[Federal Register: July 15, 2010 (Volume 75, Number 135)]
[Notices]
[Page 41207-41210]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy10-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0296]
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 August
16, 2010.
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 e-mailed 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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400W,
Rockville, MD 20850, 301-796-3794, JonnaLynn.Capezzuto@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)--Extension
FDA 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
FDA. FDA's food labeling regulations under parts 101, 102, 104, and 105
(21 CFR parts 101, 102, 104, and 105) were issued 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 under sections 201, 301,
402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371,
and 379e). Most of these regulations derive from section 403 of the
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 act and
the FPLA.
Section 101.3 of FDA's 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
[[Page 41208]]
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. Section 101.9(g)(9) also provides for the
submission to FDA of requests for alternative approaches to nutrition
labeling. Finally, Sec. 101.9(j)(18) provides for the submission to
FDA of notices from firms claiming the small business exemption from
nutrition labeling. FDA has 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 FDA
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 to FDA to request changes in 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.
Sections 101.14(d)(2) and (d)(3) provide 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 act to appear on the label shall appear thereon
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 reporting and recordkeeping requirements
pertaining to certifications for flavors designated as containing no
artificial flavor. 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 102.33 specifies the
common or usual name for beverages that contain fruit or vegetable
juice.
Section 101.36 requires that nutrition information be provided for
dietary supplements offered for sale, unless an exemption in Sec.
101.36(h) applies. Section 101.36(f)(2) cross-references the provisions
in Sec. 101.9(g)(9) for the submission to FDA of requests for
alternative approaches to nutrition labeling. 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,
FDA has 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 of
nutrient data bases and proposed nutrition labeling values for raw
fruit, vegetables, and fish to FDA 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 ingredient 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 FDA authorize a particular nutrient content claim by
regulation. Section 101.70 provides for the submission of a petition
requesting that FDA authorize a particular health claim by regulation.
Section 101.77(c)(2)(ii)(D) requires the disclosure of the amount 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 per serving in the nutrition
labeling 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 act be in writing and that a copy of
the agreement be made available to FDA upon request. Section 101.100
also contains reporting and disclosure requirements as conditions for
claiming certain labeling exemptions (e.g., Sec. 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 Federal, State,
or local government. Section 101.108 provides for the submission to FDA
of a written proposal requesting a temporary exemption from certain
requirements of Sec. 101.9 and Sec. 105.66 for the purpose of
conducting food labeling experiments with FDA's 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
shall include the identity of the food source from which the protein
was derived.
Part 104, which pertains to nutritional quality guidelines for
foods, cross-
[[Page 41209]]
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 disclosure and other information collection requirements in the
previously mentioned regulations are placed primarily upon
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.
The purpose of the 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
FDA provide the basis for the agency to permit new labeling statements
or to grant exemptions from certain labeling requirements.
Recordkeeping requirements enable FDA 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 act or the
FPLA.
In the Federal Register of July 15, 2009 (74 FR 34353), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on this
information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR
Section and Annual Frequency Total Annual Hours per
Part/Form No. of Respondents per Response Responses Response Total Hours
No.
----------------------------------------------------------------------------------------------------------------
101.3, 25,000 1.03 25,750 .5 12,875
101.22, 102
and 104
----------------------------------------------------------------------------------------------------------------
101.4, 25,000 1.03 25,750 1 25,750
101.22,
101.100,
102, 104
and 105
----------------------------------------------------------------------------------------------------------------
101.5 25,000 1.03 25,750 0.25 6,438
----------------------------------------------------------------------------------------------------------------
101.9, 25,000 1.03 25,750 4 103,000
101.13(n),
101.14(d)(3
), 101.62,
and 104
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101.9(g)(9 12 1 12 4 48
and
101.36(f)(2
)
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101.9(j)(18) 10,000 1 10,000 8 80,000
and
101.36(h)(2
) Form FDA
3570
----------------------------------------------------------------------------------------------------------------
101.10 300,000 1.5 450,000 0.25 112,500
----------------------------------------------------------------------------------------------------------------
101.12(b) 29 2.3 67 1 67
----------------------------------------------------------------------------------------------------------------
101.12(e) 25 1 25 1 25
----------------------------------------------------------------------------------------------------------------
101.12(g) 5,000 1 5,000 1 5,000
----------------------------------------------------------------------------------------------------------------
101.12(h) 5 1 5 80 400
----------------------------------------------------------------------------------------------------------------
101.13(d)(1) 200 1 200 1 200
and 101.67
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101.13(j)(2) 5,000 1 5,000 1 5,000
,
101.13(k),
101.54,
101.56,
101.60,
101.61, and
101.62
----------------------------------------------------------------------------------------------------------------
101.13(q)(5) 300,000 1.5 450,000 0.75 337,500
----------------------------------------------------------------------------------------------------------------
101.14(d)(2) 300,000 1.5 450,000 0.75 337,500
----------------------------------------------------------------------------------------------------------------
101.15 160 10 1,600 8 12,800
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101.22(i)(4) 25 1 25 1 25
----------------------------------------------------------------------------------------------------------------
101.30 and 1,500 5 7,500 1 7,500
102.33
----------------------------------------------------------------------------------------------------------------
101.36 300 40 12,000 4 48,000
----------------------------------------------------------------------------------------------------------------
101.42 and 1,000 1 1,000 0.5 500
101.45
----------------------------------------------------------------------------------------------------------------
101.45(c) 5 4 20 4 80
----------------------------------------------------------------------------------------------------------------
101.69 3 1 3 25 75
----------------------------------------------------------------------------------------------------------------
101.70 5 1 5 80 400
----------------------------------------------------------------------------------------------------------------
101.79(c)(2) 1,000 1 1,000 0.25 250
(i)(D)
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[[Page 41210]]
101.79(c)(2) 100 1 100 0.25 25
(iv)
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101.100(d) 1,000 1 1,000 1 1,000
----------------------------------------------------------------------------------------------------------------
101.105 and 25,000 1.03 25,750 0.5 12,875
101.100(h)
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101.108 1 1 1 40 40
----------------------------------------------------------------------------------------------------------------
Total 1,109,873
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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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No. of Record- Annual Frequency Total Annual
21 CFR Section keepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.12(e) 25 1 25 1 25
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101.13(q)(5) 300,000 1.5 450,000 0.75 337,500
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101.14(d)(2) 300,000 1.5 450,000 0.75 337,500
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101.22(i)(4) 25 1 25 1 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.100(d)(2) 1,000 1 1,000 1 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.105(t) 100 1 100 1 100
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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.
The estimated annual reporting and recordkeeping burdens are based
on agency communications with industry and FDA's knowledge of and
experience with food labeling and the submission of petitions and
requests to the agency. Where an agency regulation implements an
information collection requirement in the act or the FPLA, only any
additional burden attributable to the regulation has been included in
FDA's burden estimate.
No burden has been estimated for those requirements where the
information to be disclosed is information that has been supplied by
FDA. Also, no burden has been estimated for information that is
disclosed to third parties as a usual and customary part of a food
producer's normal business activities. Under 5 CFR 1320.3(c)(2), the
public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the public
is not a collection of information. Under 5 CFR 1320.3(b)(2), the time,
effort, and financial resources necessary to comply with a collection
of information are excluded from the burden estimate if the reporting,
recordkeeping, or disclosure activities needed to comply are usual and
customary because they would occur in the normal course of activities.
In this request for extension of OMB approval under the PRA, FDA is
no longer combining the burden hours associated with OMB Control
Numbers 0910-0395 (collection titled, ``Food Labeling: Nutrition
Labeling of Dietary Supplements on a `Per Day' Basis'') and 0910-0515
(collection titled, ``Food Labeling: Trans Fatty Acids in Nutrition
Labeling''), with the burden hours approved under OMB Control Number
0910-0381 (collection titled, ``Food Labeling Regulations'') as
announced previously. Such consolidation may occur in the future.
Dated: July 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17229 Filed 7-14-10; 8:45 am]
BILLING CODE 4160-01-S