[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.177]

[Page 38-39]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
 
                      Subpart B_Food Preservatives
 
Sec.  172.177  Sodium nitrite used in processing smoked chub.

    The food additive sodium nitrite may be safely used in combination 
with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation 
from Clostridium botulinum type E in the commercial processing of smoked 
chub in accordance with the following prescribed conditions:
    (a) All fish in smoking establishments shall be clean and wholesome 
and shall be expeditiously processed, packed, and stored under adequate 
sanitary conditions in accordance with good manufacturing practice.
    (b) The brining procedure is controlled in such a manner that the 
water phase portion of the edible portion of the finished smoked product 
has a salt (NaCl) content of not less than 3.5 percent, as measured in 
the loin muscle, and the sodium nitrite content of the edible portion of 
the finished smoked product is not less than 100 parts per million and 
not greater than 200 parts per million, as measured in the loin muscle.
    (c) Smoked chub shall be heated by a controlled heat process which 
provides a monitoring system positioned in as many strategic locations 
in the smokehouse as necessary to assure a continuous temperature 
throughout each fish of at least 160 [deg]F for a minimum of 30 minutes.
    (d) The finished product shall be cooled to a temperature of 50 
[deg]F or below within 3 hours after smoking and further cooled to a 
temperature of 38 [deg]F or below within 12 hours after smoking. A 
temperature of 38 [deg]F or below shall be maintained during all 
subsequent

[[Page 39]]

storage and distribution. All shipping containers, retail packages, and 
shipping records shall indicate with appropriate notice the perishable 
nature of the product and specify that the product shall be held under 
refrigeration (38 [deg]F or below) until consumed.
    (e) To assure safe use of the additive:
    (1) The label and labeling of the additive container shall bear, in 
addition to the other information required by the Act, the name of the 
additive.
    (2) The label or labeling of the additive container shall bear 
adequate directions to assure use in compliance with the provisions of 
this section.