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Sec. 540.375 Canned Salmon - Adulteration Involving Decomposition (CPG 7108.10)

REGULATORY ACTION GUIDANCE:

*The following represents criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct issuance of a section 305 notice by District Offices:

Examination of the sample by two qualified organoleptic analysts (see Remarks) in accordance with the sample examination plans specified in TABLES 1 and 2 shows either:

1. A number of defective cans that equals or exceeds the number required for action (see TABLES 1 and 2),

or

2. Two or more Class III cans in either the first portion examined or in the total sample.

NOTE: One Class III can in the first portion examined of any lot size is a basis for further examination. The term "defective cans" as used in the criteria above and in TABLES 1 and 2 includes both Class II cans and Class III cans.*

SPECIMEN CHARGE:

*The article was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce, within the meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a decomposed substance by reason of the presence therein of decomposed salmon.

NOTE: If the evidence establishes that the article became adulterated after receipt in interstate commerce, or if the evidence does not establish when the article became adulterated and the violation is such that it could have occurred anywhere, then charge only that the article "is adulterated while held for sale after shipment in interstate commerce."*

*REMARKS:

Contact the Division of Field Science (HFC-140) for information concerning ORA analysts qualified in organoleptic analysis for decomposition.*

*TABLE 1. Sample Examination Plan and Legal Action Criteria for 1/4 Pound Through 1 Pound Cans


Number of
Number of Defective Defective
Cans in 1st Portion Cans in
Total
First Required Second Total Sample
Portion for Required Portion Sample Required
Code/Lot Size Legal for Further2 Size Size for Legal
Size (Cases)1 (Cans) Action Examination (Cans) (Cans) Action

< than 100 18 3 1 or 2 32 50 5
100 - 199 20 3 1 or 2 48 68 9
200 - 499 24 4 2 or 3 64 88 11
500 - 799 30 4 2 or 2 80 110 17
800 - 999 36 5 2 - 4 96 132 23
1000-1499 42 6 2 - 5 112 154 26
1500 or > 48 6 2 - 5 128 176 30

1 For uncased lots, code or lot sizes are based on the equivalent of 48 cans per case.

2 Sample is actionable under guide criteria when examination shows two or more Class III cans. Consequently, further examination of the sample is not required when two or more Class III cans are found in the first portion examined.*

*TABLE 2. Sample Examination Plan and Legal Action Criteria for Cans Over 1 Pound Through 4-Pounds

Number of
Number of Defective Defective
Cans in 1st Portion Cans in
Total
First Required Second Total Sample
Portion for Required Portion Sample Required
Code/Lot Size Legal for Further2 Size Size for Legal
Size (Cases)1 (Cans) Action Examination (Cans) (Cans) Action
< than 100 6 2 1 12 18 2
100 - 199 7 2 1 16 23 2
200 - 499 8 2 1 22 30 2
500 - 799 10 2 1 27 37 3
800 - 999 11 3 1 or 2 30 41 4
1000-1499 12 3 1 or 2 32 44 6
1500 or > 16 3 1 or 2 38 54 6


1 For uncased lots, code or lot sizes are based on the equivalent of 12 cans per case.

2 Sample is actionable under guide criteria when examination shows two or more Class III cans. Consequently, further examination of the sample is not required when two or more Class III cans are found in the first portion examined.*

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 10/30/89