Source: https://www.federalregister.gov/documents/2001/01/22/01-1567/agency-information-collection-activities-submission-for-omb-review-comment-request-food-labeling
Timestamp: 2017-10-23 19:36:55
Document Index: 199655450

Matched Legal Cases: ['arts 101', '§ 101', '§ 101', '§ 101', '§\u2009101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101']

Federal Register :: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Food Labeling Regulations
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Food Labeling Regulations
Submit written comments on the collection of information by February 21, 2001.
6620-6623 (4 pages)
Food Labeling Regulations—21 CFR Parts 101, 102, 104, and 105 (OMB Control No. 0910-0381)—Extension
https://www.federalregister.gov/d/01-1567 https://www.federalregister.gov/d/01-1567
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 § 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, § 101.9(j)(18) provides for the submission to FDA of notices from firms claiming the small business exemption from nutrition labeling.
Section 101.13 requires that nutrition information be provided in accordance with § 101.9 for any food product for which a nutrient content claim is made. Under some circumstances, § 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 § 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 Start Printed Page 6621percentage 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 § 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 § 101.36(h) applies. Section 101.36(f)(2) cross-references the provisions in § 101.9(g)(9) for the submission to FDA of requests for alternative approaches to nutrition labeling. Also, § 101.36(h)(2) cross-references the provisions in § 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 § 101.45 contains guidelines for providing such information. Also, § 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 (§ 101.4) and disclosure of information concerning performance characteristics (§ 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 101.105 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 §§ 101.9 and 105.66 for the purpose of conducting food labeling experiments with FDA's authorization.
In the Federal Register of October 10, 2000 (65 FR 60195), the agency requested comments on the proposed collection of information. The agency received several comments, none of which were relevant to the PRA.
101.3 and 101.22, and 102 and 104 17,000 1.03 17,500 0.5 8,750 0
101.4, 101.22, and 101.100, and 102, 104, and 105 17,000 1.03 17,500 1 17,500 0
101.9, 101.13(n), 101.14(d)(3), and 101.62, and 104 17,000 1.03 17,500 4 70,000 $1,000,000
101.14(d)2 265,000 1.5 397,500 0.75 298,125 0
101.42 and 101.45 72,270 1 72,270 0.50 36,135 0
101.1002 1,000 1 1,000 1 1,000 0
Total 996,8691 $16,800,000
1 Due to a clerical error, the total that appeared in table 1 in the Federal Register of Tuesday, October 10, 2000 (65 FR 60195), was incorrect. Table 1 of this document contains the correct estimates.
2 Sections 101.14(d)(2) and 101.100(d) were incorrectly cited in table 1 in the Federal Register of Tuesday, October 10, 2000 (65 FR 60195). Table 1 of this document contains the correct citations.
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 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.
[FR Doc. 01-1567 Filed 1-19-01; 8:45 am]