[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)]
[Notices]
[Pages 71107-71109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28185]



[[Page 71107]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 31, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Food Allergen Labeling and Reporting''. Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, 8455 
Colesville Road, COLE-14526, Silver Spring, MD 20993-0002, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 Federal Food, Drug, 
and Cosmetic Act (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)).
    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.
    In the Federal Register of August 12, 2014 (79 FR 47145), we 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 71108]]

information. Although one comment was received, it did not respond to 
any of the four collection of information topics solicited and 
therefore is not discussed in this document.
    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       Total     Avg. burden                  Total
        FD&C Act Section          Number of     disclosures      annual        per      Total hours    capital
                                 respondents  per respondent  disclosures   disclosure                  costs
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403(w)(1); review labels for          77,500               1       77,500            1       77,500            0
 compliance with food allergen
 labeling requirements.........
403(w)(1); redesign labels to          3,875               1        3,875           16       62,000   $7,071,875
 comply with food allergen
 labeling requirements.........
                                --------------------------------------------------------------------------------
    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 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

[[Page 71109]]

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                        Average
        FD&C Act Section             Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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403(w)(6); petition for                        5               1               5             100             500
 exemption......................
403(w)(7); notification.........               5               1               5              68             340
                                 -------------------------------------------------------------------------------
    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 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: November 24, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28185 Filed 11-28-14; 8:45 am]
BILLING CODE 4164-01-P