[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 [email protected]. 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.
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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
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.
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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
21 CFR section/form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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...........
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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.
[[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