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monocytogenes

Among Selected Categories of Ready-to-Eat Foods. Available in Docket No.

1

1999N-1168, Vols. 23 through 28, and at

Quantitative Assessment of Relative Risk to Public

2

Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat

3

Foods,

4

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/F

5

oodProcessingHACCP/ucm073110.htm

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6.

Doyle ME, Mazzotta AS, Wang T, Wiseman DW, and Scott VN. 2001. Heat resistance of

7

Listeria monocytogenes

.

Journal of Food Protection

64 (3): 410-429.

8

7.

ISO 18593. Microbiology of food and animal feeding stuffs – Horizontal methods for

9

sampling techniques from surfaces using contact plates and swabs.

10

11

8.

AOAC Research Institute

Performance Tested Methods

SM

Program

validation outline

12

protocol:

Comparative Evaluation of the 3M

Molecular Detection Assay Listeria

13

monocytogenes 2 and of the 3M

Molecular Detection Assay Listeria

2 (February 2015)

14

15

9.

ISO 16140:2003. Microbiology of food and animal feeding stuffs – Protocol for the

16

validation of alternative methods.

17

18

10. U. S. Food and Drug Administration

Bacteriological Analytical Manual

, Chapter 3

Aerobic

19

Plate Count (

January 2001) (Accessed January 2015)

20

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm063346.m

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22

11. Least Cost Formulations, Ltd., MPN Calculator Version 1.6

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www.lcfltd.com/customer/LCFMPNCalculator.exe

(Accessed January 2015)

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12. AOAC International,

Evaluation of the

VITEK 2

Gram Positive (GP) Microbial

26

Identification Test Card: Collaborative Study

, Journal of AOAC International, 95, 1425

27

(2012)

28

29

13. Wehling, P., LaBudde, R., Brunelle, S., Nelson, M.

Probability of Detection (POD) as a

30

Statistical Model for the Validation of Qualitative Methods.

Journal of AOAC

31

International, Vol. 94, No. 1, 2011.

32

33

14. Least Cost Formulations, Ltd., AOAC Binary Data Interlaboratory Study Workbook Version

34

2.2 (2011)

-http://lcfltd.com/aoac/aoac-binary-v2-2.xls(

Accessed January 2015)

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36

15. Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th Ed., Appendix J:

37

AOAC INTERNATIONAL Methods Committee Guidelines for Validation of

38

Microbiological Methods for Food and Environmental Surfaces, AOAC INTERNATIONAL,

39

Gaithersburg, MD,

40

http://www.aoac.org/imis15_prod/AOAC_Docs/StandardsDevelopment/eoma_appendix_j.pdf

(Accessed

41

January 2015)

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