[Federal Register: August 8, 2008 (Volume 73, Number 154)]
[Notices]
[Page 46302-46307]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au08-69]
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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.
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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 http://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 http://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
http://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.
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\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.
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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.
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\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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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\
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\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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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:
<bullet> 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;
<bullet> Whether the risk of presence of a major food allergen is
unavoidable even when current good manufacturing practices are
followed;
<bullet> Whether a major food allergen is present in some, but not
all, of the product; and
<bullet> 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
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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 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
http://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 http://www.regulations.gov.
VII. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at http://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
http://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 http://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 http://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
http://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
Meeting Registration and Deadline Information