Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting, 58407-58410 [2017-26690]
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
58407
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2—Continued
Number of
respondents
21 CFR section/[FDA form No.]
Total ..............................................................................
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
4,634,247.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 For most elements, ‘‘Total Hours’’ reflects estimated average burden as calculated by multiplying the number of respondents by the frequency of response and time necessary for the corresponding activity. In other instances, ‘‘Total Hours’’ is the average burden we attribute to all
respondents, where individual respondent and time-frequency values have been estimated. All figures have been rounded to the nearest whole
number.
We retain the currently approved
burden estimate for the information
collection associated with the
provisions identified above. At the same
time, we have added burden estimate
associated with § 314.103, although in
an effort to reduce burden, we have
issued associated guidance to assist
respondents with the relevant
information collection.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26670 Filed 12–11–17; 8:45 am]
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.
ADDRESSES:
BILLING CODE 4164–01–P
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.
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.
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SUMMARY:
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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.
PO 00000
Frm 00030
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• 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/
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
fdsys/pkg/FR-2015-09-18/pdf/201523389.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, PRAStaff@
fda.hhs.gov.
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:
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TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
FD&C Act section/activity
403(w)(1); review labels for compliance with food allergen
labeling requirements .......................................................
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Number of
disclosures
per
respondent
77,500
Fmt 4703
Sfmt 4703
Total annual
disclosures
1
77,500
E:\FR\FM\12DEN1.SGM
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Average
burden per
disclosure
Total hours
1
77,500
58409
Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
disclosures
per
respondent
Number of
respondents
FD&C Act section/activity
Average
burden per
disclosure
Total annual
disclosures
Total hours
403(w)(1); redesign labels to comply with food allergen labeling requirements ..........................................................
3,875
1
3,875
16
62,000
Total ..............................................................................
........................
........................
........................
........................
139,500
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 × 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 × 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
responses per
respondent
Number of
respondents
FD&C Act Section/Activity
Average
burden per
response
Total annual
responses
Total hours
403(w)(6); petition for exemption .........................................
403(w)(7); notification ..........................................................
5
5
1
1
5
5
100
68
500
340
Total ..............................................................................
........................
........................
........................
........................
840
1 There
are no capital or operating and maintenance costs associated with the information collection.
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
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 × 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 × 20 hours + 3 × 100 hours)/
5). Therefore, we estimate that the
burden associated with notifications
will be 340 hours annually (5
notifications × 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
VerDate Sep<11>2014
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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
[Docket No. FDA–2017–D–6528]
Refusal of Inspection by a Foreign
Food Establishment or Foreign
Government; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled ‘‘Refusal
of Inspection by a Foreign Food
Establishment or Foreign Government.’’
This draft guidance, when finalized,
will provide information for foreign
food establishments subject to our
inspection, as well as foreign
governments, on when we may consider
that a foreign food establishment or a
government of a foreign country has
refused to permit an inspection by us as
provided in the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the draft guidance
by February 26, 2018 to ensure that the
Agency considers your comment on the
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
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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–
2017–D–6528 for ‘‘Refusal of Inspection
by a Foreign Food Establishment or
Foreign Government.’’ 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.
• 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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
FD&C Act section/activity respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
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..........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 139,500
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of Average
FD&C Act Section/Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
403(w)(6); petition for 5 1 5 100 500
exemption......................
403(w)(7); notification......... 5 1 5 68 340
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 840
----------------------------------------------------------------------------------------------------------------
\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
