Food Labeling; Current Trends in the Use of Allergen Advisory Labeling: Its Use, Effectiveness, and Consumer Perception; Public Hearing; Request for Comments, 46302-46307 [E8-18280]
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We also require three new collections
which are the primary focus of this
supporting statement. First, we have
added new § 489.20(u)(2) to require a
hospital to require all physicians who
are members of the hospital’s medical
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[FR Doc. E8–18361 Filed 8–7–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0429]
Food Labeling; Current Trends in the
Use of Allergen Advisory Labeling: Its
Use, Effectiveness, and Consumer
Perception; Public Hearing; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public hearing on the use of advisory
labeling of allergens in foods. FDA is
developing a long-term strategy to assist
manufacturers in using allergen
advisory labeling that is truthful and not
misleading, conveys a clear and uniform
message, and adequately informs foodallergic consumers and their caregivers.
To that end, FDA is soliciting comments
and information to assist the agency in
determining how manufacturers
currently use advisory labeling, how
consumers interpret different advisory
labeling statements, and what wording
is likely to be most effective in
communicating to consumers the
likelihood that an allergen may be
present in a food. The agency is also
interested in receiving comments about
whether consumers find advisory
labeling helpful for making food
purchasing decisions. This public
hearing is the first step in closing
existing knowledge gaps in developing
our long-term strategy.
DATES: The public hearing will be held
on September 16, 2008, from 9 a.m. to
4:30 p.m. The closing date for
registration is September 8, 2008. See
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section V of this document for other
dates associated with participation in
the hearing. Submit written or
electronic comments (i.e., submissions
other than notices of participation and
written material associated with an oral
presentation) by January 14, 2009. The
administrative record of the hearing will
remain open until January 14, 2009.
ADDRESSES: Public hearing. The public
hearing will be held at the Harvey W.
Wiley Federal Building, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, (Metro stop: College Park on the
Green Line).
Registration. Submit electronic
notices of participation for the hearing
to https://www.cfsan.fda.gov/
register.html. We encourage you to use
this method of registration, if possible.
Submit written notices of participation
by mail, fax, or e-mail to Isabelle Howes,
U.S. Department of Agriculture
Graduate School, 600 Maryland Ave.,
SW., suite 330, Washington, DC 20024–
2520, FAX: 202–479–6801, or e-mail:
Isabelle_Howes@grad.usda.gov. You
may also submit oral notices of
participation by phone to Isabelle
Howes, U.S. Department of Agriculture
Graduate School (see FOR FURTHER
INFORMATION CONTACT).
Written material associated with an
oral presentation. Submit written
material associated with an oral
presentation by mail, fax, or e-mail to
Isabelle Howes.
Comments. Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. For additional
information on submitting comments,
see section VI in this document.
FOR FURTHER INFORMATION CONTACT:
For questions about registration or
written material associated with an
oral presentation, or to register
orally: Isabelle Howes, 202–314–
4713.
For all other questions about the
hearing or if you need parking or
special accommodations due to a
disability: Juanita Yates, Center for
Food Safety and Applied Nutrition,
Food and Drug Administration,
301–436–1731, e-mail:
Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Food allergies affect approximately
two percent of adults and about five
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percent of infants and young children in
the United States. Currently, there is no
cure for food allergies. The only
successful method to manage food
allergies is avoidance of foods
containing allergens. Consumers can
attempt to avoid food substances to
which they are allergic by reading
ingredient labels to see whether a food
product contains an allergenic
ingredient. However, allergenic
substances may be inadvertently
incorporated into food products that are
not formulated to contain these
substances; consequently, their presence
is not required to be declared on food
labels. FDA is concerned with food
allergens, including food allergens
inadvertently incorporated into
manufactured foods, due to the number
of reports concerning consumers who
have experienced adverse reactions
following exposure to an allergenic
substance in a food. This concern has
prompted several agency actions
targeting food manufacturers, including:
(1) Issuing a notice to manufacturers
entitled ‘‘Label Declaration of Allergenic
Substances in Foods’’ in 1996 (Ref. 1);
(2) forming an FDA/state partnership in
1998 to increase industry’s
understanding of food allergens and to
identify effective manufacturing
controls; and (3) issuing a food allergen
guidance document in 2001 (Ref. 2).
Information on these initiatives is
available at the FDA Web site on
allergens at https://www.cfsan.fda.gov/
~dms/wh-alrgy.html.
FDA stated in the 1996 notice to
manufacturers that it is aware that some
manufacturers are voluntarily labeling
their products with statements such as
‘‘may contain (allergen).’’ FDA advised
that, because adhering to current good
manufacturing practices (CGMPs) is
essential for effective reduction of
adverse allergic reactions, advisory
labeling1 should not be used in lieu of
adherence to CGMPs. The agency urged
food manufacturers to take all steps
necessary to eliminate cross-contact2
1 The purpose of advisory labeling is generally to
alert food-allergic consumers to the possibility of
allergen cross-contact. Although these labels vary
by content, common formulations include ‘‘This
product was processed on machinery used to
process (allergen)’’ and ‘‘May contain (allergen).’’
While this document uses, where appropriate, the
term ‘‘advisory labeling,’’ FDA considers the term
‘‘advisory labeling’’ to be synonymous with
‘‘precautionary labeling,’’ a term sometimes used to
describe these circumstances.
2 Cross-contact occurs when a residue or other
trace amount of a food allergen is present on a food
contact surface or production machinery, or is airborne, and unintentionally becomes incorporated
into a product not intended to contain the allergen.
Cross-contact may also result from customary
methods of growing and harvesting crops, as well
as from the use of shared storage, transportation, or
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and to ensure the absence of allergens
in their finished food products. In
addition, FDA encouraged
manufacturers to declare voluntarily
any allergenic ingredient of a flavor,
spice, or color by identifying the
allergenic ingredient in the ingredient
list.
A. Food Allergen Labeling and
Consumer Protection Act of 2004
On August 2, 2004, the United States
Congress enacted the Food Allergen
Labeling and Consumer Protection Act
of 2004 (FALCPA) (Title II of Public
Law No. 108–282). FALCPA amended
the Federal Food, Drug, and Cosmetic
Act (the act) by imposing new labeling
requirements on packaged foods that
contain ‘‘major food allergens.’’ Section
201(qq) of the act (21 U.S.C. 321(qq))
defines ‘‘major food allergen’’ as milk,
eggs, fish, Crustacean shellfish, tree
nuts, wheat, peanuts, and soybeans or
any other ingredient that contains
protein derived from one of these foods
or food groups. FALCPA requires that
the labels of foods that contain an
ingredient that is a major food allergen
declare this ingredient in one of two
ways: (1) By including the name of the
food source from which the allergen is
derived in parentheses following the
common or usual name of the major
food allergen in the list of ingredients in
instances when the name of the food
source of the major food allergen does
not appear elsewhere in the ingredient
statement or is not used in the common
or usual name of the ingredient, or (2)
by placing the word ‘‘Contains’’
followed by the name of the food source
from which the major food allergen is
derived immediately after or adjacent to
the list of ingredients.
These allergen labeling requirements
assist consumers in avoiding substances
to which they are allergic. However, as
previously discussed in this section,
allergenic substances may be
inadvertently incorporated into food
products that are not formulated to
contain them. FALCPA does not require
the use of advisory labeling, including
statements describing the potential
presence of unintentional ingredients in
food products resulting from the food
manufacturing process.
B. Information Available to FDA
Regarding Advisory Labeling
FDA has gathered information on
advisory labeling by conducting its own
consumer research and reviewing other
published consumer research.
production equipment. FDA considers the term
‘‘cross-contact’’ to be synonymous with ‘‘crosscontamination,’’ a term sometimes used to describe
these circumstances.
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Additionally, the agency investigated
cross-contact that occurs during
manufacturing and examined
manufacturers’ use of advisory labeling
to alert consumers to the possibility that
a food may contain allergens. The
information FDA has collected provides
insight into the types of advisory
statements currently used by
manufacturers and the reasons
manufacturers use advisory labeling.
Furthermore, the consumer research
provides an understanding as to how
consumers perceive particular advisory
statements and what wording
consumers prefer and find credible.
FDA’s findings are summarized as
follows:
1. Cross-Contact and Use of Advisory
Labeling
FDA has found that unintentional
cross-contact of foods with major food
allergens may occur at almost any step
of the manufacturing process and for
various reasons (Ref. 3). Cross-contact
can occur due to allergens in raw
ingredients or in processing aids,
allergens in reworked product,3 and
allergen carry-over from the use of
shared equipment. Such potential
sources of unintentional allergen crosscontact exist regardless of the
manufacturer’s size or food product.
Many food manufacturers have allergencontrol measures in place, such as the
use of dedicated facilities or dedicated
production lines, to prevent the crosscontact of major food allergens with
their products. Manufacturers also use a
variety of advisory statements on
package labels, such as, ‘‘May contain
(allergen),’’ ‘‘Produced in a plant that
processes (allergen),’’ ‘‘Produced on
shared equipment that processes
(allergen),’’ and ‘‘Processed on
equipment that also processes
(allergen).’’ These manufacturers use
advisory labeling for a variety of
reasons, such as to advise consumers of
the potential presence of an allergen, to
avoid the need to develop and use
multiple labels, or to reduce legal
liabilities.
2. Consumer Studies
FDA surveyed food-allergic adults or
their caregivers and non-food-allergic
adults to learn which of the following
food-allergen advisory statements they
preferred (Ref. 4):
3 As a verb, ‘‘rework’’ refers to the practice of
reintroducing food product material that has been
through some or all of the manufacturing process
into an earlier stage of the production process of a
subsequently produced food product. As a noun or
adjective, ‘‘rework’’ refers to the food product
material that is reintroduced into the production
process.
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(1) ‘‘Allergy Information: May contain
peanuts.’’
(2) ‘‘May Contain Peanuts.’’
(3) ‘‘Manufactured on the same
equipment as foods that contain
peanut.’’
(4) ‘‘Produced in a facility with an
allergy control plan. The possibility of
contact with allergenic ingredients has
been minimized. May still contain trace
amount of peanut.’’
Survey participants preferred the
statement ‘‘Allergy Information: May
contain peanuts’’ over the other three
statements. This finding is similar to
other research that shows that people
prefer warning information that is
preceded by signal words, such as
‘‘Allergy Information,’’ possibly because
signal words help to quickly draw
people’s attention to important
information (Ref. 5).
FDA also conducted an experiment
that compared the four statements listed
previously relative to buying, eating, or
serving a food item (Ref. 4). The
experiment yielded two important
findings. The first important finding
was that participants thought the risk of
the food containing allergens was
greater when any of the four advisory
statements was on the food label than
when there was no allergen advisory
statement. The second important
finding was that participants answered
the questions about buying, eating, or
serving the product differently
depending on which advisory statement
they were responding to. The
experimental results showed that
participants who looked at food
packages bearing the advisory
statements ‘‘Allergy information: May
contain peanuts’’ or ‘‘May contain
peanuts’’ believed these foods were
more likely to contain peanuts. In
contrast, participants looking at food
packages with the other two statements
believed those foods were less likely to
contain peanuts.4
FDA also reviewed research
conducted by the Food Allergy &
Anaphylaxis Network (FAAN). FAAN’s
consumer surveys explored how
consumers with food allergies
responded to advisory labeling by either
heeding it or ignoring it (Ref. 6).
According to FAAN’s consumer
surveys, consumers with food allergies
are increasingly ignoring advisory
4 It is important to keep in mind that these two
consumer research studies focused on the presence
of peanuts. Peanut allergy can produce severe
allergic responses, and even those not affected by
peanut allergy appear to be aware that peanut
allergy is serious for those with the allergy. The
research results may have been different had a food
allergen other than peanut been the subject of the
advisory statements.
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labeling. Additional FAAN research
examined retail packaged foods bearing
various advisory labeling statements for
peanuts and then analyzed the products
to determine the prevalence of peanut
residue. FAAN’s analysis found
detectable peanut residues in some of
the products with allergy advisory
statements. This finding is important
because it indicates that allergic
consumers who ignore advisory labeling
statements are risking their health by
consuming foods that have advisory
labeling because some of these foods
contain allergens.
C. Other Initiatives on Food Allergen
Advisory Labeling
The use of advisory labeling has
steadily increased in the United States.
As mentioned in section I.B.1. of this
document, different food companies use
different advisory statements and have
different reasons for using advisory
labeling. FDA is aware that voluntary
criteria for determining when to use
advisory labeling exist in the United
States. In 2001, in response to food
allergy concerns, the Food Allergy
Issues Alliance (Ref. 7), a private group
of representatives from industry, a trade
group, a consumer group, and academia
recommended using the following
criteria to evaluate a food to determine
whether advisory labeling is
appropriate:
• Whether the presence of a major
food allergen is documented through
visual examination or analytical testing
of the processing line, equipment,
ingredient or product, or other means;
• Whether the risk of presence of a
major food allergen is unavoidable even
when current good manufacturing
practices are followed;
• Whether a major food allergen is
present in some, but not all, of the
product; and
• Whether the presence of a major
food allergen is potentially hazardous.
FDA is aware that other countries
have developed or are currently
developing criteria to ensure uniformity
in the use of advisory labeling to warn
consumers that a food may
inadvertently contain an allergen. The
Canadian government is currently
reviewing precautionary statements for
food allergens and making
recommendations regarding their use on
the labels of packaged foods. For
example, Canada is updating its policy
to restrict the options for different
precautionary statements. The proposed
options for precautionary statements in
Canada are: (1) ‘‘may contain (allergen)’’
or (2) ‘‘not suitable for consumption by
persons with an allergy to (allergen)’’
(Ref. 8). Further, where incoming
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ingredients have been labeled with a
precautionary statement, manufacturers
are advised to use the same statement
on the finished product label unless the
allergen in the finished product is not
likely to represent a health risk.
Similar initiatives are evolving in
Australia and New Zealand. An
industry forum has developed the
Voluntary Incidental Trace Allergen
Labeling (VITAL) procedure to provide
a risk-based approach for food
manufacturers to use in assessing the
impact of allergen cross-contact and to
provide appropriate allergen advisory
labeling (Ref. 9). The VITAL Allergen
Action Level Grid (‘‘Vital Grid’’)
determines whether allergens present in
a food due to incidental cross-contact
should be labeled and, if so, whether
this labeling should state whether an
allergen may be present or whether an
allergen is actually present (i.e.,
identified as an ingredient). VITAL uses
a three-level grid to determine if the
presence of residual protein from
allergenic substances through
unavoidable cross-contact warrants
advisory labeling. The VITAL Action
Levels are: (1) Action Level 1—Green
Zone—advisory labeling is not required
for the allergen under evaluation; (2)
Action Level 2—Yellow Zone—advisory
labeling stating that the allergen under
evaluation may be present is advised;
and (3) Action Level 3—Red Zone—
significant levels of the allergen are
likely to be present in the food;
therefore, listing the allergen in the
ingredient list is advised.
D. Need for Long-Term United States
Strategy to Manage Allergen Advisory
Labeling
As previously discussed in this
document, FDA has reviewed available
information and data and found that the
use of advisory label statements is not
uniform. In addition, research indicated
a range of consumer understanding and
behavior with regard to advisory
labeling. Research also indicated that
some food products that contain
advisory labeling have been shown to
contain detectable residues of food
allergens (Ref. 6). Allergic consumers
who ignore advisory label statements
assume the risk of potential adverse
reactions by consuming these food
products. If manufacturers choose to use
advisory labeling to inform consumers
of the potential presence of food
allergens in the finished products, such
labeling must be truthful and not
misleading and should provide clear,
uniform, and accurate information to
food-allergic consumers about the
potential presence of food allergens. As
currently used in the marketplace,
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advisory labeling may not be protecting
the health of allergic consumers;
therefore, FDA believes that it is in the
best interest of the public health,
especially for food-allergic consumers,
that FDA develop a long-term strategy to
address allergen advisory labeling.
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II. Purpose and Scope of the Hearings
FDA is developing a long-term
strategy to assist manufacturers in using
allergen advisory labeling that is
truthful and not misleading, conveys a
clear and uniform message, and
adequately informs allergic consumers
and their caregivers. To that end, FDA
is soliciting comments and information
to assist the agency in determining how
manufacturers currently use advisory
labeling, how consumers interpret
different advisory labeling statements,
and what wording is most effective in
communicating to consumers the
likelihood that an allergen may be
present in a food. The agency is also
interested in learning whether
consumers find advisory labeling
helpful for making food purchasing
decisions.
The scope of this hearing is
determined by this document. FDA
invites general comments on the issues
and questions listed in section III of this
document.
III. Issues and Questions for Discussion
The following issues and questions
will be discussed at the public hearing:
Issue 1: FDA is developing a longterm strategy to assist manufacturers in
ensuring that allergen advisory labeling
is truthful and not misleading, conveys
a clear and uniform message, and
adequately informs allergic consumers
and their caregivers. To help us better
understand under what circumstances
manufacturers use advisory labeling, we
ask the following questions:
Question 1. What manufacturing
circumstances prompt manufacturers to
place advisory statements on a food
label? What manufacturing
circumstances do not prompt
manufacturers to include an advisory
statement? Why?
Question 2. If we decide to develop
guidance for using advisory labeling,
should we incorporate any of the
guidelines from the Food Allergy Issues
Alliance or the principles of the VITAL
system? If so, why?
Question 3. Are there circumstances
under which there is no possibility of
cross-contact with a food allergen? If so,
what are they?
Question 4. When manufacturers
declare an allergenic ingredient in the
ingredient list or in the ‘‘Contains’’
statement, do they also use an advisory
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statement indicating the presence of that
ingredient? If so, why? What do allergic
consumers think of such labeling? Do
consumers consume the food product if
they are allergic to the allergen referred
to in the advisory statement? Is the
presence of both an advisory statement
and a ‘‘Contains’’ statement that include
the same allergen on the same food label
confusing? Why or why not?
Question 5. What criteria and
considerations does a small firm rely on
when determining whether to use
advisory labeling? Are these the same
criteria and considerations that a large
firm relies on? How frequently does a
small firm use advisory labeling
compared to a large firm? If we decide
to develop guidance for using advisory
labeling, what options should we
investigate to consider the
circumstances of small firms?
Question 6. How do manufacturers
decide whether to label their finished
products with advisory labeling when
their incoming ingredients are labeled
with advisory statements?
Issue 2: FDA is also assessing whether
advisory labeling is useful to consumers
and how consumers interpret advisory
labeling statements. Currently, industry
uses many different advisory
statements, such as ‘‘May contain
(allergen),’’ ‘‘(allergen) traces,’’
‘‘Produced on shared equipment that
processes (allergen),’’ and ‘‘Produced in
a plant that processes (allergen).’’ We
are concerned that allergic consumers
may be risking their health by ignoring
labeling designed to inform them of the
potential presence of allergens in foods.
To help us better understand what type
of advisory labeling is most effective in
helping consumers avoid adverse
allergic reactions, we ask the following
questions:
Question 7. Consumer research
suggests that different advisory
statements convey different degrees of
potential for the inadvertent presence of
an allergen in a food. What message do
manufacturers want to convey by an
advisory statement generally?
Question 8. What specific advisory
statements adequately inform
consumers of the potential risk of crosscontact with allergenic materials? What
advisory statements most accurately
communicate to consumers and their
caregivers the potential risk of the
presence of the allergen? Why?
Question 9. If you are a food-allergic
consumer or caregiver to such a
consumer, do you ever ignore advisory
statements? If so, which types of
statements, and why?
Question 10. In addition to the
information and data mentioned in this
document, what additional information
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or data are available that would assist us
in understanding consumers’
perceptions of, use of, and need for
specific advisory statements and
advisory labeling in general?
Issue 3: FDA is assessing how
advisory statements should be worded
to be the most effective in
communicating the likelihood that an
allergen may be present in a food.
Consumer focus group research shows
that the elements essential for an
effective warning or safe handling
statement are: a description of the
hazard, handling instructions for
avoiding the hazard, and an
instructional statement that describes
conditions under which the hazard
occurs and what action to take if the
hazard is not avoided (Ref. 10). This
same research indicates that label
messages are more credible when
consumers know the reason for the
message. The agency has previously
used this consumer study information to
craft the warning statements and safe
handling statements found in 21 CFR
101.17. To help us better understand
how advisory statements should be
worded to be the most effective in
communicating the likelihood that an
allergen may be present in a food, we
ask the following questions:
Question 11. What elements are
needed in an advisory statement to
adequately inform consumers of the
potential for the inadvertent presence of
an allergen and would communicate to
allergic consumers a consistent and
effective message regarding the risk of
consuming the product?
Question 12. How would the use of
consistent and effective advisory
labeling affect consumer understanding
of the potential for an allergen to be
present in a food?
IV. Notice of Hearing Under 21 CFR
Part 15
Under authority delegated by the
Commissioner of Food and Drugs (the
Commissioner), the Associate
Commissioner for Policy and Planning
finds that it is in the public interest to
permit persons to present information
and views at a public hearing regarding
the use of allergen advisory labeling and
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR part 15). The presiding officer
will be the Commissioner or his
designee. The presiding officer will be
accompanied by a panel of FDA
employees with relevant expertise.
Persons who wish to participate in the
hearing (either by making a presentation
or as a member of the audience) must
file a notice of participation (see DATES,
ADDRESSES, FOR FURTHER INFORMATION
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CONTACT, and section V of this
document). Under authority delegated
by the Commissioner, the Associate
Commissioner for Policy and Planning
has determined under § 15.20(c) that
advance submissions of oral
presentations are necessary for the panel
to formulate useful questions to be
posed at the hearing under § 15.30(e),
and that the submission of a
comprehensive outline or summary is
an acceptable alternative to the
submission of the full text of the oral
presentation. For efficiency, we request
that individuals and organizations with
common interests consolidate their
requests for oral presentation and
request time for a joint presentation
through a single representative. After
reviewing the notices of participation
and accompanying information, we will
schedule each oral presentation and
notify each participant of the time
allotted to the presenter and the
approximate time that the presentation
is scheduled to begin. If time permits,
we may allow interested persons who
attend the hearing but did not submit a
notice of participation in advance to
make an oral presentation at the
conclusion of the hearing. The hearing
schedule will be available at the
hearing.
After the hearing, the schedule and a
list of participants will be placed on file
in the Division of Dockets Management
(see ADDRESSES) under the docket
number listed in brackets in the heading
of this document.
To ensure timely handling of any
mailed notices of participation, written
material associated with presentations,
or comments, any outer envelope
should be clearly marked with the
docket number listed in brackets in the
heading of this document along with the
statement ‘‘Food Labeling; Current
Trends in the Use of Allergen Advisory
Labeling: Its Use, Effectiveness, and
Consumer Perception; Public Hearing;
Request for Comments.’’
Under § 15.30(f), the hearing is
informal, and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation.
Public hearings under part 15 are
subject to FDA’s policy and procedures
for electronic media coverage of FDA’s
public administrative proceedings (part
10 (21 CFR part 10, subpart C)). Under
§ 10.205, representatives of the
electronic media may be permitted,
subject to the procedures and
limitations in § 10.206, to videotape,
film, or otherwise record FDA’s public
VerDate Aug<31>2005
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administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b). For additional information
about transcripts, see section VII in this
document.
Any handicapped persons requiring
special accommodations to attend the
hearing should direct those needs to the
appropriate contact person (see FOR
FURTHER INFORMATION CONTACT).
To the extent that the conditions for
the hearing, as described in this
document, conflict with any provisions
set out in part 15, this document acts as
a waiver of these provisions as specified
in §§ 10.19 and 15.30(h). In particular,
§ 15.21(a) states that the notice of
hearing will provide persons an
opportunity to file a written notice of
participation with the Division of
Dockets Management within a specified
period of time. If the public interest
requires, e.g., if a hearing is to be
conducted within a short period of time,
the notice may name a specific FDA
employee and telephone number to
whom an oral notice of participation
may be given. If the public interest
requires, the notice may also provide for
submitting notices of participation at
the time of the hearing. In this
document, the conditions for the
hearing specify that notices of
participation be submitted
electronically to an agency Web site, to
a contact person who will accept notices
of participation by mail, telephone, fax,
or e-mail, or in person on the day of the
hearing (as time and space permits). In
addition, the conditions for the hearing
specify that written material associated
with an oral presentation be provided to
a contact person who will accept it by
mail, fax, or e-mail rather than to the
Division of Dockets Management. We
are using these procedures to facilitate
the exchange of information between
participants and the agency. Under
authority delegated by the
Commissioner, the Associate
Commissioner for Policy and Planning
finds under § 10.19 that no participant
will be prejudiced, the ends of justice
will thereby be served, and the action is
in accordance with law if notices of
participation are submitted by any of
the procedures listed in this document.
V. How to Participate in the Hearing
Registration by submission of a notice
of participation is necessary to ensure
participation and will be accepted on a
first-come, first-served basis. The
closing date for registration is
September 8, 2008. The notice of
participation may be submitted
electronically, orally, or by fax, mail, or
e-mail (see ADDRESSES and FOR FURTHER
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
INFORMATION CONTACT). We encourage
you to submit your notice of
participation electronically. A single
copy of any notice of participation is
sufficient.
The notice of participation must
include your name, title, business
affiliation (if applicable), address,
telephone number, fax number (if
available), and e-mail address (if
available). If you wish to request an
opportunity to make an oral
presentation during the open public
comment period of the hearing, your
notice of participation also must include
the title of your presentation, the
sponsor of the oral presentation (e.g.,
the organization paying travel expenses
or fees), if any; and the approximate
amount of time requested for the
presentation. Presentations will be
limited to the questions and subject
matter identified in section III of this
document, and, depending on the
number of requests received, we may be
obliged to limit the time allotted for
each presentation (e.g., 5 minutes each).
Under § 15.20(c), if you request an
opportunity to make an oral
presentation, you must submit your
presentation (either as the full text of
the presentation or as a comprehensive
outline or summary). You may submit
your presentation by e-mail, fax, or
mail. A single copy of your presentation
is sufficient. See ADDRESSES and FOR
FURTHER INFORMATION CONTACT for
information on where to send your
presentation.
Persons who wish to request an
opportunity to make an oral
presentation must submit a notice of
participation by August 26, 2008, and
also must submit either the full text of
the oral presentation or a
comprehensive outline or summary of
the oral presentation by September 8,
2008. Individuals who request an
opportunity to make an oral
presentation will be notified of the
scheduled time for their presentation
prior to the hearing. All other persons
wishing to attend the hearing must
submit a notice of participation by
September 8, 2008. Persons requiring
special accommodations due to a
disability must submit a notice of
participation by September 8, 2008, and
should inform the contact person of
their request (see FOR FURTHER
INFORMATION CONTACT). Persons wishing
to park onsite should inform the contact
person of their request by September 10,
2008.
We will also accept notices of
participation onsite on a first-come,
first-served basis; however, space is
limited and registration will be closed
when the maximum seating capacity is
E:\FR\FM\08AUN1.SGM
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Federal Register / Vol. 73, No. 154 / Friday, August 8, 2008 / Notices
reached. Requests for an opportunity to
make a presentation from individuals or
organizations that did not make such a
request in advance may be granted if
time permits.
Persons who submit a notice of
participation in advance of the hearing
should check in at the on-site
registration desk between 8 a.m. and 9
a.m. Persons who wish to submit a
notice of participation on-site on the
day of the hearing may do so at the
registration desk between 8 a.m. and 9
a.m. We encourage all participants to
attend the entire hearing. Because the
hearing will be held in a Federal
building, hearing participants must
present photo identification and plan
adequate time to pass through the
security system.
We may post all submissions and
received comments without change to
https://www.regulations.gov, including
any personal information provided.
pwalker on PROD1PC71 with NOTICES
VI. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments for consideration at or after
the hearing in addition to, or in place of,
a request for an opportunity to make an
oral presentation (see section V of 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
VII. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm. It may be
viewed at the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD-ROM after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
VerDate Aug<31>2005
17:25 Aug 07, 2008
Jkt 214001
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
VIII. References
We have placed the following
references on display in the Division of
Dockets Management (see ADDRESSES)
and interested parties may see them
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 site after this document
publishes in the Federal Register.)
1. Center for Food Safety and Applied
Nutrition, U.S. Food and Drug
Administration, ‘‘Notice to Manufacturers,
Label Declaration of Allergenic Substances in
Foods,’’ June 10, 1996.
2. Food and Drug Administration, 2001,
‘‘Statement of Policy for Labeling and
Preventing Cross-contact of Common Food
Allergens; Compliance Policy Guide’’
accessible at https://www.fda.gov/ora/
compliance_ref/cpg/cpgfod/cpg555–250.htm
3. Center for Food Safety and Applied
Nutrition, U.S. Food and Drug
Administration, ‘‘Report to the Committee on
Health, Education, Labor, and Pensions,
United States Senate and the Committee on
Energy and Commerce, United States House
of Representatives,’’ July 2006, accessible at
https://www.cfsan.fda.gov/~acrobat/
alrgrep.pdf
`
4. Verrill, Linda and Conrad J. Choiniere.
(2009). ‘‘Are Food Allergen Advisory
Statements Really Warnings?: Variation in
Consumer Preferences and Consumption
Decisions,’’ Journal of Food Products
Marketing. 15(2) (accepted for publication).
5. Wogalter, M.S., M.J. Kalsher, R. Rashid,
(1999), ‘‘Effect of Signal Word and Source
Attribution on Judgments of Warning
Credibility and Compliance Likelihood,’’
International Journal of Industrial
Ergonomics. 1999 24:185–192.
6. Hefle, S.L., T.J. Furlong, L. Niemann, H.
Lemon-Mule, S. Sicherer, S.L. Taylor, (2007),
‘‘Consumer Attitudes and Risks Associated
With Packaged Foods Having Advisory
Labeling Regarding the Presence of Peanuts,’’
Journal of Allergy and Clinical Immunology,
120(1):171–176.
7. Food Allergy Issues Alliance, ‘‘Food
Allergen Labeling Guidelines,’’ May 2001.
8. Canadian Food Inspection Agency,
‘‘Precautionary Labelling Regarding Food
Allergens in Pre-packaged Foods’’ September
25, 2007, accessible at https://
www.inspection.gc.ca/english/fssa/invenq/
inform/20070925e.shtml on March 26, 2008.
9. Australian Food and Grocery Council
Allergen Forum, ‘‘Food Industry Guide to
Allergen Management and Labelling,’’ 2007
revised edition, accessible at https://
www.allergenbureau.net/downloads/allergenguide/Allergen_Guide_2007.pdf on March 26,
2008.
10. Levy, A.S., ‘‘Review of Research
Communicating Warning Information,’’
Consumer Studies Branch, Office of
Scientific Analysis and Support, Center for
Food Safety and Applied Nutrition, Food and
Drug Administration, June 1997.
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46307
Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–18280 Filed 8–7–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Initial Review Group,
Subcommittee I—Career Development.
Date: September 30–October 1, 2008.
Time: 8 a.m. to 5 a.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza National Airport,
1480 Crystal Drive, Arlington, VA
22202.
Contact Person: Sonya Roberson, PhD,
Scientific Review Officer, Resources
And Training Review Branch, Division
of Extramural Activities, National
Cancer Institute, 6116 Executive Blvd.,
Room 8109, Bethesda, MD 20892, 301–
594–1182, robersos@mail.nih.gov.
Name of Committee: National Cancer
Institute Initial Review Group,
Subcommittee H—Clinical Groups.
Date: October 13–14, 2008.
Time: 8 a.m. to 9 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott, 5151 Pooks
Hill Road, Bethesda, MD 20814.
Contact Person: Timothy C. Meeker,
MD, PhD, Scientific Review Officer,
Resources and Training Review Branch,
Division of Extramural Activities,
National Cancer Institute, 6116
Executive Boulevard, Room 8103,
Bethesda, MD 20892, (301) 594–1279,
meekert@mail.nih.gov.
E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 73, Number 154 (Friday, August 8, 2008)]
[Notices]
[Pages 46302-46307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18280]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0429]
Food Labeling; Current Trends in the Use of Allergen Advisory
Labeling: Its Use, Effectiveness, and Consumer Perception; Public
Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing on the use of advisory labeling of allergens in foods. FDA is
developing a long-term strategy to assist manufacturers in using
allergen advisory labeling that is truthful and not misleading, conveys
a clear and uniform message, and adequately informs food-allergic
consumers and their caregivers. To that end, FDA is soliciting comments
and information to assist the agency in determining how manufacturers
currently use advisory labeling, how consumers interpret different
advisory labeling statements, and what wording is likely to be most
effective in communicating to consumers the likelihood that an allergen
may be present in a food. The agency is also interested in receiving
comments about whether consumers find advisory labeling helpful for
making food purchasing decisions. This public hearing is the first step
in closing existing knowledge gaps in developing our long-term
strategy.
DATES: The public hearing will be held on September 16, 2008, from 9
a.m. to 4:30 p.m. The closing date for registration is September 8,
2008. See section V of this document for other dates associated with
participation in the hearing. Submit written or electronic comments
(i.e., submissions other than notices of participation and written
material associated with an oral presentation) by January 14, 2009. The
administrative record of the hearing will remain open until January 14,
2009.
ADDRESSES: Public hearing. The public hearing will be held at the
Harvey W. Wiley Federal Building, Food and Drug Administration, Center
for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College
Park, MD 20740-3835, (Metro stop: College Park on the Green Line).
Registration. Submit electronic notices of participation for the
hearing to https://www.cfsan.fda.gov/register.html. We encourage you to
use this method of registration, if possible. Submit written notices of
participation by mail, fax, or e-mail to Isabelle Howes, U.S.
Department of Agriculture Graduate School, 600 Maryland Ave., SW.,
suite 330, Washington, DC 20024-2520, FAX: 202-479-6801, or e-mail:
Isabelle_Howes@grad.usda.gov. You may also submit oral notices of
participation by phone to Isabelle Howes, U.S. Department of
Agriculture Graduate School (see FOR FURTHER INFORMATION CONTACT).
Written material associated with an oral presentation. Submit
written material associated with an oral presentation by mail, fax, or
e-mail to Isabelle Howes.
Comments. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.regulations.gov. For additional information on submitting comments,
see section VI in this document.
FOR FURTHER INFORMATION CONTACT:
For questions about registration or written material associated
with an oral presentation, or to register orally: Isabelle Howes, 202-
314-4713.
For all other questions about the hearing or if you need parking or
special accommodations due to a disability: Juanita Yates, Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 301-
436-1731, e-mail: Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Food allergies affect approximately two percent of adults and about
five
[[Page 46303]]
percent of infants and young children in the United States. Currently,
there is no cure for food allergies. The only successful method to
manage food allergies is avoidance of foods containing allergens.
Consumers can attempt to avoid food substances to which they are
allergic by reading ingredient labels to see whether a food product
contains an allergenic ingredient. However, allergenic substances may
be inadvertently incorporated into food products that are not
formulated to contain these substances; consequently, their presence is
not required to be declared on food labels. FDA is concerned with food
allergens, including food allergens inadvertently incorporated into
manufactured foods, due to the number of reports concerning consumers
who have experienced adverse reactions following exposure to an
allergenic substance in a food. This concern has prompted several
agency actions targeting food manufacturers, including: (1) Issuing a
notice to manufacturers entitled ``Label Declaration of Allergenic
Substances in Foods'' in 1996 (Ref. 1); (2) forming an FDA/state
partnership in 1998 to increase industry's understanding of food
allergens and to identify effective manufacturing controls; and (3)
issuing a food allergen guidance document in 2001 (Ref. 2). Information
on these initiatives is available at the FDA Web site on allergens at
https://www.cfsan.fda.gov/~dms/wh-alrgy.html.
FDA stated in the 1996 notice to manufacturers that it is aware
that some manufacturers are voluntarily labeling their products with
statements such as ``may contain (allergen).'' FDA advised that,
because adhering to current good manufacturing practices (CGMPs) is
essential for effective reduction of adverse allergic reactions,
advisory labeling\1\ should not be used in lieu of adherence to CGMPs.
The agency urged food manufacturers to take all steps necessary to
eliminate cross-contact\2\ and to ensure the absence of allergens in
their finished food products. In addition, FDA encouraged manufacturers
to declare voluntarily any allergenic ingredient of a flavor, spice, or
color by identifying the allergenic ingredient in the ingredient list.
---------------------------------------------------------------------------
\1\ The purpose of advisory labeling is generally to alert food-
allergic consumers to the possibility of allergen cross-contact.
Although these labels vary by content, common formulations include
``This product was processed on machinery used to process
(allergen)'' and ``May contain (allergen).'' While this document
uses, where appropriate, the term ``advisory labeling,'' FDA
considers the term ``advisory labeling'' to be synonymous with
``precautionary labeling,'' a term sometimes used to describe these
circumstances.
\2\ Cross-contact occurs when a residue or other trace amount of
a food allergen is present on a food contact surface or production
machinery, or is air-borne, and unintentionally becomes incorporated
into a product not intended to contain the allergen. Cross-contact
may also result from customary methods of growing and harvesting
crops, as well as from the use of shared storage, transportation, or
production equipment. FDA considers the term ``cross-contact'' to be
synonymous with ``cross-contamination,'' a term sometimes used to
describe these circumstances.
---------------------------------------------------------------------------
A. Food Allergen Labeling and Consumer Protection Act of 2004
On August 2, 2004, the United States Congress enacted the Food
Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title
II of Public Law No. 108-282). FALCPA amended the Federal Food, Drug,
and Cosmetic Act (the act) by imposing new labeling requirements on
packaged foods that contain ``major food allergens.'' Section 201(qq)
of the act (21 U.S.C. 321(qq)) defines ``major food allergen'' as milk,
eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and
soybeans or any other ingredient that contains protein derived from one
of these foods or food groups. FALCPA requires that the labels of foods
that contain an ingredient that is a major food allergen declare this
ingredient in one of two ways: (1) By including the name of the food
source from which the allergen is derived in parentheses following the
common or usual name of the major food allergen in the list of
ingredients in instances when the name of the food source of the major
food allergen does not appear elsewhere in the ingredient statement or
is not used in the common or usual name of the ingredient, or (2) by
placing the word ``Contains'' followed by the name of the food source
from which the major food allergen is derived immediately after or
adjacent to the list of ingredients.
These allergen labeling requirements assist consumers in avoiding
substances to which they are allergic. However, as previously discussed
in this section, allergenic substances may be inadvertently
incorporated into food products that are not formulated to contain
them. FALCPA does not require the use of advisory labeling, including
statements describing the potential presence of unintentional
ingredients in food products resulting from the food manufacturing
process.
B. Information Available to FDA Regarding Advisory Labeling
FDA has gathered information on advisory labeling by conducting its
own consumer research and reviewing other published consumer research.
Additionally, the agency investigated cross-contact that occurs during
manufacturing and examined manufacturers' use of advisory labeling to
alert consumers to the possibility that a food may contain allergens.
The information FDA has collected provides insight into the types of
advisory statements currently used by manufacturers and the reasons
manufacturers use advisory labeling. Furthermore, the consumer research
provides an understanding as to how consumers perceive particular
advisory statements and what wording consumers prefer and find
credible. FDA's findings are summarized as follows:
1. Cross-Contact and Use of Advisory Labeling
FDA has found that unintentional cross-contact of foods with major
food allergens may occur at almost any step of the manufacturing
process and for various reasons (Ref. 3). Cross-contact can occur due
to allergens in raw ingredients or in processing aids, allergens in
reworked product,\3\ and allergen carry-over from the use of shared
equipment. Such potential sources of unintentional allergen cross-
contact exist regardless of the manufacturer's size or food product.
Many food manufacturers have allergen-control measures in place, such
as the use of dedicated facilities or dedicated production lines, to
prevent the cross-contact of major food allergens with their products.
Manufacturers also use a variety of advisory statements on package
labels, such as, ``May contain (allergen),'' ``Produced in a plant that
processes (allergen),'' ``Produced on shared equipment that processes
(allergen),'' and ``Processed on equipment that also processes
(allergen).'' These manufacturers use advisory labeling for a variety
of reasons, such as to advise consumers of the potential presence of an
allergen, to avoid the need to develop and use multiple labels, or to
reduce legal liabilities.
---------------------------------------------------------------------------
\3\ As a verb, ``rework'' refers to the practice of
reintroducing food product material that has been through some or
all of the manufacturing process into an earlier stage of the
production process of a subsequently produced food product. As a
noun or adjective, ``rework'' refers to the food product material
that is reintroduced into the production process.
---------------------------------------------------------------------------
2. Consumer Studies
FDA surveyed food-allergic adults or their caregivers and non-food-
allergic adults to learn which of the following food-allergen advisory
statements they preferred (Ref. 4):
[[Page 46304]]
(1) ``Allergy Information: May contain peanuts.''
(2) ``May Contain Peanuts.''
(3) ``Manufactured on the same equipment as foods that contain
peanut.''
(4) ``Produced in a facility with an allergy control plan. The
possibility of contact with allergenic ingredients has been minimized.
May still contain trace amount of peanut.''
Survey participants preferred the statement ``Allergy Information:
May contain peanuts'' over the other three statements. This finding is
similar to other research that shows that people prefer warning
information that is preceded by signal words, such as ``Allergy
Information,'' possibly because signal words help to quickly draw
people's attention to important information (Ref. 5).
FDA also conducted an experiment that compared the four statements
listed previously relative to buying, eating, or serving a food item
(Ref. 4). The experiment yielded two important findings. The first
important finding was that participants thought the risk of the food
containing allergens was greater when any of the four advisory
statements was on the food label than when there was no allergen
advisory statement. The second important finding was that participants
answered the questions about buying, eating, or serving the product
differently depending on which advisory statement they were responding
to. The experimental results showed that participants who looked at
food packages bearing the advisory statements ``Allergy information:
May contain peanuts'' or ``May contain peanuts'' believed these foods
were more likely to contain peanuts. In contrast, participants looking
at food packages with the other two statements believed those foods
were less likely to contain peanuts.\4\
---------------------------------------------------------------------------
\4\ It is important to keep in mind that these two consumer
research studies focused on the presence of peanuts. Peanut allergy
can produce severe allergic responses, and even those not affected
by peanut allergy appear to be aware that peanut allergy is serious
for those with the allergy. The research results may have been
different had a food allergen other than peanut been the subject of
the advisory statements.
---------------------------------------------------------------------------
FDA also reviewed research conducted by the Food Allergy &
Anaphylaxis Network (FAAN). FAAN's consumer surveys explored how
consumers with food allergies responded to advisory labeling by either
heeding it or ignoring it (Ref. 6). According to FAAN's consumer
surveys, consumers with food allergies are increasingly ignoring
advisory labeling. Additional FAAN research examined retail packaged
foods bearing various advisory labeling statements for peanuts and then
analyzed the products to determine the prevalence of peanut residue.
FAAN's analysis found detectable peanut residues in some of the
products with allergy advisory statements. This finding is important
because it indicates that allergic consumers who ignore advisory
labeling statements are risking their health by consuming foods that
have advisory labeling because some of these foods contain allergens.
C. Other Initiatives on Food Allergen Advisory Labeling
The use of advisory labeling has steadily increased in the United
States. As mentioned in section I.B.1. of this document, different food
companies use different advisory statements and have different reasons
for using advisory labeling. FDA is aware that voluntary criteria for
determining when to use advisory labeling exist in the United States.
In 2001, in response to food allergy concerns, the Food Allergy Issues
Alliance (Ref. 7), a private group of representatives from industry, a
trade group, a consumer group, and academia recommended using the
following criteria to evaluate a food to determine whether advisory
labeling is appropriate:
Whether the presence of a major food allergen is
documented through visual examination or analytical testing of the
processing line, equipment, ingredient or product, or other means;
Whether the risk of presence of a major food allergen is
unavoidable even when current good manufacturing practices are
followed;
Whether a major food allergen is present in some, but not
all, of the product; and
Whether the presence of a major food allergen is
potentially hazardous.
FDA is aware that other countries have developed or are currently
developing criteria to ensure uniformity in the use of advisory
labeling to warn consumers that a food may inadvertently contain an
allergen. The Canadian government is currently reviewing precautionary
statements for food allergens and making recommendations regarding
their use on the labels of packaged foods. For example, Canada is
updating its policy to restrict the options for different precautionary
statements. The proposed options for precautionary statements in Canada
are: (1) ``may contain (allergen)'' or (2) ``not suitable for
consumption by persons with an allergy to (allergen)'' (Ref. 8).
Further, where incoming ingredients have been labeled with a
precautionary statement, manufacturers are advised to use the same
statement on the finished product label unless the allergen in the
finished product is not likely to represent a health risk.
Similar initiatives are evolving in Australia and New Zealand. An
industry forum has developed the Voluntary Incidental Trace Allergen
Labeling (VITAL) procedure to provide a risk-based approach for food
manufacturers to use in assessing the impact of allergen cross-contact
and to provide appropriate allergen advisory labeling (Ref. 9). The
VITAL Allergen Action Level Grid (``Vital Grid'') determines whether
allergens present in a food due to incidental cross-contact should be
labeled and, if so, whether this labeling should state whether an
allergen may be present or whether an allergen is actually present
(i.e., identified as an ingredient). VITAL uses a three-level grid to
determine if the presence of residual protein from allergenic
substances through unavoidable cross-contact warrants advisory
labeling. The VITAL Action Levels are: (1) Action Level 1--Green Zone--
advisory labeling is not required for the allergen under evaluation;
(2) Action Level 2--Yellow Zone--advisory labeling stating that the
allergen under evaluation may be present is advised; and (3) Action
Level 3--Red Zone--significant levels of the allergen are likely to be
present in the food; therefore, listing the allergen in the ingredient
list is advised.
D. Need for Long-Term United States Strategy to Manage Allergen
Advisory Labeling
As previously discussed in this document, FDA has reviewed
available information and data and found that the use of advisory label
statements is not uniform. In addition, research indicated a range of
consumer understanding and behavior with regard to advisory labeling.
Research also indicated that some food products that contain advisory
labeling have been shown to contain detectable residues of food
allergens (Ref. 6). Allergic consumers who ignore advisory label
statements assume the risk of potential adverse reactions by consuming
these food products. If manufacturers choose to use advisory labeling
to inform consumers of the potential presence of food allergens in the
finished products, such labeling must be truthful and not misleading
and should provide clear, uniform, and accurate information to food-
allergic consumers about the potential presence of food allergens. As
currently used in the marketplace,
[[Page 46305]]
advisory labeling may not be protecting the health of allergic
consumers; therefore, FDA believes that it is in the best interest of
the public health, especially for food-allergic consumers, that FDA
develop a long-term strategy to address allergen advisory labeling.
II. Purpose and Scope of the Hearings
FDA is developing a long-term strategy to assist manufacturers in
using allergen advisory labeling that is truthful and not misleading,
conveys a clear and uniform message, and adequately informs allergic
consumers and their caregivers. To that end, FDA is soliciting comments
and information to assist the agency in determining how manufacturers
currently use advisory labeling, how consumers interpret different
advisory labeling statements, and what wording is most effective in
communicating to consumers the likelihood that an allergen may be
present in a food. The agency is also interested in learning whether
consumers find advisory labeling helpful for making food purchasing
decisions.
The scope of this hearing is determined by this document. FDA
invites general comments on the issues and questions listed in section
III of this document.
III. Issues and Questions for Discussion
The following issues and questions will be discussed at the public
hearing:
Issue 1: FDA is developing a long-term strategy to assist
manufacturers in ensuring that allergen advisory labeling is truthful
and not misleading, conveys a clear and uniform message, and adequately
informs allergic consumers and their caregivers. To help us better
understand under what circumstances manufacturers use advisory
labeling, we ask the following questions:
Question 1. What manufacturing circumstances prompt manufacturers
to place advisory statements on a food label? What manufacturing
circumstances do not prompt manufacturers to include an advisory
statement? Why?
Question 2. If we decide to develop guidance for using advisory
labeling, should we incorporate any of the guidelines from the Food
Allergy Issues Alliance or the principles of the VITAL system? If so,
why?
Question 3. Are there circumstances under which there is no
possibility of cross-contact with a food allergen? If so, what are
they?
Question 4. When manufacturers declare an allergenic ingredient in
the ingredient list or in the ``Contains'' statement, do they also use
an advisory statement indicating the presence of that ingredient? If
so, why? What do allergic consumers think of such labeling? Do
consumers consume the food product if they are allergic to the allergen
referred to in the advisory statement? Is the presence of both an
advisory statement and a ``Contains'' statement that include the same
allergen on the same food label confusing? Why or why not?
Question 5. What criteria and considerations does a small firm rely
on when determining whether to use advisory labeling? Are these the
same criteria and considerations that a large firm relies on? How
frequently does a small firm use advisory labeling compared to a large
firm? If we decide to develop guidance for using advisory labeling,
what options should we investigate to consider the circumstances of
small firms?
Question 6. How do manufacturers decide whether to label their
finished products with advisory labeling when their incoming
ingredients are labeled with advisory statements?
Issue 2: FDA is also assessing whether advisory labeling is useful
to consumers and how consumers interpret advisory labeling statements.
Currently, industry uses many different advisory statements, such as
``May contain (allergen),'' ``(allergen) traces,'' ``Produced on shared
equipment that processes (allergen),'' and ``Produced in a plant that
processes (allergen).'' We are concerned that allergic consumers may be
risking their health by ignoring labeling designed to inform them of
the potential presence of allergens in foods. To help us better
understand what type of advisory labeling is most effective in helping
consumers avoid adverse allergic reactions, we ask the following
questions:
Question 7. Consumer research suggests that different advisory
statements convey different degrees of potential for the inadvertent
presence of an allergen in a food. What message do manufacturers want
to convey by an advisory statement generally?
Question 8. What specific advisory statements adequately inform
consumers of the potential risk of cross-contact with allergenic
materials? What advisory statements most accurately communicate to
consumers and their caregivers the potential risk of the presence of
the allergen? Why?
Question 9. If you are a food-allergic consumer or caregiver to
such a consumer, do you ever ignore advisory statements? If so, which
types of statements, and why?
Question 10. In addition to the information and data mentioned in
this document, what additional information or data are available that
would assist us in understanding consumers' perceptions of, use of, and
need for specific advisory statements and advisory labeling in general?
Issue 3: FDA is assessing how advisory statements should be worded
to be the most effective in communicating the likelihood that an
allergen may be present in a food. Consumer focus group research shows
that the elements essential for an effective warning or safe handling
statement are: a description of the hazard, handling instructions for
avoiding the hazard, and an instructional statement that describes
conditions under which the hazard occurs and what action to take if the
hazard is not avoided (Ref. 10). This same research indicates that
label messages are more credible when consumers know the reason for the
message. The agency has previously used this consumer study information
to craft the warning statements and safe handling statements found in
21 CFR 101.17. To help us better understand how advisory statements
should be worded to be the most effective in communicating the
likelihood that an allergen may be present in a food, we ask the
following questions:
Question 11. What elements are needed in an advisory statement to
adequately inform consumers of the potential for the inadvertent
presence of an allergen and would communicate to allergic consumers a
consistent and effective message regarding the risk of consuming the
product?
Question 12. How would the use of consistent and effective advisory
labeling affect consumer understanding of the potential for an allergen
to be present in a food?
IV. Notice of Hearing Under 21 CFR Part 15
Under authority delegated by the Commissioner of Food and Drugs
(the Commissioner), the Associate Commissioner for Policy and Planning
finds that it is in the public interest to permit persons to present
information and views at a public hearing regarding the use of allergen
advisory labeling and is announcing that the public hearing will be
held in accordance with part 15 (21 CFR part 15). The presiding officer
will be the Commissioner or his designee. The presiding officer will be
accompanied by a panel of FDA employees with relevant expertise.
Persons who wish to participate in the hearing (either by making a
presentation or as a member of the audience) must file a notice of
participation (see DATES, ADDRESSES, FOR FURTHER INFORMATION
[[Page 46306]]
CONTACT, and section V of this document). Under authority delegated by
the Commissioner, the Associate Commissioner for Policy and Planning
has determined under Sec. 15.20(c) that advance submissions of oral
presentations are necessary for the panel to formulate useful questions
to be posed at the hearing under Sec. 15.30(e), and that the
submission of a comprehensive outline or summary is an acceptable
alternative to the submission of the full text of the oral
presentation. For efficiency, we request that individuals and
organizations with common interests consolidate their requests for oral
presentation and request time for a joint presentation through a single
representative. After reviewing the notices of participation and
accompanying information, we will schedule each oral presentation and
notify each participant of the time allotted to the presenter and the
approximate time that the presentation is scheduled to begin. If time
permits, we may allow interested persons who attend the hearing but did
not submit a notice of participation in advance to make an oral
presentation at the conclusion of the hearing. The hearing schedule
will be available at the hearing.
After the hearing, the schedule and a list of participants will be
placed on file in the Division of Dockets Management (see ADDRESSES)
under the docket number listed in brackets in the heading of this
document.
To ensure timely handling of any mailed notices of participation,
written material associated with presentations, or comments, any outer
envelope should be clearly marked with the docket number listed in
brackets in the heading of this document along with the statement
``Food Labeling; Current Trends in the Use of Allergen Advisory
Labeling: Its Use, Effectiveness, and Consumer Perception; Public
Hearing; Request for Comments.''
Under Sec. 15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10, subpart C)). Under Sec. 10.205,
representatives of the electronic media may be permitted, subject to
the procedures and limitations in Sec. 10.206, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec. 15.30(b). For additional information about
transcripts, see section VII in this document.
Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the appropriate contact person
(see FOR FURTHER INFORMATION CONTACT).
To the extent that the conditions for the hearing, as described in
this document, conflict with any provisions set out in part 15, this
document acts as a waiver of these provisions as specified in
Sec. Sec. 10.19 and 15.30(h). In particular, Sec. 15.21(a) states
that the notice of hearing will provide persons an opportunity to file
a written notice of participation with the Division of Dockets
Management within a specified period of time. If the public interest
requires, e.g., if a hearing is to be conducted within a short period
of time, the notice may name a specific FDA employee and telephone
number to whom an oral notice of participation may be given. If the
public interest requires, the notice may also provide for submitting
notices of participation at the time of the hearing. In this document,
the conditions for the hearing specify that notices of participation be
submitted electronically to an agency Web site, to a contact person who
will accept notices of participation by mail, telephone, fax, or e-
mail, or in person on the day of the hearing (as time and space
permits). In addition, the conditions for the hearing specify that
written material associated with an oral presentation be provided to a
contact person who will accept it by mail, fax, or e-mail rather than
to the Division of Dockets Management. We are using these procedures to
facilitate the exchange of information between participants and the
agency. Under authority delegated by the Commissioner, the Associate
Commissioner for Policy and Planning finds under Sec. 10.19 that no
participant will be prejudiced, the ends of justice will thereby be
served, and the action is in accordance with law if notices of
participation are submitted by any of the procedures listed in this
document.
V. How to Participate in the Hearing
Registration by submission of a notice of participation is
necessary to ensure participation and will be accepted on a first-come,
first-served basis. The closing date for registration is September 8,
2008. The notice of participation may be submitted electronically,
orally, or by fax, mail, or e-mail (see ADDRESSES and FOR FURTHER
INFORMATION CONTACT). We encourage you to submit your notice of
participation electronically. A single copy of any notice of
participation is sufficient.
The notice of participation must include your name, title, business
affiliation (if applicable), address, telephone number, fax number (if
available), and e-mail address (if available). If you wish to request
an opportunity to make an oral presentation during the open public
comment period of the hearing, your notice of participation also must
include the title of your presentation, the sponsor of the oral
presentation (e.g., the organization paying travel expenses or fees),
if any; and the approximate amount of time requested for the
presentation. Presentations will be limited to the questions and
subject matter identified in section III of this document, and,
depending on the number of requests received, we may be obliged to
limit the time allotted for each presentation (e.g., 5 minutes each).
Under Sec. 15.20(c), if you request an opportunity to make an oral
presentation, you must submit your presentation (either as the full
text of the presentation or as a comprehensive outline or summary). You
may submit your presentation by e-mail, fax, or mail. A single copy of
your presentation is sufficient. See ADDRESSES and FOR FURTHER
INFORMATION CONTACT for information on where to send your presentation.
Persons who wish to request an opportunity to make an oral
presentation must submit a notice of participation by August 26, 2008,
and also must submit either the full text of the oral presentation or a
comprehensive outline or summary of the oral presentation by September
8, 2008. Individuals who request an opportunity to make an oral
presentation will be notified of the scheduled time for their
presentation prior to the hearing. All other persons wishing to attend
the hearing must submit a notice of participation by September 8, 2008.
Persons requiring special accommodations due to a disability must
submit a notice of participation by September 8, 2008, and should
inform the contact person of their request (see FOR FURTHER INFORMATION
CONTACT). Persons wishing to park onsite should inform the contact
person of their request by September 10, 2008.
We will also accept notices of participation onsite on a first-
come, first-served basis; however, space is limited and registration
will be closed when the maximum seating capacity is
[[Page 46307]]
reached. Requests for an opportunity to make a presentation from
individuals or organizations that did not make such a request in
advance may be granted if time permits.
Persons who submit a notice of participation in advance of the
hearing should check in at the on-site registration desk between 8 a.m.
and 9 a.m. Persons who wish to submit a notice of participation on-site
on the day of the hearing may do so at the registration desk between 8
a.m. and 9 a.m. We encourage all participants to attend the entire
hearing. Because the hearing will be held in a Federal building,
hearing participants must present photo identification and plan
adequate time to pass through the security system.
We may post all submissions and received comments without change to
https://www.regulations.gov, including any personal information
provided.
VI. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments for consideration at or
after the hearing in addition to, or in place of, a request for an
opportunity to make an oral presentation (see section V of 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
VII. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
It may be viewed at the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. A transcript will also be available in either hardcopy or on CD-
ROM after submission of a Freedom of Information request. Written
requests are to be sent to Division of Freedom of Information (HFI-35),
Office of Management Programs, Food and Drug Administration, 5600
Fishers Lane, rm. 6-30, Rockville, MD 20857.
VIII. References
We have placed the following references on display in the Division
of Dockets Management (see ADDRESSES) and interested parties may see
them 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 site after this document publishes in the
Federal Register.)
1. Center for Food Safety and Applied Nutrition, U.S. Food and
Drug Administration, ``Notice to Manufacturers, Label Declaration of
Allergenic Substances in Foods,'' June 10, 1996.
2. Food and Drug Administration, 2001, ``Statement of Policy for
Labeling and Preventing Cross-contact of Common Food Allergens;
Compliance Policy Guide[rdquo,] accessible at https://www.fda.gov/
ora/compliance_ref/cpg/cpgfod/cpg555-250.htm
3. Center for Food Safety and Applied Nutrition, U.S. Food and
Drug Administration, ``Report to the Committee on Health, Education,
Labor, and Pensions, United States Senate and the Committee on
Energy and Commerce, United States House of Representatives,'' July
2006, accessible at https://www.cfsan.fda.gov/~acrobat/alrgrep.pdf
4. Verrill, Linda and Conrad J. Choini[egrave]re. (2009). ``Are
Food Allergen Advisory Statements Really Warnings?: Variation in
Consumer Preferences and Consumption Decisions,'' Journal of Food
Products Marketing. 15(2) (accepted for publication).
5. Wogalter, M.S., M.J. Kalsher, R. Rashid, (1999), ``Effect of
Signal Word and Source Attribution on Judgments of Warning
Credibility and Compliance Likelihood,'' International Journal of
Industrial Ergonomics. 1999 24:185-192.
6. Hefle, S.L., T.J. Furlong, L. Niemann, H. Lemon-Mule, S.
Sicherer, S.L. Taylor, (2007), ``Consumer Attitudes and Risks
Associated With Packaged Foods Having Advisory Labeling Regarding
the Presence of Peanuts,'' Journal of Allergy and Clinical
Immunology, 120(1):171-176.
7. Food Allergy Issues Alliance, ``Food Allergen Labeling
Guidelines,'' May 2001.
8. Canadian Food Inspection Agency, ``Precautionary Labelling
Regarding Food Allergens in Pre-packaged Foods'' September 25, 2007,
accessible at https://www.inspection.gc.ca/english/fssa/invenq/
inform/20070925e.shtml on March 26, 2008.
9. Australian Food and Grocery Council Allergen Forum, ``Food
Industry Guide to Allergen Management and Labelling,'' 2007 revised
edition, accessible at https://www.allergenbureau.net/downloads/
allergen-guide/Allergen_Guide_2007.pdf on March 26, 2008.
10. Levy, A.S., ``Review of Research Communicating Warning
Information,'' Consumer Studies Branch, Office of Scientific
Analysis and Support, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, June 1997.
Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18280 Filed 8-7-08; 8:45 am]
BILLING CODE 4160-01-S