[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15848-15850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07545]


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

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.

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

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 May 14, 
2018.

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 0910-0792. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD

[[Page 15849]]

20852, 301-796-5733, [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 0910-0792--Extension

    This information collection supports third-party disclosure 
requirements of food allergen labeling, as well as 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 
(21 U.S.C. 343(w)(6) and (7)). 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 sets forth the requirements for 
declaring the presence of each major food allergen on the product 
label. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) defines a 
major food allergen as ``[m]ilk, egg, fish (e.g., bass, flounder, or 
cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts 
(e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans'' and 
also as a food ingredient that contains protein derived from such 
foods. The definition excludes any highly refined oil derived from a 
major food allergen and any ingredient derived from such highly refined 
oil.
    In some cases, the production of an ingredient derived from a major 
food allergen may alter or eliminate the allergenic proteins in that 
derived ingredient to such an extent that it does not contain 
allergenic protein. In addition, a major food allergen may be used as 
an ingredient or as a component of an ingredient such that the level of 
allergenic protein in finished food products does not cause an allergic 
response that poses a risk to human health. Therefore, FALCPA provides 
two mechanisms through which such ingredients may become exempt from 
the labeling requirement of section 403(w)(1) of the FD&C Act. An 
ingredient may obtain an exemption through submission and approval of a 
petition containing scientific evidence that demonstrates that the 
ingredient ``does not cause an allergic response that poses a risk to 
human health'' (section 403(w)(6) of the FD&C Act). Alternately, an 
ingredient may become exempt through submission of a notification 
containing scientific evidence showing that the ingredient ``does not 
contain allergenic protein'' or that there has been a previous 
determination through a premarket approval process under section 409 of 
the FD&C Act (21 U.S.C. 348) that the ingredient ``does not cause an 
allergic response that poses a risk to human health'' (section 
403(w)(7) of the FD&C Act).

A. Third-Party Disclosure

    The labeling requirements of section 403(w)(1) of the FD&C Act 
apply to all packaged foods sold in the United States that are 
regulated under the FD&C Act, including both domestically manufactured 
and imported foods. As noted, section 403(w)(1) of the FD&C Act 
requires that the label of a food product declare the presence of each 
major food allergen. We estimate the information collection burden of 
the third-party disclosure associated with food allergen labeling under 
section 403(w)(1) of the FD&C Act as the time needed for a manufacturer 
to review the labels of new or reformulated products for compliance 
with the requirements of section 403(w)(1) of the FD&C Act and the time 
needed to make any needed modifications to the labels of those 
products.
    The 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.

B. Reporting

    Under section 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 document entitled ``Food Allergen Labeling Exemption Petitions 
and Notifications: Guidance for Industry,'' sets forth our 
recommendations with regard to the information that an interested party 
should submit in such a petition or notification. The guidance states 
that to evaluate these petitions and notifications, we will consider 
scientific evidence that describes: (1) The identity or composition of 
the ingredient; (2) the methods used to produce the ingredient; (3) the 
methods used to characterize the ingredient; (4) the intended use of 
the ingredient in food; and (5) either (a) for a petition--data and 
information, including the expected level of consumer exposure to the 
ingredient, that demonstrate that the ingredient, when manufactured and 
used as described, does not cause an allergic response that poses a 
risk to human health; or (b) for a notification, data and information 
that demonstrate that the ingredient, when manufactured as described, 
does not contain allergenic protein, or documentation of a previous 
determination under a process under section 409 of the FD&C Act that 
the ingredient does not cause an allergic response that poses a risk to 
human health.
    We use information submitted in petitions and notifications to 
determine whether the ingredient satisfies the criteria of section 
403(w)(6) and (7) of the FD&C Act for granting the exemption.
    In the Federal Register of December 12, 2017 (82 FR 58407), we 
published a

[[Page 15850]]

60-day notice inviting public comment on the proposed extension of this 
collection of information. One comment was received that expressed 
support for the information collection but did not otherwise respond to 
the topics solicited, nor did the comment suggest we revise our burden 
estimate. We therefore retain the currently approved estimate of the 
associated burden for the information collection, which is as follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
    FD&C act section/activity       respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
403(w)(1); review labels for              77,500               1          77,500               1          77,500
 compliance with food allergen
 labeling requirements..........
403(w)(1); redesign labels to              3,875               1           3,875              16          62,000
 comply with food allergen
 labeling requirements..........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         139,500
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Using a labeling cost model 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 there are 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. We assume an annual entry rate 
of 10 percent for new or reformulated UPCs (77,500), and assume 5 
percent of labels may be redesigned (3,875). We estimate an 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, and we estimate 16 hours for the redesign of a label. Together we 
estimate a total annual hourly burden of 139,500 in third-party 
disclosure.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    FD&C act section/activity        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
403(w)(6); petition for                        5               1               5             100             500
 exemption......................
403(w)(7); notification.........               5               1               5              68             340
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             840
----------------------------------------------------------------------------------------------------------------
\1\There are no capital 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 assume that we will receive 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. 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. The burden estimate has not increased since the initial OMB 
approval.

    Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07545 Filed 4-11-18; 8:45 am]
 BILLING CODE 4164-01-P