REGULATORY ACTION GUIDANCE:
- Insect Infested Wheat
Reconditioning will be considered adequate when macroscopic examination of representative samples reveals an average of no more than 0.4% insect damaged kernels.
- Rodent Excreta Pellet Contaminated Wheat
Reconditioning will be considered adequate when all the following conditions are met:
- Not more than one pellet is found upon examination of 20 representative pints.
- The wheat has been scoured to the extent that examination of representative samples reveals that 50% or more of the kernels show removal of the surface seed coat layers down to the cross cell layer (removal of approximately 20% of the kernel) and practically all the beard is gone.
- Examination of representative samples shows no Salmonella organisms to be present; evidence proves the wheat has been heat treated in such a manner as to insure killing any Salmonella organisms present.
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.