[Federal Register: July 25, 2001 (Volume 66, Number 143)]
[Proposed Rules]
[Page 38591-38594]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy01-29]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 00P-1322]
Food Safety and Food Labeling; Presence and Labeling of Allergens
in Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Announcement of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting on the labeling of food products containing allergens. The
purpose of the meeting is to stimulate discussion and to obtain
information to help FDA determine what additional actions may be
necessary to provide consumers with adequate information on product
labels. The meeting will focus on: Source or plain English labeling;
advisory labeling (e.g., ``May contain [name of food allergen]''); and
labeling of ingredients exempted from declaration (common or usual
names of flavorings, spices, and colors; incidental additives).
DATES: The public meeting will be held on August 13, 2001, from 9 a.m.
to 4 p.m. Please preregister by close of business on August 6, 2001.
Preregistered persons should check in before the meeting between 8:30
a.m. and 9 a.m. Late registration will be accepted contingent on space
availability. Comments must be submitted no later than October 29,
2001.
ADDRESSES: The meeting will be held at the Cohen Bldg., 330
Independence Ave. SW., Washington, DC 20201, 202-619-1299 (Metro:
Federal Center SW.). All attendees must enter the building at the
Independence Ave. entrance.
Submit written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. You may also send comments to the Dockets Management Branch
at the following e-mail address: FDADOCKETS@oc.fda.gov, or at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.
FOR FURTHER INFORMATION CONTACT:
For registration: Please register by close of business on August 6,
2001, electronically at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Once on this Internet site, select
Docket No. 00P-1322 (Food Labeling and Allergen Contamination Control)
and follow the directions. You may also register by mail at Dockets
Management Branch (address above).
For registration information: Ayesha Weaver, Center for Food Safety
and Applied Nutrition (HFS-822), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-3587, FAX 202-205-5295.
For general information: Catalina Ferre-Hockensmith, Center for
Food Safety and Applied Nutrition (HFS-822), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4168, FAX
202-205-5295.
SUPPLEMENTARY INFORMATION:
I. Background
Each year FDA receives reports of consumers who experience adverse
reactions following exposure to allergenic substances in foods. Food
allergies are abnormal responses of the immune system, especially the
production of allergen-specific IgE antibodies, to naturally occurring
proteins in certain foods that most individuals can eat safely. Most
consumers are aware of their specific sensitivities and rely on the
food label to avoid foods that might result in an allergenic reaction.
However, adverse reactions often occur when an allergen-sensitive
consumer consumes an allergenic substance that has not been declared on
the food label.
Section 403 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 343) requires food labels to bear a complete listing of all
the ingredients in a food. This permits consumers to obtain accurate
information about the foods that they eat by reading the ingredient
list. However, the act and FDA's regulations provide two narrow
exemptions from the ingredient labeling requirement. First, section
403(i) of the act provides that flavorings, spices, and colors may be
declared collectively without naming each one. In some instances, these
collective ingredients contain subingredients that are allergens. (FDA
is exploring whether allergenic ingredients in spices, flavorings, or
colors should be declared, section 403(i) of the act notwithstanding.)
Second, FDA regulations exempt incidental additives (e.g., processing
aids) from ingredient declaration if they are present in a food at
insignificant levels and do not have a technical or functional effect
in the finished product (Sec. 101.100(a)(3) (21 CFR 101.100(a)(3))).
Thus, in some cases
[[Page 38592]]
food labels may not provide consumers with food allergies with
information about all the ingredients that are in the foods that they
eat.
In addition to exemptions for ingredient labeling, there are other
ways in which consumers may inadvertently come in contact with
allergenic substances. For instance, some consumers may be unaware of
the allergenic source of ingredients declared by their common or usual
names in the ingredient statement. For example, consumers may not
understand that the source of the ingredients ``whey'' and ``casein''
is ``milk,'' which is a common food allergen. Another area of concern
is the potential, inadvertent introduction of an allergenic ingredient
to a food (e.g., cross-contact during manufacturing where traces of
peanuts end up in a product that does not normally contain peanuts
because the product is manufactured on the same production line as a
product containing peanuts).
The undeclared presence of allergens in foods is a serious public
health issue because the ingestion of food allergens is potentially
life-threatening to sensitive individuals. Therefore, as part of its
public health mission to keep food safe, FDA has been focusing
increased attention and activity on issues relating to food allergens,
especially the proper labeling of products containing such allergens
and the control of food allergens in products not intended to contain
such allergens.
Currently, the only successful method to manage food allergy is
avoidance of foods containing the allergen. FDA's allergen awareness
efforts are currently focused on the eight foods that are most
frequently implicated in serious allergic responses: (1) Peanuts; (2)
soybeans; (3) milk; (4) eggs; (5) fish; (6) crustacea (e.g., lobster,
crab, shrimp); (7) tree nuts (e.g., almonds, chestnuts, macadamia nuts,
pecans, walnuts, hazelnuts or filberts, cashews, brazil nuts,
pistachios, pine nuts); and (8) wheat.
There has been growing activity surrounding food allergens. The
number of allergen-related food recalls increased steadily since 1990.
Further, FDA has received correspondence from consumers, as well as
from members of Congress (on behalf of their constituents) expressing
concern about undeclared allergens in foods. FDA has also received a
citizen petition requesting agency action to address food allergens
(Docket No. 99P-2148). Similarly, in May of 2000, the attorneys general
of nine States expressed their concern about food allergens and
submitted a petition asking FDA to amend its regulations on food
labeling and manufacturing practices (Docket No. 00P-1322).
In response to food allergy concerns, the Food Allergy Issues
Alliance (a private group comprised of industry and trade group
representatives and a consumer group, as well as a scientific advisor
representing academia) recently submitted (May 2001) a consensus
document on guidelines for food allergen labeling (Ref. 1). The Food
Allergy Issues Alliance asserted that the guidelines would address food
allergen issues their member companies would be implementing soon
without requiring FDA to amend or issue regulations.
FDA replied to their submission (Refs. 2, 3, and 4) stating that
the agency considered the guidelines a significant step forward in
addressing the prevalence and identification of the eight most common
food allergens in plain, simple language. The agency also indicated it
was pleased that the document recognized the public health need to
disclose food allergens. FDA finally noted that the Food Allergy Issues
Alliance guidelines laid the groundwork for addressing additional food
allergen issues in the future. The agency finds the guidelines
consistent with both our positions on food allergens (as articulated in
the past) and with the purpose behind the public meeting, as described
later in this document, and therefore is an appropriate starting point
for discussions at the public meeting.
FDA's concern about food allergens has prompted several agency
actions, most notably a notice to manufacturers on the label
declaration of allergens (1996), an FDA/State partnership to increase
industry's understanding of allergens and to identify effective
manufacturing controls (1998), and issuance of food allergen guidance
documents (2001). Information on these initiatives is available at the
FDA Web site on allergens at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/wh-alrgy.html.
II. Public Meeting--August 13, 2001
FDA is announcing a public meeting on August 13, 2001, to explore
certain allergen-related labeling issues in greater detail. The meeting
is intended to aid the agency in determining what additional actions
may be warranted to further assist consumers with food allergies in
identifying products containing food allergens and to assist
manufacturers in producing foods that are safe for consumers with food
allergies.
The agency is requesting written and oral comments in three topic
areas relating to food allergens within the context outlined above: (1)
Source or plain English labeling; (2) advisory labeling (e.g., ``May
contain [name of food allergen]''); and (3) labeling of ingredients
exempted from declaration (common or usual names of flavorings, spices,
and colors; incidental additives). Recommendations from the petition
submitted by the attorneys general of nine States (Docket No. 00P-1322)
and the allergen-labeling guidelines from the Food Allergy Issues
Alliance (Ref. 1) are incorporated into the discussion of the three
topic areas, as appropriate.
A. Source or Plain English Labeling
FDA recognizes that many of the common or usual names for
ingredients listed in the ingredient statement are not understood by
consumers to be derived from food allergens (e.g., ``caseinate'' or
``whey'' derived from ``milk'' and ``albumin'' derived from ``egg'').
FDA is considering whether additional labeling of food products is
necessary in some instances to ensure that allergenic consumers are
informed about the presence of food allergens.
FDA is considering how best to make source or plain English
labeling more widely available to consumers so that the labels will be
more understandable. To assist the agency in its deliberations, FDA is
asking several questions relating to source labeling:
1. What plain English terms would be understandable for the eight
most common food allergens?
2. What source or plain English labeling format or formats would be
most informative to consumers? Are the formats from the Food Allergy
Issues Alliance appropriate and sufficient? Are the recommendations in
the petition from the attorneys general of nine States warranted and
beneficial? Are multiple formats confusing to consumers, and if so, is
there a single format that would be preferable? If so, why?
3. Should source or plain English labeling be voluntary or
mandatory for the eight most common food allergens?
B. Advisory Labeling (e.g., ``May contain [name of food allergen]'')
Advisory labeling includes statements such as ``may contain
peanuts'' or ``made on shared equipment'' on food packaging labels.
FDA's current position is that advisory labeling should not be used in
lieu of adherence to good manufacturing practices (GMPs) because
adhering to GMPs is essential for effective reduction of adverse
reactions. Food that contains an allergen due to cross-contact or other
contamination may be considered adulterated under section 402(a)(4) of
the act (21 U.S.C. 342(a)(4)) because it has been prepared, packed, or
held under insanitary
[[Page 38593]]
conditions that may render the food injurious to health. Thus, FDA
believes advisory labeling should not be the norm, and manufacturers
should strive to eliminate the presence of allergenic materials that
are not intentionally added to a specific food product.
However, FDA recognizes that advisory labeling is an attempt by
manufacturers to inform consumers of the possibility that cross-contact
may have occurred such that the product contains an allergenic
substance. FDA is considering whether, and if so, under what
circumstances advisory labeling should be permitted when appropriate
manufacturing controls are not sufficient to guarantee the absence of
allergenic substances in a particular food product. If permitted, clear
criteria will be needed to guide the use of such statements.
Additionally, FDA is assessing whether advisory labeling is useful to
consumers, how consumers interpret advisory labeling statements, and
what wording would be most understandable. To help the agency better
understand if there is a need for advisory labeling, when it would be
appropriate, how such statements would be used by consumers, and what
wording would be most helpful to the consumer, the agency asks the
following questions:
1. Under what circumstances, if any, should advisory labeling
statements (e.g., ``May contain [name of allergen]'') be permitted, and
what impact would those circumstances have on manufacturers and on
consumers? Should the recommendations in the petition from the
attorneys general of nine States be adopted? Do the criteria from the
Food Allergy Issues Alliance form a reasonable basis for determining
when a manufacturer may use advisory labeling on a particular product
or should other criteria be used? Why?
2. Are there better alternatives for advisory labeling than the
type of wording that currently exists (e.g., ``May contain [name of
specific allergen],'' ``Made on shared equipment,'' ``Manufactured in a
facility that also processes [name of specific allergen]'')? Do such
statements adequately inform consumers of possible cross-contact with
allergenic materials? How do consumers interpret the wording of such
labeling? Should advisory labeling statements be prescriptive (i.e.,
one or more specific statements) or flexible?
3. Where should advisory labeling statements be located on the food
label? How prominent should advisory labeling statements be on the
label? Should the location and prominence of advisory labeling
statements be prescribed?
C. Labeling of Ingredients Exempted From Declaration (Common or Usual
Names of Flavorings, Spices, and Colors; Incidental Additives)
1. Common or Usual Names of Flavorings, Spices, and Colors
As previously noted, the collective naming of flavors, spices, and
certain colors is one of the exemptions to the requirement for the
complete labeling of ingredients (section 403(i) of the act). This
exemption permits these ingredients to be listed collectively in the
ingredient statement (e.g., ``Ingredients: * * *flavorings * * *'')
without naming each by its common or usual name. Food labels with
collectively named flavorings, spices, and colors may not adequately
inform individuals who wish to avoid allergenic substances,
particularly when the allergenic substance is not specifically
identified.
FDA believes that the declaration of allergenic ingredients in
individual flavorings, spices, and colors is necessary for consumers to
adequately protect themselves from exposure to food allergens. On a
case-by-case basis, FDA has used notice-and-comment rulemaking to
require the declaration of individual allergenic flavorings, spices,
and colors. This is a labor-intensive and time-consuming process for
the agency.
FDA is considering whether continuing to address allergenic
flavorings, spices, and colors on a case-by-case basis is the best
approach available to the agency. The petition from the attorneys
general of nine States (Docket No. 00P-1322) recommended amending the
regulations for flavorings derived from one of the eight most common
allergenic substances to require the declaration of the presence of the
allergen (e.g., peanut flavoring). The allergen-labeling guidelines
from the Food Allergy Issues Alliance (Ref. 1) advocated additional
voluntary disclosure of food allergens that are intentionally part of
foods, including substances exempted from labeling by regulations
(e.g., flavorings). Questions for the public meeting relate to the
alternatives available to the agency:
1. Should the agency continue to address the labeling of individual
allergenic flavorings, spices, and colors on a case-by-case basis, or
should there be a generally applicable policy?
2. Should the information on allergenic components of flavorings,
spices, and colors be included in the ingredient list? Is there a
better location or format for this information? Explain.
3. For individual flavorings, spices, or colors that contain one of
the eight most common allergens, should listing the common or usual
name of the individual flavoring, spice, or color on the product
labeling be voluntary or mandatory?
2. Labeling of Incidental Additives
Incidental additives that are present in a food at insignificant
levels and do not have any technical or functional effect in that food
have been exempted by regulation from labeling on an ingredient
statement (Sec. 101.100(a)(3)). Incidental additives include substances
that have no technical or functional effect in the finished product,
processing aids, and substances that may migrate to the food from
equipment or packaging. FDA has stated that because very small amounts
of some allergenic substances can cause serious allergic responses,
allergens that cause serious allergic reactions cannot be considered to
be present at an ``insignificant'' level in the food. The agency has
stated that all allergenic substances introduced as ingredients or as
the result of manufacturing processes do not qualify as incidental
additives and must be declared in the ingredient statement on the label
of a food product (Ref. 5).
With regard to incidental additives, FDA understands that the main
difficulty is that manufacturers may be unaware that a particular minor
ingredient or processing byproduct may be allergenic and therefore must
be declared on product labels. The petition from the attorneys general
of nine States (Docket No. 00P-1322) recommended amending the
regulations for ingredients that are derived from one of the eight most
common allergenic substances to specify that such ingredients may not
be considered incidental additives under Sec. 101.100(a)(3) and must be
declared on the product label. The allergen-labeling guidelines from
the Food Allergy Issues Alliance (Ref. 1) suggested that food companies
follow FDA's current guidance regarding the labeling of ``incidental
ingredients'' that are or that contain one of the eight most common
food allergens by declaring the allergen in the ingredient list of the
food. The questions for the public meeting relate to gathering
information and exploring educational alternatives to increase
manufacturer understanding:
1. What, if any, minor ingredients would manufacturers be unlikely
to recognize as containing food allergens and therefore not include on
the label, and what kinds of manufacturing processes would
manufacturers be unlikely to recognize as inadvertently introducing
food allergens?
2. When products that contain food allergens will be further
processed or
[[Page 38594]]
repacked, is food allergen labeling sufficient on such intermediate
products or is it necessary to have clearer labeling on intermediate
products to ensure that food allergens are appropriately declared on
the retail packaging of the final product?
3. Should the agency codify its policy to specifically state that
incidental additives that are food allergens are not exempt from
labeling and must be declared in the ingredient statement on the label?
III. Summary
FDA's public meeting, scheduled for August 13, 2001, is intended to
help the agency determine what additional actions may be warranted to
provide consumers with adequate food allergen information on product
labels. FDA recognizes that there are additional food allergen areas
that may need to be addressed at future meetings or through agency
actions, e.g., food handling practices and providing food allergen
information in restaurant settings. However, at this time, the agency
is focusing on issues relating to labeling and manufacturing of the
eight most common food allergens; therefore, the public meeting will be
restricted to discussion of the topic areas described above.
IV. Registration and Requests to Make Oral Presentations
If you would like to attend the meeting, you must preregister in
writing by close of business on August 6, 2001, either electronically
or by mail (information above). You must provide your name, title,
business affiliation (if applicable), address, telephone number, fax
number, e-mail address, and the type of organization you represent
(e.g., industry, consumer organization).
Preregistered persons should check in before the meeting between
8:30 a.m. and 9 a.m. Persons who have not preregistered may register
before the meeting between 8:30 a.m. and 9 a.m., dependent on space
availability. All attendees must enter the building at the Independence
Ave. entrance. If you need special accommodations due to disability
(e.g., sign language interpreter), please inform the contact person
when you register.
If, in addition to attending, you wish to make an oral presentation
during the meeting, you must indicate this on your registration form
and submit: (1) A brief written statement of the general nature of the
views you wish to present, and (2) the names and addresses of all
persons who will participate in the presentation. Depending on the
number of people who register to make presentations, we will limit the
time allotted for each presentation (from 3 to 5 minutes). If you
decide at the meeting that you wish to make a comment, you must sign up
at the registration desk, dependent on time availability. It is
anticipated that, if time permits, persons attending the meeting will
have the opportunity to ask questions during the meeting.
V. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written or electronic comments regarding the topics
addressed at the public meeting on or before October 29, 2001. Two
copies of any comments are to be submitted, except that individuals may
submit one 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 Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
VI. Transcripts
You may access a copy of the transcript on the FDA Web site at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov, request a transcript of the meeting from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 20
working days after the meeting, at a cost of 10 cents per page, or
examine a transcript of the meeting after September 10, 2001, at the
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
VII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen between 9 a.m. and 4
p.m., Monday through Friday.
1. Letter from Regina Hildwine, National Food Processors
Association (NFPA), Lisa D. Katic, Grocery Manufacturers of America
(GMA), and Anne Munoz-Furlong, Food Allergy and Anaphylaxis Network
(FAAN), to Joseph A. Levitt, Center for Food Safety and Applied
Nutrition (CFSAN), FDA, May 22, 2001.
2. Letter from Joseph Levitt, CFSAN/FDA, to Regina Hildwine of
NFPA, May 30, 2001.
3. Letter from Joseph Levitt, CFSAN/FDA, to Lisa D. Katic of
GMA, May 30, 2001.
4. Letter from Joseph Levitt, CFSAN/FDA, to Anne Munoz-Furlong
of FAAN, May 30, 2001.
5. ``Compliance Policy Guide (CPG)--Statement of Policy for
Labeling and Preventing Cross-Contact of Common Food Allergens''
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/compliance--ref/cpg/cpgfod/cpg555-250.htm
VIII. Registration
REGISTRATION FORM--PUBLIC MEETING ON ALLERGENS IN FOODS
Instructions: Please register using this form by close of business on
August 6, 2001, electronically at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Once on this Internet
site, select Docket No. 00P-1322 (Food Labeling and Allergen
Contamination Control) and follow the directions. You may also register
by mail at Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 70852.
Name: ________________________
Title: ________________________
Organization: ________________________
Address: ________________________
Telephone: ________________________
FAX: ________________________
E-mail: ________________________
Please indicate the type of organization you represent:
Industry ________________
Government ________________
Consumer Organization ________________
Media ________________
Law Firm ________________
Educational Organization ________________
Other (specify) ________________
Do you wish to make an oral presentation?
Yes ______
No ______
If yes, you must also submit the following:
1. A brief written statement of the general nature of the views you
wish to present.
2. The names and addresses of all persons who will participate in
the presentation.
Depending on the number of people who register to make presentations,
we will limit the time allotted for each presentation (from 3 to 5
minutes).
Dated: July 20, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-18617 Filed 7-23-01; 12:16 pm]
BILLING CODE 4160-01-S