
[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Notices]
[Pages 65663-65667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25975]


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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 December 31, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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, we are publishing this notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Food 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

[[Page 65664]]

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.
    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 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 0910-0515 and 0910-0395 respectively, however the 
approval periods for these collections have expired. To remedy this 
oversight, to most appropriately streamline these information 
collections, and to eliminate redundancy in our 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 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-

[[Page 65665]]

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 in this document, 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)).
    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    Total hours
                                                                           respondents   per respondent    disclosures   per  disclosure
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101.3, 101.22, 102, and 104; statement of identity labeling                      25,000            1.03          25,750            0.5            12,875
 requirements..........................................................
101.4, 101.22, 101.100, 102, 104, and 105; ingredient labeling                   25,000            1.03          25,750            1              25,750
 requirements..........................................................
101.5; requirement to specify the name and place of business of the              25,000            1.03          25,750            0.25            6,438
 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 104; labeling requirements           25,000            1.03          25,750            4             103,000
 for disclosure of nutrition information...............................
101.9(g)(9) and 101.36(f)(2); alternative means of compliance permitted              12            1                 12            4                  48
101.10; requirements for nutrition labeling of restaurant foods........         300,000            1.5          450,000            0.25          112,500
101.12(b); RACC for baking powder, baking soda and pectin..............              29            2.3               67            1                  67

[[Page 65666]]

 
101.12(e); adjustment to the RACC of an aerated food permitted.........              25            1                 25            1                  25
101.12(g); requirement to disclose the serving size that is the basis             5,000            1              5,000            1               5,000
 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 disclose nutrition information             200            1                200            1                 200
 for any food product for which a nutrient content claim is made.......
101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60, 101.61, and 101.62;              5,000            1              5,000            1               5,000
 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 disclose the basis for               300,000            1.5          450,000            0.75          337,500
 nutrient content claims made for their food...........................
101.14(d)(2); general requirements for disclosure of nutrition                  300,000            1.5          450,000            0.75          337,500
 information related to health claims for food products................
101.15; requirements pertaining to prominence of required statements                160           10              1,600            8              12,800
 and use of foreign language...........................................
101.22(i)(4); supplier certifications for flavors designated as                      25            1                 25            1                  25
 containing no artificial flavors......................................
101.30 and 102.33; labeling requirements for fruit or vegetable juice             1,500            5              7,500            1               7,500
 beverages.............................................................
101.36; nutrition labeling of dietary supplements......................             300           40             12,000            4.025          48,300
101.42 and 101.45; nutrition labeling of raw fruits, vegetables, and              1,000            1              1,000            0.5               500
 fish..................................................................
101.45(c); databases of nutrient values for raw fruits, vegetables, and               5            4                 20            4                  80
 fish..................................................................
101.79(c)(2)(i)(D); disclosure requirements for food labels that                  1,000            1              1,000            0.25              250
 contain a folate/neural tube defect health claim......................
101.79(c)(2)(iv); disclosure of amount of folate for food labels that               100            1                100            0.25               25
 contain a folate/neural tube defect health claim......................
101.100(d); disclosure of agreements that form the basis for exemption            1,000            1              1,000            1               1,000
 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 requirements for food not accurately          25,000            1.03          25,750            0.5            12,875
 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
                             21 CFR section                                  Number of      records per    Total  annual    burden per      Total hours
                                                                           recordkeepers   recordkeeper       records      recordkeeping
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101.12(e); recordkeeping to document the basis for density-adjusted RACC              25            1                 25            1                 25
101.13(q)(5); recordkeeping to document the basis for nutrient content           300,000            1.5          450,000            0.75         337,500
 claims.................................................................
101.14(d)(2); recordkeeping to document nutrition information related to         300,000            1.5          450,000            0.75         337,500
 health claims for food products........................................
101.22(i)(4); recordkeeping to document supplier certifications for                   25            1                 25            1                 25
 flavors designated as containing no artificial flavors.................
101.100(d)(2); recordkeeping pertaining to agreements that form the                1,000            1              1,000            1              1,000
 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 65667]]

 
101.105(t); recordkeeping pertaining to disclosure requirements for food             100            1                100            1                100
 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\
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                                                                                             Number of                        Average
                         21 CFR section/form No.                             Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
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101.9(j)(18) and 101.36(h)(2); procedure for small business nutrition             10,000               1          10,000               8          80,000
 labeling exemption notice using Form FDA 3570..........................
101.12(h); petitions to establish or amend a RACC.......................               5               1               5              80             400
101.69; petitions for nutrient content claims...........................               3               1               3              25              75
101.70; petitions for health claims.....................................               5               1               5              80             400
101.108; written proposal for requesting temporary exemptions from                     1               1               1              40              40
 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.

    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 titled, ``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 
titled, ``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: October 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25975 Filed 10-31-13; 8:45 am]
BILLING CODE 4160-01-P


