
[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Notices]
[Pages 79461-79465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31215]


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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) 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 January 
29, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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 Labeling Regulations--21 CFR Parts 101, 102, 104, and 105 (OMB 
Control Number 0910-0381)--Revision to Include Collections Previously 
Approved By OMB, But Currently in Use Without Approval

    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 (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 
(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 FPLA.
    Upon review of the information collection requests supporting these 
food labeling regulations, FDA found that the third-party disclosure 
burdens associated with the requirements found in Sec. Sec.  
101.9(c)(2)(ii) and 101.36(b)(2) to

[[Page 79462]]

declare the amount of trans fatty acids present in a food, and with 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 are in use without current OMB 
approval. These collections of information were previously approved by 
OMB under control numbers 0910-0595 and 0910-0395 respectively; 
however, the approval period for these collections has expired. To 
remedy this oversight, to most appropriately streamline these 
information collections, and to eliminate redundancy in its information 
collection requests, we seek to revise the instant collection to 
include these third-party disclosure elements and have included them in 
the burden estimates and discussion in this document in support of our 
approval request for OMB control number 0910-0381.
    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 non-aerated 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 fruit, 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

[[Page 79463]]

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)).
    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 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 November 1, 2013 (78 FR 65663), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Several comments were received in response 
to the notice. Many were generally supportive of the necessity of our 
food labeling regulations. Other comments were beyond the scope of the 
four collections of information topics on which the notice solicits 
comments and will therefore not be discussed in this document.
    A number of comments referenced our Federal Register notice 
published on November 8, 2013 (78 FR 67169) (``the November 8, 2013, 
notice''), announcing the tentative determination that partially 
hydrogenated oils (PHOs) are no longer ``generally recognized as safe'' 
(GRAS). Some comments supported this determination while others opposed 
it. Supportive comments suggested that labels should be placed on food 
packaging warning consumers of the negative health effects of the trans 
fatty acid component of PHOs. FDA notes that it does not require 
warning labels on food containing trans fatty acid, but we agree that 
trans fatty acid content should be provided in the nutrition labeling 
of food. In the Federal Register of July 11, 2003 (68 FR 41434), we 
issued a final rule (``the July 2003 final rule'') amending our 
nutrition labeling regulations to require declaration of the trans 
fatty acid content of food in the nutrition label of conventional foods 
and dietary supplements (Sec.  101.9(c)(2)(ii)). This requirement was 
effective January 1, 2006. The November 8, 2013, notice seeks comments 
on our preliminary determination that PHOs are not GRAS and we have 
submitted comments relevant to this topic to that docket as well. If 
FDA makes a final determination that PHOs are not GRAS, the food 
industry would be required to phase out the use of PHOs in food over 
time, not place warning labels on their food products.
    FDA estimates the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
101.3, 101.22, 102, and 104;              25,000            1.03          25,750           0.5            12,875
 statement of identity labeling
 requirements...................
101.4, 101.22, 101.100, 102,              25,000            1.03          25,750           1              25,750
 104, and 105; ingredient
 labeling requirements..........
101.5; requirement to specify             25,000            1.03          25,750           0.25            6,438
 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...............
101.9, 101.13(n), 101.14(d)(3),           25,000            1.03          25,750           4             103,000
 101.62, and 104; labeling
 requirements for disclosure of
 nutrition information..........
101.9(g)(9) and 101.36(f)(2);                 12            1                 12           4                  48
 alternative means of compliance
 permitted......................

[[Page 79464]]

 
101.10; requirements for                 300,000            1.5          450,000           0.25          112,500
 nutrition labeling of
 restaurant foods...............
101.12(b); RACC for baking                    29            2.3               67           1                  67
 powder, baking soda, and pectin
101.12(e); adjustment to the                  25            1                 25           1                  25
 RACC of an aerated food
 permitted......................
101.12(g); requirement to                  5,000            1              5,000           1               5,000
 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....
101.13(d)(1) and 101.67;                     200            1                200           1                 200
 requirements to disclose
 nutrition information for any
 food product for which a
 nutrient content claim is made.
101.13(j)(2), 101.13(k), 101.54,           5,000            1              5,000           1               5,000
 101.56, 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           300,000            1.5          450,000           0.75          337,500
 restaurants disclose the basis
 for nutrient content claims
 made for their food............
101.14(d)(2); general                    300,000            1.5          450,000           0.75          337,500
 requirements for disclosure of
 nutrition information related
 to health claims for food
 products.......................
101.15; requirements pertaining              160           10              1,600           8              12,800
 to prominence of required
 statements and use of foreign
 language.......................
101.22(i)(4); supplier                        25            1                 25           1                  25
 certifications for flavors
 designated as containing no
 artificial flavors.............
101.30 and 102.33; labeling                1,500            5              7,500           1               7,500
 requirements for fruit or
 vegetable juice beverages......
101.36; nutrition labeling of                300           40             12,000           4.025          48,300
 dietary supplements............
101.42 and 101.45; nutrition               1,000            1              1,000           0.5               500
 labeling of raw fruits,
 vegetables, and fish...........
101.45(c); databases of nutrient               5            4                 20           4                  80
 values for raw fruits,
 vegetables, and fish...........
101.79(c)(2)(i)(D); disclosure             1,000            1              1,000           0.25              250
 requirements for food labels
 that contain a folate/neural
 tube defect health claim.......
101.79(c)(2)(iv); disclosure of              100            1                100           0.25               25
 amount of folate for food
 labels that contain a folate/
 neural tube defect health claim
101.100(d); disclosure of                  1,000            1              1,000           1               1,000
 agreements that 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);                   25,000            1.03          25,750           0.5            12,875
 disclosure 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                     Average burden
         21 CFR section             Number of      records per     Total annual         per         Total hours
                                  recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
101.12(e); recordkeeping to                  25              1                25            1                 25
 document the basis for density-
 adjusted RACC.................
101.13(q)(5); recordkeeping to          300,000              1.5         450,000            0.75         337,500
 document the basis for
 nutrient content claims.......
101.14(d)(2); recordkeeping to          300,000              1.5         450,000            0.75         337,500
 document nutrition information
 related to health claims for
 food products.................
101.22(i)(4); recordkeeping to               25              1                25            1                 25
 document supplier
 certifications for flavors
 designated as containing no
 artificial flavors............
101.100(d)(2); recordkeeping              1,000              1             1,000            1              1,000
 pertaining to 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..

[[Page 79465]]

 
101.105(t); recordkeeping                   100              1               100            1                100
 pertaining to 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
     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
----------------------------------------------------------------------------------------------------------------
\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.
    As noted, we are revising this collection to include previously 
approved third-party disclosure burdens associated with the requirement 
to declare the amount of trans fatty acids present in a food, including 
dietary supplements. The third-party disclosure burden hours formerly 
associated with OMB control number 0910-0515 (collection entitled, 
``Food Labeling: Trans Fatty Acids in Nutrition Labeling'') are 
represented by the citation to Sec.  101.9 on line 4 of table 1 and the 
citation to Sec.  101.36 on line 17 of table 1. For this revision, we 
have not added burden hours to line 4 or line 17 of table 1 because, 
based on our experience with food labeling, the 4 hours estimated for 
meeting the labeling requirements of Sec.  101.9 and the 4 hours 
estimated for meeting the labeling requirements of Sec.  101.36 are 
appropriate estimates of the total time it takes a respondent to meet 
our requirements for nutrition labeling in Sec. Sec.  101.9 and 101.36.
    We are also revising this collection to include previously approved 
third-party disclosure burdens associated with 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. The third-party disclosure burden hours 
formerly associated with OMB control number 0910-0395 (collection 
entitled, ``Food Labeling: Nutrition Labeling of Dietary Supplements on 
a `Per Day' Basis'') are represented by the citation to Sec.  101.36 on 
line 17 of Table 1 and the addition of 300 hours to our previous 
estimate of 48,000 hours. For this revision, we added 300 burden hours 
to line 17 of table 1 because voluntary labeling on a ``per day'' basis 
is in addition to the required ``per serving'' basis. We estimate that 
``per day'' information would generally be placed on, at most, 10 
percent of the estimated 12,000 disclosures, for a total of 1,200 
annual disclosures, and that a respondent will spend 15 minutes (0.25 
hours) per disclosure, for a total of 300 hours. Thus, the total 
estimated burden on line 17 of table 1 is 48,300 hours and average 
burden per disclosure on line 17 of table 1 has been increased from 4.0 
to 4.025 hours, to represent an averaging of the burden hours across 
all of the estimated 12,000 disclosures.
    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 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-31215 Filed 12-27-13; 8:45 am]
BILLING CODE 4160-01-P


