To: Food and Drug Administration, LACF Registration Coordinator

From: Dr. Barbara Ingham, Associate Professor Food Science, University of Wisconsin-Madison

Re: Least Sterilizing Value of the Scheduled Process for Acidified Canned Foods

May 2009

The United States Food and Drug Administration requires processors to include a Least Sterilizing Value
of the Scheduled Process on all Form 2541a documents that are filed with the agency. In an effort to
assist Wisconsin small businesses as they complete this form, the following documentation has been
developed.

According to the classic work of Stumbo (1973) Thermobacteriology in Food Processing the most
important organisms in pasteurized foods are the pathogenic bacteria: Mycobacterium tuberculosis,
Brucella spp., Coxiella burnetti, Salmonella spp., Staphylococcus aureus, Streptococcus pyogenes, and
Clostridium botulinum, and assorted spoilage microorganisms. Current evidence would add Escherichia
coli O157:H7 to this list. Acidified foods such as pickles and salsa receive a pasteurization process if they
undergo a thermal treatment.

Data has been published listing the D150 and z values for these important organisms. According to this
data, the ‘worst case’ scenario lists a D150 of 3.0 min and a z value of 16. If we assume a required 7-log
reduction of the pathogen or spoilage organism of interest, and a ‘worst case’ scenario, the following
table can be constructed (data obtained by graphing known values and interpolation):

Reference Temperature (°F) Target F-value to achieve a 7-log reduction (min)

150°F 21.0 min
155°F 8.9 min
160°F 5.0 min
165°F 2.4 min
170°F 1.1 min
175°F 0.57 min
180°F 0.3 min

Processors who bring a product to 150°F and hold for 21 min will achieve the necessary destruction;
similarly holding at 180°F for 0.3 min will also reach the target F-value. Such time/temperature
combinations may be achieved as part of the hot-fill and hold process, or through a boiling water
canning process with the heating temperature of 212°F. This ‘worst case’ scenario does not account for
the low pH of acidified foods which would reduce the time necessary to achieve the 7-log reduction and,
thus, provides for an extra margin of safety.