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Produce Safety Standards
Information available related to Produce Safety Standards under the FDA Food Safety Modernization Act (FSMA).
- Guidance and Rules
- Sections of the Law Relating to Produce Safety Standards
- Coordination with USDA on Produce Safety
- FDA Outreach on Produce Safety
- Public Meetings
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. FDA has compiled from CDC data information regarding produce associated outbreaks which occurred between 1996 and 2010 where contamination is likely to have happened early in the production chain, during growing, harvesting, manufacturing, processing, packing, holding, or transportation. This FDA data set demonstrates that from 1996 to 2010, approximately 131 produce-related reported outbreaks occurred, resulting in 14,350 outbreak-related illnesses, 1,382 hospitalizations and 34 deaths. These outbreaks were associated with approximately 20 different fresh produce commodities. This is a significant public health burden that is largely preventable.
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.
As a key element of this preventive approach, FDA was mandated under FSMA to establish science-based, minimum standards for the safe growing, harvesting, packing, and holding of produce on farms to minimize contamination that could cause serious adverse health consequences or death.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Docket Number: FDA-2011-N-0921; comments due by November 22, 2013
The comment period under the 2010 open docket on produce safety is now closed. (See the Federal Register Notice for FDA Produce Safety Docket.) More than 800 comments were received in all from all parts of the country – an unprecedented number in an FDA produce-related rulemaking action -- from growers large and small; environmental groups; state and local government agencies; retail food chains; academia; consumers, and others who wanted their voices heard and their best practices considered in the development of a fresh produce safety rule. Many of those comments were used to inform the writing of the current proposed rule for produce safety standards.
Produce Safety Alliance
FDA and the U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) established the Produce Safety Alliance to provide produce farmers, along with other groups, the information they need to ensure the safety of fresh produce for consumers. The Produce Safety Alliance is providing fundamental, on-farm food safety knowledge and will assist farmers with the information that they will need to comply with FDA's produce safety regulation. It is housed at Cornell University through a USDA Agricultural Marketing Service grant funded cooperatively by both USDA and FDA. Cornell’s national Good Agricultural Practices (GAPs) program has been a leader in the development of education outreach materials on GAPs and in dissemination of food safety knowledge to the agricultural community. For more information, visit the Produce Safety Alliance’s page .
FDA has also supported the establishment of a Sprout Safety Alliance in cooperation with the Institute for Food Safety and Health, Illinois Institute of Technology to conduct education and outreach to promote the safe production of fresh sprouts. FDA is launching this specific initiative in light of a number of outbreaks that have been attributed to sprouts, and because specific requirements for sprouts are included in the proposed rule on produce safety. The Alliance will develop and identify new and existing educational materials to help industry, particularly small companies, grow safe sprouts. Also, this effort will help prepare sprout farms to comply with the proposed produce safety rule. Read more on the Sprout Alliance.
FDA has worked with the U.S. Department of Agriculture throughout the development of the proposed produce safety regulations. Through this collaboration, FDA was able to gather information and expertise on specific issues, such as the National Organic Program, while USDA was briefed on the progress of the draft proposals. In addition, FDA and USDA’s Agricultural Marketing Service have worked together with Cornell University to develop the Produce Safety Alliance – the primary mechanism for reaching out to and educating farmers. This public-private partnership will develop and disseminate training and education programs to provide produce farms across the country with fundamental food safety knowledge.
Since early 2010, FDA and USDA technical experts, scientists, and other staff participated in listening sessions and meetings in 13 states. In some of those states, we were able to tour farms large and small and talk with people who have the “on-the-ground” knowledge that FDA realizes must be reflected in the proposed rule. The states visited have included: Arizona, California, Delaware, Florida, Georgia, Maryland, Nevada, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas and Washington.
- Proposed Rules to Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Portland, OR
March 27, 2013
- Proposed Rules to Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chicago, IL
March 11, 2013
- Proposed Rules to Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Washiongton, DC
February 28, 2013