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HHS/FDA RIN: 0910-AG35 Publication ID: Fall 2009 
Title: ●Produce Safety Regulation 
Abstract: The Food and Drug Administration 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, it does not 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 operation. FDA intends to issue guidance after the proposed rule is finalized 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
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   
Legal Deadline:  None

Statement of Need: FDA has determined that enforceable standards (as opposed to voluntary recommendations) for the production and packing of fresh produce are necessary to ensure best practices are commonly adopted.

Summary of the Legal Basis: FDA's legal basis derives in part from sections 402(a)(4) and 701(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 342(a)(4) and 371(a)). The agency has promulgated regulations that respond to a number of the provisions of the 1986 amendments. This final rule would address additional provisions of these amendments.

Alternatives: An alternative to this rulemaking would be to update FDA’s 1998 GAPs Guide. However, even though the 1998 guidance has been well received and widely adopted, outbreaks associated with fresh produce continue. Outbreak investigations also continue to observe conditions and practices that are not consistent with the voluntary recommendations. FDA believes a regulation containing clear, enforceable standards would be more effective in ensuring best practices are widely adopted.

Anticipated Costs and Benefits: FDA estimates that the costs to more than 300,000 domestic and foreign producers and packers of fresh produce from the proposal would include one-time costs (e.g., new tools and equipment) and recurring costs (e.g., monitoring, training, recordkeeping). FDA anticipates that the benefits would be a reduction in foodborne illness and deaths associated with fresh produce. Monetized estimates of costs and benefits are not available at this time.

Risks: This regulation would directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with foodborne infections resulting from the consumption of contaminated fresh produce. Less restrictive and less comprehensive approaches have not been effective in reducing the problems addressed by this regulation. FDA anticipates that the regulation would lead to a significant decrease in foodborne illness associated with fresh produce in the U.S.

Action Date FR Cite
NPRM  10/00/2010    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
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