Draft Guidance for Industry: Acidified Foods PDF Free Download
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THE ASSOCIPlION FOR
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February 8, 2011
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: Draft Guidance for Industry: Acidified Foods
[Docket No. FDA-2010-D-0434]
Dear Sir or Madam:
The Association for Dressings and Sauces (ADS) is the international trade association representing
manufacturers of salad dressings, mayonnaise and condiment sauces and the suppliers to the industry.
ADS submits the following comments regarding the draft guidance, "Guidance for Industry: Acidified
Foods" published in the September 27, 2010
Federal Register
(75 FR 59268). In the remainder of this
document, the term "dressings and sauces" refers to mayonnaise, salad dressings, sauces and condiments
with a pH of 4.6 or below.
Mayonnaise, dressings and sauces produced at a pH of 4.6 or below have a remarkable safety record, and
research studies have confirmed the safety of these products. There have been no confioned incidences in
which foodbome pathogens have grown in such mayonnaise or salad dressings; in addition, such
mayonnaise, dressings and sauces have not been directly identified as the cause of any foodborne illness.
Dr. Richard Smittle reported that foodborne pathogens die off at various rates depending on the organism,
acid type, acid concentration, storage temperature, organism adaptability and pH
(1)
.
Beuchat et al.
demonstrated the rapid death rate of
Salmonella, Escherichia coli
0157:H7 and
Listeria monocytogenes
in commercially manufactured shelf-stable, dairy-based, pourable full-fat ranch (pH 2.87 -3.72), reduced
fat ranch (pH 2.82 - 3.19), full-fat blue cheese (pH 3.08 - 3.87) and reduced-fat blue cheese (pH 2.83 —
3.49) salad dressings stored at 25°Celsius
(2)•
Mayonnaise, salad dressings and sauces with a pH of 4.6 or below have had a qualified exclusion under
the language of the existing acidified food regulation. In Section III. A ("Acid Foods") of the draft
guidance, FDA confirms that processors of acid foods, defined as those foods that have a natural pH of
4.6 or below, are not required to register and file a scheduled process. The Agency has also stated that
examples of acid foods include "standardized and nonstandardized food dressings (such as mayonnaise)
and condiment sauces (such as ketchup) that have a natural pH of 4.6 or below." We agree with this
assessment and believe that all dressings and sauces with a pH of 4.6 or below should be considered acid
foods.
Fog
)0101- ov 3y
Division of Dockets Management (HFA-305)
February 8, 2011
Page Two
In considering the distinction between acid and acidified foods, it is important for FDA to recognize how
mayonnaise, dressings and sauces are formulated and processed. These products are not inherently low-
acid foods which are made acidic through the addition of an acid. Rather, they are formulated with a
variety of ingredients to meet certain finished product specifications, including pH. Attempting to define
a new category of "acidified" dressings and sauces is not a useful undertaking because
there is no
significant microbiological difference between acid and acidified foods at the same finished product pH.
Using the decision tree to create a class of "acidified" dressings and sauces would not produce a food
safety benefit. Therefore, maymmaise, salad dressings, sauces and condiments with a pH of 4.6 or below
should be considered acid foods as stated in the draft acidified foods guidance.
To reiterate, ADS recommends that mayonnaise, dressings, sauces, and condiments with a finished
product pH of 4.6 or below should be exempt from the acidified food regulations. We believe that
all dressings and sauces with a pH of 4.6 or below should be considered acid foods. Focusing on
considerations for food safety plans under the new FDA Food Safety Modernization Act of 2010 is
the better approach.
ADS also submits the following comments with reference to specific parts of the guidance, but believes
that the principle outlined in bold in the preceding paragraph should continue to be the controlling
approach; namely, that finished product pH be the determining factor in assessing the safety of
mayonnaise, dressings, sauces and condiments.
Acidified Ingredients/Foods
The FDA recommends (Section III.B. "Acidified Foods") that processors consider any finished product
containing an acidified food (as an ingredient) as an acidified food and thus, covered by the acidified
foods regulations. We believe that the inclusion of an acidified ingredient in a formula should not
automatically make the product an acidified food. Incorporating acidified ingredients into a formula
generally presents a lower food safety risk than the inclusion of low-acid ingredients. Tartar sauce is an
example of a product that contains a standardized acid food (mayonnaise or spoonable salad dressing) and
an acidified food, pickle relish. A tartar sauce prepared with these ingredients does not present a food
safety risk.
Small Amount of Low-Acid Foods and Low-acid Ingredients
The FDA recommends that processors consider a "small amount of low-acid food(s)" to be no more than
10 percent by weight of low-acid foods in the finished product (Section 111.14. "Terms"). The calculations
in Table 3 for determining the percent by weight of low-acid foods in a finished product exclude the
weight of water and oil used to formulate the product. The FDA states that water and oil are low-acid
foods that do not appreciably affect the finished equilibrium pH for the purpose of evaluating whether the
amount of low-acid foods in the finished product is a "small amount." Oil and watet al e key components
of condiment sauces and dressings. We recommend that these ingredients be included in the total product
weight when determining the percent low-acid ingredients in the formula but oil and water should
continue to be excluded as low-acid ingredients. The recommended calculation for weight of non-acid
ingredients does not take into consideration the relative strength or buffering capabilities of the acid
ingredients. For instance, 300 grain vinegar would require less quantity in total weight versus 60 grain
vinegar in the formula to achieve the same result. The difference in weight of the two products could
affect the proposed 10 percent calculation level yet the final result for product safety would be the same.
The pH calculation for the acid component weight should include the weight of the water as that then
Division of Dockets Management (HFA-305)
February 8, 2011
Page Three
defines the true pH and percent of the dissolved acid portion of the formula. Vegetable oils do not have a
pH value since they do not contain water and as such, the hydrogen ion concentration of oils cannot be
measured. Therefore, oils do not negatively affect the functionality of the acid component of the formula
as it is the aqueous phase acidity that drives functionality of the acid component.
In the draft guidance, the FDA states the recommendation that a "small amount of low-acid food(s)"
should be no more than 10 percent by weight of low-acid foods in the finished product is based on the
Agency's experience with determining, on a case-by-case basis for filed processes, the amount of low-
acid food that should be considered a "small amount." Since product formulations vary and there are
numerous product formulas on the market, it would seem that the basis for the determination of the 10
percent standard would be a scientific formula or calculation. Since it is not possible for the FDA to
review every product formula on the market, there could possibly be some cases where the 10 percent
standard is not applicable.
Salt, color, sugar and flavors are noted as low-acid ingredients in the draft guidance. We believe the
original intent of the regulation was to assure the safety of products with low-acid particulates (e.g.,
vegetables, spices). We believe that water soluble ingredients such as salt, color, sugar and flavors should
be excluded from the calculations of the percent by weight of low-acid ingredients. The key concern is
the acidification of the non-acid components. Larger particulates should be the concern in achieving
equilibrium within the defined timeline instead of the total weight of soluble spices or small particulate
material that readily hydrates and absorb the acid solution.
Significant Difference in pH
Calculating a limit on significant shift in pH seems arbitrary especially if the final equilibrium pH is
achieved within the 24 hour guidelines and is less than the key safety hurdles given all of the current
justifications for the recommendations. If the concern is around the accuracy of the pH determination,
then the threshold should be dropped to compensate instead for how much the total pH shifts. This is
especially relevant if the level of pH is significantly below the threshold (i.e., 4.2 or less). A shift from
3.0 to 3.7 would not have an impact on the true safety of the product. Products with a final pH below 3.8
should be allowed a change of more than 0.4 pH units since the safety of the product is not impacted by
the pH change. The limits should be expressed as a final pH rather than limit the pH change to 0.4.
Processing Acidified Foods
The draft guidance, Section J.5. "Adequacy of the Scheduled Process," states the following:
"Under 21 CFR 108.25(c)(3)(ii), we may request that a processor provide information we deem necessary
to determine the adequacy of the process. Consistent with 21 CFR114.3(b) and 114.80(a)(1), the
requested information may include information related to:
•
Adequacy of the process to destroy vegetative cells of microorganisms, including microorganisms
of public health significance and microorganisms of non-health significance; and
•
Adequacy of the process to destroy spores of microorganisms capable of germinating and
reproducing and increasing the pH of acidified foods above 4.6."
We believe the information in the second bullet, "adequacy of the process to destroy spores of
microorganisms capable of germinating and reproducing and increasing the pH of acidified foods above
4.6" is not consistent with the acidified foods regulations since the regulations do not mention the term
Regards,
eannie Milewski, M.S.
Executive Director
Division of Dockets Management (HFA-305)
February 8, 2011
Page Four
"spores" or the destruction or control of spores. This approach is an entirely different hurdle than
previously defined and, we believe, is unnecessary. It is well-documented that spores of foodborne
pathogens are unable to germinate and grow in mayonnaise and dressings at a pH below 4.5, and
therefore are of no significance to the safety of these products
3
. As such, we believe that the FDA should
be consistent with the elements of the recent FDA Food Safety Modernization Act and rely on effective
food safety plans to ensure the safety of products rather than suggesting a scheduled process which would
do nothing to advance the food safety of this category as a whole.
Error
Example 7 in Appendix 1, -Barbecue Sauce Manufactured by Company G" contains an error in Step G.
The draft guidance references -fresh apples" as an acid ingredient in the manufacture of barbecue sauce.
The example should reference the acid ingredients - vinegar and tomato paste in Step G since these
ingredients are listed earlier in the example.
Time Burden Estimates
The time burden estimates provided by the FDA in the
Federal Register
notice underestimates the time
and cost required to develop procedures, create documentation, identify and contract with process
authorities, conduct research in heat penetration studies, microbiological challenge studies or lethality
curves and conduct internal training as required for compliance to 21 CFR part 114. The burden estimate
is not limited to filing a process with the FDA on a computer. These administrative burdens are
significantly underestimated and should be reconsidered — especially in light of our assertion that such
activity would not benefit the consumer of dressing and sauce products.
ADS appreciates your consideration of these comments.
References
1.
Smittle, R. B. 2000. Microbiological safety of mayonnaise, salad dressings, and sauces produced in
the United States: A Review.
J. Food Prot.
63:1144-1153.
2.
Beuchat, L. R., J. Ryu,
B. B.
Adler, and M. D. Harrison. 2006. Death of
Salmonella, Escherichia
coli
0157:H7, and
Listeria monocytogenes
in Shelf-Stable, Dairy-Based, Pourable Salad Dressings.
J. Food Prot.
69:801-814.
3.
International Commission on Microbiological Specifications for Foods (ICMSF), 1998. Oil- and Fat-
based Foods. In Microorganisms in Foods, Vol. 6. Microbial Ecology of Food Commodities, Blackie
Academic & Professional, London, 390-417
~
The Association for Dressings & Sauces
1100 Johnson Ferry Road, Suite 300
Atlanta, Georgia 30342
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