[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
CONSUMPTION--Table of Contents
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 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
(2) The label or labeling of the additive container shall bear
adequate directions to assure use in compliance with the provisions of
Additives that reference this regulation: