The food additives regulations provide for the addition of sodium nitrite in smoked, cured, tuna, sable, salmon and shad (21 CFR 172.175).
REGULATORY ACTION GUIDANCE:
The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605).
- For Tuna:
The sodium nitrite concentration in the edible portions, determined by analysis of a composite sample consisting of equal portions from a minimum of ten subs, exceeds 15 ppm.
- For Salmon, Sable, Shad:
The sodium nitrite concentration in the edible portions, determined by analysis of a composite sample consisting of equal portions from a minimum of ten subs, exceeding 220 ppm.
NOTE: Referral to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) is authorized where both the original and check analysis exceed the legal tolerance but do not meet or exceed the compliance policy guide, provided sampling and analytical techniques are adequate to prove conclusively that the legal tolerance has been exceeded. In such case all analytical data including work sheets should be submitted along with the recommendation for action.
*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.