REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

The dried black-eyed peas contain an average of 10% or more by count of class 6 damage or higher, minimum of 12 subsamples examined.

NOTE: See FDA Technical Bulletin No. 5 - Macroanalytical Procedures Manual, V-116 for classification of black-eyed peas damaged by lygus bug.

REMARKS:

If there is reason to believe the lot was graded and certified by the U.S. Department of Agriculture, submit the following information via EMS or FAX to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding:

Sample Number Date of Shipment

Article Involved Dealer

Amount of Lot Shipper

Codes Analytical Conclusions

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 said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insect damaged peas.

NOTES:

1. If the evidence establishes that the article became adulterated after receipt in interstate commerce, then charge only that the article "is adulterated while held for sale after shipment in interstate commerce."

2. If the evidence does not establish where the article became adulterated and the violation is such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then also charge only that the article "is adulterated while held for sale after shipment in interstate commerce."

*Material between asterisks is new or revised.*

Issued: 11/7/79

Reissued: 10/1/80

Revised: 12/8/88, 3/95