Supervisory Consumer Safety Officer

0910-AG35 201410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes Private Sector 21 CFR 112 21 USC 342 21 USC 350h 21 USC 371 42 USC 264 PL 111-353 (signed on January 4, 2011) Judicial Final 10/00/2015 Yes

FDA is taking this action to meet the requirements of the FSMA and to address the food safety challenges associated with fresh produce and, thereby, protect the public health. Data indicate that between 1973 and 1997, outbreaks of foodborne illness in the U.S. associated with fresh produce increased in absolute numbers and as a proportion of all reported foodborne illness outbreaks. The Agency issued general good agricultural practice guidelines for fresh fruits and vegetables over a decade ago. Incorporating prevention-oriented public health principles, and incorporating what we have learned in the past decade into a regulation is a critical step in establishing standards for the production and harvesting of produce, and reducing the foodborne illness attributed to fresh produce.

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FDA is relying on the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), provided by section 105 of the Food Safety Modernization Act (codified primarily in section 419 of the FD&C Act (21 U.S.C. 350h)). FDA's legal basis also derives in part from sections 402(a)(3), 402(a)(4), and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). FDA also intends to rely on section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease.

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Section 105 of the Food Safety Modernization Act requires FDA to conduct this rulemaking.

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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. The monetized annual benefits of this rule are estimated to be $1 billion, and the monetized annual costs are estimated to be $460 million, domestically.

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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 associated with the consumption of fresh produce. Less restrictive and less comprehensive approaches have not been sufficiently 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 consumed in the United States.

]]> NPRM 01/16/2013 78 FR 3503 NPRM Comment Period End 05/16/2013 NPRM Comment Period Extended 04/26/2013 78 FR 24692 NPRM Comment Period Extended End 09/16/2013 NPRM Comment Period Extended 08/09/2013 78 FR 48637 NPRM Comment Period Extended End 11/15/2013 Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Rule 08/19/2013 78 FR 50358 Notice of Intent To Prepare Environmental Impact Statement for the Proposed Rule Comment Period End 11/15/2013 NPRM Comment Period Extended 11/20/2013 78 FR 69605 NPRM Comment Period Extended End 11/22/2013 Environmental Impact Statement for the Proposed Rule; Comment Period Extended 03/11/2014 79 FR 13593 Environmental Impact Statement for the Proposed Rule; Comment Period Extended End 04/18/2014 Supplemental NPRM 09/29/2014 79 FR 58433 Supplemental NPRM Comment Period End 12/15/2014 Final Rule 10/00/2015 Yes Businesses None No Yes No Samir Assar Supervisory Consumer Safety Officer 0910 Food and Drug Administration FDA 240 402-1636 samir.assar@fda.hhs.gov Human Foods Program, Office of Food Safety, 5001 Campus Drive, College Park MD 20740