
[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.

-----------------------------------------------------------------------

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of the draft guidance entitled, ``Draft Guidance for Industry: Food 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, 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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of
                    FD&C Act section                         Number of      disclosures    Total annual     Avg. burden     Total hours    Total capital
                                                            respondents   per respondent    disclosures   per disclosure                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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..................................
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............         139,500      $7,071,875
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
        FD&C Act section             Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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 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


