REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure recommendations 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*:
Parasite findings meet or exceed the following tolerances:
1. Tullibees, Ciscoes, Inconnus, Chubs and White Fish 50 cysts per 100 pounds (whole fish or fillets), provided that 20% of the fish examined are infested.
2. Blue Fin and Other Fresh Water Herring a. Fish averaging one pound or less: 60 cysts per 100 fish, provided that 20% of the fish examined are infested.
b. Fish averaging over one pound: 60 cysts per 100 pounds of fish, provided that 20% of the fish examined are infested.
3. Rose Fish (Red Fish and Ocean Perch): 3 percent of the fillets examined contain one or more copepods accompanied by pus pockets.
If there is reason to believe that a lot was packed under the supervision of or certified by the National Marine Fisheries Service National Oceanic and Atmospheric Administration, US Department of Commerce, *e-mail* or FAX the following information to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:
Amount of Lot
Date of Shipment
The article was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce within 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 parasitic cysts.
*Material between asterisks is new or revised.*
Issued: 10/1/80 Revised: 10/30/89, 3/95, 5/2005 Updated: 11/29/2005
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.