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 °F for a minimum of 30 minutes.

(d) The finished product shall be cooled to a temperature of 50 °F or below within 3 hours after smoking and further cooled to a temperature of 38 °F or below within 12 hours after smoking. A temperature of 38 °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 °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.