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FDA Regulations on Fermented Foods (Hint: None)

fermentation, fermented foods, beneficial bacteria, healthy, gut health, microbiomeFermented Food Rules

The FDA does NOT regulate fermented foods. Why?  They have not found ANY cases of food illnesses because “From the food safety point of view, the benefits of fermentation include the inhibition of the growth of most pathogenic bacteria and the formation of bacterial toxins” (World Health Organization report).

Many people are unsure about what makes fermentation different from home canning and pickled foods. In general, preserving food is all about the pH, or acid level, in the food because the acid content prevents the growth of botulism, a deadly bacteria.  The process of fermentation produces acid-loving bacteria, which in turn lowers the overall acid content to a pH below 4.6.

Fermentation is all about the relationship of food nutrients and live bacteria as a means of food preservation.  In contrast, other food preservation methods like hot water bath canning, pressure canning, and pickling are only means to preserving food by removing the ability for bad bacteria to grow.

“…control[ing] botulinum bacteria depends on the acidity of the food. Acidity may be natural, as in most fruits, or added, as in pickled food. Low-acid canned foods are not acidic enough to prevent the growth of these bacteria. Acid foods contain enough acid to block their growth, or destroy them more rapidly when heated. The term “pH” is a measure of acidity; the lower its value, the more acid the food. The acidity level in foods can be increased by adding lemon juice, citric acid, or vinegar.” (USDA)

Differences Between Methods

  • Home canning, hot water bath: uses high temperature water heat to kill bacteria. Need to regulate the time spent in the hot water. Recommended only for “high acid foods.”

Boiling water bath canning involves packing jars with food, completely covering the jars with water, heating the water to boiling (212 degrees Fahrenheit (F), 100 degrees Celsius (C)), and processing for 5 to 85 minutes, depending on the food product, style of pack, and jar size. Boiling removes the oxygen remaining in the jar, which helps to form a tight seal between the lid and the rim. The heat used for this method of canning is sufficient to kill vegetative bacterial cells found in the food.”

  • Home canning, pressure canning: heats up the water even hotter in a sealed canner in order to get the temperature hot enough to kill and pressurize the sealed container in order to prevent bacteria growth.  Time and pounds per pressure needs to be regulated.

Mold growth in foods can raise the pH of the food. In home canned products, this could mean that the high acid products could become low acid [due to the heat and pressure during processing] and therefore run the risk of botulism or other bacterial spoilage. Thus, any home canned product that shows signs of mold growth should be discarded. USDA and microbiologists now recommend against even scooping out the mold on jams and jelly products and using the remaining jam or jelly, even though that used to be suggested.”

Botulinum spores are very hard to destroy at boiling-water temperatures; the higher the can­ner temperature, the more easily they are destroyed….Pressure does not destroy microorganisms, but high temperatures applied for an adequate period of time do kill microorganisms.”

  • Pickling: adding a vinegar to the food in order to lower the pH level. Food is then processed in a hot water bath to inhibit bacteria growth.

“The addition of vinegar or the formation of acid through the fermentation process decreases pH, preventing the growth of C. botulinum.”

“Heat processing is recommended for all pickle products to destroy organisms that cause spoilage and to inactivate enzymes that may affect flavor, color, and texture.”

  • Fermentation: natural process where naturally occurring bacteria found on raw vegetables convert the food’s carbohydrates into lactic acid, which lowers the pH below 4.0.

Numerous articles cite USDA’s leading microbiologist, Fred Breidt, Jr., saying that fermentation is “‘almost bulletproof,'” when done properly.  “It’s hard to mess it up. Things can go wrong, but it’s rare.”  He goes on to stress that “Just normal fermentation will kill the organisms,” said Breidt. “But you don’t want to ignore good handling and good sanitary practices.”

“…the natural bacteria in the vegetables break down the components of the vegetables into forms easier to digest and often more nutritious than the raw vegetable itself.  Breidt said that fermented vegetables can be safer than raw vegetables, thanks to the ability of lactic acid, which forms during fermentation, to hunt down and kill any harmful bacteria that might be present.”

Fermenting foods is a simple process when “proper” food safety practices are followed: salt: water ratio, clean environment, storage time, and temperature are key to tasty food.

FDA Guidelines for Acidified Foods

“The proposed rules to establish 21 CFR 108.25 (41 FR 30442) and part 114 (41 FR 30457) specifically addressed fermented foods and pickled foods (e.g., the title of the proposed regulations included fermented foods and pickled foods). Fermented foods (such as some kinds of sauerkraut, cucumber pickles, and green olives) are low-acid foods subjected to the action of acid-producing microorganisms to reduce the pH of the food to 4.6 or below. Pickled foods are low-acid foods that are reduced to a pH of 4.6 or below either by fermentation or by marinating in an acid solution (usually vinegar, i.e., acetic acid). Pickled foods may be maintained and stored in either the acid solution resulting from fermentation or in the marinating solution, or in a fresh acid solution applied after fermentation or marinating is complete.

“Comments to the proposed rules noted that the proposed rules gave no examples in which any proven improper fermentation caused a fermented food to be a health hazard (44 FR 16204 at 16204; 44 FR 16230 at 16231). These comments questioned the inclusion of fermented foods in the regulations. In the final rules we acknowledged that we could not find reports of cases of botulism caused by commercially processed fermented foods (44 FR 16204 at 16204; 44 FR 16230 at 16231). We stated that, in the absence of known illnesses or deaths from commercially prepared fermented foods, the regulation should apply only to acidified foods. We further advised that pickled foods (including foods pickled by fermentation) that are prepared by acidification are acidified foods (44 FR 16204 at 16204) and, thus, the definition of acidified foods states that some acidified foods may be called “pickles” or “pickled” (21 CFR 114.3(b)). Thus, low-acid foods to which acid(s) or acid food(s) are added and that have a pH of 4.6 or below and a water activity above 0.85 are acidified foods subject to the requirements in 21 CFR 108.25 and part 114, irrespective of whether the low-acid food is also subjected to the action of acid-producing microorganisms.

We do not require processors of fermented foods to register their establishment(s) and foods they process (using Form FDA 2541) if these foods do not also meet the definition of an acidified food (or if these processors do not process other foods subject to 21 CFR part 113 or part 114). We also do not require such processors to provide us with information on scheduled processes for their foods (using Form FDA 2541a). For processors who voluntarily submit to FDA registration and scheduled process on fermented foods that they conclude are not also acidified foods, we recommend and plan to follow the same approach described in Section III.A for voluntary submissions for acid foods.

I. Fermented Food(s) Containing Small Amounts of Low-Acid Food(s)

“As discussed above (see section III.C of this document), in 1979 we acknowledged that we had not found reports of cases of botulism caused by commercially processed fermented foods (44 FR 16204; 44 FR 16230 at 16231) and, thus, stated that the regulation should apply only to acidified foods. We further advised that pickled foods (including foods pickled by fermentation) that are prepared by acidification are acidified foods (44 FR 16204).

“Since 1979, we have not received information implicating commercially processed fermented foods in cases of botulism. However, the food industry evolves over time, and some of the products available today (such as fermented olives stuffed with a low-acid food) may not have been on the market in 1979. We see no meaningful scientific difference between potential safety concerns presented by fermented foods containing added low-acid foods and potential safety concerns presented by acid foods containing added low-acid foods. Therefore, if you add a low-acid food to a fermented food, we recommend that you evaluate the product using the stepwise process described in Decision Tables 2 through 6 in section III.H.5 of this document. To do so, you would evaluate a fermented food as if it were an acid food, using the steps in these tables. If the amount of low-acid food(s) in your fermented food is not a “small amount,” or if the resultant finished equilibrium pH of your product containing a small amount of low-acid food significantly differs from that of the fermented food, we recommend that you consider the fermented food to be an acidified food subject to the requirements of 21 CFR 108.25 and part 114.

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