html), 2011. Accessed and

printed on July 27, 2012.

28. Partnership for Food Safety Education, "Fight Bac!" (http://www.fightbac.org/),

2012. Accessed and printed on July 27, 2012.

29. FDA, "Consumers. Food Safety, Nutrition Information, and Campaigns,"

(http://www.fda.gov/Food/ResourcesForYou/Consumers/default.htm), 2012.

Accessed and printed on July 27, 2012.

30. FDA, "Health Educators. Food Safety & Nutrition Education Campaigns,"

(http://www.fda.gov/Food/ResourcesForYou/HealthEducators/default.htm), 2012.

Accessed and printed on July 27, 2012.

31. FDA Memorandum, "Consultation with USDA on Food Processing Sector

Study," 2011.

32. FDA, "Food Processing Sector Study," 2011.

33. FSIS, "National Advisory Committee on Microbiological Criteria for Foods.

About NACMCF,"
5

(http://www.fsis.usda.gov/About_FSIS/NACMCF_Background/index.asp), 2010.

Accessed and printed on December 12, 2011.

34. National Advisory Committee on Microbiological Criteria for Foods, "Hazard

Analysis and Critical Control Point Principles and Application Guidelines,"

Journal of Food Protection, 61:1246-1259, 1998.

35. Codex Alimentarius Commission, "Hazard Analysis and Critical Control Point

(HACCP) System and Guidelines for Its Application. Annex to CAC/RCP 1-1969

(Rev. 4 - 2003)," 2003.

36. National Advisory Committee on Microbiological Criteria for Foods, "Hazard

Analysis and Critical Control Point System," International Journal of Food

Microbiology, 16:1-23, 1992.

37. FDA, "Grade "A" Pasteurized Milk Ordinance (2011 Revision)," 2012.

38. European Parliament and the Council of the European Union, "Regulation (EC)

No 852/2004 of the European Parliament and of the Council," (http://eur-

lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:139:0001:0054:en:PDF

), April 29, 2004. Accessed and printed on December 13, 2011.

39. Food Standards Australia New Zealand, "Standard 3.2.1 - Food Safety Programs,"

2007.

40. Canadian Food Inspection Agency, "Food Safety Enhancement Program / Hazard

Analysis Critical Control Points," (http://www.inspection.gc.ca/food/fsep-

haccp/eng/1299855874288/1299859914238), September 10, 2011. Accessed and

printed on July 31, 2012.


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41. Global Food Safety Initiative, "Enhancing Food Safety Through Third Party

Certification," 2011.

42. World Health Organization, "Hazard Analysis Critical Control Point System

(HACCP)," 2007.

43. Food and Agriculture Organization, "Manual on the Application of the HACCP

System in Mycotoxin Prevention and Control,"

(http://www.fao.org/docrep/005/y1390e/y1390e00.htm), 2001. Accessed and

printed on October 14, 2011.

44. Codex Alimentarius Commission, "General Principles of Food Hygiene,

CAC/RCP 1-1969 (Rev. 4-2003)," 2003.

45. Scallan, E., R. M. Hoekstra, F. J. Angulo, R. V. Tauxe, M. A. Widdowson, S. L.

Roy, J. L. Jones, and P. M. Griffin, "Foodborne Illness Acquired in the United

States--Major Pathogens," Emerging Infectious Diseases, 17:7-15, 2011.

46. Scallan, E., P. M. Griffin, F. J. Angulo, R. V. Tauxe, and R. M. Hoekstra,

"Foodborne Illness Acquired in the United States--Unspecified Agents,"

Emerging Infectious Diseases, 17:16-22, 2011.

47. CDC, "CDC 2011 Estimates: Method,"

(http://www.cdc.gov/foodborneburden/PDFs/FACTSHEET_E_2011ESTIMATES

.pdf), 2011. Accessed and printed on October 14, 2011.

48. Scheutz, F., E. Moller Nielsen, J. Frimodt-Moller, N. Boisen, S. Morabito, R.

Tozzoli, J. P. Nataro, and A. Caprioli, "Characteristics of the Enteroaggregative

Shiga Toxin/Verotoxin-Producing Escherichia coli O104:H4 Strain Causing the


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Outbreak of Haemolytic Uraemic Syndrome in Germany, May to June 2011,"

Eurosurveillance, 16:6, 2011.

49. FDA, "Bad Bug Book: Foodborne Pathogenic Microorganisms and Natural

Toxins Handbook. Second Edition," 2012.

50. CDC, "Vital Signs: Incidence and Trends of Infection with Pathogens Transmitted

Commonly Through Food - Foodborne Diseases Active Surveillance Network, 10

U.S. Sites, 1996-2010," MMWR, 60:749-755, 2011.

51. CDC, "What Is Salmonellosis?" (http://www.cdc.gov/Salmonella/general/), April

5, 2012. Accessed and printed on July 27, 2012.

52. Codex Alimentarius Commission, "Guidelines on the Application of General

Principles of Food Hygiene to the Control of Listeria monocytogenes in Ready-

to-Eat Foods, CAC/GL 61 - 2007," 2007.

53. FDA and USDA, "Quantitative Assessment of Relative Risk to Public Health

from Foodborne Listeria monocytogenes Among Selected Categories of Ready-

to-Eat Foods,"

(http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafet

yAssessment/ucm183966.htm), September, 2003. Accessed and printed on July

24, 2012.

54. Food and Agriculture Organization and World Health Organization, "Risk

Assessment of Listeria monocytogenese in Ready-to-Eat Foods, Technical

Report," 2004.

55. FDA and USDA, "Listeria monocytogenes Risk Assessment: Executive

Summary,"
8

(http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafet

yAssessment/ucm185292.htm), 2003. Accessed and printed on December 12,

2011.

56. FDA and USDA, "Listeria monocytogenes Risk Assessment: VII. Interpretation

and Conclusions,"

(http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafet

yAssessment/ucm185289.htm), September, 2003. Accessed and printed on

October 17, 2011.

57. CDC, "Norovirus: Clinical Overview,"

(http://www.cdc.gov/norovirus/hcp/clinical-overview.html), April 12, 2012.

Accessed and printed on July 19, 2012.

58. FDA Memorandum, "Food GMP Modernization Working Group: Summary of

Food Recalls, 1999-2003," 2004.

59. FDA Memorandum, "Analysis of Food Recalls Initiated in 2008-2009 by an FDA

CGMP Working Group," 2012.

60. FDA, "FDA Foods Program, The Reportable Food Registry: A New Approach to

Targeting Inspection Resources and Identifying Patterns of Adulteration. First

Annual Report: September 8, 2009 - September 7, 2010,"

(http://www.fda.gov/downloads/Food/FoodSafety/FoodSafetyPrograms/RFR/UC

M240647.pdf), January, 2011. Accessed and printed on August 29, 2011.

61. FDA, "FDA Foods Program, The Reportable Food Registry: A New Approach to

Targeting Inspection Resources and Identifying Patterns of Adulteration. Second

Annual Report: September 8, 2010 - September 7, 2011," (


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http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/ucm200958.htm

), 2012.

62. CDC, "Foodborne Outbreak Online Database (FOOD). Search Results

Highlighted for 2006-2007 Salmonella Tennessee Outbreak in Peanut Butter.,"

2011. Accessed and printed on October 18, 2011.

63. CDC, "Multistate Outbreak of Salmonella Serotype Tennessee Infections

Associated with Peanut Butter - United States, 2006-2007," MMWR, 56:521-524,

2007.

64. FDA, "Establishment Inspection Report Conagra Grocery Products 02/14/2007,"

2007.

65. FDA, "Establishment Inspection Report Conagra Foods 08/20/2007," 2007.

66. CDC, "Multistate Outbreak of Salmonella Infections Associated with Peanut

Butter and Peanut Butter-Containing Products - United States, 2008-2009,"

MMWR, 58:85-90, 2009.

67. Cavallaro, E., K. Date, C. Medus, S. Meyer, B. Miller, C. Kim, S. Nowicki, S.

Cosgrove, D. Sweat, P. Quyen, J. Flint, E. R. Daly, J. Adams, E. Hyytia-Trees, P.

Gerner-Smidt, R. M. Hoekstra, C. Schwensohn, A. Langer, S. V. Sodha, M. C.

Rogers, F. J. Angulo, R. V. Tauxe, I. T. Williams, and C. Barton Behravesh,

"Salmonella Typhimurium Infections Associated with Peanut Products," New

England Journal of Medicine, 365:601-610, 2011.

68. FDA, "Amended Form 483 (Inspectional Observations) for Peanut Corporation of

America, Blakely, GA, 02/05/2009,"

(http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronic
10

ReadingRoom/UCM109834.pdf), February 5, 2009. Accessed and printed on

October 19, 2011.

69. FDA, "Form 483 (Inspectional Observations) for Peanut Corporation of America,

Plainview, TX, 02/26/2009,"

(http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronic

ReadingRoom/UCM114852.pdf), February 26, 2009. Accessed and printed on

October 17, 2011.

70. CDC, "Foodborne Outbreak Online Database (FOOD). Search Results

Highlighted for 2007 Salmonella Wandsworth and Salmonella Typhimurium

Outbreak in Puffed Snacks.," 2011. Accessed and printed on November 18, 2011.

71. CDC, "Foodborne Outbreak Online Database (FOOD). Search Results

Highlighted for 2008-2009 Listeria Outbreak in Mexican-Style Cheese," 2011.

Accessed and printed on October 18, 2011.

72. Jackson, K. A., M. Biggerstaff, M. Tobin-D'Angelo, D. Sweat, R. Klos, J. Nosari,

O. Garrison, E. Boothe, L. Saathoff-Huber, L. Hainstock, and R. P. Fagan,

"Multistate Outbreak of Listeria monocytogenes Associated with Mexican-Style

Cheese Made from Pasteurized Milk Among Pregnant, Hispanic Women,"

Journal of Food Protection, 74:949-953, 2011.

73. California Department of Public Health, "Outbreak of Salmonella Rissen

Associated with Ground White Pepper,"

(http://www.cdph.ca.gov/programs/DFDRS/Documents/QSS_Presentation_SRiss

en_and_%20white%20pepper_010611.pdf), 2011. Accessed and printed on

October 17, 2011.


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74. CDC, "Foodborne Outbreak Online Database (FOOD). Search Results

Highlighted for 2008 Salmonella Rissen Outbreak in Ground White Pepper,"

2011. Accessed and printed on November 23, 2011.

75. FDA, "Warning Letter to U.F. Union International Food Company, 11/24/1009,"

(http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192435.htm

), November 24, 2009. Accessed and printed on October 17, 2011.

76. CDC, "Multistate Outbreak of E. coli O157:H7 Infections Linked to Eating Raw

Refrigerated, Prepackaged Cookie Dough,"

(http://www.cdc.gov/ecoli/2009/0630.html), June 30, 2009. Accessed and printed

on October 17, 2011.

77. FDA Public Health Focus Document, "E. coli in Nestlé Toll House Cookie

Dough," (http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm169858.htm),

July 13, 2009. Accessed and printed on October 17, 2011.

78. FDA, "Nestlé USA's Baking Division Initiates Voluntary Recall,"

(http://www.fda.gov/Safety/Recalls/ucm167954.htm), 2009. Accessed and printed

on October 19, 2011.

79. FDA, "Information on the Recalled Jensen Farms Whole Cantaloupes,"

(http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm), January

9, 2012. Accessed and printed on July 19, 2012.

80. CDC, "Multistate Outbreak of Listeriosis Linked to Whole Cantaloupes from

Jensen Farms, Colorado," (http://www.cdc.gov/listeria/outbreaks/cantaloupes-

jensen-farms/120811/index.html), December 8, 2011. Accessed and printed on

July 31, 2012.


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81. FDA, "Pesticide Monitoring Program - FY 2008,"

(http://www.fda.gov/downloads/Food/FoodSafety/FoodContaminantsAdulteration

/Pesticides/ResidueMonitoringReports/UCM230537.pdf), December 9, 2010.

Accessed and printed on October 14, 2011.

82. FDA, "CPG Sec. 570.375 Aflatoxin in Peanuts and Peanut Products," 2005.

83. FDA, "CPG Sec. 570.200 Brazil Nuts - Adulteration with Aflatoxin," 2005.

84. FDA, "CPG Sec. 570.500 Pistachio Nuts - Aflatoxin Adulteration," 2005.

85. FDA, "CPG Sec.510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice

Products - Adulteration with Patulin," 2005.

86. Taylor, S. L. and World Health Organization (WHO), "Histamine Poisoning

Associated with Fish, Cheese, and Other Foods,"

(http://whqlibdoc.who.int/hq/1985-86/VPH_FOS_85.1.pdf), 1985. Accessed and

printed on October 17, 2011.

87. Stratton, J. E., R. W. Hutkins, and S. L. Taylor, "Biogenic Amines in Cheese and

Other Fermented Foods: A Review," Journal of Food Protection, 54:460-469,

1991.

88. FDA, "Supporting Document for Recommended Maximum Level for Lead in

Candy Likely To Be Consumed Frequently by Small Children,"

(http://www.fda.gov/Food/FoodSafety/FoodContaminantsAdulteration/Metals/Le

ad/ucm172050.htm), November, 2006. Accessed and printed on October 14,

2011.

89. Williams, J. H., T. D. Phillips, P. E. Jolly, J. K. Stiles, C. M. Jolly, and D.

Aggarwal, "Human Aflatoxicosis in Developing Countries: a Review of


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Toxicology, Exposure, Potential Health Consequences, and Interventions,"

American Journal of Clinical Nutrition, 80:1106-1122, 2004.

90. Shephard, G. S., "Risk Assessment of Aflatoxins in Food in Africa," Food

Additives and Contaminants: Part A -- Chemistry, Analysis, Control, Exposure

and Risk Assessment, 25:1246-1256, 2008.

91. Sampson, H. A., "Update on Food Allergy," Journal of Allergy and Clinical

Immunology, 113:805-819, 2004.

92. Sampson, H. A., "Food Allergy--Accurately Identifying Clinical Reactivity,"

Allergy, 60 Suppl 79:19-24, 2005.

93. Sicherer, S. H. and H. A. Sampson, "Food Allergy," Journal of Allergy and

Clinical Immunology, 125:S116-S125, 2010.

94. Branum, A. M. and S. L. Lukacs, "Food Allergy Among Children in the United

States," Pediatrics, 124:1549-1555, 2009.

95. Bindslev-Jensen, C., D. Briggs, and M. Osterballe, "Can We Determine a

Threshold Level for Allergenic Foods by Statistical Analysis of Published Data in

the Literature?" Allergy, 57:741-746, 2002.

96. Taylor, S. L., J. A. Nordlee, L. M. Niemann, and D. M. Lambrecht, "Allergen

Immunoassays - Considerations for Use of Naturally Incurred Standards,"

Analytical and Bioanalytical Chemistry, 395:83-92, 2009.

97. Taylor, S. L., D. A. Moneret-Vautrin, R. W. R. Crevel, D. Sheffield, M. Morisset,

P. Dumont, B. C. Remington, and J. L. Baumert, "Threshold Dose for Peanut:

Risk Characterization Based upon Diagnostic Oral Challenge of a Series of 286

Peanut-Allergic Individuals," Food and Chemical Toxicology, 48:814-819, 2010.


14

98. Ross, M. P., M. Ferguson, D. Street, K. Klontz, T. Schroeder, and S. Luccioli,

"Analysis of Food-Allergic and Anaphylactic Events in the National Electronic

Injury Surveillance System," Journal of Allergy and Clinical Immunology,

121:166-171, 2008.

99. Simon, M. R. and Z. D. Mulla, "A Population-Based Epidemiologic Analysis of

Deaths from Anaphylaxis in Florida," Allergy, 63:1077-1083, 2008.

100. Yocum, M. W., J. H. Butterfield, J. S. Klein, G. W. Volcheck, D. R. Schroeder,

and M. D. Silverstein, "Epidemiology of Anaphylaxis in Olmsted County: A

Population-Based Study," Journal of Allergy and Clinical Immunology, 104:452-

456, 1999.

101. Branum, A. M. and S. L. Lukacs, "Food Allergy Among U.S. Children: Trends in

Prevalence and Hospitalizations," NCHS Date Brief, 10, 2008.

102. Jackson, W. F., Food Allergy, Belgium, ILSI Press, 2003.

103. FDA, "Nationwide Milk Allergen Recall of Kroger 'Meals Made Simple Shrimp

Linguini'," (http://www.fda.gov/Safety/Recalls/ucm222663.htm), August 14,

2010. Accessed and printed on October 17, 2011.

104. FDA, "Brand Castle, LLC Issues Allergy Alert on Undeclared Egg in Icing of

Licensed Rice Krispies Treats Holiday Village Kit Distributed Through Michaels

Retail Stores Only," (http://www.fda.gov/Safety/Recalls/ucm238089.htm),

December 23, 2010. Accessed and printed on October 17, 2011.

105. FDA, "The Pictsweet Company Announces a Voluntary Recall of Frozen Green

Peas Due to Possible Health Risk,"


15

(http://www.fda.gov/Safety/Recalls/ucm229838.htm), October 15, 2010.

Accessed and printed on October 17, 2011.

106. FDA, "Flowers Foods Issues Voluntary Recall on Certain English Muffins and

One Bread Item," (http://www.fda.gov/Safety/Recalls/ucm254434.htm), May 3,

2011. Accessed and printed on October 17, 2011.

107. Ayotte, J. D., S. M. Flanagan, and W. S. Morrow, "Occurrence of Uranium and


222
Radon in Glacial and Bedrock Aquifers in the Northern United States, 1993-

2003. U.S. Geological Survey Scientific Investigations Report 2007-5037,"

(http://pubs.usgs.gov/sir/2007/5037/), October 17, 2007. Accessed and printed on

November 14, 2011.

108. Focazio, M. J., Z. Szabo, T. F. Kraemer, A. H. Mullin, T. H. Barringer, and V. T.

dePaul, "Occurrence of Selected Radionuclides in Ground Water Used for

Drinking Water in the United States: A Targeted Reconnaissance Survey, 1998.

U.S. Geological Survey Water-Resources Investigations Report 00-4273,"

(http://pubs.usgs.gov/wri/wri004273/pdf/wri004273.pdf), 2001. Accessed and

printed on October 14, 2011.

109. World Health Organization, "FAQs: Japan Nuclear Concerns,"

(http://www.who.int/hac/crises/jpn/faqs/en/index.html), September 20, 2011.

Accessed and printed on October 17, 2011.

110. Codex Alimentarius Commission, "Principles for the Establishment and

Application of Microbiological Criteria for Foods, CAC/GL 21 - 1997," 1997.

111. International Commission on Microbiological Specifications for Foods,

"Microbiological Hazards and Their Control," In: Microorganisms in Foods 7.


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Microbiological Testing in Food Safety Management, edited by R. B. Tompkin,

L. Gram, T. A. Roberts, R. L. Buchanan, M. van Schothorst, S. Dahms, and M. B.

Cole, New York, Chapter 1, pp. 1-21, Kluwer Academic / Plenum Publishers,

2002.

112. International Commission on Microbiological Specifications for Foods,

"Selection and Use of Acceptance Criteria," In: Microorganisms in Foods 7.

Microbiological Testing in Food Safety Management, edited by R. B. Tompkin,

L. Gram, T. A. Roberts, R. L. Buchanan, M. van Schothorst, S. Dahms, and M. B.

Cole, New York, Chapter 4, pp. 79-97, Kluwer Academic / Plenum Publishers,

2002.

113. FDA, "Transcript: Public Meeting on the Food Safety Modernization Act: Focus

on Preventive Controls for Facilities,"

(http://www.fda.gov/downloads/Food/FoodSafety/FSMA/UCM253612.pdf),

April 20, 2011. Accessed and printed on October 14, 2011.

114. FDA, "Webcast Videos: Public Meeting on the Food Safety Modernization Act:

Focus on Preventive Controls for Facilities,"

(http://www.fda.gov/Food/FoodSafety/FSMA/ucm250377.htm#webcast), April

20, 2011. Accessed and printed on October 14, 2011.

115. FDA, "Draft Qualitative Risk Assessment. Risk of Activity/Food Combinations

for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located

on a Farm," 2012.

116. FDA, "Guidance for Industry: Questions and Answers Regarding Registration of

Food Facilities (Edition 4); Final Guidance," 2004.


17

117. FDA, "Guidance for Industry: Questions and Answers Regarding Establishment

and Maintenance of Records By Persons Who Manufacture, Process, Pack,

Transport, Distribute, Receive, Hold, or Import Food (Edition 5)," 2012.

118. FDA, "Guidance for Industry: Antimicrobial Food Additives," 1999.

119. Codex Alimentarius Commission, "Codex Alimentarius Commission Procedural

Manual, Twentieth Edition," 2011.

120. FDA, "FDA Allergy Warning Letter. Notice to Manufacturers Label Declaration

of Allergenic Substances in Foods," 1996.

121. Deibel, K., T. Trautman, T. DeBoom, W. H. Sveum, G. Dunaif, V. N. Scott, and

D. T. Bernard, "A Comprehensive Approach to Reducing the Risk of Allergens in

Foods," Journal of Food Protection, 60:436-441, 1997.

122. Taylor, S. L. and J. L. Baumert, "Cross-Contamination of Foods and Implications

for Food Allergic Patients," Current Allergy and Asthma Reports, 10:265-270,

2010.

123. Food Allergy Research and Resource Program, "Components of an Effective

Allergen Control Plan. A Framework for Food Processors,"

(http://farrp.unl.edu/c/document_library/get_file?p_l_id=4070800&folderId=2103

644&name=DLFE-22219.pdf), 2011. Accessed and printed on October 17, 2011.

124. Jackson, L. S., F. M. Al-Taher, M. Moorman, J. W. DeVries, R. Tippett, K. M. J.

Swanson, F. Tong-Jen, R. Salter, G. Dunaif, S. Estes, S. Albillos, and S. M.

Gendel, "Cleaning and Other Control and Validation Strategies to Prevent

Allergen Cross-Contact in Food-Processing Operations," Journal of Food

Protection, 71:445-458, 2008.


18

125. Troller, J. A., "Sanitizing," In: Sanitation in Food Processing, edited by S. Taylor,

2nd edition,San Diego, Chapter 5, pp. 52-70, Academic Press, Inc., 1993.

126. FDA, "Draft Guidance for Industry: Control of Listeria monocytogenes in

Refrigerated or Frozen Ready-to-Eat Foods," 2008.

127. Codex Alimentarius Commission, "Guideline for the Validation of Food Safety

Control Measures, CAC/GL 69-2008," 2008.

128. Anderson, J. E., R. R. Beelman, and S. Doores, "Persistence of Serological and

Biological Activities of Staphylococcal Enterotoxin A in Canned Mushrooms,"

Journal of Food Protection, 59:1292-1299, 1996.

129. Bennett, M. R. and R. W. Berry, "Serological Reactivity and in Vivo Toxicity of

Staphylococcus aureus Enterotoxins A and D in Selected Canned Foods," Journal

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130. FDA, "Guidance for Industry: Questions and Answers Regarding Adverse Event

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