[Federal Register Volume 65, Number 196 (Tuesday, October 10, 2000)]
[Notices]
[Pages 60195-60199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1521]


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 11, 2000.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: Peggy Schlosburg, Office of 
Information Resources Management (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

[[Page 60196]]

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 of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (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)

    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 in 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 of 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 
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 
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 served foods, 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

[[Page 60197]]

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 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 Secs. 101.9 and 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 
above 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1.--Estimated Annual Reporting Burden
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                                                                                                                                          Total Capital,
                                                          No. of          Annual       Total Annual      Hours per                        Operating, and
              21 CFR Sections and Parts                 Respondents    Frequency per     Responses       Response         Total Hours       Maintenance
                                                                         Response                                                              Costs
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101.3, 101.22 and 102 and 104                          17,000               1.03       17,500               0.5           8,750                     0
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101.4, 101.22, 101.100 and 102, 104, and 105           17,000               1.03       17,500               1            17,500                     0
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101.5                                                  17,000               1.03       17,500               0.25          4,375                     0
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101.9, 101.13(n), 101.14(d)(3), 101.62, and 104        17,000               1.03       17,500               4            70,000            $1,000,000
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101.9(g)(9) and 101.36(f)(2)                               12               1              12               4                48                     0
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101.9(j)(18) and 101.36(h)(2)                          10,000               1          10,000               8            80,000                     0
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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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[[Page 60198]]

 
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) and 101.67                                   200               1             200               1               200                     0
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101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60,        2,500               1           2,500               1             2,500                     0
 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 102.33                                       1,500               3.3         5,000               1             5,000                     0
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101.36                                                    300              40          12,000               4            48,000           $15,000,000
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101.42 and 101.45                                      72,270               1          72,270               0.5          36,135                     0
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101.45(c)                                                   5               4              20               4                80                     0
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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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101.77(c)(2)(ii)(D)                                     1,000               1           1,000               0.25            250                     0
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101.79(c)(2)(iv)                                          100               1             100               0.25             25                     0
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101.100(d)                                              1,000               1           1,000               1             1,000                     0
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101.105 and 101.100(h)                                 17,000               1.03       17,500               0.5           8,750                     0
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101.108                                                     0               0               0              40                 0                     0
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Total                                                                                                                   985,000           $16,800,000
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                                 Table 2.--Estimated Annual Recordkeeping Burden
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                                                                                                  Total Capital,
 21 CFR Sections      No. of          Annual       Total Annual      Hours per                    Operating, and
    and Parts      Recordkeepers   Frequency per      Records         Record        Total Hours     Maintenance
                                   Recordkeepers                                                       Costs
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101.12(e)              25               1              25               1              25               0
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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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101.22(i)(4)           25               1              25               1              25               0
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101.100(d)(2)       1,000               1           1,000               1           1,000               0
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101.105(t)            100               1             100               1             100               0
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Total                                                                             597,400               0
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    These estimates are based on the document 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 that published in the Federal Register of 
January 6, 1993 (58 FR 2927); agency communications with industry; and 
FDA's knowledge of and experience with food labeling and the submission 
of petitions and requests to

[[Page 60199]]

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 2, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-25810 Filed 10-6-00; 8:45 am]
BILLING CODE 4160-01-F