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HHS/FDA RIN: 0910-AC58 Publication ID: Fall 2003 
Title: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Part 110)(Section 610 Review) 
Abstract: Part 110 (21 CFR part 110) describes regulations for current good manufacturing practice in manufacturing, packing, and holding human food. Part 110 contains regulations describing sanitary practices for personnel, buildings and facilities, and equipment. It also includes regulations on production and process controls for manufacturing practices and on defect action levels for natural or unavoidable defects in food for human use that present no health hazard. FDA is undertaking a review of part 110 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in part 110 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities.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 part 110; (2) the nature of complaints or comments received concerning the regulations in part 110; (3) the complexity of the regulations in part 110; (4) the extent to which the regulations in part 110 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 in the area affected by the regulations in part 110. 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 princples set forth in the Executive order. The combined effect of the two reviews will be to determine if it is possible to redesign current good manufacturing practices in ways that will maintain or increase the effectiveness of preventive and sanitary controls, 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: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 110 
Legal Authority: 21 USC 342; 21 USC 371; 21 USC 374; 42 USC 264 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Begin Review  05/01/2003   
End Review  12/00/2003   
Regulatory Flexibility Analysis Required: Undetermined  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

 
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