Acrylamide in Food; Request for Comments and for Scientific Data and Information, 43134-43138 [E9-20495]
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Wanda K. Jones,
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BILLING CODE 4150–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0393]
Acrylamide in Food; Request for
Comments and for Scientific Data and
Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice; request for comments
and scientific data and information.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
comments and scientific data and
information on acrylamide in food.
Acrylamide is a chemical that can form
in some foods during certain types of
high-temperature cooking. FDA is
seeking information on practices that
manufacturers have used to reduce
acrylamide in food and the reductions
they have been able to achieve in
acrylamide levels. FDA is considering
issuing guidance for industry on
reduction of acrylamide levels in food
products.
DATES: Submit comments and scientific
data and information by November 24,
2009.
Submit written comments
and scientific data and information to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments and scientific data
and information to https://
www.regulations.gov.
jlentini on DSKJ8SOYB1PROD with NOTICES
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Lauren Posnick Robin, Center for Food
Safety and Applied Nutrition (HFS–
317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–1639.
SUPPLEMENTARY INFORMATION:
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I. Background
A. Introduction
In 2002, scientists in Sweden
announced the discovery of the
chemical acrylamide in a variety of
heated foods (Ref. 1). Further research
subsequently determined that
acrylamide can form in some foods
during certain types of high-temperature
cooking (Refs. 2 and 3). Acrylamide in
food is a concern because it has been
found to be carcinogenic in rodents and
is therefore considered a potential
carcinogen for humans (Refs. 4 and 5).
Since the identification of acrylamide
in food, research around the world has
centered on measuring acrylamide
exposure in the diet, studying the
toxicology and epidemiology of
acrylamide exposure, and reducing
(mitigating) acrylamide levels in food.
Information on FDA’s activities on
acrylamide can be found on FDA’s Web
site (Ref. 6). FDA’s research program has
focused on toxicology but has also
included research on mitigation for
consumers (Ref. 7). Based on this
research and other findings, FDA added
information to its Web site in 2008 for
consumers interested in reducing their
acrylamide exposure from food.
However, FDA’s general advice for
acrylamide and eating is for consumers
to adopt a healthy eating plan consistent
with the Dietary Guidelines for
Americans (Refs. 6 and 8). The Dietary
Guidelines for Americans suggests a diet
that emphasizes fruits, vegetables,
whole grains, and fat-free or low-fat
milk and milk products; includes lean
meats, poultry, fish, beans, eggs, and
nuts; and is low in saturated fats, trans
fats, cholesterol, salt (sodium), and
added sugars.
FDA has not issued guidance for
manufacturers on reducing acrylamide
in food. However, it is anticipated that
new information will soon be available
about the toxicology of acrylamide,
which may confirm acrylamide’s
carcinogenicity in laboratory animals.
International efforts to develop
approaches to acrylamide mitigation are
also beginning to prove successful.
Moreover, FDA is aware that at least
some manufacturers in the United States
are seeking ways to reduce acrylamide
in their products. For these reasons,
FDA is considering issuing guidance for
industry on reduction of acrylamide
levels in food products.
This document summarizes
information available to FDA about
acrylamide formation, exposure,
toxicology, levels in food, and
techniques to mitigate acrylamide. This
notice also identifies areas in which
additional data and information would
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be helpful to FDA in learning more
about acrylamide mitigation techniques
and levels of acrylamide in food. These
areas are outlined in more detail in
section II of this document.
B. Formation and Exposure
Acrylamide forms in foods primarily
from a reaction between asparagine, an
amino acid, and reducing sugars such as
glucose and fructose. This reaction is
part of the Maillard reaction, which
leads to color, flavor, and aroma
changes in cooked foods (Refs. 2, 3, and
9). Acrylamide formation usually occurs
at elevated temperatures used when
frying or baking (above 120 °C (248 °F))
and in low moisture conditions,
although acrylamide has also been
identified in some fruit and vegetable
products heated at lower temperatures
or higher moisture conditions (Refs. 10
through 13). Also, formation occurs
primarily in plant-based foods, notably
potato products such as French fries and
potato chips; coffee; and cereal-grainbased foods such as cookies, crackers,
breakfast cereals, and toasted bread.
Thousands of food samples have been
analyzed for acrylamide since 2002.
Based on its own database of acrylamide
levels in U.S. foods (Refs. 12 and 13),
FDA estimates acrylamide intake for the
average U.S. consumer as 0.4
microgram/kilogram body weight/day
(μg/kg-bw/d) (Ref. 14). International
estimates for the average consumer
range from 0.2 to 1.4 μg/kg-bw/d (Ref.
15). Based on estimates from different
countries, the Joint Food and
Agriculture Organization/World Health
Organization (FAO/WHO) Expert
Committee on Food Additives (JECFA)
identified an average acrylamide intake
of 1 μg/kg-bw/d for the general
consumer and 4 μg/kg-bw/d for high
consumers (Ref. 4).
Based on measured levels of
acrylamide in certain foods and on how
frequently these foods are consumed in
the United States, FDA identified the
following 10 foods (in ranked order) that
contribute the most acrylamide to the
U.S. diet: French fries (restaurant
prepared), French fries (oven baked),
potato chips, breakfast cereals, cookies,
brewed coffee, toast, pies and cakes,
crackers, and soft (nontoasted) breads
(Ref. 14). The JECFA evaluation
concurred that the major foods
contributing to total exposure for most
countries were French fries, potato
chips, coffee, pastry and sweet cookies,
and breads and toasts (Ref. 4).
C. Toxicology
Several international toxicology
evaluations of acrylamide have been
completed since the identification of
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acrylamide in food in 2002 (Refs. 4 and
5). An initial FAO/WHO consultation in
2002 called the presence of acrylamide
in food ‘‘a major concern’’ based on
acrylamide’s ability to induce cancer
and heritable mutations in laboratory
animals. In 2005, an international
evaluation of acrylamide by JECFA
identified margins of exposure (MOEs)
for acrylamide of 300 for general
consumers and 75 for high consumers.
JECFA considers the MOE of 300
calculated for acrylamide to be low for
a compound that is genotoxic and
carcinogenic and concluded that the
levels of acrylamide in food were of
concern.
Under the sponsorship of the National
Toxicology Program, FDA’s National
Center for Toxicological Research
(NCTR) embarked in 2002 on a series of
new toxicology assays for acrylamide.
These studies were designed to address
deficiencies in earlier carcinogenicity
studies and to provide more reliable
data on potential carcinogenic risk of
acrylamide and other potential effects of
acrylamide exposure. The work at NCTR
includes long-term carcinogenicity
bioassays of acrylamide and its
metabolite glycidamide in mice and
rats, as well as toxicokinetic,
bioavailability, mutagenicity, and
neurodevelopmental studies (Refs. 16
through 34). NCTR’s work also includes
the development of a physiologically
based pharmacokinetic model for
acrylamide and glycidamide (Refs. 19
and 34).
D. Reduction of Acrylamide Levels in
Food
Since the discovery of acrylamide in
food in 2002, the international research
community has explored numerous
strategies for reducing acrylamide levels
in food products. This work is
summarized in the scientific literature
(e.g., Refs. 35 through 48), as well as in
guidance materials prepared by
industry, other governments, and
international organizations. Notable
guidance materials include the
Acrylamide ‘‘Toolbox’’ produced by the
Confederation of Food and Drink
Industries of the European Union
(CIAA) (Ref. 49), CIAA ‘‘Toolbox’’
brochures on selected foods for smalland medium-sized businesses (Refs. 50
through 54), the ‘‘Review of Acrylamide
Mitigation in Biscuits, Crackers and
Crispbread’’ produced by the
Association of the Chocolate, Biscuits,
and Confectionary Industries of the
European Union (CAOBISCO) (Ref. 55),
and ‘‘Guidelines to Authorities and
Consumer Organisations on Home
Cooking and Consumption’’ and
‘‘Manual on strategies to food
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industries, restaurants, etc., to minimize
acrylamide formation’’ produced by the
Heat-Generated Food Toxicants:
Identification, Characterization and Risk
Minimisation (HEATOX) Project (Refs.
56 and 57). The Codex Committee on
Contaminants in Foods (CCCF) has also
prepared a Code of Practice for the
Reduction of Acrylamide in Foods (Ref.
58), with the U.S. Delegation to CCCF
participating in preparation of the code
of practice as co-lead of the document
working group.
Research on acrylamide mitigation
has focused on reducing acrylamide in
potato products, cereal-grain-based
products (e.g., baked goods), and coffee
through interventions directed at raw
materials, additional ingredients, and
processing (Ref. 58). As a result of this
research, effective mitigation measures
have been identified for reducing
acrylamide levels in some potato and
cereal products; however, no proven
mitigation measures have been devised
for coffee (Refs. 49 and 58).
Potato products. For potato products,
mitigation practices directed at raw
materials focus on controlling reducing
sugar levels, for example: (1) Selecting
potato cultivars that are low in reducing
sugars, (2) checking sugar levels of
incoming potato lots using chemical
analysis or fry testing, (3) storing
potatoes above 6 °C (43 °F) to avoid lowtemperature sweetening, (4) using
reconditioning to lower sugar levels in
stored potatoes, and (5) avoiding use of
immature potatoes, which have higher
sugar levels. Other mitigation practices
for potato products address additional
ingredients, including using the enzyme
asparaginase to reduce levels of the
acrylamide precursor asparagine,
partially substituting potato ingredients
with nonpotato ingredients, and
formulating recipes to include
ingredients such as sodium
pyrophosphate and calcium salts (Refs.
49 and 58). Finally, acrylamide
mitigation practices for potato products
also address processing steps. For
French fries, such practices include: (1)
Washing or blanching (with or without
added ingredients such as sodium
pyrophosphate and cation salts), (2)
cutting thicker potato pieces, (3)
removing fines (fine pieces of potato),
(4) setting fryer temperature no higher
than 175 °C (347 °F), and (5) cooking
fries to a golden yellow color rather than
a golden brown color. For potato chips,
such practices include: (1) Optimizing
time and temperature cooking
conditions, (2) cooking to a golden
yellow color, (3) utilizing vacuum frying
or flash frying with rapid cooling, and
(4) using optical sorting to remove
darker chips (Refs. 49 and 58).
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Cereal grain products. In cereal-grainbased foods, strain selection and
agronomic practices targeted at reducing
asparagine levels in raw materials (such
as ensuring adequate sulfur fertilization)
show potential to reduce acrylamide
(Refs. 49 and 58). Mitigation measures
directed at additional ingredients
include use of asparaginase to deplete
asparagine and partial substitution of
higher-asparagine flours (e.g., wheat,
rye) with lower-asparagine flours (e.g.,
rice). Substitution of whole-grain flours
with highly processed flours can also
reduce acrylamide, but use of highly
processed flours does not provide the
nutritional benefits associated with
whole-grain flours. Other ingredientdirected measures that may reduce
acrylamide in baked goods include
substitution of ammonium-based raising
agents with potassium- and sodiumbased raising agents, avoidance of
reducing sugars during baking, addition
of calcium salts, and modification of the
use of minor ingredients (e.g., spices)
and rework (Refs. 49 and 58). Processing
changes shown to decrease acrylamide
in cereal-based foods include adjusting
the time-temperature profile of baking
processes, extending dough
fermentation times, controlling final
moisture content, and not over-baking
or over-toasting foods (Refs. 49 and 58).
E. Levels of Acrylamide in Food
Measured acrylamide levels in food
are summarized in multiple databases,
publications, and evaluations (e.g., Refs.
4, 12, 13, and 59). Levels of acrylamide
in food vary widely, from undetectable
amounts in some cereal grain- and
potato-based products (e.g., untoasted
bread and mashed potatoes) to more
than 5000 μg/kg in a cereal grain
product (e.g., grain-based coffee
substitute) (Refs. 12 and 13).
Acrylamide levels also can vary widely
within individual food types (e.g., Ref.
12). For example, in data collected by
FDA, levels of acrylamide in potato
chips varied from nearly 120 μg/kg to
over 1200 μg/kg (Ref. 12). There may
also be considerable variation within
different lots of the same product due to
variation in raw materials and
processing conditions. Despite the wide
range of acrylamide levels for a given
food, the availability of proven
mitigation practices (Refs. 49 through
58) suggests that it may be feasible to
recommend, for some foods, levels for
acrylamide that all manufacturers
should be capable of achieving.
II. Request for Comments and for
Scientific Data and Information
FDA is seeking additional scientific
data and information on (1) methods for
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reducing acrylamide levels in food and
(2) reductions that manufacturers have
been able to achieve in acrylamide
levels. Accordingly, FDA invites all
interested parties to submit comments
and scientific data and information on
the topics identified. FDA is also
seeking specific data and other
information on the following questions:
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A. Methods for Reducing Acrylamide
Levels in Food
1. Are you (manufacturers) currently
taking any steps to reduce acrylamide
levels in your food products? If yes,
what methods are you using? Please list
mitigation methods by food type (e.g.,
potato chip) and, where possible, by
product line (e.g., potato chip line one).
It is not necessary to identify product
line by brand name. Please provide as
many details as possible, including
being specific about changes to
methods, e.g., identify new and
previous frying temperatures rather than
simply indicating that the frying
temperature was lowered.
2. Which methods, if any, have not
proved successful or cost-effective for
reducing acrylamide in your products?
Please identify food types and/or
product lines for which particular
methods have not proved successful or
cost-effective. Where possible, identify
the reasons these methods have not
proved successful or cost-effective.
3. What changes in ingredients (e.g.,
addition of cation salts, amino acids, or
spices; blanching with sodium
pyrophosphate; substitution of grains or
sugars; replacement of ammonium
bicarbonate) have proved effective and
feasible in lowering acrylamide levels in
your products? Please provide specific
details about product types and
manufacturing process changes.
4. Do you use asparaginase to lower
acrylamide levels in any of your
products? If so, in which of your
products has asparaginase proved
effective and feasible in lowering
acrylamide levels? Please provide
specific details about product types and
manufacturing process changes.
5. What changes in precooking
parameters (e.g., blanching,
fermentation) and cooking parameters
(e.g., time and temperature of cooking,
final moisture content) have proved
effective and feasible in lowering
acrylamide levels in your products?
Please provide specific details about
product types and manufacturing
process changes. Are techniques such as
flash frying and vacuum frying feasible
methods of acrylamide reduction?
6. What mitigation methods might be
more or less appropriate for small
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manufacturers? Please provide a
rationale for your response.
7. Do you monitor acrylamide
formation and reduction? If yes, what
endpoint (e.g., browning, measurement
of acrylamide levels) do you use?
8. What are standard practices in the
United States for delivery, storage,
temperature control, reconditioning,
and screening (e.g., by fry testing) of
potatoes? What potato cultivars in the
United States are appropriate for
production of French fries, potato chips,
and other potato-based snacks? What
cultivars are not acceptable for
producing these products and/or
roasting or frying potatoes at home? Is
it appropriate to specify an acceptable
level of reducing sugars in incoming lots
of potatoes and, if so, what level is
appropriate?
9. What changes have you made, if
any, to the instructions on food
packaging to reduce acrylamide
formation during final preparation of
food products by consumers?
10. Aside from changes to the
instructions on food packaging, are
there other steps that manufacturers can
take to help consumers reduce
acrylamide in food, such as labeling instore potatoes for appropriate use?
11. Are there other important sources
of information on reducing acrylamide
levels in food that FDA has not
identified in this document? If yes,
please identify such sources.
12. Are there any other sources of
information about proposed acrylamide
mitigation techniques (particularly as
applied to U.S. products) that might be
more useful or accurate than the
information described in this
document?
B. Levels of Acrylamide in Food
Among the information that would be
helpful to FDA in potentially
recommending levels for acrylamide in
food is data on reductions achieved by
manufacturers using mitigation
techniques. Some information on
acrylamide levels can be found in
existing databases and publications
(Refs. 4, 12, 13, and 59), but these
databases may reflect, at least in part,
acrylamide levels before mitigation
measures were applied. Data from more
targeted or ongoing sampling plans (e.g.,
Refs. 60 through 64) and from legal
settlements (Ref. 65) may also be useful
sources of information on acrylamide
levels in food, although some of this
information may be limited in scope or
applicable primarily to European
products.
1. What acrylamide levels have you
observed before and after applying
mitigation practices? Please break down
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your data by food type (e.g., potato chip)
and, where possible, by product line
(e.g., potato chip line one). It is not
necessary to identify a product line by
brand name. Please include, if possible,
measurements of acrylamide levels in
individual samples, as well as statistical
endpoints (e.g., means, medians,
standard deviations). Finally, please
identify the acrylamide mitigation
measures you used to achieve these
reductions.
2. Do you anticipate being able to
achieve further reductions by applying
different or additional approaches? If
yes, please identify the approaches. If
no, please explain what limits your
ability to further reduce the levels of
acrylamide in particular products.
3. What factors, if any, have affected
your ability to consistently achieve
certain levels of acrylamide or certain
percentage reductions?
4. For what food types, if any, would
it be appropriate to recommend levels
for acrylamide? Please provide an
explanation of your response.
5. What reduced acrylamide levels
should manufacturers be able to achieve
for the following foods: French fries,
potato chips, breakfast cereals, coffee,
and cookies and other baked goods?
What reduced acrylamide levels should
manufacturers be able to achieve for
other potato- or corn-based snacks?
6. What additional factors, if any,
should FDA consider if it recommends
levels for acrylamide in foods?
7. Are there important sources of
information that FDA has not identified
in this document on levels of
acrylamide in food and reductions in
acrylamide levels achieved by
manufacturers? If yes, please identify
such sources.
8. Are there any other sources of
information about attainable levels of
acrylamide in food that might be more
useful or accurate than the information
described in this notice?
C. Comments
Interested parties may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
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III. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but FDA is not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Tareke, E., P. Rydberg, P. Karlsson, S.
¨
Eriksson, and M. Tornqvist, ‘‘Analysis of
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Dodson, ‘‘Acrylamide is formed in the
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449, 2002.
3. Stadler, R.H., I. Blank, N. Varga, F.
Robert, J. Hau, P.A. Guy, M.C. Robert, and S.
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Accessed online at https://www.who.int/ipcs/
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11. Roach, J.A.G., D. Andrzejewski, M.L.
Gay, D. Nortrup, and S.M. Musser, ‘‘Rugged
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‘‘Survey Data on Acrylamide in Food:
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assessment for acrylamide,’’ 2006. Accessed
online at https://www.fda.gov/Food/
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Delongchamp, L. Muskhelishvili, A.R.
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McDaniel, and D.R. Doerge, ‘‘The effects of
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2005.
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64. Health Canada, ‘‘Health Canada’s
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65. Office of the Attorney General, State of
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Settles Potato Chip Lawsuit With Heinz,
Frito-Lay & Kettle Foods,’’ August 1, 2008.
Accessed online at https://ag.ca.gov/
newsalerts/release.php?id=1595&.
Dated: August 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20495 Filed 8–25–09; 8:45 am]
BILLING CODE 4160–01–S
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[Federal Register Volume 74, Number 164 (Wednesday, August 26, 2009)]
[Notices]
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From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20495]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0393]
Acrylamide in Food; Request for Comments and for Scientific Data
and Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments and scientific data and
information.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting comments
and scientific data and information on acrylamide in food. Acrylamide
is a chemical that can form in some foods during certain types of high-
temperature cooking. FDA is seeking information on practices that
manufacturers have used to reduce acrylamide in food and the reductions
they have been able to achieve in acrylamide levels. FDA is considering
issuing guidance for industry on reduction of acrylamide levels in food
products.
DATES: Submit comments and scientific data and information by November
24, 2009.
ADDRESSES: Submit written comments and scientific data and information
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments and scientific data and information to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1639.
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
In 2002, scientists in Sweden announced the discovery of the
chemical acrylamide in a variety of heated foods (Ref. 1). Further
research subsequently determined that acrylamide can form in some foods
during certain types of high-temperature cooking (Refs. 2 and 3).
Acrylamide in food is a concern because it has been found to be
carcinogenic in rodents and is therefore considered a potential
carcinogen for humans (Refs. 4 and 5).
Since the identification of acrylamide in food, research around the
world has centered on measuring acrylamide exposure in the diet,
studying the toxicology and epidemiology of acrylamide exposure, and
reducing (mitigating) acrylamide levels in food. Information on FDA's
activities on acrylamide can be found on FDA's Web site (Ref. 6). FDA's
research program has focused on toxicology but has also included
research on mitigation for consumers (Ref. 7). Based on this research
and other findings, FDA added information to its Web site in 2008 for
consumers interested in reducing their acrylamide exposure from food.
However, FDA's general advice for acrylamide and eating is for
consumers to adopt a healthy eating plan consistent with the Dietary
Guidelines for Americans (Refs. 6 and 8). The Dietary Guidelines for
Americans suggests a diet that emphasizes fruits, vegetables, whole
grains, and fat-free or low-fat milk and milk products; includes lean
meats, poultry, fish, beans, eggs, and nuts; and is low in saturated
fats, trans fats, cholesterol, salt (sodium), and added sugars.
FDA has not issued guidance for manufacturers on reducing
acrylamide in food. However, it is anticipated that new information
will soon be available about the toxicology of acrylamide, which may
confirm acrylamide's carcinogenicity in laboratory animals.
International efforts to develop approaches to acrylamide mitigation
are also beginning to prove successful. Moreover, FDA is aware that at
least some manufacturers in the United States are seeking ways to
reduce acrylamide in their products. For these reasons, FDA is
considering issuing guidance for industry on reduction of acrylamide
levels in food products.
This document summarizes information available to FDA about
acrylamide formation, exposure, toxicology, levels in food, and
techniques to mitigate acrylamide. This notice also identifies areas in
which additional data and information would be helpful to FDA in
learning more about acrylamide mitigation techniques and levels of
acrylamide in food. These areas are outlined in more detail in section
II of this document.
B. Formation and Exposure
Acrylamide forms in foods primarily from a reaction between
asparagine, an amino acid, and reducing sugars such as glucose and
fructose. This reaction is part of the Maillard reaction, which leads
to color, flavor, and aroma changes in cooked foods (Refs. 2, 3, and
9). Acrylamide formation usually occurs at elevated temperatures used
when frying or baking (above 120 [deg]C (248 [deg]F)) and in low
moisture conditions, although acrylamide has also been identified in
some fruit and vegetable products heated at lower temperatures or
higher moisture conditions (Refs. 10 through 13). Also, formation
occurs primarily in plant-based foods, notably potato products such as
French fries and potato chips; coffee; and cereal-grain-based foods
such as cookies, crackers, breakfast cereals, and toasted bread.
Thousands of food samples have been analyzed for acrylamide since
2002. Based on its own database of acrylamide levels in U.S. foods
(Refs. 12 and 13), FDA estimates acrylamide intake for the average U.S.
consumer as 0.4 microgram/kilogram body weight/day (microg/kg-bw/d)
(Ref. 14). International estimates for the average consumer range from
0.2 to 1.4 microg/kg-bw/d (Ref. 15). Based on estimates from different
countries, the Joint Food and Agriculture Organization/World Health
Organization (FAO/WHO) Expert Committee on Food Additives (JECFA)
identified an average acrylamide intake of 1 microg/kg-bw/d for the
general consumer and 4 microg/kg-bw/d for high consumers (Ref. 4).
Based on measured levels of acrylamide in certain foods and on how
frequently these foods are consumed in the United States, FDA
identified the following 10 foods (in ranked order) that contribute the
most acrylamide to the U.S. diet: French fries (restaurant prepared),
French fries (oven baked), potato chips, breakfast cereals, cookies,
brewed coffee, toast, pies and cakes, crackers, and soft (nontoasted)
breads (Ref. 14). The JECFA evaluation concurred that the major foods
contributing to total exposure for most countries were French fries,
potato chips, coffee, pastry and sweet cookies, and breads and toasts
(Ref. 4).
C. Toxicology
Several international toxicology evaluations of acrylamide have
been completed since the identification of
[[Page 43135]]
acrylamide in food in 2002 (Refs. 4 and 5). An initial FAO/WHO
consultation in 2002 called the presence of acrylamide in food ``a
major concern'' based on acrylamide's ability to induce cancer and
heritable mutations in laboratory animals. In 2005, an international
evaluation of acrylamide by JECFA identified margins of exposure (MOEs)
for acrylamide of 300 for general consumers and 75 for high consumers.
JECFA considers the MOE of 300 calculated for acrylamide to be low for
a compound that is genotoxic and carcinogenic and concluded that the
levels of acrylamide in food were of concern.
Under the sponsorship of the National Toxicology Program, FDA's
National Center for Toxicological Research (NCTR) embarked in 2002 on a
series of new toxicology assays for acrylamide. These studies were
designed to address deficiencies in earlier carcinogenicity studies and
to provide more reliable data on potential carcinogenic risk of
acrylamide and other potential effects of acrylamide exposure. The work
at NCTR includes long-term carcinogenicity bioassays of acrylamide and
its metabolite glycidamide in mice and rats, as well as toxicokinetic,
bioavailability, mutagenicity, and neurodevelopmental studies (Refs. 16
through 34). NCTR's work also includes the development of a
physiologically based pharmacokinetic model for acrylamide and
glycidamide (Refs. 19 and 34).
D. Reduction of Acrylamide Levels in Food
Since the discovery of acrylamide in food in 2002, the
international research community has explored numerous strategies for
reducing acrylamide levels in food products. This work is summarized in
the scientific literature (e.g., Refs. 35 through 48), as well as in
guidance materials prepared by industry, other governments, and
international organizations. Notable guidance materials include the
Acrylamide ``Toolbox'' produced by the Confederation of Food and Drink
Industries of the European Union (CIAA) (Ref. 49), CIAA ``Toolbox''
brochures on selected foods for small- and medium-sized businesses
(Refs. 50 through 54), the ``Review of Acrylamide Mitigation in
Biscuits, Crackers and Crispbread'' produced by the Association of the
Chocolate, Biscuits, and Confectionary Industries of the European Union
(CAOBISCO) (Ref. 55), and ``Guidelines to Authorities and Consumer
Organisations on Home Cooking and Consumption'' and ``Manual on
strategies to food industries, restaurants, etc., to minimize
acrylamide formation'' produced by the Heat-Generated Food Toxicants:
Identification, Characterization and Risk Minimisation (HEATOX) Project
(Refs. 56 and 57). The Codex Committee on Contaminants in Foods (CCCF)
has also prepared a Code of Practice for the Reduction of Acrylamide in
Foods (Ref. 58), with the U.S. Delegation to CCCF participating in
preparation of the code of practice as co-lead of the document working
group.
Research on acrylamide mitigation has focused on reducing
acrylamide in potato products, cereal-grain-based products (e.g., baked
goods), and coffee through interventions directed at raw materials,
additional ingredients, and processing (Ref. 58). As a result of this
research, effective mitigation measures have been identified for
reducing acrylamide levels in some potato and cereal products; however,
no proven mitigation measures have been devised for coffee (Refs. 49
and 58).
Potato products. For potato products, mitigation practices directed
at raw materials focus on controlling reducing sugar levels, for
example: (1) Selecting potato cultivars that are low in reducing
sugars, (2) checking sugar levels of incoming potato lots using
chemical analysis or fry testing, (3) storing potatoes above 6 [deg]C
(43 [deg]F) to avoid low-temperature sweetening, (4) using
reconditioning to lower sugar levels in stored potatoes, and (5)
avoiding use of immature potatoes, which have higher sugar levels.
Other mitigation practices for potato products address additional
ingredients, including using the enzyme asparaginase to reduce levels
of the acrylamide precursor asparagine, partially substituting potato
ingredients with nonpotato ingredients, and formulating recipes to
include ingredients such as sodium pyrophosphate and calcium salts
(Refs. 49 and 58). Finally, acrylamide mitigation practices for potato
products also address processing steps. For French fries, such
practices include: (1) Washing or blanching (with or without added
ingredients such as sodium pyrophosphate and cation salts), (2) cutting
thicker potato pieces, (3) removing fines (fine pieces of potato), (4)
setting fryer temperature no higher than 175 [deg]C (347 [deg]F), and
(5) cooking fries to a golden yellow color rather than a golden brown
color. For potato chips, such practices include: (1) Optimizing time
and temperature cooking conditions, (2) cooking to a golden yellow
color, (3) utilizing vacuum frying or flash frying with rapid cooling,
and (4) using optical sorting to remove darker chips (Refs. 49 and 58).
Cereal grain products. In cereal-grain-based foods, strain
selection and agronomic practices targeted at reducing asparagine
levels in raw materials (such as ensuring adequate sulfur
fertilization) show potential to reduce acrylamide (Refs. 49 and 58).
Mitigation measures directed at additional ingredients include use of
asparaginase to deplete asparagine and partial substitution of higher-
asparagine flours (e.g., wheat, rye) with lower-asparagine flours
(e.g., rice). Substitution of whole-grain flours with highly processed
flours can also reduce acrylamide, but use of highly processed flours
does not provide the nutritional benefits associated with whole-grain
flours. Other ingredient-directed measures that may reduce acrylamide
in baked goods include substitution of ammonium-based raising agents
with potassium- and sodium-based raising agents, avoidance of reducing
sugars during baking, addition of calcium salts, and modification of
the use of minor ingredients (e.g., spices) and rework (Refs. 49 and
58). Processing changes shown to decrease acrylamide in cereal-based
foods include adjusting the time-temperature profile of baking
processes, extending dough fermentation times, controlling final
moisture content, and not over-baking or over-toasting foods (Refs. 49
and 58).
E. Levels of Acrylamide in Food
Measured acrylamide levels in food are summarized in multiple
databases, publications, and evaluations (e.g., Refs. 4, 12, 13, and
59). Levels of acrylamide in food vary widely, from undetectable
amounts in some cereal grain- and potato-based products (e.g.,
untoasted bread and mashed potatoes) to more than 5000 microg/kg in a
cereal grain product (e.g., grain-based coffee substitute) (Refs. 12
and 13). Acrylamide levels also can vary widely within individual food
types (e.g., Ref. 12). For example, in data collected by FDA, levels of
acrylamide in potato chips varied from nearly 120 microg/kg to over
1200 microg/kg (Ref. 12). There may also be considerable variation
within different lots of the same product due to variation in raw
materials and processing conditions. Despite the wide range of
acrylamide levels for a given food, the availability of proven
mitigation practices (Refs. 49 through 58) suggests that it may be
feasible to recommend, for some foods, levels for acrylamide that all
manufacturers should be capable of achieving.
II. Request for Comments and for Scientific Data and Information
FDA is seeking additional scientific data and information on (1)
methods for
[[Page 43136]]
reducing acrylamide levels in food and (2) reductions that
manufacturers have been able to achieve in acrylamide levels.
Accordingly, FDA invites all interested parties to submit comments and
scientific data and information on the topics identified. FDA is also
seeking specific data and other information on the following questions:
A. Methods for Reducing Acrylamide Levels in Food
1. Are you (manufacturers) currently taking any steps to reduce
acrylamide levels in your food products? If yes, what methods are you
using? Please list mitigation methods by food type (e.g., potato chip)
and, where possible, by product line (e.g., potato chip line one). It
is not necessary to identify product line by brand name. Please provide
as many details as possible, including being specific about changes to
methods, e.g., identify new and previous frying temperatures rather
than simply indicating that the frying temperature was lowered.
2. Which methods, if any, have not proved successful or cost-
effective for reducing acrylamide in your products? Please identify
food types and/or product lines for which particular methods have not
proved successful or cost-effective. Where possible, identify the
reasons these methods have not proved successful or cost-effective.
3. What changes in ingredients (e.g., addition of cation salts,
amino acids, or spices; blanching with sodium pyrophosphate;
substitution of grains or sugars; replacement of ammonium bicarbonate)
have proved effective and feasible in lowering acrylamide levels in
your products? Please provide specific details about product types and
manufacturing process changes.
4. Do you use asparaginase to lower acrylamide levels in any of
your products? If so, in which of your products has asparaginase proved
effective and feasible in lowering acrylamide levels? Please provide
specific details about product types and manufacturing process changes.
5. What changes in precooking parameters (e.g., blanching,
fermentation) and cooking parameters (e.g., time and temperature of
cooking, final moisture content) have proved effective and feasible in
lowering acrylamide levels in your products? Please provide specific
details about product types and manufacturing process changes. Are
techniques such as flash frying and vacuum frying feasible methods of
acrylamide reduction?
6. What mitigation methods might be more or less appropriate for
small manufacturers? Please provide a rationale for your response.
7. Do you monitor acrylamide formation and reduction? If yes, what
endpoint (e.g., browning, measurement of acrylamide levels) do you use?
8. What are standard practices in the United States for delivery,
storage, temperature control, reconditioning, and screening (e.g., by
fry testing) of potatoes? What potato cultivars in the United States
are appropriate for production of French fries, potato chips, and other
potato-based snacks? What cultivars are not acceptable for producing
these products and/or roasting or frying potatoes at home? Is it
appropriate to specify an acceptable level of reducing sugars in
incoming lots of potatoes and, if so, what level is appropriate?
9. What changes have you made, if any, to the instructions on food
packaging to reduce acrylamide formation during final preparation of
food products by consumers?
10. Aside from changes to the instructions on food packaging, are
there other steps that manufacturers can take to help consumers reduce
acrylamide in food, such as labeling in-store potatoes for appropriate
use?
11. Are there other important sources of information on reducing
acrylamide levels in food that FDA has not identified in this document?
If yes, please identify such sources.
12. Are there any other sources of information about proposed
acrylamide mitigation techniques (particularly as applied to U.S.
products) that might be more useful or accurate than the information
described in this document?
B. Levels of Acrylamide in Food
Among the information that would be helpful to FDA in potentially
recommending levels for acrylamide in food is data on reductions
achieved by manufacturers using mitigation techniques. Some information
on acrylamide levels can be found in existing databases and
publications (Refs. 4, 12, 13, and 59), but these databases may
reflect, at least in part, acrylamide levels before mitigation measures
were applied. Data from more targeted or ongoing sampling plans (e.g.,
Refs. 60 through 64) and from legal settlements (Ref. 65) may also be
useful sources of information on acrylamide levels in food, although
some of this information may be limited in scope or applicable
primarily to European products.
1. What acrylamide levels have you observed before and after
applying mitigation practices? Please break down your data by food type
(e.g., potato chip) and, where possible, by product line (e.g., potato
chip line one). It is not necessary to identify a product line by brand
name. Please include, if possible, measurements of acrylamide levels in
individual samples, as well as statistical endpoints (e.g., means,
medians, standard deviations). Finally, please identify the acrylamide
mitigation measures you used to achieve these reductions.
2. Do you anticipate being able to achieve further reductions by
applying different or additional approaches? If yes, please identify
the approaches. If no, please explain what limits your ability to
further reduce the levels of acrylamide in particular products.
3. What factors, if any, have affected your ability to consistently
achieve certain levels of acrylamide or certain percentage reductions?
4. For what food types, if any, would it be appropriate to
recommend levels for acrylamide? Please provide an explanation of your
response.
5. What reduced acrylamide levels should manufacturers be able to
achieve for the following foods: French fries, potato chips, breakfast
cereals, coffee, and cookies and other baked goods? What reduced
acrylamide levels should manufacturers be able to achieve for other
potato- or corn-based snacks?
6. What additional factors, if any, should FDA consider if it
recommends levels for acrylamide in foods?
7. Are there important sources of information that FDA has not
identified in this document on levels of acrylamide in food and
reductions in acrylamide levels achieved by manufacturers? If yes,
please identify such sources.
8. Are there any other sources of information about attainable
levels of acrylamide in food that might be more useful or accurate than
the information described in this notice?
C. Comments
Interested parties may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
[[Page 43137]]
III. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
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22. Gamboa da Costa, G., M.I. Churchwell, L.P. Hamilton, L.S.
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Twaddle, R. Snyder, T.R. Fennell, and D.R. Doerge, ``Role of CYP2E1
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26. Mani[egrave]re, I., T. Godard, D.R. Doerge, M.I. Churchwell,
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McDaniel, L.E. Lyn-Cook, and D.R. Doerge, ``Genotoxicity of
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28. Martins, C., N.G. Oliveira, M. Pingarilho, G. Gamboa da
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29. Mei, N., J. Hu, M.I. Churchwell, L. Guo, M.M. Moore, D.R.
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[[Page 43138]]
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39. Guenther, H., E. Anklam, T. Wenzl, and R.H. Stadler,
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Dated: August 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20495 Filed 8-25-09; 8:45 am]
BILLING CODE 4160-01-S