
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27504-27508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 
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 (PRA).

DATES: Fax written comments on the collection of information by July 
17, 2017.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0381. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726.

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.

[[Page 27505]]

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.
    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 101.7 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. 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 (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-

[[Page 27506]]

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 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)).
    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.
    In the Federal Register of December 30, 2016 (81 FR 96462), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. In this notice, FDA did not accurately 
reflect amendments approved in the final rule, technical amendments for 
21 CFR parts 1, 100, 101, and 104, ``Food Labeling; Technical 
Amendments,'' dated August 29, 2016 (81 FR 59129), which changed 
section 101.105 to section 101.7. This has been corrected in this 
notice. In addition, FDA received two comments from the 60-day notice. 
One comment was not related to the PRA and will not be addressed here, 
and one comment was PRA-related and is addressed in this document.
    (Comment) One commenter stated that ensuring that food is labeled 
accurately and correctly is important because people should know 
exactly what is inside of different foods. Labeling food accurately and 
correctly ensures no information about the food is hidden because some 
people have allergies, and people should be allowed to provide 
feedback.
    (Response) FDA agrees with this comment, and this collection of 
information reinforces that food should be labeled accurately, with no 
hidden ingredients, for the public's health and safety. In addition, 
the renewal of this collection of information provides the public the 
opportunity to comment and provide feedback on this collection.
    FDA estimates the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third Party Disclosure Burden \1\
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                                                                    Number of
                                                    Number of      disclosures    Total annual
              21 CFR section/part                  respondents         per         disclosures        Average burden per disclosure         Total hours
                                                                   respondent
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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  .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 means              12               1              12  4......................................              48
 of compliance permitted.
101.10; requirements for nutrition labeling of          300,000             1.5         450,000  .25 (15 minutes).......................         112,500
 restaurant foods.
101.12(b); RACC for baking powder, baking soda               29             2.3              67  1......................................              67
 and pectin.

[[Page 27507]]

 
101.12(e); adjustment to the RACC of an aerated              25               1              25  1......................................              25
 food permitted.
101.12(g); requirement to disclose the serving            5,000               1           5,000  1......................................           5,000
 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  .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  .75 (45 minutes).......................         337,500
 disclosure of nutrition information related to
 health claims for food products.
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  .5 (30 minutes)........................             500
 fruits, vegetables, and fish.
101.45(c); databases of nutrient values for raw               5               4              20  4......................................              80
 fruits, vegetables, and fish.
101.79(c)(2)(i)(D); disclosure requirements for           1,000               1           1,000  .25 (15 minutes).......................             250
 food labels that contain a folate/neural tube
 defect health claim.
101.79(c)(2)(iv); disclosure of amount of                   100               1             100  .25 (15 minutes).......................              25
 folate for food labels that contain a folate/
 neural tube defect health claim.
101.100(d); disclosure of agreements that form            1,000               1           1,000  1......................................           1,000
 the basis for exemption from the labeling
 requirements of section 403(c), (e), (g), (h),
 (i), (k), and (q) of the FD&C Act.
101.7 and 101.100(h); disclosure requirements            25,000            1.03          25,750  .5 (30 minutes)........................          12,875
 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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101.7(t); recordkeeping pertaining to                       100               1             100  1......................................             100
 disclosure requirements for food not
 accurately labeled for quantity of contents.
101.12(e); recordkeeping to document the basis               25               1              25  1......................................              25
 for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the             300,000             1.5         450,000  .75 (45 minutes).......................         337,500
 basis for nutrient content claims.
101.14(d)(2); recordkeeping to document                 300,000             1.5         450,000  .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.
                                                --------------------------------------------------------------------------------------------------------
    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
     21 CFR section/form No.         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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.........................
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
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 27508]]

    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: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12443 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P


