[Federal Register Volume 79, Number 155 (Tuesday, August 12, 2014)]
[Notices]
[Pages 47145-47148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19004]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1030]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Allergen Labeling and Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA 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of the draft guidance entitled, ``Draft Guidance for Industry: Food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 http://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, [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 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 http://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