
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96462-96467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1155]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling Regulations

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 the proposed collection of certain 
information by the Agency. 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of our food labeling regulations and on Form FDA 3570, Model 
Small Business Nutrition Labeling Exemption Notice, which small 
businesses may use to claim the small business exemption from nutrition 
labeling.

DATES: Submit either electronic or written comments on the collection 
of information by February 28, 2017.

[[Page 96463]]


ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-1155 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Labeling Regulations.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 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, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's 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 Labeling Regulations--21 CFR Parts 101, 102, 104, and 105; OMB 
Control Number 0910-0381--Extension

    Our food labeling regulations require food producers to disclose to 
consumers and others specific information about themselves or their 
products on the label or labeling of their products. Related 
regulations require that food producers retain records establishing the 
basis for the information contained in the label or labeling of their 
products and provide those records to regulatory officials. Finally, 
certain regulations provide for the submission of food labeling 
petitions to us. We issued our food labeling regulations under parts 
101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) under the 
authority of sections 4, 5, and 6 of the Fair Packaging and Labeling 
Act (the FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301, 
402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 
371, and 379e). Most of these regulations derive from section 403 of 
the FD&C Act, which provides that a food product shall be deemed to be 
misbranded if, among other things, its label or labeling fails to bear 
certain required information concerning the food product, is false or 
misleading in any particular, or bears certain types of unauthorized 
claims. The disclosure requirements and other collections of 
information in the regulations in parts 101, 102, 104, and 105 are 
necessary to ensure that food products produced or sold in the United 
States are in compliance with the labeling provisions of the FD&C Act 
and the FPLA.

[[Page 96464]]

    Section 101.3 of our food labeling regulations requires that the 
label of a food product in packaged form bear a statement of identity 
(i.e., the name of the product), including, as appropriate, the form of 
the food or the name of the food imitated. Section 101.4 prescribes 
requirements for the declaration of ingredients on the label or 
labeling of food products in packaged form. Section 101.5 requires that 
the label of a food product in packaged form specify the name and place 
of business of the manufacturer, packer, or distributor and, if the 
food producer is not the manufacturer of the food product, its 
connection with the food product. Section 101.9 requires that nutrition 
information be provided for all food products intended for human 
consumption and offered for sale, unless an exemption in Sec.  101.9(j) 
applies to the product. In particular, Sec.  101.9(c)(2)(ii) requires 
that the amount of trans fatty acids present in a food must be declared 
on the nutrition label on a separate line immediately under the line 
for the declaration of saturated fat. Section 101.9(g)(9) provides that 
interested parties may submit to us requests for alternative approaches 
to nutrition labeling requirements. Finally, Sec.  101.9(j)(18) 
provides that firms claiming the small business exemption from 
nutrition labeling must submit notice to us supporting their claim 
exemption. We developed Form FDA 3570 to assist small businesses in 
claiming the small business exemption from nutrition labeling. The form 
contains all the elements required by Sec.  101.9(j)(18).
    Section 101.10 requires that restaurants provide nutrition 
information, upon request, for any food or meal for which a nutrient 
content claim or health claim is made. Section 101.12(b) provides the 
reference amount that is used for determining the serving sizes for 
specific products, including baking powder, baking soda, and pectin. 
Section 101.12(e) provides that a manufacturer that adjusts the 
reference amount customarily consumed (RACC) of an aerated food for the 
difference in density of the aerated food relative to the density of 
the appropriate nonaerated reference food must be prepared to show us 
detailed protocols and records of all data that were used to determine 
the density-adjusted RACC. Section 101.12(g) requires that the label or 
labeling of a food product disclose the serving size that is the basis 
for a claim made for the product if the serving size on which the claim 
is based differs from the RACC. Section 101.12(h) provides for the 
submission of petitions requesting that we change the reference amounts 
defined by regulation.
    Section 101.13 requires that nutrition information be provided in 
accordance with Sec.  101.9 for any food product for which a nutrient 
content claim is made. Under some circumstances, Sec.  101.13 also 
requires the disclosure of other types of information as a condition 
for the use of a nutrient content claim. For example, under Sec.  
101.13(j), if the claim compares the level of a nutrient in the food 
with the level of the same nutrient in another ``reference'' food, the 
claim must also disclose the identity of the reference food, the amount 
of the nutrient in each food, and the percentage or fractional amount 
by which the amount of the nutrient in the labeled food differs from 
the amount of the nutrient in the reference food. It also requires that 
when this comparison is based on an average of food products, this 
information must be provided to consumers or regulatory officials upon 
request. Section 101.13(q)(5) requires that restaurants document and 
provide to appropriate regulatory officials, upon request, the basis 
for any nutrient content claims they have made for the foods they sell.
    Section 101.14(d)(2) and (d)(3) provides for the disclosure of 
nutrition information in accordance with Sec.  101.9 and, under some 
circumstances, certain other information as a condition for making a 
health claim for a food product. Section 101.15 provides that, if the 
label of a food product contains any representation in a foreign 
language, all words, statements, and other information required by or 
under authority of the FD&C Act to appear on the label must appear in 
both the foreign language and in English. Section 101.22 contains 
labeling requirements for the disclosure of spices, flavorings, 
colorings, and chemical preservatives in food products. Section 
101.22(i)(4) sets forth disclosure and recordkeeping requirements 
pertaining to certifications for flavors designated as containing no 
artificial flavors. Section 101.30 specifies the conditions under which 
a beverage that purports to contain any fruit or vegetable juice must 
declare the percentage of juice present in the beverage and the manner 
in which the declaration is to be made.
    Section 101.36 requires that nutrition information be provided for 
dietary supplements offered for sale, unless an exemption in Sec.  
101.36(h) applies. In particular, Sec.  101.36(b)(2) requires that the 
amount of trans fatty acids present in dietary supplements must be 
declared on the nutrition label on a separate line immediately under 
the line for the declaration of saturated fat. Section 101.36(e) 
permits the voluntary declaration of the quantitative amount and the 
percent of Daily Value of a dietary ingredient on a ``per day'' basis 
in addition to the required ``per serving'' basis, if a dietary 
supplement label recommends that the dietary supplement be consumed 
more than once per day. Section 101.36(f)(2) cross-references the 
provisions in Sec.  101.9(g)(9) for the submission to us of requests 
for alternative approaches to nutrition labeling requirements. Also, 
Sec.  101.36(h)(2) cross-references the provisions in Sec.  
101.9(j)(18) for the submission of small business exemption notices. As 
noted previously, we developed Form FDA 3570 to assist small businesses 
in claiming the small business exemption from nutrition labeling. The 
form contains all the elements required by Sec.  101.36(h)(2).
    Section 101.42 requests that food retailers voluntarily provide 
nutrition information for raw fruits, vegetables, and fish at the point 
of purchase, and Sec.  101.45 contains guidelines for providing such 
information. Also, Sec.  101.45(c) provides for the submission to us of 
nutrient databases and proposed nutrition labeling values for raw 
fruit, vegetables, and fish for review and approval.
    Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify 
information that must be disclosed as a condition for making particular 
nutrient content claims. Section 101.67 provides for the use of 
nutrient content claims for butter, and cross-references requirements 
in other regulations for information declaration (Sec.  101.4) and 
disclosure of information concerning performance characteristics (Sec.  
101.13(d)). Section 101.69 provides for the submission of a petition 
requesting that we authorize a particular nutrient content claim by 
regulation. Section 101.70 provides for the submission of a petition 
requesting that we authorize a particular health claim by regulation. 
Section 101.77(c)(2)(ii)(D) requires the disclosure of soluble fiber 
per serving in the nutrition labeling of a food bearing a health claim 
about the relationship between soluble fiber and a reduced risk of 
coronary heart disease. Section 101.79(c)(2)(iv) requires the 
disclosure of the amount of folate in the nutrition label of a food 
bearing a health claim about the relationship between folate and a 
reduced risk of neural tube defects.
    Section 101.100(d) provides that any agreement that forms the basis 
for an exemption from the labeling requirements of section 403(c), (e), 
(g), (h), (i), (k), and (q) of the FD&C Act be

[[Page 96465]]

in writing and that a copy of the agreement be made available to us 
upon request. Section 101.100 also contains reporting and disclosure 
requirements as conditions for claiming certain labeling exemptions 
(e.g., 101.100(h)).
    Section 101.105 specifies requirements for the declaration of the 
net quantity of contents on the label of a food in packaged form and 
prescribes conditions under which a food whose label does not 
accurately reflect the actual quantity of contents may be sold, with 
appropriate disclosures, to an institution operated by a Federal, 
State, or local government. Section 101.108 provides for the submission 
to us of a written proposal requesting a temporary exemption from 
certain requirements of Sec. Sec.  101.9 and 105.66 for the purpose of 
conducting food labeling experiments with our authorization.
    Regulations in part 102 define the information that must be 
included as part of the statement of identity for particular foods and 
prescribe related labeling requirements for some of these foods. For 
example, Sec.  102.22 requires that the name of a protein hydrolysate 
will include the identity of the food source from which the protein was 
derived.
    Part 104, which pertains to nutritional quality guidelines for 
foods, cross references several labeling provisions in part 101 but 
contains no separate information collection requirements.
    Part 105 contains special labeling requirements for hypoallergenic 
foods, infant foods, and certain foods represented as useful in 
reducing or maintaining body weight.
    The purpose of our food labeling requirements is to allow consumers 
to be knowledgeable about the foods they purchase. Nutrition labeling 
provides information for use by consumers in selecting a nutritious 
diet. Other information enables a consumer to comparison shop. 
Ingredient information also enables consumers to avoid substances to 
which they may be sensitive. Petitions or other requests submitted to 
us provide the basis for us to permit new labeling statements or to 
grant exemptions from certain labeling requirements. Recordkeeping 
requirements enable us to monitor the basis upon which certain label 
statements are made for food products and whether those statements are 
in compliance with the requirements of the FD&C Act or the FPLA.
    Description of Respondents: Respondents to this information 
collection are manufacturers, packers, and distributors of food 
products. Because of the existence of exemptions and exceptions, not 
all of the requirements apply to all food producers or to all of their 
products. Some of the regulations affect food retailers, such as 
supermarkets and restaurants.
    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
                21 CFR section                    Number of      disclosures    Total annual         Average burden per disclosure          Total hours
                                                 respondents   per respondent    disclosures
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101.3, 101.22, 102 and 104; statement of               25,000            1.03          25,750  .5 (30 minutes)..........................          12,875
 identity labeling requirements.
101.4, 101.22, 101.100, 102, 104 and 105;              25,000            1.03          25,750  1........................................          25,750
 ingredient labeling requirements.
101.5; requirement to specify the name and             25,000            1.03          25,750  0.25 (15 minutes)........................           6,438
 place of business of the manufacturer,
 packer, or distributor and, if the food
 producer is not the manufacturer of the food
 product, its connection with the food
 product.
101.9, 101.13(n), 101.14(d)(3), 101.62, and            25,000            1.03          25,750  .40 (24 minutes).........................         103,000
 104; labeling requirements for disclosure of
 nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative                  12               1              12  4........................................              48
 means of compliance permitted.
101.10; requirements for nutrition labeling           300,000             1.5         450,000  0.25 (15 minutes)........................         112,500
 of restaurant foods.
101.12(b); RACC for baking powder, baking                  29             2.3              67  1........................................              67
 soda and pectin.
101.12(e); adjustment to the RACC of an                    25               1              25  1........................................              25
 aerated food permitted.
101.12(g); requirement to disclose the                  5,000               1           5,000  1........................................           5,000
 serving size that is the basis for a claim
 made for the product if the serving size on
 which the claim is based differs from the
 RACC.
101.13(d)(1) and 101.67; requirements to                  200               1             200  1........................................             200
 disclose nutrition information for any food
 product for which a nutrient content claim
 is made.
101.13(j)(2), 101.13(k), 101.54, 101.56,                5,000               1           5,000  1........................................           5,000
 101.60, 101.61, and 101.62; additional
 disclosure required if the nutrient content
 claim compares the level of a nutrient in
 one food with the level of the same nutrient
 in another food.
101.13(q)(5); requirement that restaurants            300,000             1.5         450,000  0.75 (45 minutes)........................         337,500
 disclose the basis for nutrient content
 claims made for their food.
101.14(d)(2); general requirements for                300,000             1.5         450,000  0.75 (45 minutes)........................         337,500
 disclosure of nutrition information related
 to health claims for food products.

[[Page 96466]]

 
101.15; requirements pertaining to prominence             160              10           1,600  8........................................          12,800
 of required statements and use of foreign
 language.
101.22(i)(4); supplier certifications for                  25               1              25  1........................................              25
 flavors designated as containing no
 artificial flavors.
101.30 and 102.33; labeling requirements for            1,500               5           7,500  1........................................           7,500
 fruit or vegetable juice beverages.
101.36; nutrition labeling of dietary                     300              40          12,000  4.025....................................          48,300
 supplements.
101.42 and 101.45; nutrition labeling of raw            1,000               1           1,000  0.5 (30 minutes).........................             500
 fruits, vegetables, and fish.
101.45(c); databases of nutrient values for                 5               4              20  4........................................              80
 raw fruits, vegetables, and fish.
101.79(c)(2)(i)(D); disclosure requirements             1,000               1           1,000  0.25 (15 minutes)........................             250
 for food labels that contain a folate/neural
 tube defect health claim.
101.79(c)(2)(iv); disclosure of amount of                 100               1             100  0.25 (15 minutes)........................              25
 folate for food labels that contain a folate/
 neural tube defect health claim.
101.100(d); disclosure of agreements that               1,000               1           1,000  1........................................           1,000
 form the basis for exemption from the
 labeling requirements of section 403(c),
 (e), (g), (h), (i), (k), and (q) of the FD&C
 Act.
101.105 and 101.100(h); disclosure                     25,000            1.03          25,750  0.5 (30 minutes).........................          12,875
 requirements for food not accurately labeled
 for quantity of contents and for claiming
 certain labeling exemptions.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................       1,029,258
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                  Number of
                21 CFR section                    Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
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101.12(e); recordkeeping to document the                   25               1              25  1........................................              25
 basis for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the           300,000             1.5         450,000  0.75 (45 minutes)........................         337,500
 basis for nutrient content claims.
101.14(d)(2); recordkeeping to document               300,000             1.5         450,000  0.75 (45 minutes)........................         337,500
 nutrition information related to health
 claims for food products.
101.22(i)(4); recordkeeping to document                    25               1              25  1........................................              25
 supplier certifications for flavors
 designated as containing no artificial
 flavors.
101.100(d)(2); recordkeeping pertaining to              1,000               1           1,000  1........................................           1,000
 agreements that form the basis for an
 exemption from the labeling requirements of
 section 403(c), (e), (g), (h), (i), (k), and
 (q) of the FD&C Act.
101.105(t); recordkeeping pertaining to                   100               1             100  1........................................             100
 disclosure requirements for food not
 accurately labeled for quantity of contents.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         676,150
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     21 CFR section/Form No.         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
101.9(j)(18) and 101.36(h)(2);            10,000               1          10,000               8          80,000
 procedure for small business
 nutrition labeling exemption
 notice using Form FDA 3570.....
101.12(h); petitions to                        5               1               5              80             400
 establish or amend a RACC......
101.69; petitions for nutrient                 3               1               3              25              75
 content claims.................
101.70; petitions for health                   5               1               5              80             400
 claims.........................

[[Page 96467]]

 
101.108; written proposal for                  1               1               1              40              40
 requesting temporary exemptions
 from certain regulations for
 the purpose of conducting food
 labeling experiments...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          80,915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated annual third party disclosure, recordkeeping, and 
reporting burdens are based on our communications with industry and our 
knowledge of and experience with food labeling and the submission of 
petitions and requests to us.
    We expect that the burden hours for submissions under Sec.  101.108 
will be insignificant. Section 101.108 was originally issued to provide 
a procedure whereby we could grant exemptions from certain food 
labeling requirements. Exemption petitions have infrequently been 
submitted in the recent past; none have been submitted since 
publication on January 6, 1993, of the final regulations implementing 
section 403(q) and (r) of the FD&C Act. Thus, in order to maintain OMB 
approval of Sec.  101.108 to accommodate the possibility that a food 
producer may propose to conduct a labeling experiment on its own 
initiative, we estimate that we will receive one or fewer submissions 
under Sec.  101.108 in the next 3 years.

    Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31733 Filed 12-29-16; 8:45 am]
 BILLING CODE 4164-01-P


