[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71920-71922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0530]


Voluntary Disclosure of Sesame as an Allergen: Draft Guidance for 
Industry; Availability; Agency Information Collection Activities; 
Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Voluntary 
Disclosure of Sesame as an Allergen.'' The draft guidance, when 
finalized, will provide food manufacturers with FDA's current views on 
sesame as an allergen and will provide recommendations to voluntarily 
disclose sesame in certain circumstances where such disclosure is not 
currently required. The guidance is intended to help individuals who 
are allergic to sesame identify those foods that may contain sesame as 
an ingredient. This draft guidance is not final nor is it in effect at 
this time.

DATES: Submit either electronic or written comments on the draft 
guidance by January 11, 2021 to ensure that we consider your comment on 
the draft guidance before we begin work on the final version of the 
guidance. Submit electronic or written comments on the proposed 
collection of information in the draft guidance by January 11, 2021.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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 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-2020-D-0530 for ``Voluntary Disclosure of Sesame as an Allergen: 
Guidance for Industry.'' Received comments 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, 240-
402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Office of Nutrition and Food Labeling, Food Labeling and Standards 
Staff, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: 
Carol D'lima, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2371.
    With regard to the proposed collection of information: Domini Bean, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Voluntary Disclosure of Sesame as an Allergen.'' We are 
issuing this draft guidance consistent with our good guidance practices 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent the current thinking of FDA on this topic. It does not 
establish any rights for any person

[[Page 71921]]

and is not binding on FDA or the public. You can use an alternate 
approach if it satisfies the requirements of the applicable statutes 
and regulations.
    In the Federal Register of October 30, 2018 (83 FR 54594), we 
published a document inviting 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. The document 
also asked specific questions regarding the prevalence of allergies and 
allergic reactions due to sesame in the United States and the 
prevalence and amounts of undeclared sesame in foods. For example, we 
asked for examples of products or product categories that contain 
sesame as a spice, flavor, color, or incidental additive. The notice 
also stated that we had received a citizen petition in 2014 requesting, 
in part, that we issue a rule to require that sesame seeds and sesame 
products be regulated similarly to how major food allergens are 
regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(available at https://www.regulations.gov/docket?D=FDA-2014-P-2035). 
Among the various issues, the petition wanted FDA to require sesame's 
disclosure by the common or usual name ``sesame'' in food labeling and 
when present in ingredients, including a spice, flavoring, coloring, or 
incidental additive.
    We received over 4,800 comments to the document from individual 
consumers and patients, as well as consumer and patient advocacy 
groups, medical professionals and patient caretakers, industry and 
trade associations, and academic institutions. Some comments submitted 
data and information from published studies. Data and information 
received in response to the document highlighted U.S. national 
prevalence data on sesame and other food allergens. Our communications 
about the notice directed the public to submit adverse events due to 
sesame to the CFSAN Adverse Event Reporting System (CAERS). We received 
over 500 individual adverse event reports.
    Under our statute and regulations, if whole sesame seeds are used 
as an ingredient, they must be declared on the label (see section 
403(i) of the FD&C Act (21 U.S.C 343(i)); 21 CFR 101.4); however, under 
current regulations, sesame can, in some circumstances, such as when 
ground in a spice blend, be declared in an ingredient statement as 
simply ``spice'' or ``flavor,'' so its presence may not be obvious to 
consumers. Some comments to the document highlighted the lack of 
consistent labeling of sesame on food and stated this was a major 
problem for those with a sesame allergy.
    Based on information received in the comments to the notice, the 
2014 citizen petition, and comments submitted to the corresponding 
docket, other correspondence, as well as adverse event reports and 
recent publications with prevalence data, it appears that sesame 
allergy may be an increasing problem in the U.S. population. We 
continue to evaluate the emerging evidence and are working to develop 
factors to inform future regulatory actions related to sesame and other 
emerging food allergens, including possible labeling requirements. As 
we engage in this important work, we recommend, in the interim, that 
manufacturers voluntarily take steps to help consumers who are allergic 
or sensitive to sesame by disclosing the presence of sesame in packaged 
foods, even in circumstances where such disclosure would not be 
required (e.g., in spices and flavorings). The guidance would 
recommend, when finalized, that manufacturers voluntarily declare 
sesame in the ingredient list when it is used in foods as a ``flavor'' 
or ``spice'' in a parenthetical following the spice or flavor, such as, 
``spice (sesame),'' ``spices (including sesame),'' ``flavor (sesame),'' 
or ``flavors (including sesame).'' Similarly, if a term is used for a 
food that is or contains sesame, such as tahini, the guidance would 
recommend that sesame be included in a parenthesis, e.g., ``tahini 
(sesame)'' in the ingredient list. This will help consumers, especially 
those allergic to sesame, avoid foods that could cause an allergic 
reaction.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry

OMB Control Number 0910-0792--Revision

    The draft guidance, when finalized, will provide food manufacturers 
with recommendations regarding voluntarily declaring sesame in certain 
circumstances where such declaration is not currently required. For 
example, if a term is used for a food that is or contains sesame, the 
guidance would recommend that sesame should be included in a 
parenthesis in the ingredient list.
    Description of respondents: The respondents to this collection of 
information are manufacturers and packers of packaged foods sold in the 
United States.
    We estimate the burden of this collection of information as 
follows:

[[Page 71922]]



                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                            Number of
                        Activity                            Number of    disclosures per   Total annual   Average burden    Total hours    Total capital
                                                           respondents      respondent      disclosures   per disclosure                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review labels to follow guidance recommendations.......          77,500                1          77,500               1          77,500               0
Redesign labels to follow guidance recommendations.....             775                1             775              16          12,400      $1,414,375
                                                        ------------------------------------------------------------------------------------------------
    Total..............................................  ..............  ...............  ..............  ..............          89,900       1,414,375
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    We base these estimates from our experience with our food allergen 
labeling program and our labeling cost model. We estimate that there 
are approximately 775,000 Universal Product Codes (UPCs) of FDA-
regulated foods. Using FDA's labeling cost model, we estimate the entry 
rate of new UPCs to be approximately 8 percent per year. Based on the 
approximate entry rate of new UPCs, we estimate the rate of new or 
reformulated UPCs to be approximately 10 percent per year, or 77,500 
products (775,000 x10 percent). Thus, we estimate that 77,500 new or 
reformulated products are sold annually in the United States. Assuming 
an association of 1 respondent to each of the 77,500 new or 
reformulated products, we estimate that 77,500 respondents will each 
review the label of one of the 77,500 new or reformulated products, as 
reported in table 1, row 1. We have no data on how many label reviews 
would identify an opportunity to redesign the label. Therefore, we 
further estimate, for the purposes of this analysis, that 1 percent of 
the reviewed labels of new or reformulated products, or 775 labels 
(77,500 x 1 percent) would be redesigned as recommended by the 
guidance. Assuming an association of 1 respondent to each of the 775 
labels, we estimate that 775 respondents will each redesign 1 label. 
Using our labeling cost model, we estimate that it will take an average 
of 16 hours to complete the administration and internal design work for 
the redesign of a label to follow the recommendations of the guidance, 
as reported in table 1, row 2. Consequently, the burden of redesigning 
the 775 labels of new or reformulated products is 12,400 hours, as 
reported in table 1, row 2.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: November 2, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24727 Filed 11-10-20; 8:45 am]
BILLING CODE 4164-01-P


