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Kombucha brewing under the food and drug administration model Food Code: risk analysis and processing guidance.

Introduction

Kombucha is a fermented beverage made from brewed tea and sugar. The taste is slightly sweet and acidic and it may have residual carbon dioxide. Kombucha is consumed in many countries as a health beverage. It is believed to have prophylactic and therapeutic benefits toward a wide variety of ailments (Greenwalt, Steinkraus, & Ledford, 2000).

The kombucha process resembles a vinegar fermentation. Like vinegar, kombucha is a yeast fermentation of sugar to alcohol followed by a bacterial fermentation of alcohol to acetic acid. The symbiotic culture forms a pellicle or biofilm on the surface of the brew often called a mushroom or SCOBY (symbiotic culture of bacteria and yeast). The yeasts in the mixture metabolize sucrose into glucose and fructose, then into ethanol and carbon dioxide (Mayser, Fromme, Leitzmann, & Grander, 1995). Ethanol is then oxidized by the bacteria (in the presence of air) to acetaldehyde, then to acetic acid (Mayser et al., 1995). Typically, the alcohol and acetic acid content of kombucha is less than 1%, respectively, but each can rise to 3% during a long ferment (~30 days; Mayser et al., 1995). The acetic acid bacteria also utilize glucose to produce gluconic acid to approximately 2%. Fructose is used to a lesser extent and some remains after the fermentation. Some glucose will remain unmetabolized, and together with the remaining fructose, provides sweetness.

As a fermented beverage, kombucha would be categorized in the Food and Drug Administration (FDA) model Food Code as a specialized process. A retail or food service operator would need to request a variance from their regulatory authority as defined in the Food Code section 3-502.11 (Food and Drug Administration [FDA], 2009). This section also requires that the operator submit a food safety plan to the regulatory authority for approval before commencing operations. Below is a hazard analysis and critical control points (HACCP)-based risk analysis of the process to help both operators and regulators maintain safe production of kombucha.

Process Flow

Naturally, kombucha recipes will vary. The general process has been described by Greenwalt and co-authors (2000) and includes infusing tea leaves (~4-5 g/L) into freshly boiled water. Sugar (sucrose) is added at 50-150 g/L (5% to 15%). The tea is allowed to brew for approximately 10 minutes and the tea leaves are removed. The tea is cooled to room temperature and approximately 100 ml/L (10%) of fresh-fermented kombucha containing the microbial mat from a previous batch is added to the sweetened tea. It is then covered with a clean porous cloth (e.g., cheese cloth) and incubated at room temperature for about 7-10 days. If the fermentation is allowed to continue beyond 10 days, acidity may rise to levels potentially harmful to consumers (equivalent to drinking undiluted vinegar).

Kombucha Hazards Analysis (Table 1)

Biological Hazards

Most boiling water with black or green tea infusions start at a pH of [less than or equal to] 5. Once fermentation starts that pH is reduced in approximately seven days to a finishing pH of [less than or equal to] 2.5. Fermentations such as wort to beer have a similar pH reduction during fermentation, although beer will finish closer to pH 4. Since the initial infusion uses boiling water we consult Table A of section 1-201.10(B) (FDA, 2009) to determine if this is a potentially hazardous food (PHF). The tea infusion would not be a PHF if the pH were <4.6. Since the tea is heated but not packaged, however, it may be subject to contamination after cooling. Therefore, we must also consult Table B of section 1-201.10(B) (FDA, 2009) that requires a pH [less than or equal to] 4.2 to be a non-PHF Since kombucha starts at a potentially hazardous pH (~5) and finishes below 4.2 this process would require food safety monitoring to ensure safety. This is also confirmed in the Food Code under section 3-502.11 (FDA, 2009), where it requires a food safety plan for any process that uses acidification to make a PHF into a non-PHF.

Chemical Hazards

FDA has evaluated the practices of several commercial producers of the kombucha and found no pathogenic organisms or other hygiene violations (Centers for Disease Control and Prevention [CDC], 1996). Kombucha consumption has proven to be harmful in only a few documented instances (Srinivasan, Smolinske, & Greenbaum, 1997). The possibility of toxic effects when kombucha is consumed in large quantities became a concern after two incidents in the U.S. in 1995. One individual died from perforations of the intestinal tract and severe acidosis. It was speculated that because she had recently increased her consumption threefold to 12 oz. that kombucha was the cause. The surviving victim mentioned that she increased the length of the fermentation time from 7 days to 14 days, and she could hardly manage swallowing the very acidic tea but did anyway. It was later determined that the individuals had severe preexisting conditions that made them susceptible to acidosis. These two cases of illness were investigated to determine if kombucha played a role in the development of metabolic acidosis or other toxic effects. It was concluded that kombucha is not harmful at about 4 oz. per day; however, potential risks are associated with excessive consumption or consumption by an individual with preexisting health problems (CDC, 1995).

Alcohol is certainly debatable as a hazard, but is not debatable as an impetus for taxes. Recently Severson (2010) reported some commercial producers of kombucha were forced to recall unpasteurized versions from grocery store shelves when the alcohol content exceeded 0.5%. Some brands continued to ferment and may produce up to 3% alcohol in the bottle. This happens because yeast continues to ferment sugars producing alcohol and carbon dioxide. In a closed container the buildup of carbon dioxide inhibits the conversion of alcohol to acetic acid.

Controlling Food Safety

Critical Control Points, Critical Limits, Monitoring, Corrective Actions, and Record Keeping

Of all of the steps in Table 1, only one is critical to prevent the potential for acid-resistant pathogens: step 5. In this step the fermentation proceeds from pH ~5 to [less than or equal to] 4.2. Therefore the critical limit is pH [less than or equal to] 4.2. The pH should be monitored using a calibrated digital pH meter for ease and accuracy (versus paper). The main corrective action if the pH > 4.3 would be to continue fermentation and remeasure. If the pH does not reach pH [less than or equal to] 4.2 in seven days the culture is most likely contaminated or the fermentation temperature is too cold. In this case discard is recommended. Start a new batch with a newly purchased commercial culture. A record of the pH of kombucha should be kept to verify that the safe pH level has been reached. An example would be to create a simple table (Table 2). For each batch, mark the start date (manufacture date) and starting pH, then mark each successive pH measurement until pH [less than or equal to] 4.2. You may optionally continue to measure pH since the operational target is 2.5. Operators will also need to keep a calibration log (Table 3). If the pH goes below 2.5 the operator can add fresh brewed tea to return it to pH [greater than or equal to] 2.5. A pH measurement guide including calibration instructions can be found at http://extension.usu.edu/files/publications/publication/ FN_Food_Safety_2008-01.pdf.

Good Manufacturing Practices

Controls and preventative measures that don't meet the threshold of being critical, but nonetheless are needed to ensure safety, are contained in good manufacturing practices and standard operating procedures (SOPs). These controls are found in Table 1 under preventative measures. Using these preventative measures is recommended.

1. Use hot ([greater than or equal to] 165[degrees]F) water to steep tea (kills vegetative pathogens if present).

2. Use only clean and sanitary equipment and utensils.

3. Use a commercially purchased culture on first use. Reuse only culture from kombucha that shows no signs of mold or unusual contamination.

4. Kombucha with a pH of below 2.5 or that tastes especially acidic should not be offered to consumers. A corrective action would be to dilute the high acidity with fresh brewed tea until pH [greater than or equal to] 2.5, but never higher than pH 4.2.

5. Discard all kombucha that is showing signs of mold contamination. Do not reuse for inoculum.

6. Consumer warnings: Consumers should be notified that no more than 4 oz. per day is recommended (see CDC references) and that they should not be immunocompromised. Furthermore, they should be made aware that minor amounts of alcohol may be present.

7. Health claims: kombucha is suggested to offer health benefits. Operators are discouraged from marketing or labeling health claims such as drinking will "cure" some ailment.

SOPs

SOPs are written, step-by-step instructions to accomplish a food safety objective. The following are recommended.

1. A detailed pH measurement and calibration SOP.

2. A detailed process instruction sheet to tell employees how to make kombucha using the food safety measures outlined in this report. The SOP must describe how employees will measure and record on a pH log.

Retail Sale of Kombucha (Packaging)

Retail sale of kombucha is beyond the scope of this report. Described below, however, are some minimum concerns to this specialized process.

Many commercial processors bottle kombucha. The main food safety hazard is acid-resistant pathogens. Bottling kombucha at a pH [less than or equal to] 4.2 will ensure no pathogen growth. Another hazard is bottling an actively fermenting kombucha beverage. Carbon dioxide will build up inside the container causing pressure. As the pressure exceeds the ability of the container to hold it, leakage or breakage occurs. Bottles can explode, forming projectile hazards. The last concern is shelf life, where spoilage from mold can occur or alcohol can build up >0.5%. Typically, as a little carbon dioxide builds up, acetic acid production will cease. So an excess acid hazard is unusual.

Fermented beverages (foods) are exempt from acidified foods canning regulations. Therefore they do not need any filings or notifications to FDA. Likewise, any refrigerated beverage (food) is also exempt from these same regulations.

Option 1: The best method is to pasteurize kombucha for bottling. Pasteurization will kill the culture preventing carbon dioxide or alcohol buildup in bottles. A simple recommendation is to heat kombucha to 180[degrees]F and bottle immediately. After 30 seconds invert bottle and hold for another 30 seconds. Allow bottles to cool. Pasteurized and bottled kombucha with a pH [less than or equal to] 4.2 is shelf stable (room temperature).

Option 2: This method relies on refrigeration and antifungal preservatives to minimize hazards and spoilage. Add 0.1% sodium benzoate and 0.1% potassium sorbate to kombucha with a pH [less than or equal to] 4.2. Bottle kombucha at any temperature. Keep refrigerated until use. Benzoate and sorbate will prevent mold growth and minimize yeast growth. Minimal to no growth of acetic acid bacteria will occur in bottles without significant oxygen. A refrigerated shelf life will need to be determined based on eventual yeast growth with carbon dioxide and alcohol production. If this proves difficult the operator may want to find a commercial kombucha culture with yeasts that do not grow well at refrigeration temperature.

Option 3: This method relies on refrigeration alone to minimize hazards and spoilage. Bottle kombucha at any temperature. Keep refrigerated until use. A refrigerated shelf life will need to be determined based on eventual yeast growth with carbon dioxide and alcohol production. If this proves difficult the operator may want to find a commercial kombucha culture with yeasts that do not grow well at refrigeration temperature.

Operators seeking to package kombucha for retail sale must also address labeling. Labeling issues are not covered here and operators are encouraged to inquire with their regulator or their state's department of agriculture. Generally, regulators who oversee grocery (retail) have information on requirements for retail labels.

Questions and Answers

Can I make diet or low-sugar kombucha?

No. The sugar is required as part of the fermentation process. Without sugar no alcohol is produced and without alcohol no acetic acid can be produced.

I make kombucha using tea and other ingredients (e.g., fruit). Can I still use this guideline?

Yes, provided the added ingredient does not raise the starting pH over that of the original tea (~pH 5). It might still be safe to brew using higher starting pH levels, but the operator would need to consult a processing authority.

Can I use this report as my HACCP Plan?

This report contains some of the information needed for an HACCP plan, just not in the typical table format. If the regulatory authority will accept it, it is sufficient. Copies of the recipe(s), a pH log, pH meter calibration log, and SOPs would need to be added to complete the food safety plan. If the kombucha is bottled, information on safe bottling and labels must also be included.

How strict is the recommendation from the CDC about limiting consumption of kombucha to 4 oz. per day?

The CDC recommendations are exactly that--recommendations. They are in response to two older and ill persons who became ill. One died. The analysis suggested they drank 12 oz. per day of very acidic kombucha. So, the recommendations are not to overferment kombucha and limit servings.

I've read that the kombucha culture is sensitive to sanitizers. How can I sanitize utensils and wares so the culture is not harmed?

FDA model Food Code section 4-703.11 permits submerging previously cleaned wares and utensils in hot water ([greater than or equal to] 160[degrees]F) for [greater than or equal to]30 seconds. This will sanitize the wares and not leave any chemical residue.

Corresponding Author: Brian Nummer, Associate Professor, Nutrition, Dietetics and Food Sciences, Utah State University, 8700 Old Main Hill, Logan, UT 84322. E-mail: brian. nummer@usu.edu.

References

Centers for Disease Control and Prevention. (1995). Unexplained severe illness possibly associated with consumption of kombucha tea--Iowa. Morbidity and Mortality Weekly Report, 44(48), 892-900.

Centers for Disease Control and Prevention. (1996). CDC editorial note. Journal of the American Medical Association, 275(2), 97-98.

Food and Drug Administration. (2009). Food code. Retrieved from http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ FoodCode/UCM2019396.htm

Greenwalt, C.J., Steinkraus, K.H., & Ledford, R.A. (2000). Kombucha, the fermented tea: Microbiology, composition, and claimed health effects. Journal of Food Protection, 63(7), 976-981.

Mayser, P., Fromme, S., Leitzmann, C., & Grander, K. (1995). The yeast spectrum of the "tea fungus kombucha." Mycoses, 38(7-8), 289-295.

Severson, K. (2010). Kombucha may be treated like alcohol, government says. Retrieved from http://dinersjournal.blogs.nytimes.com/2010/ 06/25/kombucha-may-be-treated-like-alcohol-government-says/

Srinivasan, R., Smolinske S., & Greenbaum, D. (1997). Probable gastrointestinal toxicity of kombucha tea. Journal of General Internal Medicine, 12(10), 643-644.

Brian A. Nummer, PhD Retail-Foodservice Food Safety Consortium Utah State University Cooperative Extension
TABLE 1

Kombucha Hazards Analysis

Step Description Hazards Created, Eliminated,
 or Reduced

1 Boil water. Potable water should be free
 of hazards.

2 Add tea and sugar and steep Biological: sporeformers may be
 10 minutes. heat shocked and germinate.

3 Remove tea leaves and cool. Biological: cross
 contamination.

4 Add 10% inoculum. Biological: mold or wild
 culture cross contamination.

5 Ferment at room temperature Biological: pathogen, mold, or
 7-10 days. wild culture growth. Chemical:
 acetic acid can leach metal.

6 Refrigerate covered. Biological: overfermentation
 may increase acetic acid to
 hazardous levels. As
 fermentation slows, mold
 growth potential increases.

7 Filter or remove Biological: cross
 culture mass. contamination.

8A Option 1: consume on Chemical: a potential for
 premises. acidosis or acid ingestion
 exists. If mold is present
 mycotoxins could form.

8B Option 2: package for Biological: spoilage with mold
 retail sale. or yeasts. Over fermentation
 producing excessive acetic
 acid.

 Option 2: labeling. Chemical: a potential for
 acidosis or acid ingestion
 exists.

Step Description Preventative Measures

1 Boil water. Boiling water will kill
 vegetative pathogens.

2 Add tea and sugar and steep Clostridium perfringens and
 10 minutes. Bacillus cereus do not grow
 well or at all at pH [less
 than or equal to]5.
 Clostridium botulinum can grow
 down to pH 4.7. The addition
 of an active fermentation
 culture will outcompete
 sporeformers to prevent
 growth.

3 Remove tea leaves and cool. Use clean and sanitized
 utensils. Keep container
 covered with clean and
 sanitized porous cloth (e.g.,
 cheese cloth). The pH of
 [less than or equal to]5
 will prevent C. perfringens
 outgrowth. Therefore cooling
 parameters need not be
 monitored.

4 Add 10% inoculum. Use a commercially purchased
 culture on first use. Reuse
 only culture from kombucha
 that shows no signs of mold or
 unusual contamination. The pH
 of the reused culture should
 be [less than or equal to] 4.2
 to minimize the
 potential for acid resistant
 pathogens.

5 Ferment at room temperature Ferment aerobically (in the
 7-10 days. presence of air) to ensure
 Option 2: labeling. acetic acid production to pH
 [less than or equal to]4.2.
 The typical end point is
 pH 2.5. Ferment in a safe,
 nonmetallic food-grade
 container.

6 Refrigerate covered. Refrigeration at pH [less
 than or equal to]4.2 would
 not be required for food
 safety, but it should be used
 for quality and to prevent
 spoilage from molds.
 Refrigerated kombucha should
 be covered, preferably with a
 tight fitting lid. This way a
 small amount of carbon dioxide
 will build up and minimize
 mold growth.

7 Filter or remove Use clean and sanitized
 culture mass. utensils.

8A Option 1: consume on The pH end point should be
 premises. [greater than or equal to]2.5.
 Overfermentation can
 increase acetic acid to
 hazardous levels. Consumers
 should be notified that no
 more than 4 oz. per day is
 recommended and that they
 should not be
 immunocompromised.

8B Option 2: package for Option 1: Pasteurize-hot fill
 retail sale. at 180[degrees]F into clean
 containers. Cap and invert 15
 seconds. Cool.

 Option 2: Fill
 packaging at any temperature
 and store refrigerated with a
 shelf life that precludes mold
 development, excessive acetic
 acid, or excessive carbon
 dioxide buildup.

 Option 3:
 Same as option 2, but add 0.1%
 sodium benzoate and 0.1%
 potassium sorbate to prevent
 mold growth.

 Option 2: labeling. Consumers should be notified
 that no more than 4 oz. per
 day is recommended and that
 they should not be
 immunocompromised. They also
 should be made aware that
 small amounts of alcohol may
 be present. Labeling claims
 are outside the scope of this
 article, but health claims
 would not be recommended
 (e.g., "cures health
 problems").

TABLE 2

Kombucha pH Log

# Start Date Date Date Date Date Date Date
 /pH /pH /pH /pH /pH /pH /pH

1
2
etc.

TABLE 3

pH Calibration Log

Date/pH/* Date/pH/* Date/pH/* Date/pH/* Date/pH/* Date/pH/*

Note. Record date of calibration, calibration pH, and 'initials of
calibrator. Indicate manufacturer's suggested calibration interval
(usually daily).
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Title Annotation:SPECIAL REPORT
Author:Nummer, Brian A.
Publication:Journal of Environmental Health
Date:Nov 1, 2013
Words:3177
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