Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting, 47145-47148 [2014-19004]
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Federal Register / Vol. 79, No. 155 / Tuesday, August 12, 2014 / Notices
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Dated: August 7, 2014.
Martique Jones,
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[FR Doc. 2014–19027 Filed 8–11–14; 8:45 am]
BILLING CODE 4120–01–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 or we) is
announcing an opportunity for public
comment on our proposed collection of
certain information. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice invites comments on
the information collection provisions of
the labeling requirements for major food
allergens in the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) and the
information collection provisions of the
draft guidance entitled, ‘‘Draft Guidance
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SUMMARY:
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for Industry: Food Allergen Labeling
Exemption Petitions and Notifications.’’
Submit either electronic or
written comments on the collection of
information by October 14, 2014.
DATES:
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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
before submitting the collection to OMB
for approval. To comply with this
requirement, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our 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.
SUPPLEMENTARY INFORMATION:
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Food Allergen Labeling and
Reporting—(OMB Control Number
0910–NEW)
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 (21
U.S.C. 343(w)(6)). 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 (21 U.S.C. 343(w)(7)).
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In the Federal Register of May 8, 2014
(79 FR 26435), we published a notice of
availability for the draft guidance
document entitled, ‘‘Draft Guidance for
Industry: Food Allergen Labeling
Exemption Petitions and Notifications.’’
This draft guidance is intended to help
industry prepare petitions and
notifications seeking exemptions from
the labeling requirements for
ingredients derived from major food
allergens. Persons with access to the
Internet may obtain the guidance at
https://www.fda.gov/FoodGuidances.
II. Analysis of the Proposed Information
Collection
The proposed information collection
seeks OMB approval of the third party
disclosure requirements of food allergen
labeling under section 403(w)(1) of the
FD&C Act, as well as OMB approval of
the reporting associated with the
submission of petitions and
notifications seeking exemptions from
the labeling requirements for
ingredients derived from major food
allergens under section 403(w)(6) and
(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 primary user of the allergen
information disclosed on the label or
labeling of food products is the
consumer that purchases the food
product. Consumers will use the
information to help them make choices
concerning their purchase of a food
product, including choices related to
substances that the consumer wishes to
avoid due to their potential to cause
adverse reactions. Additionally, we
intend to use the information to
determine whether a manufacturer or
other supplier of food products is
meeting its statutory obligations. Failure
of a manufacturer or other supplier of
food products to label its products in
compliance with section 403(w)(1) of
the FD&C Act may result in a product
being misbranded under the FD&C Act
and the manufacturer or packer and the
product subject to regulatory action.
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:
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
FD&C Act section
Total annual
disclosures
Avg. burden
per disclosure
Total
hours
Total
capital costs
403(w)(1); review labels for compliance
with food allergen labeling requirements ....................................................
403(w)(1); redesign labels to comply with
food allergen labeling requirements .....
77,500
1
77,500
1
77,500
0
3,875
1
3,875
16
62,000
$7,071,875
Total ..................................................
........................
........................
........................
........................
139,500
$7,071,875
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1 There
are no operating and maintenance costs associated with this collection of information.
We used our labeling cost model (Ref.
1) to estimate the number of new or
reformulated products sold in the
United States, annually, that are affected
by the requirements of section 403(w)(1)
of the FD&C Act. 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 our 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 × 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
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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 the
need to redesign the label. Therefore, we
further estimate, for the purposes of this
analysis, that 5 percent of the reviewed
labels of new or reformulated products,
or 3,875 labels (77,500 × 5 percent)
would need to 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 labels, we estimate that 3,875
respondents will each redesign one
label, as reported in table 1, row 2.
Our estimate of the average burdens
per disclosure reported in table 1 is
based on our experience with food
labeling and our labeling cost model.
We estimate the average burden for the
review of labels for compliance with the
food allergen labeling requirements
under section 403(w)(1) of the FD&C Act
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to be 1 hour. Consequently, the burden
of reviewing the labels of new or
reformulated products is 77,500 hours,
as reported in table 1. Using our labeling
cost model, we estimate that it takes an
average of 16 hours to complete the
administration and internal design work
for the redesign of a label to comply
with the food allergen labeling
requirements under section 403(w)(1) of
the FD&C Act. Consequently, the burden
of redesigning the 3,875 labels of new or
reformulated products is 62,000 hours,
as reported in table 1.
Using our labeling cost model, we
estimate the capital cost to be $1,825 per
label for external design services for the
redesign of a label. Consequently for
3,875 labels, the total capital costs are
$7,071,875 (3,875 labels × $1,825 per
label), as reported in table 1.
B. Reporting
Under sections 403(w)(6) and (7) of
the FD&C Act, interested parties may
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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).
Our draft guidance document entitled,
‘‘Draft Guidance for Industry: Food
Allergen Labeling Exemption Petitions
and Notifications,’’ sets forth our
recommendations with regard to the
information that an interested party
should submit in such a petition or
notification. The draft 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 either
5. 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
5. 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 will use the information
submitted in the petition or notification
to determine whether the ingredient
satisfies the criteria of sections
403(w)(6) and (7) of the FD&C Act for
granting the exemption.
Description of respondents: The
respondents to this collection of
information are manufacturers and
packers of packaged foods sold in the
United States that seek an exemption
from the labeling requirement of section
403(w)(1) of the FD&C Act.
We estimate the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
FD&C Act section
Total
annual
responses
Average
burden
per response
Total
hours
403(w)(6); petition for exemption .........................................
403(w)(7); notification ..........................................................
5
5
1
1
5
5
100
68
500
340
Total ..............................................................................
........................
........................
........................
........................
840
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the number of petitions and
notifications received in recent years,
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, as reported in
table 2, rows 1 and 2.
We base our estimate of the average
burdens per response reported in table
2 on our experience with other petition
processes. We estimate that a petition
would take, on average, 100 hours to
develop and submit (Ref. 2). Therefore,
we estimate that the 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
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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 would submit
scientific evidence demonstrating that
the ingredient when manufactured as
described does not contain allergenic
protein. We estimate that it would take
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 that it would take
a respondent approximately 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
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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 reported in table 2.
III. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
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
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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, Steven M. ‘‘Food Allergen
Petitions and Notifications,’’ Memorandum
to File. August 8, 2011.
MSC 7616, Bethesda, MD 20892, 301–402–
3938, lr228v@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Cancer Control, National Institutes of Health,
HHS)
Dated: August 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18997 Filed 8–11–14; 8:45 am]
[FR Doc. 2014–19004 Filed 8–11–14; 8:45 am]
Dated: August 6, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
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[FR Doc. 2014–18991 Filed 8–11–14; 8:45 am]
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National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
National Institute of Mental Health;
Notice of Meeting
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
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The meeting will be open to the
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Individuals who plan to attend and
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The meeting will be closed to the
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provisions set forth in sections
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as amended. The grant applications and
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confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
National Cancer Institute; Notice of
Closed Meeting
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID Peer Review Meeting.
Date: September 4, 2014.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, Room
3130, 6700B Rockledge Drive, Bethesda, MD
20817 (Telephone Conference Call).
Contact Person: Roberta Binder, Ph.D.,
Scientific Review Officer, Scientific, Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, Room 3130, Bethesda, MD
20892–7616, 301–496–7966, rbinder@
niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel ‘‘NIAID Investigator Initiated
Program Project Applications (P01).’’
Date: September 17, 2014.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3120, 6700B Rockledge Drive, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Lynn Rust, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
Name of Committee: National Cancer
Institute Special Emphasis Panel; Retroviral
Pathogenesis, Treatment and Prevention.
Date: September 11, 2014.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
5W030, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Thomas M. Vollberg,
Ph.D., Scientific Review Officer, Research
Technology and Contract Review, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W102, Bethesda, MD 20892–8329, 240–276–
6341, vollbergt@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
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Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
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National Institutes of Health
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Dated: August 6, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
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Name of Committee: National Advisory
Mental Health Council.
Date: September 18, 2014.
Open: 8:30 a.m. to 12:30 p.m.
Agenda: Presentation of NIMH Director’s
Report and discussion of NIMH program and
policy issues.
Place: National Institutes of Health (NIH),
Neuroscience Center, Conference Rooms C/
D/E, 6001 Executive Boulevard, Rockville,
MD 20852.
Closed: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
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Place: National Institutes of Health,
Neuroscience Center, Conference Rooms C/
D/E, 6001 Executive Boulevard, Rockville,
MD 20852.
Contact Person: Jane A. Steinberg, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Mental Health, NIH,
Neuroscience Center, 6001 Executive Blvd.,
Room 6154, MSC 9609, Bethesda, MD 20892–
9609, 301–443–5047.
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]]>Agencies
[Federal Register Volume 79, Number 155 (Tuesday, August 12, 2014)]
[Notices]
[Pages 47145-47148]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19004]
-----------------------------------------------------------------------
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 or we) is announcing an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the PRA),
Federal Agencies are required to publish notice in the Federal Register
concerning each proposed collection of information and to allow 60 days
for public comment in response to the notice. This notice invites
comments on the information collection provisions of the labeling
requirements for major food allergens in the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) and the information collection provisions
of the draft guidance entitled, ``Draft Guidance for Industry: Food
Allergen Labeling Exemption Petitions and Notifications.''
DATES: Submit either electronic or written comments on the collection
of information by October 14, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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 before
submitting the collection to OMB for approval. To comply with this
requirement, we are publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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-NEW)
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 (21 U.S.C.
343(w)(6)). 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 (21 U.S.C.
343(w)(7)).
[[Page 47146]]
In the Federal Register of May 8, 2014 (79 FR 26435), we published
a notice of availability for the draft guidance document entitled,
``Draft Guidance for Industry: Food Allergen Labeling Exemption
Petitions and Notifications.'' This draft guidance is intended to help
industry prepare petitions and notifications seeking exemptions from
the labeling requirements for ingredients derived from major food
allergens. Persons with access to the Internet may obtain the guidance
at https://www.fda.gov/FoodGuidances.
II. Analysis of the Proposed Information Collection
The proposed information collection seeks OMB approval of the third
party disclosure requirements of food allergen labeling under section
403(w)(1) of the FD&C Act, as well as OMB approval of the reporting
associated with the submission of petitions and notifications seeking
exemptions from the labeling requirements for ingredients derived from
major food allergens under section 403(w)(6) and (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 primary user of the allergen information disclosed on the label
or labeling of food products is the consumer that purchases the food
product. Consumers will use the information to help them make choices
concerning their purchase of a food product, including choices related
to substances that the consumer wishes to avoid due to their potential
to cause adverse reactions. Additionally, we intend to use the
information to determine whether a manufacturer or other supplier of
food products is meeting its statutory obligations. Failure of a
manufacturer or other supplier of food products to label its products
in compliance with section 403(w)(1) of the FD&C Act may result in a
product being misbranded under the FD&C Act and the manufacturer or
packer and the product subject to regulatory action.
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:
Table 1--Estimated Annual Third Party Disclosure Burden \1\
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Number of
FD&C Act section Number of disclosures Total annual Avg. burden Total hours Total capital
respondents per respondent disclosures per disclosure costs
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403(w)(1); review labels for compliance with food 77,500 1 77,500 1 77,500 0
allergen labeling requirements.........................
403(w)(1); redesign labels to comply with food allergen 3,875 1 3,875 16 62,000 $7,071,875
labeling requirements..................................
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Total............................................... .............. .............. .............. .............. 139,500 $7,071,875
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\1\ There are no operating and maintenance costs associated with this collection of information.
We used our labeling cost model (Ref. 1) to estimate the number of
new or reformulated products sold in the United States, annually, that
are affected by the requirements of section 403(w)(1) of the FD&C Act.
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 our 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 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, as reported in table 1, row 1.
We have no data on how many label reviews would identify the need to
redesign the label. Therefore, we further estimate, for the purposes of
this analysis, that 5 percent of the reviewed labels of new or
reformulated products, or 3,875 labels (77,500 x 5 percent) would need
to 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 labels, we estimate that 3,875 respondents will each redesign
one label, as reported in table 1, row 2.
Our estimate of the average burdens per disclosure reported in
table 1 is based on our experience with food labeling and our labeling
cost model. We estimate the average burden for the review of labels for
compliance with the food allergen labeling requirements under section
403(w)(1) of the FD&C Act to be 1 hour. Consequently, the burden of
reviewing the labels of new or reformulated products is 77,500 hours,
as reported in table 1. Using our labeling cost model, we estimate that
it takes an average of 16 hours to complete the administration and
internal design work for the redesign of a label to comply with the
food allergen labeling requirements under section 403(w)(1) of the FD&C
Act. Consequently, the burden of redesigning the 3,875 labels of new or
reformulated products is 62,000 hours, as reported in table 1.
Using our labeling cost model, we estimate the capital cost to be
$1,825 per label for external design services for the redesign of a
label. Consequently for 3,875 labels, the total capital costs are
$7,071,875 (3,875 labels x $1,825 per label), as reported in table 1.
B. Reporting
Under sections 403(w)(6) and (7) of the FD&C Act, interested
parties may
[[Page 47147]]
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).
Our draft guidance document entitled, ``Draft Guidance for
Industry: Food Allergen Labeling Exemption Petitions and
Notifications,'' sets forth our recommendations with regard to the
information that an interested party should submit in such a petition
or notification. The draft 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 either
5. 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
5. 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 will use the information submitted in the petition or
notification to determine whether the ingredient satisfies the criteria
of sections 403(w)(6) and (7) of the FD&C Act for granting the
exemption.
Description of respondents: The respondents to this collection of
information are manufacturers and packers of packaged foods sold in the
United States that seek an exemption from the labeling requirement of
section 403(w)(1) of the FD&C Act.
We estimate the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
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Number of
FD&C Act section Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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 costs or operating and maintenance costs associated with this collection of
information.
Based on the number of petitions and notifications received in
recent years, 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, as
reported in table 2, rows 1 and 2.
We base our estimate of the average burdens per response reported
in table 2 on our experience with other petition processes. We estimate
that a petition would take, on average, 100 hours to develop and submit
(Ref. 2). Therefore, we estimate that the 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 would submit scientific evidence demonstrating that the
ingredient when manufactured as described does not contain allergenic
protein. We estimate that it would take 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 that it would take a respondent
approximately 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 reported in
table 2.
III. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
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
[[Page 47148]]
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, Steven M. ``Food Allergen Petitions and
Notifications,'' Memorandum to File. August 8, 2011.
Dated: August 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19004 Filed 8-11-14; 8:45 am]
BILLING CODE 4164-01-P
