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*Corresponding Author: Irving J. Pflug, Department of Food Science and Nutrition ,University of Minnesota, USA.
Citation: Irving J. Pflug, 2018. Controlling Clostridium botulinum in Heat-Preserved Food. J Nutrition and Food processing, 1(1); DOI: 10.31579/2637-8914/003
Copyright: © 2018 Irving J. Pflug. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Received: 03 February 2018 | Accepted: 20 February 2018 | Published: 26 February 2018
Keywords: clostridium botulinum hazard; food-poisoning; process delivery failure; heat preserved food
The purpose of this report is to explain, in easy to understand outline form, the basic principles of controlling Clostridium botulinum in heat-preserved food.
There are three major parts to the story:
(1) Truths regarding the Clostridium botulinum problem,
(2) Controlling the Clostridium botulinum hazard; and
(3) Estimating the probability of process failure.
The later includes errors that may occur in the process design area and errors that may occur in the process delivery area.
In the report, "Science, Practice and Human Errors in Controlling Clostridium botulinum in Heat-Preserved Food in Hermetic Containers," by Pflug, Irving J., Journal of Food Protection, 73(5):993-1002 (2010), the important story of Clostridium botulinum has been told in detail, but the important results have been hidden by the author's syntax. In this manuscript, "Controlling Clostridium botulinum in Heat-Preserved Food," we hope to make available the details of Clostridium botulinum control.
The purpose of this report is to explain, in easy to understand, outline form, the basic principles of controlling Clostridium botulinum in heat-preserved food.
Quite simply, there are three major aspects to Clostridium botulinum control:
(1) Facts regarding the Clostridium botulinum organism and its spores;
(2) How to control the Clostridium botulinum hazard; and
(3) Estimating the probability of process failure.
Truths Regarding the Clostridium botulinum Problem
Clostridium botulinum spores are not our problem; we are the problem in not being willing to accept and solve our human errors.
a. Errors in delivering the thermal process are the overwhelming cause of botulism food-poisoning incidents. This fact was recognized by those who prepared the 1971, FDA Commercial Food Processing Regulations; the regulations included procedures for finding and correcting commercial processing errors when they occur. We need to recognize and accept that human errors are always occurring and that they regularly occur in the processing of low-acid canned foods.
b. Acceptance of the idea that microbial survival is a function of the number of microorganisms present and the resistance of the specific culture. The factors involved are best described by the equation,
F121.1° C = D121.1 C (log N0 - log NF).
c. Acceptance of the probability nature of microbial survival that was stimulated by the NASA Viking Project.
d. The ability of any bacterial-spore species to survive a heat process is not a constant
value but is variable; it is determined by the species and how the spores were grown, how tested, and the post-heating environment. Bacterial spores do not have constant DT-values!
e. In preserving low-acid canned foods (LACFs), we have three microbial groups, regarding heat resistance: C. botulinum (D121.1°C-value of less than 0.2 min); resistant, mesophilic, spore-forming microorganisms (D121.1°C-value of the order of 1 min); and thermophilic, spore-forming microorganisms (D121.1°C-value of 3 to 6 min).
2.Controlling the Clostridium botulinum Hazard
a. The delivery of the thermal process to cans of food is the weak link in the chain of operations in preventing botulism. Human operators who fail to use the posted or a correct thermal process or are careless in the delivery of the thermal process are the primary cause of botulism problems. Botulism incidents such as the Bon Vivant or Castleberry Foods not only cause human suffering but have a very high economic cost. A lack of quality control in the retort room caused both of these companies to suffer great financial loss.
b. When a food manufacturer follows the Good Manufacturing Practices (GMP) food regulations, the probability of a failure in the design and validation of the thermal process is so small as to be negligible compared to the probability of delivery failure. The probability of a process delivery failure is also small when the operator follows the FDA regulations regarding the use of accurate instrumentation and the conscientious gathering and reviewing of processing records.
c.Controlling C. botulinum in both commercially and home-processed food is a management and quality-control problem: In commercial processing, the FDA mandates there must be a series of measurements and quality control (QC) checks to develop confidence that the probability of the designed process not being delivered to the retort load of product is of the order of one in one million (1.0 x 10-6). In restaurant and home processing, we have to rely on the operator to carry out the processing specifications correctly. It is suggested that a data record for the process be kept to reduce the probability of an error.
d.The studies of Esty and Meyer (1922) regarding the resistance of laboratory- grown C. botulinum spores, tested using conditions designed to determine maximum survival times, are the basic data of the maximum FT - and DT-values available today. The probability of any laboratory-grown C. botulinum spores surviving an F0-value of 2.45 minutes is extremely small. It is realistic to use this value as the starting point in designing commercial.
LACF processes because
(1) It offers a large factor of safety and
(2) It has almost no effect on the design F0 which must also take care of the resistant mesophiles that are usually at least five times as resistant as C. botulinum spores.
(5) Circumstantial evidence indicates that Appert's (1810) water-bath process or the home-canning water-bath processes of 180 or 210 minutes, in use from 1900 to 1930, were able to control C. botulinum spores. Consequently, a thermal-process F0 of the order of 1.0 minute must be able to control C. botulinum spores on products with natural contamination.
(6) Significant spoilage by mesophilic spores in product that supports their growth is a sign of an inadequate process and should warrant immediate process analysis.
(7) Cans of food that contain botulinum toxin will have received a small F0-value.
3.Estimating the Probability of Process Failure
How do we arrive at an overall probability of a low-acid canned food (LACF) botulism incident when we have a situation where there are several vastly-different probability levels among processing conditions?
A first step toward making a statistical analysis is to define the experimental unit. We are going to use a different experimental unit in the process-design area than in the process delivery area. For process design, we will use the individual container; however, in the process-delivery area, we will make our probability judgments on the basis of the processing unit. What is the processing unit? A processing unit is one or more containers that have the same general microbial load and receive the same thermal process. Each processing unit is a separate consideration and has an independent probability from all other processes. It is the batch, lot, retort (autoclave) load, or the single product, single-day production, of the restaurant or home canner. When there is a problem, it is a specific retort (autoclave) load problem, or in the restaurant or home-preservation area, it is the batch of a specific product production.
Process design probability judgments should be made on the basis of the total number of individual containers to which the process design is applicable.
3.1 Errors that May Occur in the Process Design Area
The calculated process is incorrect for processing conditions.
1.Error in the heat-penetration data: wrong product, product ingredient change, change in viscosity, change in particle conditions.
2.Wrong process parameters used in the process calculation: i.e., z-value, temperatures both initial and cooling.
3.Error in the calculated scheduled process is estimated to be of the order of one error in 106 processes designed.
4.Inadequate process validation (no validation carried out).
5.Failure to validate or inadequate validation is estimated to be of the order of one non-validated process in 104 processes designed.
3.2 Errors that May Occur in the Process Delivery Area
1.Process Failure: manufacturing errors that affect delivery of the scheduled process.
2.Product: change in formulation; fh different from value used in calculation; change in viscosity of the product; change in particle size.
3.Equipment: change in headspace or fill weight.
4.The probability of a manufacturing error is estimated to be of the order of one delivery error in 40 to 100 batches.
5.People failures: operator failure; operator failed to follow written procedures - wrong temperature, time, or both; errors in review of records.
6.Record failure: errors in critical values in processing records; for example, retort temperature, process time, pressure, process records, etc.
7.Review failure: Failure to review records by the production supervisor, the quality-control department plus another member of management.
8.Failure to act: Failure of QC department to take corrective action on an adverse processing-record report.
9.The probability of an undetected delivery error is estimated to be of the order of one in 1.0 x 106 (after 3 reviews).
The equation for this calculation is: P = P(1) x P(2) x P(3) = P(0.01) x P(0.01) x P(0.01) = 1.0 x 10-6
1.There are several straight forward ways we can control the Clostridium botulinum hazard in heat-preserved food.
2.The primary causes of botulism food-poisoning incidents result from human errors.
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