[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Notices]
[Page 62081-62084]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc03-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0483]
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) 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 information collection
provisions in FDA's food labeling regulations.
DATES: Submit written or electronic comments on the collection of
information by December 30, 2003.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-250), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20857. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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, FDA is publishing notice for an extension of the
proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's 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)
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
[[Page 62082]]
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. 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.
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.
Section 101.14 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
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 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.
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.
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-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
[[Page 62083]]
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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Total Capital,
21 CFR No. of Annual Total Annual Hours per Operating,&
Sections Respondents Frequency per Responses Response Total Hours Maintenance
Response Costs
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101.3, 101.22, 17,000 1.03 17,500 0.5 8,750 0
102 and 104
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101.4, 101.22, 17,000 1.03 17,500 1 17,500 0
101.100, 102,
104, and 105
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101.5 17,000 1.03 17,500 0.25 4,375 0
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101.9, 17,000 1.03 17,500 4 70,000 $1,000,000
101.13(n),
101.14(d)(3),
101.62, and
104
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101.9(g)(9) 12 1 12 4 48 0
and
101.36(f)(2)
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101.9(j)(18) 10,000 1 10,000 8 80,000 0
and
101.36(h)(2)
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101.10 265,000 1.5 397,500 0.25 99,375 0
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101.12(b) 29 2.3 66 1 66 $39,600
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101.12(e) 25 1 25 1 25 0
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101.12(g) 5,000 1 5,000 1 5,000 0
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101.12(h) 5 1 5 80 400 $400,000
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101.13(d)(i) 200 1 200 1 200 0
and 101.67
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101.13(j)(2), 2,500 1 2,500 1 2,500 0
101.13(k),
101.54,
101.56,
101.60,
101.61, and
101.62
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101.13(q)(5) 265,000 1.5 397,500 0.75 298,125 0
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101.14(d)(2) 265,000 1.5 397,500 0.75 298,125 0
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101.15 160 10 1,600 8 12,800 0
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101.22(i)(4) 25 1 25 1 25 0
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101.30 and 1,500 3.3 5,000 1 5,000 0
102.33
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101.36 300 40 12,000 4 48,000 $15,000,000
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101.42 and 72,270 1 72,270 0.5 36,135 0
101.45
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101.45(c) 5 4 20 4 80 0
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[[Page 62084]]
101.69 3 1 3 25 75 0
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101.70 3 1 3 80 240 $400,000
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101.79(c)(2)(i 1,000 1 1,000 0.25 250 0
i)(D)
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101.79(c)(2)(i 100 1 100 0.25 25 0
v)
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101.100(d) 1,000 1 1,000 1 1,000 0
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101.105 and 17,000 1.03 17,500 0.5 8,750 0
101.100(h)
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101.108 0 0 0 40 0 0
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Total ................ .............. .............. ............. 996,000 $16,800,000
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Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual Total Hours
21 CFR No. of Frequency per Annual per Total
Sections Recordkeepers Recordkeeping Records Record Hours
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101.12(e) 25 1 25 1 25
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101.13(q)(5 265,000 1.5 397,500 0.75 298,125
)
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101.14(d)(2 265,000 1.5 397,500 0.75 298,125
)
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101.22(i)(4 25 1 25 1 25
)
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101.100(d)( 1,000 1 1,000 1 1,000
2)
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101.105(t) 100 1 100 1 100
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Total .............. ............. ........ ........ 597,400
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\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
In the Federal Register of January 6, 1993 (58 FR 2927), FDA
published a document based on these estimates entitled ``Regulatory
Impact Analysis of the Final Rules to Amend the Food Labeling
Regulations,'' which is the agency's most recent comprehensive review
of food labeling costs. The estimates are also 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.
Dated: October 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27388 Filed 10-30-03; 8:45 am]
BILLING CODE 4160-01-S