REGULATORY ACTION GUIDANCE:
The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
The composite analyzed in accordance with the applicable methods outlined in the current edition of the Official Methods of Analysis of the Association of Official Analytical Chemists and supplements (at the time of this transmittal Fourteenth Edition, Section 25.146-152) shows:
Methyl mercury expressed as mercury in excess of 1 ppm (edible portion only).
NOTE: Recommendations for legal action must clearly indicate the exact portion of the food used for analysis. The portion used for analysis must be prepared by the appropriate procedure outlined in Volume I of the Pesticide Analytical Manual, Sections 141.12 and 141.22.
*Material between asterisks is new or revised.*
Revised: 3/95, 5/2005
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.