REGULATORY ACTION GUIDANCE (IMPORTS ONLY):
- Oysters and clams
Detain if the average of the subs examined or three or more of five subs examined equal or exceed:
- E. coli contents (IMVIC confirmed ++ --, or - + --) 230 per 100 grams:
- Aerobic plate count at 35oC. of 500,000 per gram.
If E. coli are present in lesser numbers and coliforms exceed 2,400 per 100 grams in three out of five subs examined, submit findings to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) for consideration.
Conduct usual examination and request advice from HFS-605.
*Material between asterisks is new or revised.*
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.