Science & Research

Volume IV - 2.17 Document Change History

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Orientation and Training
Food and Drug Administration

DOCUMENT NO.:
IV-02

VERSION NO.:1.7

Section 2 - Microbiology

EFFECTIVE DATE:
10-01-03

REVISED:
08-25-14

Version
No.
Status
(I, R, C)
Date
Approved
Location of Change History Name & Title
Author Approving Official

1.2

R

09/01/05

Table of Contents – deleted 2.13.3; added 2.15
Added Section 2.1 D and 2.3 D.; revised 2.4 B.; revised 2.13, 2.13.1 C., and 2.13.2 C.

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1.3

R

01/23/08

Section 2.6 Viruses added
Section 2.7 Select Agents added
Section 2.17 Document/Change History added
Sections 2.6 – 2.14 renumbered to 2.8 to 2.16

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1.4

R 01/23/08

2.1 A. - added sentence to end of paragraph
2.1 B. - revised first paragraph
2.1 D.2. - changed third bullet to serial dilutions
2.2 B.1. - removed "use" from end of sentence
2.2 D. - 1. updated; 2. and 3. updated weblink; added 7.
2.3 B.4. - updated reference
2.3 C. - revised 2., 8., 9., 10., 11., 14., and 16.
2.4 B.1 - updated hyperlink
2.5.1 C. - revised 2., 8., and 13
2.5.2 B - revised third sentence in second paragraph
2.4.2 C. 6. - removed "medium"
2.5.3 B.1 - revised second sentence
2.5.3.1. C. 3. - changed media to medium
2.5.4 C. 3. and 4. - changed agar to medium
2.5.5. B.2 - removed reference
2.5.6 C.5 - revised question
2.5.7 C - 2. analyses changed to analysis; 5. revised question
2.5.12 B. - defined TSC in last paragraph; removed BAM method reference
2.5.13 B. - second paragraph deleted
2.6 A.2. - deleted first sentence
2.7 - revised third line
2.7 A.2. - added "USDA"
2.7 B. - second and fourth link deleted; third link updated
2.11 A.2. - changed to Acidified and Low Acid Canned Food
2.11 B - revised and updated links
2.11 C.7. - changed to acidified and low acid canned food
2.13 B.4. - added <71>
2.13 C. 1 - revised second question
2.14 A.1. and 2. - revised
2.14 B - added <61>
2.15 - updated IOM reference; updated CFR references; added 21 CFR 111
2.15 C.3. - added "Firm"
2.16 Answer Key - revised questions 2.3 1., 2.3 8., 2.3 10., 2.3 11., 2.3 14., 2.3 16., 2.5.1 2., 2.5.1 13, 2.5.2 6, 2.5.3.1 3., 2.5.4 3., 2.5.4 4., 2.5.6 5., 2.5.7 2., 2.5.9 1., 2.8 1., 2.8 2., 2.9 4., 2.11 7., 2.13.1

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1.5

R

02/14/13

Header – Division of Field Science changed to Office of Regulatory Affairs

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1.6

R

05/02/14

2.4. A. – added “or electronic”
2.13. A. 6. – revised
2.16 Answer Key – revised questions 1.4.4 and 2.13.3

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1.7

R

08-25-14

2.5.1 – Question 5 –deleted; Question 6 – “species” changed to “serovars” & added “typically”; Question 8 – “groups” changed to “serovars” 2.16 Appendix – Answer Key – revised questions 2.5.4, 2.5.6, & 2.5.8; deleted question 2.5.5.

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