[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58407-58410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1030]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Allergen Labeling and Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements for declaring major food allergens under the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by February 12, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 12, 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 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-2014-N-1030 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Allergen Labeling and 
Reporting.'' 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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/

[[Page 58408]]

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: 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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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, including 
each proposed extension of an existing 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.

Food Allergen Labeling and Reporting

OMB Control Number 0910-0792--Extension

    This information collection supports the reporting associated with 
the submission of petitions and notifications seeking exemptions from 
the labeling requirements for ingredients derived from major food 
allergens, and the Agency's associated guidance document.
I. Background
    The Food Allergen Labeling and Consumer Protection Act of 2004 
(FALCPA) (Title II, Pub. L. 108-282) amended the FD&C Act by defining 
the term ``major food allergen'' and stating that foods regulated under 
the FD&C Act are misbranded unless they declare the presence of each 
major food allergen on the product label using the name of the food 
source from which the major food allergen is derived. Section 403(w)(1) 
of the FD&C Act (21 U.S.C. 343(w)(1)) sets forth the requirements for 
declaring the presence of each major food allergen on the product 
label. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) defines a 
major food allergen as ``[m]ilk, egg, 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'' and 
also as a food ingredient that contains protein derived from such 
foods. The definition excludes any highly refined oil derived from a 
major food allergen and any ingredient derived from such highly refined 
oil.
    In some cases, the production of an ingredient derived from a major 
food allergen may alter or eliminate the allergenic proteins in that 
derived ingredient to such an extent that it does not contain 
allergenic protein. In addition, a major food allergen may be used as 
an ingredient or as a component of an ingredient such that the level of 
allergenic protein in finished food products does not cause an allergic 
response that poses a risk to human health. Therefore, FALCPA provides 
two mechanisms through which such ingredients may become exempt from 
the labeling requirement of section 403(w)(1) of the FD&C Act. An 
ingredient may obtain an exemption through submission and approval of a 
petition containing scientific evidence that demonstrates that the 
ingredient ``does not cause an allergic response that poses a risk to 
human health'' (section 403(w)(6) of the FD&C Act). Alternately, an 
ingredient may become exempt through submission of a notification 
containing scientific evidence showing that the ingredient ``does not 
contain allergenic protein'' or that there has been a previous 
determination through a premarket approval process under section 409 of 
the FD&C Act (21 U.S.C. 348) that the ingredient ``does not cause an 
allergic response that poses a risk to human health'' (section 
403(w)(7) of the FD&C Act).
A. Third-Party Disclosure
    The labeling requirements of section 403(w)(1) of the FD&C Act 
apply to all packaged foods sold in the United States that are 
regulated under the FD&C Act, including both domestically manufactured 
and imported foods. As noted, section 403(w)(1) of the FD&C Act 
requires that the label of a food product declare the presence of each 
major food allergen. We estimate the information collection burden of 
the third-party disclosure associated with food allergen labeling under 
section 403(w)(1) of the FD&C Act as the time needed for a manufacturer 
to review the labels of new or reformulated products for compliance 
with the requirements of section 403(w)(1) of the FD&C Act and the time 
needed to make any needed modifications to the labels of those 
products. The allergen information disclosed on the label or labeling 
of a food product benefits consumers who purchases that food product. 
Because even small exposure to a food allergen can potentially cause an 
adverse reaction, consumers use food labeling information to help 
determine their product choices.
    FDA estimates the third-party disclosure burden of the collection 
of information as follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
                                     Number of      disclosures    Total annual       Average
    FD&C Act section/activity       respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
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403(w)(1); review labels for              77,500               1          77,500               1          77,500
 compliance with food allergen
 labeling requirements..........

[[Page 58409]]

 
403(w)(1); redesign labels to              3,875               1           3,875              16          62,000
 comply with food allergen
 labeling requirements..........
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    Total.......................  ..............  ..............  ..............  ..............         139,500
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\1\ There are no operating and maintenance costs associated with this collection of information.

    We have retained the currently approved burden estimate associated 
with the information collection. Based on our experience with the 
information collection since it was established 3 years ago, we 
estimate that there are approximately 690,000 Universal Product Codes 
(UPCs) of FDA-regulated foods and approximately 85,000 UPCs of FDA-
regulated dietary supplements for a total of 775,000 UPCs (Ref. 1). 
Using the labeling cost model, we estimate the entry rate of new UPCs 
to be 8 percent per year. Based on the 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 x 10 percent). Thus, we 
estimate that, annually, 77,500 new or reformulated products are sold 
in the United States. Assuming an association of one 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. We estimate an average of 1 hour for the review 
of labels for compliance with the food allergen labeling requirements 
under section 403(w)(1) of the FD&C Act, for a total of 77,500 hours 
annually, as reflected in table 1, row 1.
    We have no data on how many label reviews would identify the need 
to redesign the label. For purposes of this analysis, therefore, we 
estimate 5 percent, or 3,875 labels (77,500 x 5 percent) will be 
redesigned to comply with the requirements of section 403(w)(1) of the 
FD&C Act. Assuming an association of one respondent to each of the 
3,875 redesigned labels and averaging 16 hours to complete the label 
redesign, we estimate a total of 62,000 hours annually for this 
activity, as reflected in table 1, row 2.
B. Reporting
    Under sections 403(w)(6) and (7) of the FD&C Act, respondents may 
request from us a determination that an ingredient is exempt from the 
labeling requirement of section 403(w)(1) of the FD&C Act. An 
ingredient may obtain an exemption through submission and approval of a 
petition containing scientific evidence that demonstrates that the 
ingredient ``does not cause an allergic response that poses a risk to 
human health'' (section 403(w)(6) of the FD&C Act). This section also 
states that ``the burden shall be on the petitioner to provide 
scientific evidence (including the analytical method used to produce 
the evidence) that demonstrates that such food ingredient, as derived 
by the method specified in the petition, does not cause an allergic 
response that poses a risk to human health.'' Alternately, an 
ingredient may become exempt through submission of a notification 
containing scientific evidence showing that the ingredient ``does not 
contain allergenic protein'' or that there has been a previous 
determination through a premarket approval process under section 409 of 
the FD&C Act that the ingredient ``does not cause an allergic response 
that poses a risk to human health'' (section 403(w)(7) of the FD&C 
Act).
    The guidance document entitled, ``Food Allergen Labeling Exemption 
Petitions and Notifications: Guidance for Industry,'' sets forth our 
recommendations with regard to the information that respondents should 
submit in such a petition or notification. The guidance states that to 
evaluate these petitions and notifications, we will consider scientific 
evidence that describes: (1) The identity or composition of the 
ingredient; (2) the methods used to produce the ingredient; (3) the 
methods used to characterize the ingredient; (4) the intended use of 
the ingredient in food; and (5) either (a) for a petition--data and 
information, including the expected level of consumer exposure to the 
ingredient, that demonstrate that the ingredient, when manufactured and 
used as described, does not cause an allergic response that poses a 
risk to human health; or (b) for a notification, data and information 
that demonstrate that the ingredient, when manufactured as described, 
does not contain allergenic protein, or documentation of a previous 
determination under a process under section 409 of the FD&C Act that 
the ingredient does not cause an allergic response that poses a risk to 
human health. We use the information submitted in the petition or 
notification to determine whether the ingredient satisfies the criteria 
of section 403(w)(6) and (7) of the FD&C Act for granting the 
exemption.
    We estimate the reporting burden associated with the collection of 
information as follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
    FD&C Act Section/Activity        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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403(w)(6); petition for                        5               1               5             100             500
 exemption......................
403(w)(7); notification.........               5               1               5              68             340
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    Total.......................  ..............  ..............  ..............  ..............             840
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\1\ There are no capital or operating and maintenance costs associated with the information collection.


[[Page 58410]]

    Based on our experience with the collection thus far, we retain the 
currently approved burden estimate. Accordingly, we estimate that we 
will receive an average of five petitions and five notifications 
annually over the next 3 years. Assuming an association of one 
respondent to each petition or notification, we estimate that five 
respondents will each submit one petition and five respondents will 
each submit one notification. We estimate a petition takes, on average, 
100 hours to develop and submit (Ref. 2). Therefore, we estimate the 
total burden associated with petitions will be 500 hours annually (5 
petitions x 100 hours per petition).
    The burden of a notification involves collecting documentation that 
a food ingredient does not pose an allergen risk. Either we can make a 
determination that the ingredient does not cause an allergic response 
that poses a risk to human health under a premarket approval or 
notification program under section 409 of the FD&C Act, or the 
respondent submits scientific evidence demonstrating that the 
ingredient when manufactured as described does not contain allergenic 
protein. We estimate it takes a respondent 20 hours to prepare and 
submit a notification based on our determination under a process under 
section 409 of the FD&C Act that the ingredient does not cause an 
allergic response. We estimate respondents may spend 100 hours to 
prepare a notification submitting scientific evidence (including the 
analytical method used) that demonstrates that the food ingredient (as 
derived by the method specified in the notification, where applicable) 
does not contain allergenic protein. We have no data on how many 
notifications would be based on our determination that the ingredient 
does not cause an allergic response or based on scientific evidence 
that demonstrates that the food ingredient does not contain allergenic 
protein. Therefore, we estimate that three of the five notifications 
would be based on scientific evidence, and two of the five 
notifications would be based on our determination. The average time per 
notification is then estimated to be 68 hours (2 x 20 hours + 3 x 100 
hours)/5). Therefore, we estimate that the burden associated with 
notifications will be 340 hours annually (5 notifications x 68 hours 
per notification), as reflected in table 2.
II. References
    The following references are on display in 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. RTI International, ``Model to Estimate Costs of Using Labeling as 
a Risk Reduction Strategy for Consumer Products Regulated by the 
Food and Drug Administration, Final Report.'' Prepared for Andrew 
Stivers, FDA/CFSAN. Prepared by Muth, M., M. Ball, M. Coglaiti, and 
S. Karns. RTI Project Number 0211460.005. March 2011.
2. Gendel, S.M., ``Food Allergen Petitions and Notifications.'' 
Memorandum to File. August 8, 2011.

    Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26690 Filed 12-11-17; 8:45 am]
 BILLING CODE 4164-01-P