[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54594-54596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3809]


Sesame as an Allergen in Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) invites data and 
other information on the prevalence and severity of sesame allergies in 
the United States and the prevalence of sesame-containing foods sold in 
the United States that are not required to disclose sesame as an 
ingredient. We are taking this action to inform possible regulatory 
action on sesame to protect and promote the public health.

DATES: Submit either electronic or written comments on this document by 
December 31, 2018.

ADDRESSES: You may submit comments as follows. Electronic comments must 
be submitted on or before December 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 31, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the

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manner detailed (see ``Written/Paper Submissions'' and 
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-3809 for ``Sesame as an Allergen in Foods.''
    Received comments, those filed in a timely manner (see ADDRESSES), 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carol D'Lima, Office of Nutrition and 
Food Labeling, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2033.

SUPPLEMENTARY INFORMATION: 

I. Background

    Food allergies occur when the body's immune system reacts to 
certain food proteins (Ref. 1). Allergic reactions to food due to 
immunoglobulin E (IgE) antibodies cause the body to release 
inflammatory chemicals and can be particularly severe, leading to 
symptoms such as hives, facial swelling, vomiting, wheezing, shock, and 
even death. Because there is no cure for food allergies, allergic 
consumers must use avoidance to prevent allergic reactions. Successful 
avoidance requires, among other things, that allergic consumers and 
their caregivers can read and understand the relevant information on 
packaged food labels and can identify food allergens in other settings, 
such as at retail or food service establishments.
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that a 
food (other than a raw agricultural commodity) that bears or contains a 
``major food allergen'' declare the allergen using its ``common or 
usual name.'' A food is misbranded if it contains a major food allergen 
and fails to declare that major food allergen on its label using the 
major food allergen's common or usual name (section 403(w) of the FD&C 
Act). The FD&C Act defines a ``major food allergen,'' in part, as any 
of the following:
     Milk,
     Eggs,
     Fish (e.g., bass, flounder, or cod),
     Crustacean shellfish (e.g., crab, lobster, or shrimp),
     Tree nuts (e.g., almonds, pecans, or walnuts),
     Wheat,
     Peanuts, and
     Soybeans.
    See section 201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)). When 
Congress amended the FD&C Act regarding food allergens in 2004, these 
eight foods and food groups, out of more than 160 identified food 
allergens, accounted for 90 percent of serious food allergic reactions. 
We issued guidance in 2006 to help the public understand our 
implementation of the amendments, including what foods and 
manufacturers are subject to the amendments and labeling requirements 
(Ref. 2). We issued another guidance in 2014 to clarify the information 
we need when considering whether to exempt certain ingredients derived 
from major food allergens from the allergen labeling requirements (Ref. 
3). These statutory requirements with respect to a label or labeling 
for major food allergens do not alter the authority of the Secretary of 
Health and Human Services under the FD&C Act to require a label or 
labeling for other food allergens (21 U.S.C. 343 note).
    A common or usual name must accurately identify or describe, in as 
simple and direct terms as possible, the basic nature of the food or 
its characterizing properties or ingredients and can either be the name 
established by common use or the name required by a regulation (21 CFR 
102.5). In addition to the specific requirement for allergen labeling, 
any food is misbranded unless its label uses: (1) The common or usual 
name of the food, if it has one, and (2) the common or usual name of 
each ingredient, if the food is made from two or more ingredients 
(section 403(i) of the FD&C Act). Thus, the FD&C Act includes other 
authorities that assist consumers with a food allergy or other reason 
for avoiding an ingredient. For example, the label of a food made with 
sugar must declare this ingredient by its common or usual name--
``sugar''--rather than the chemical name ``sucrose'' (see section 
403(i) of the FD&C Act (21 U.S.C. 343(i))).
    In addition, section 403(x) of the FD&C Act gives us the authority 
to issue regulations requiring the disclosure of spices, flavorings, 
colorings, and incidental additives that are, or contain, allergens 
other than the eight major food allergens. We relied on this authority, 
in part, to require the labeling of carmine and cochineal in foods (see 
74 FR 207).
    In 2014, the Center for Science in the Public Interest, several 
medical professionals, and two consumer advocacy groups submitted a 
citizen petition (Ref. 4) requesting, in part, that we issue a rule to 
require that sesame seeds and sesame products be regulated in a manner 
similar to the manner in which major food allergens are regulated under 
the FD&C Act, and specifically to require sesame's disclosure by the 
common or usual name ``sesame'' in food labeling. The petition noted, 
among other things, that the European Union, Canada, Australia, and New 
Zealand require labeling of

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sesame and provided scientific information to support the petitioners' 
argument that sesame is an allergen of public health concern. The 
petition also requested that we add sesame to our list of allergens in 
our Compliance Policy Guide, which includes discussion of adulteration 
due to insufficient controls to prevent potential allergen cross-
contact (the unintentional incorporation of allergens into foods that 
are not intended to include those allergens) (Ref. 5). Since the 
citizen petition was posted, more than 750 comments have been submitted 
to the docket.
    We are interested in learning more about the prevalence and 
severity of sesame allergies in the United States, and the prevalence 
of sesame-containing foods sold in the United States that are not 
required to disclose sesame as an ingredient. We will consider the data 
and other information submitted, along with previously submitted 
information, to inform possible steps on sesame as an allergen in food 
to protect and promote the public health.

II. Additional Issues for Consideration; Request for Data and 
Information

    We invite comment, particularly scientific data and other evidence, 
about the following topics:

A. Prevalence of Allergies and Allergic Reactions Due to Sesame in the 
United States

    1. What is the prevalence of IgE-mediated sesame food allergies in 
the United States? Please provide any studies or data that support your 
conclusion, and provide your unit of measure (e.g., ``1 in 10,000 
adults''). What is the nature of the allergic response(s) to sesame in 
food and what are the impacts on consumers?
    2. How does the prevalence of IgE-mediated sesame food allergies in 
the United States compare to the prevalence of IgE-mediated allergies 
to the major food allergens? Please provide any studies or data that 
support your conclusion.
    3. What proportion of allergic reactions in the United States may 
be attributed specifically to exposure to undeclared sesame? Please 
provide any studies or data that support your conclusion.
    4. What proportion of allergic reactions to undeclared sesame occur 
in response to sesame found in packaged food products versus sesame 
found in foods served at retail or food service establishments (e.g., 
restaurants, grocery stores, supermarkets, hospitals, nursing homes, 
childcare centers, and temporary food establishments)?
    5. In packaged food products, what proportion of allergic reactions 
to sesame is due to:
    a. Sesame in generically listed spices, flavorings, colorings, or 
incidental additives;
    b. Sesame used as an ingredient and listed by some other name 
(e.g., ``tahini'' rather than ``sesame''); or
    c. Cross-contact?

B. Prevalence and Amounts of Undeclared Sesame in Foods

    1. What are examples of products or product categories that contain 
sesame as a spice, flavor, color, or incidental additive and that do 
not list ``sesame'' on the product labeling?
    2. What amount or concentration of sesame is in products or product 
categories that contain sesame as a spice, flavor, color, or incidental 
additive and that do not list ``sesame'' on the product labeling? 
Please provide a unit of measure (e.g., ``5 grams of sesame per 
kilogram of packaged food product'' or ``50 milligrams of sesame 
protein per serving'').
    3. What are examples of products or product categories other than 
``spices'' that contain sesame in one of the listed ingredients, but 
the common or usual name of that ingredient does not list ``sesame,'' 
specifically, on the product labeling? Please provide a copy of the 
labeling, if available.
    4. What amount or concentration of sesame is in products or product 
categories that contain sesame in one of the listed ingredients, but 
the common or usual name of that ingredient does not list ``sesame,'' 
specifically, on the product labeling? Please provide a unit of measure 
(e.g., ``5 grams of sesame per kilogram of packaged food product'' or 
``50 milligrams of sesame protein per serving'').
    5. What are examples of food products or product categories in 
which sesame has been found in a product because of cross-contact?
    6. What amount or concentration of sesame has been found in 
products or product categories that contain sesame because of cross-
contact? Please provide a unit of measure (e.g., ``5 grams of sesame 
per kilogram of packaged food product'' or ``50 milligrams of sesame 
protein per serving'').

C. Possible Costs of Any Future Regulatory Action FDA Might Take 
Regarding Sesame

    1. What would the costs be if we established disclosure 
requirements for sesame? We are interested in any costs, specifically 
those to manufacturers for labeling changes to reflect sesame as an 
ingredient, spice, flavor, color, or incidental additive.
    2. What would the costs be to manufacturers to control allergen 
cross-contact from sesame and what would the costs be of educating food 
managers at retail or food establishments to control for sesame as an 
allergen?
    3. What steps have manufacturers taken to eliminate or reduce 
cross-contact from sesame and/or sesame-containing ingredients?

III. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. FDA. ``Food Allergies: What You Need to Know.'' March 2017. 
Available at https://www.fda.gov/downloads/Food/ResourcesForYou/Consumers/UCM220117.pdf.
2. ``Guidance for Industry: Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling and Consumer 
Protection Act of 2004'' (Edition 4). October 2006. Available at 
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059116.htm.
3. ``Guidance for Industry: Food Allergen Labeling Exemption 
Petitions and Notifications.'' May 2014. Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm395494.htm.
4. Docket No. FDA-2014-P-2035, available at https://www.regulations.gov/docket?D=FDA-2014-P-2035.
5. ``Compliance Policy Guide Sec. 555.250 Statement of Policy for 
Labeling and Preventing Cross-contact of Common Food Allergens.'' 
August 2000. Available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-ice/documents/webcontent/ucm074552.pdf.

    Dated: October 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23635 Filed 10-29-18; 8:45 am]
 BILLING CODE 4164-01-P