The defect action levels established in this guide for macaroni and noodle products are based on an extrapolation of the defect action levels for soft wheat flour. These action levels are necessary as soft wheat flour is permitted to be incorporated into macaroni products, although most macaroni products are manufactured from durum flour and semolina which are excluded from the action levels established for wheat flour (See Sec. 578.450 for CPG 7104.06). A survey of macaroni and noodle products collected from the retail market provided data on the level of unavoidable insect and rodent filth in macaroni products and revealed that the majority of the samples contained filth levels significantly below the levels established in the guide.
REGULATORY ACTION GUIDANCE:
The following represents criteria for recommending direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*:
1. Insect Fragments: Actionable if the average insect fragments in six or more subsamples is greater than or equal to 225 per 225 grams
2. Rodent Hairs: Actionable if the average rodent hairs in six or more subsamples is greater than or equal to 4.5 per 225 grams.
*NOTE: Analyze by the method specified in AOAC XV Ed., 969.41.*
Article 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 filthy substance by reason of presence therein of insect fragments and rodent hairs.
NOTE: Only use direct citation authority when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 1/4/82 Revised: 8/96
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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