Development of AHPA Guidance on Maximum Microbial Limits for Botanical

Products Where Boiling Water is Added Before Use

DISCUSSION DRAFT
March 2012

The AHPA Tea Products Committee microbiological working group (the tea/micro WG)
is considering a proposal to adopt guidance for specific microbiological limits for finished
herbal products which are packaged and sold in dry form and subsequently prepared
with boiling water prior to consumption, as well as for dried, unprocessed herbs used as
ingredients in these products.
In developing the guidance proposed in this document, AHPA compiled microbiological
limits established by various national and international organizations (presented in
tables in the appendix to this document). Input was also provided by in-house industry
personnel with knowledge of levels of microbial contamination in raw materials and the
effects of the application of boiling water. In addition, and specifically with regard to the
proposal to recommend a separate limit for enterovirulent E. coli in addition to a limit for
total E. coli, relevant current U.S. regulations and enforcement practices were reviewed.
The proposed guidance would expand AHPA’s Guidance on Microbiology &
Mycotoxins, which currently addresses limits where manufacturers choose to establish
one or more microbiological and/or mycotoxin specifications for herbal ingredients or
dietary supplements, and specifically for (a) dried, unprocessed herbs for use as
ingredients in dietary supplements and herbal supplements in solid form consisting of
dried, unprocessed herbs; and (b) powdered extracts and soft extracts, and herbal
supplements in solid form consisting of powdered extracts or soft extracts.
Guidance for tea products (finished forms) and unprocessed herbal ingredients
To extend this guidance to herbal products that are intended to be prepared with boiling
water, and to dried, unprocessed herbs used as ingredients in these products, the
tea/micro WG recommends that AHPA’s current guidance may be expanded by adding
a new section, as follows:
“and (c)(i) for dried, unprocessed herbs for use as ingredients in herbal teas/dry
where boiling water is instructed to be added before use, and (ii) for finished product
herbal teas/dry where boiling water is instructed to be added before use:
• Total aerobic plate count: 107 colony forming units/gram
• Total yeasts and molds: 105 colony forming units/gram
• Escherichia coli: 103 colony forming units/gram
• Enterovirulent E. coli: not detected in 25 grams
• Salmonella spp.: not detected in 25 grams
• Total aflatoxins (B1 + B2 + G1 + G2): 20 µg/kg (ppb)
• Aflatoxin B1: 5 µg/kg (ppb)

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Amendments to definitions
The current guidance provides several definitions as well as limitations and conditions
that apply to current sections (a) and (b). The tea/micro WG recommends the following
additions to the list of definitions:
• “Herbal teas/dry” means a bulk or single-serving (e.g., teabag) form of an
herb, or a blend of herbs and/or herbal extracts and/or non-herbal ingredients,
that is sold or packaged for retail sale with instructions to prepare with boiling
water. Herbal teas/dry include products that are sold as foods, dietary
supplements, and over-the-counter drugs.
• Enterovirulent E. coli (EEC) means strains of E. coli that are known to cause
gastrointestinal illness in humans. Four to six specific mechanism types of
EECs are recognized. For purposes of this guidance the meaning of EEC is
limited to ETEC (enterotoxigenic E. coli), EIEC (enteroinvasive E. coli), EPEC
(enteropathogenic E. coli), and EHEC (enterohemorrhagic E. coli; includes E.
coli O157:H7).

Amendments to limitations and conditions

The tea/micro WG recommends that the list of applicable limitations and conditions be
expanded to include the following:
• The separate limitation in section (c) of this guidance for enterovirulent E. coli
is only applicable if the presence of any E. coli is detected, and is always
applicable in such cases. If any E. coli is detected in a sample, additional
testing should be conducted to determine absence or presence of
enterovirulent E. coli in the ETEC, EIEC, EPEC, or EHEC groups.
• For herbal teas/dry as addressed in section (c) of this guidance, directions for
preparation should be provided on product labels which instruct the user to
pour boiling water over the product and to allow to steep for 5 or more
minutes, or significantly similar instruction. Preparation of tea by this method
provides a microbial reduction step, which is the reason for an allowance of
non-pathogenic E. coli for these products. Preparation of herbal teas by other
means may not be sufficient to reduce microbial load and may in fact allow it
to increase. Labeled directions for use should also provide a shelf life for the
prepared tea (e.g., 8 hours) or should instruct the user to drink promptly or
refrigerate in clean containers, or should provided significantly similar
information or instructions.

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 American Herbal Products Association (AHPA) Discussion Draft Table of Botanical Microbial Limits
Not to be used without permission from AHPA
Table 1
Recommended Maximum Microbial Limits for Dried Agricultural Commodities (units in cfu/g or ml)

Organization AHPA AHPA EHIA EP NSF/ANSI USP WHO

Dried, unprocessed For Trade in
(For powdered Dried or Untreated Crude
herbs for use as Herbal Infusion Botanical Ingredient,
Plant Material ingredients in dietary
extracts and for
Raw Materials
NA Non-Extract
Powdered Intended for Further
soft extracts) Botanicals Processing
supplements (Dry)**
Total Aerobic NA or 105-107 as per
107 104 108 NA 107 105
Microbial Count specific monographs
105 (mold propagules);
Total Combined 106 each
105 103 NA 105 103 Occasionally 104 for
Yeast & Molds separately§
specific monographs
Enterobacteria (Bile-
tolerant Gram-negative 104 (coliforms) 102 (coliforms) NA NA 104 103 103
Bacteria)
not detected not detected absence in
E. coli 104 NA 102ǂ 104
in 10 g* in 10 g* 10 g
Enterovirulent E. coli NA NA NA NA “zero tolerance” NA NA
not detected not detected absent in absence in
Salmonella spp. NA not detected in 10 g NA or absent
in 10 g* in 10 g* 125 g 10 g
Staphylococcus
NA NA NA NA not detected in 10 g NA NA or absent
aureus
AHPA – American Herbal Products Association, Adopted as guidance June 2003, revised November 2009
EHIA – European Herbal Infusions Association, EHIA's recommended microbiological specifications 2011 combined (accessed February 14, 2012)
EP – European Pharmacopoeia
NSF/ANSI – NSF International Standard/American National Standard for Dietary Supplements 173 – 2010
USP – United States Pharmacopeia, USP34-NF29, 2011, General Chapter, <2023>
WHO – World Health Organization, Quality control methods for medicinal plant materials, Geneva, 1998
NA – Not Assigned
*Sample size may vary depending on the method used.
** Sampling: 5 random samples of 50 g mixed to a composite sample that is the basis for all laboratory investigations, including salmonella.
§
For mint no yeast specification is applicable due to the high natural yeast load.
ǂ If
the presence of Escherichia coli is confirmed, then testing shall be performed based on the USFDA Bacteriological Analytical Manual in Chapter
4A to determine whether the colonies are pathogenic Escherichia coli, not limited to O157:H7. There is a zero tolerance for the presence of
enterovirulent Escherichia coli.

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 AHPA Discussion Draft Table of Botanical Microbial Limits

Table 2
Recommended Maximum Microbial Limits for Botanical Products
Where Boiling Water is Added Before Use (units in cfu/g or ml)

AHPA TGA
Organization EHIA EP NSF/ANSI USP WHO
(proposed) Laboratories
Herbal teas and Herbal teas Botanicals to be
Herbal Boiling Water Botanicals to be
Treatment or ingredients (assumes (assumes Treated with
Infusions Added Before NA Treated with
Material preparation with § preparation with Boiling Water
(Dry) Use Boiling Water
boiling water) boiling water) Before Use
Total Aerobic
107 107 107* NA 105 105 107
Microbial Count
Total Combined 105 each
105 105* NA 102 103 104
Yeast & Molds separately
Enterobacteria (Bile-
tolerant Gram- NA NA NA NA 102 NA 104
negative Bacteria)
E. coli 103 103 103 NA absent in 1 g absent in 10 g 102
not detected in
Enterovirulent E. coli 25 g
NA NA NA NA NA NA
not detected in absent in absent in
Salmonella spp. 25 g 125 g 25 g
NA absent in 10 g NA none
Staphylococcus
NA NA NA NA NA NA NA
aureus
AHPA – American Herbal Products Association
EHIA – European Herbal Infusions Association, EHIA's recommended microbiological specifications 2011 combined (accessed February 14, 2012)
EP – European Pharmacopoeia Edition 6.8, Chapter 5.8.1 – Category 4A
NSF/ANSI – NSF International Standard/American National Standard for Dietary Supplements 173 – 2010
TGA Laboratories – Therapeutic Goods Administration Laboratories Consultation Paper (accessed August 24, 2011)
USP – United States Pharmacopeia, USP34-NF29, 2011, General Chapter, <2023>
WHO – World Health Organization, Quality control methods for medicinal plant materials, Geneva, 1998
NA – Not Assigned
* Acceptance criterion. Maximum acceptable count is five times this value.
§
Parts of plants which are intended for infusion with freshly boiling water and brewing for at least 5 minutes. Sampling: 5 random samples of 50 g
mixed to a composite sample that is the basis for all laboratory investigations, including salmonella.

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 AHPA Discussion Draft Table of Botanical Microbial Limits

Table 3
Recommended Maximum Microbial Limits for ‘Finished’ Botanical Products (units in cfu/g or ml)

Organization AHPA EP EP NSF/ANSI USP WHO AHPA NSF/ANSI

Dried or Herbal
Plant
Herbal supplements Antimicrobial pre- Containing Powdered supplements in
If pretreatment or Materials
in solid form treatment and/or Botanical Botanicals solid form Containing
Plant Product consisting of dried, microbial reduction in
process fail to
Ingredients, (Powdered
For
consisting of Botanical Extract
achieve compliance Internal
unprocessed herbs production process Non-Extract Botanical powdered extracts
Use
Extracts) or soft extracts
Total Aerobic
107 104ǂ 105ǂ 107 105 (104) 105 104 104
Microbial Count
Total Combined
105 102ǂ 104ǂ 105 103 (103) 103 103 103
Yeast & Molds
Enterobacteria 103 (inc.
4 2
(Bile-tolerant Gram- 10 (coliforms) 10 certain others) 104 103 103 102 (coliforms) 102
§
negative Bacteria)
not detected in absence in not detected in not detected
E. coli absent in 1 g absent in 1 g 102** 10
10 g* 10 g 10 g* in 10 g
“zero
Enterovirulent E. coli NA NA NA NA
tolerance”
NA NA
not detected in not detected absence in not detected in not detected
Salmonella spp. 10 g*
absent in 25 g absent in 10 g
in 10 g 10 g
none
10 g* in 10 g
Staphylococcus not detected not detected
NA NA NA NA NA NA
aureus in 10 g in 10 g

AHPA – American Herbal Products Association, Adopted as guidance September 2009

EHIA – European Herbal Infusions Association
EP – European Pharmacopoeia Edition 6.8, Chapter 5.8.1 – Category B and C
NSF/ANSI – NSF International Standard/American National Standard for Dietary Supplements 173 – 2010
United States Pharmacopeia, USP34-NF29, 2011, General Chapter, <2023>
WHO – World Health Organization, Quality control methods for medicinal plant materials, Geneva, 1998
NA – Not Assigned

* Sample size may vary depending on the method used.

ǂ Acceptance criterion. Maximum acceptable count is five times this value.
§
Other types of organisms (e.g. Aeromonas, Pseudomonas) may be recovered.
** If the presence of Escherichia coli is confirmed, then testing shall be performed based on the USFDA Bacteriological Analytical Manual in Chapter
4A to determine whether the colonies are pathogenic Escherichia coli, not limited to O157:H7. There is a zero tolerance for the presence of
enterovirulent Escherichia coli.
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