[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Notices]
[Pages 65663-65667]
From the Federal Register Online via the Government Publishing 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, [email protected].
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............................................................
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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........................
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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............................................................
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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