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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations analysis requirements of Executive Order 12866. However, we have examined the economic implications of this rulemaking on small businesses. On a per firm, per year basis, estimated costs are between approximately $0.3
million and $2.7 million per small yogurt manufacturer per year in 2019
dollars discounted at 3 percent and
preserving the basic nature and essential characteristics of yogurt. Because this rule may generate compliance costs for some small firms, we believe that this rule would have a significant economic impact on a substantial number of small entities.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
Abbreviation
What it means
ANPRM
AOAC International

Advance Notice of Proposed Rulemaking.
Association of Official Analytical Collaboration International formerly Association of Official Agricultural Chemists.
Code of Federal Regulations.
Colony Forming Units.
Codex Alimentarius Commission.
Daily Value.
Executive Order.
Federal Food, Drug, and Cosmetic Act.
Federal Register.
Good Manufacturing Practice.
International Organization for Standardization.
Nutrition Labeling and Education Act.
National Yogurt Association.
Reference Amount Customarily Consumed.
Universal Product Code.

CFR
CFU
Codex
DV
E.O.
FD&C Act
FR
GMP
ISO
NLEA
NYA
RACC
UPC

III. Background A. Legal Authority
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between approximately $0.4 million and $2.7 million per small yogurt manufacturer per year discounted at 7
percent. The rule will likely benefit some manufacturers by modernizing the yogurt standard to allow for technological advances in food processing and to incorporate flexibility in yogurt manufacturing while
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Section 401 of the FD&C Act directs the Secretary to issue regulations fixing and establishing for any food a reasonable definition and standard of identity whenever, in the judgment of the Secretary, such action will promote honesty and fair dealing in the interest of consumers. Section 403a1 of the FD&C Act deems food to be misbranded if its labeling is false or misleading in any particular. Labeling may be misleading due to affirmative representations made or suggested by statement, word, design, device, or any combination thereof; labeling may also be misleading due to failure to reveal facts material in light of such representations see section 201n of the FD&C Act.
Under section 701e1 of the FD&C
Act, any action for the amendment or repeal of any definition and standard of identity under section 401 of the FD&C
Act for any dairy product e.g., yogurt must begin with a proposal made either by FDA under our own initiative or by petition of any interested persons. The NYA submitted a citizen petition on February 18, 2000 Docket No. FDA
2000P0126, formerly Docket No.
2000P0685, under our procedural regulations in 21 CFR 10.30, requesting, among other things, that we revoke the standards of identity for lowfat yogurt 131.203 and nonfat yogurt 131.206 and amend the standard of
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identity for yogurt 131.200. In the Federal Register of July 3, 2003 68 FR
39873, FDA issued an advance notice of proposed rulemaking ANPRM, publishing the proposals in NYAs petition consistent with section 701e1 of the FD&C Act. The ANPRM
requested comment on whether the actions proposed in the petition would promote honesty and fair dealing in the interest of consumers. FDA
subsequently issued a proposed rule in the Federal Register of January 15, 2009
74 FR 2443 in part to respond to the citizen petition. FDA is now acting pursuant to section 701e of the FD&C
Act to finalize the rule.
B. History of the Current Standards of Identity for Yogurt, Lowfat Yogurt,and Nonfat Yogurt In the Federal Register of January 30, 1981 46 FR 9924, we published a final rule establishing standards of identity for yogurt 131.200, lowfat yogurt 131.203, nonfat yogurt 131.206, certain milk products 21 CFR 131.111, 131.112, 131.136, 131.138, 131.144, and 131.146, and eggnog 21 CFR
131.170. Interested persons were given until March 2, 1981, to file objections and request a hearing on the final rule.
Twenty-one responses were filed objecting to specific provisions of the final rule and, in most cases, requesting a hearing. In response to those objections, we stayed the effective date for provisions regarding certain milk products and eggnog. In addition, we
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stayed the following provisions in the standards of identity for yogurt, lowfat yogurt, and nonfat yogurt: 1 Provisions that restricted the type of milk-derived ingredients that may be used to increase the milk solids not fat content 131.200c1, 131.203c1, and 131.206c1 redesignated as 131.200d1, 131.203d1, and 131.206d1, respectively; 2
provisions that excluded the use of reconstituted dairy ingredients as basic ingredients 131.200a, 131.203a, and 131.206a; 3 provisions that excluded the addition of preservatives 131.200c, 131.203c, and 131.206c redesignated as 131.200d, 131.203d, and 131.206d, respectively; 4 provisions that set a minimum titratable acidity of 0.9 percent, expressed as lactic acid 131.200a, 131.203a, and 131.206a; and 5 131.200a specifying that the 3.25 percent minimum milkfat level applies after the addition of one or more of the optional sources of milk solids not fat listed in 131.200c1 redesignated as 131.200d1 47 FR 41519 at 41523, September 21, 1982.
Due to competing priorities and limited resources, we did not hold a public hearing to resolve these issues, and the effective date for these provisions has been stayed since September 21, 1982. Therefore, these provisions have never been in effect, and yogurt, lowfat yogurt, and nonfat yogurt sold in interstate commerce have
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