Some establishments under federal inspection may be experiencing supply chain shortages of synthetic sodium nitrite used to cure meat and poultry products. As a result, establishments and other stakeholders have expressed interest in substituting a portion of synthetic sodium nitrite with sodium nitrite derived from natural sources. Establishments interested in using the substitution may submit for temporary label approval under 9 CFR 412.1(f). FSIS will evaluate requests for this substitution on a case-by-case basis under its prior label approval system. Long-term use of natural sources of nitrite as curing agents will be addressed through future rulemaking efforts. 

Under the temporary allowance, for example, a portion of synthetic sodium nitrite and sodium erythorbate used to cure a ham product could be substituted with sodium nitrite from a plant-based source (e.g., cultured celery powder). The establishment would substitute synthetic sodium nitrite with the same amount of sodium nitrite from a natural source (e.g., 100 ppm synthetic sodium nitrite, 100 ppm sodium nitrite from cultured celery powder, and 547 ppm sodium erythorbate). The establishment would also be required to maintain records that document the amount and concentration of synthetic nitrite added along with the amount and concentration added from the natural source under 9 CFR 320.1(b)(10) and 381.175(b)(6).

An establishment may submit a “blanket” request for temporary approval if multiple product lines are affected. This type of request covers multiple products instead of having to fill out an application for each product individually. A blanket request for temporary approval should include a completed label application (Form 7234-1), the product formula and processing procedures, and a label for one of the products affected along with a list of other products affected.

Questions may be directed to the FSIS labeling and program delivery staff through askFSIS or by phone at 301-504-0878. More information on labeling and label approval is available on the FSIS website.