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HHS/FDA

RIN: 0910-AF64

Publication ID: Fall 2005

Title: ●Lowfat and Skim Milk and Lowfat and Nonfat Yogurt Products, Lowfat Cottage Cheese: Rev. of Stand. of Ident.; Food Lab., Nutrient Cont. Claims for Fat, Fatty Acids, and Cholesterol Cont. of Foods(Section 610 Review)
Abstract: Part 131 (21 CFR Part 131) describes regulations for standards of identity for milk and milk products. Part 133 (21 CFR Part 133) describes regulations for standards of identity for cheese and cheese products. The 1996 final rule (61 FR 58991) removed standards of identity for sweetened condensed skim milk, lowfat dry milk, evaporated skim milk, lowfat milk, acidified lowfat milk, skim (nonfat) milk, cultured skim (nonfat) milk, sour half-and-half, acidified sour half-and-half, and lowfat cottage cheese. The final rule amended the standard of identity for dry cream by removing the reference to the lowfat milk standard. The regulation also amended the nutrient content claims regulations for fat, fatty acids, and cholesterol (part 101.62) to provide for skim as a synonym for nonfat when used in labeling milk products. The purpose of this review is to determine whether the regulations in parts 131 and 133 should be continued without change, or whether they should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in parts 131 and 133; (2) the nature of complaints or comments received concerning the regulations in parts 131 and 133; (3) the complexity of the regulations in parts 131 and 133; (4) the extent to which the regulations in parts 131 and 133 overlap, duplicate, or conflict with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for the products still subject to the food standard regulations in parts 131 and 133. The section 610 review will be carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the agency's regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. The combined effect of the two reviews will be to determine if it is possible to redesign milk and cheese food standards of identity in ways that will maintain or increase the effectiveness of food labeling in providing useful information to consumers, and, at the same time, reduce compliance and other costs associated with the regulations.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
Major: Undetermined	Unfunded Mandates: No
RFA Section 610 Review: Section 610 Review
CFR Citation: 21 CFR 101 21 CFR 131 21 CFR 133
Legal Authority: 21 USC 321 21 USC 341 21 USC 343 21 USC 348 21 USC 371 21 USC 379

Legal Deadline: None

Timetable:

Action	Date	FR Cite
Begin Review	08/01/2005
End Review	12/00/2006

Regulatory Flexibility Analysis Required: No	Government Levels Affected: Undetermined
Federalism: Undetermined
Included in the Regulatory Plan: No
Agency Contact: Richard A. Williams Director, Division of Social Sciences, ORP, CFSAN Department of Health and Human Services Food and Drug Administration HFS-725, Center for Food Safety and Applied Nutrition (HFS-725), 5100 Paint Branch Parkway, College Park, MD 20740 Phone:301 436-1989 Fax:301 436-2626 Email: richard.williams@fda.hhs.gov