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HHS/FDA RIN: 0910-AG35 Publication ID: Spring 2011 
Title: Produce Safety Regulation 
Abstract: The Food Safety Modernization Act requires the Secretary to establish and publish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. FDA is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reduce the risk of illness associated with contaminated fresh produce. The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the agency issued general good agricultural practice guidelines entitled "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" (GAPs Guide). The proposed rule also will reflect comments received on the agency's 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA's proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance to assist industry in complying with the requirements of the new regulation. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 342    21 USC 371    42 USC 264    PL 111-353 (signed on January 4, 2011)   
Legal Deadline:
Action Source Description Date
NPRM  Statutory  Proposed rule not later than 12 months after the date of enactment of the Food Safety Modernization Act.   01/04/2012 
Action Date FR Cite
NPRM  01/00/2012    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Samir Assar
Supervisory Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, Office of Food Safety, 5001 Campus Drive,
College Park, MD 20740
Phone:240 402-1636