[Federal Register: February 18, 2004 (Volume 69, Number 32)]
[Notices]               
[Page 7643-7646]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe04-52]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0483]

 
Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Food Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 March 
19, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

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: 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

[[Page 7644]]

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 
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 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.Sec. 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

[[Page 7645]]

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 it 
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.
    Description of Respondents: Businesses or other for-profit 
organizations.
    In the Federal Register of July 23, 2003 (68 FR 43533), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                   Table 1.--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                                  Total Capital,
  21 CFR Sections       No. of          Annual      Total Annual     Hours per                    Operating, and
     and Parts        Respondents   Frequency per     Responses       Response      Total Hours     Maintenance
                                       Response                                                        Costs
----------------------------------------------------------------------------------------------------------------
101.3, 101.22,              17,000           1.03          17,500           0.5            8,750               0
 102, and 104
----------------------------------------------------------------------------------------------------------------
101.4, 101.22,              17,000           1.03          17,500           1             17,500               0
 101.100, 102,
 104, and 105
----------------------------------------------------------------------------------------------------------------
101.5                       17,000           1.03          17,500           0.25           4,375               0
----------------------------------------------------------------------------------------------------------------
101.9, 101.13(n),           17,000           1.03          17,500           4             70,000      $1,000,000
 101.14(d)(3),
 101.62, and 104
----------------------------------------------------------------------------------------------------------------
101.9(g)(9) and                 12           1                 12           4                 48               0
 101.36(f)(2)
----------------------------------------------------------------------------------------------------------------
101.9(j)(18) and            10,000           1             10,000           8             80,000               0
 101.36(h)(2)
----------------------------------------------------------------------------------------------------------------
101.10                     265,000           1.5          397,500           0.25          99,375               0
----------------------------------------------------------------------------------------------------------------
101.12(b)                       29           2.3               66           1                 66         $39,600
----------------------------------------------------------------------------------------------------------------
101.12(e)                       25           1                 25           1                 25               0
----------------------------------------------------------------------------------------------------------------
101.12(g)                    5,000           1              5,000           1              5,000               0
----------------------------------------------------------------------------------------------------------------
101.12(h)                        5           1                  5          80                400        $400,000
----------------------------------------------------------------------------------------------------------------
101.13(d)(i) and               200           1                200           1                200               0
 101.67
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
101.13(q)(5)               265,000           1.5          397,500           0.75         298,125               0
----------------------------------------------------------------------------------------------------------------
101.14(d)(2)               265,000           1.5          397,500           0.75         298,125               0
----------------------------------------------------------------------------------------------------------------
101.15                         160          10              1,600           8             12,800               0
----------------------------------------------------------------------------------------------------------------
101.22(i)(4)                    25           1                 25           1                 25               0
----------------------------------------------------------------------------------------------------------------
101.30 and 102.33            1,500           3.3            5,000           1              5,000               0
----------------------------------------------------------------------------------------------------------------
101.36                         300          40             12,000           4             48,000     $15,000,000
----------------------------------------------------------------------------------------------------------------
101.42 and 101.45           72,270           1             72,270           0.5           36,135               0
----------------------------------------------------------------------------------------------------------------
101.45(c)                        5           4                 20           4                 80               0
----------------------------------------------------------------------------------------------------------------
101.69                           3           1                  3          25                 75               0
----------------------------------------------------------------------------------------------------------------

[[Page 7646]]


101.70                           3           1                  3          80                240        $400,000
----------------------------------------------------------------------------------------------------------------
101.79(c)(2)(ii)(D           1,000           1              1,000           0.25             250               0
 )
----------------------------------------------------------------------------------------------------------------
101.79(c)(2)(iv)               100           1                100           0.25              25               0
----------------------------------------------------------------------------------------------------------------
101.100(d)                   1,000           1              1,000           1              1,000               0
----------------------------------------------------------------------------------------------------------------
101.105 and                 17,000           1.03          17,500           0.5            8,750               0
 101.100(h)
----------------------------------------------------------------------------------------------------------------
101.108                          0           0                  0          40                  0               0
----------------------------------------------------------------------------------------------------------------
Total                                                                                    996,869     $16,800,000
----------------------------------------------------------------------------------------------------------------


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
 21 CFR Sections         No. of       Annual  Frequency     Total Annual
    and Parts        Recordkeepers    per Recordkeepers       Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
101.12(e)                         25               1                    25               1                    25
----------------------------------------------------------------------------------------------------------------
101.13(q)(5)                 265,000               1.5             397,500               0.75            298,125
----------------------------------------------------------------------------------------------------------------
101.14(d)(2)                 265,000               1.5             397,500               0.75            298,125
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Total                                                                                                    597,400
----------------------------------------------------------------------------------------------------------------
\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: February 10, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E4-303 Filed 2-17-04; 8:45 am]

BILLING CODE 4160-01-S