The following represents criteria for 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*:
The wheat contains an average of 10 or more pink kernels per 500 grams, and the mercury residue on the pink kernels exceeds one part per million.
Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 342(a)(2)(B), in that it is a raw agricultural commodity and contains a pesticide chemical, namely, a mercurial compound, which is unsafe within meaning of 21 U.S.C. 346a(a), since no tolerance and no exemption from the requirement of a tolerance for such pesticide chemical on wheat has been prescribed by regulations promulgated pursuant to 21 U.S.C. 346a(b).
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)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.