Produce safety, especially the safety of leafy green vegetables, has been at the forefront of U.S. Food and Drug Administration’s (FDA) efforts to prevent foodborne illness after three separate E. coli outbreaks linked to leafy greens occurred in the fall of 2019, sickening 188 people. As a result, the FDA, the Centers for Disease Control and Prevention (CDC) and state partners investigated the contamination of romaine lettuce with several strains of E. coli O157:H7. The outbreaks of foodborne illness were traced back to the Salinas Valley growing region in California. The findings of this study, together with the findings from earlier leafy greens outbreaks, suggest that a potential contributing factor is the proximity of cattle to the produce fields identified in traceback investigations.

Moving forward, government agencies are working to prevent similar outbreaks caused by contaminated leafy greens. FDA has established science-based standards as part of the Produce Safety Rule of the Food Safety Modernization Act, released the Leafy Green STEC (Shiga-Toxin Producing E. coli) Action plan, and proposed enhanced traceability for leafy greens as high-risk foods. As part of the Leafy Green STEC Action Plan, U.S. Environmental Protection Agency (EPA) and FDA have worked together to create an efficacy protocol for reduction of foodborne bacteria in preharvest agricultural water. California and Arizona have created Leafy Green Products Handling Marketing Agreements to ensure food safety and consumer confidence in leafy greens. Additionally, Canada is imposing import requirements for leafy greens produced in the U.S.

Produce Safety Rule

As part of the Food Safety Modernization Act (FSMA), FDA passed The Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, also known as the Produce Safety Rule. The Produce Safety Rule addresses Good Agricultural Practices (GAPs) for farming operations. The Produce Safety Rule establishes science-based minimum standards for the growing, harvesting, packing, and holding of fruits and vegetable for human consumption; agricultural water; application of biological soil amendments of animal origin; prevention of sprout contamination; prevention of contamination by grazing and working animals; worker health and hygiene; and use of equipment, tools, and buildings. For more information on the Produce Safety Rule, please see our Produce Safety Rule Highlights Fact Sheet.

Leafy Green STEC Action Plan

Due to the reoccurring nature of outbreaks associated with leafy greens, FDA has developed a commodity-specific action plan for leafy greens that furthers the goals of the Produce Safety Rule in an effort to reduce contamination. FDA plans to take actions in 2020 to advance work in three areas related to leafy greens: (1) prevention, (2) response, and (3) addressing knowledge gaps.

In prevention, FDA has worked with the EPA to establish a new protocol for the development and registration of antimicrobial treatments for preharvest agricultural water. Companies can use data developed under this protocol to support the EPA registration of products that can treat preharvest agricultural water against foodborne bacteria such as E. coli or Salmonella. FDA also wants to focus on providing education and technical assistance to industry and other stakeholders, with greater emphasis on the potential impact of adjacent land uses and continued emphasis on the importance of agricultural water quality. FDA is planning to issue proposed revisions of the Food Safety Modernization Act’s (FSMA) agricultural water requirements for produce other than sprouts before the end of the year.

For response, FDA recently published the previously mentioned investigation report on the E. coli O157:H7 outbreaks in the Salinas Valley. FDA will be conducting follow up surveillance of that region during this fall’s growing and harvest season.

FDA recognizes the gaps in knowledge surrounding contamination of produce. In announcing the action plan, FDA Commissioner Stephen Hahn stated that: “[d]eveloping new science to learn how pathogens survive and move through the environment can help us protect these foods that are mostly eaten without cooking or processing to eliminate microbial hazards.” FDA reaffirms that they have an unwavering commitment to protecting the health of the American public and that the Leafy Greens STEC Action Plan shows how they are honoring their commitment to the public.

Proposed Rule for Traceability

As part of FSMA and in an effort to quickly trace instances of contamination back to the source, FDA is required to designate a list of “high-risk” foods that are subject to additional recordkeeping requirements. To satisfy this portion of FSMA, FDA has released the Requirements for Additional Traceability Records for Certain Foods proposed rule which is intended to make it easier to rapidly and effectively track the movement of a food to prevent a foodborne illness outbreak. FDA also released the Food Traceability List which identifies foods, such as leafy greens, that require the additional proposed traceability records. . To review the proposed rule and make comments, click here.

Leafy Green Products Handler Marketing Agreements

As part of statewide initiatives to prevent contamination of leafy greens, California and Arizona have established Leafy Green Products Handler Marketing Agreements (LGMA) with the goal of assuring safe leafy greens and confidence in food safety programs. The two states, which produce 90% of the U.S.’s supply of leafy greens, have “sister programs” that are almost identical. These programs are centered around food safety practices that are implemented on leafy greens farms and verified through government audits. The LGMAs created a science-based food safety system to protect public health by reducing potential sources of contamination and establishing a culture of food safety on the farm. Members of the LGMAs agree to develop and implement a food safety plan, provide food safety training to employees, and complete a USDA audit of their food safety plan to verify compliance. The LGMA food safety program uses a combination of scheduled and unscheduled government audits and requires 100% compliance to ensure food safety.

The LGMAs were created in 2007 after an outbreak of E. coli that sickened over 200 people. The agreements are updated regularly to reflect advances in science and changes in regulations. Thus, the LGMAs and Produce Safety Rule are very similar. The California Department of Food and Agriculture (CFDA), who conducts California LGMA audits, also conducts Produce Safety Rule verification audits for FDA. CFDA will recognize leafy greens farms that have met requirements for certification under the LGMA as compliant with the Produce Safety Rule.

Canadian Import requirements

To prevent the importation of contamination leafy greens, Canada has announced import requirements on romaine lettuce from the United States in response to the recent outbreaks of E. coli O157:H7 illnesses. Based on the FDA’s findings that the contaminated lettuce came from the California Salinas valley, Canada has imposed greater import requirements for romaine lettuce originating from that area.

The Canadian Food Inspection Agency (CFIA) is implementing temporary import conditions for romaine lettuce originating from the California Salinas valley. This import requirement will require Salinas valley importers of romaine lettuce to conduct microbial testing and provide a Certificate of Analysis for each shipment to demonstrate that the product does not contain detectable levels of E. coli O157:H7. For growers outside of the California Salinas valley, the CFIA will allow the importation of romaine lettuce from the USA if: the importer has a valid Safe Food for Canadians license; the importer indicates the geographical origin of the romaine lettuce; romaine lettuce grown in California has been handled by a certified member of the California LGMA or Arizona LGMA; or a certification of analysis is provided. This measure is in effect for all shipments arriving in Canada between October 7 and December 31, 2020.

Protecting Leafy Greens and Preventing Outbreaks through a holistic system

The measures discussed above show the shift in the focus of food safety from a reactionary to preventative model. As shown through Canada’s import requirements and the enactment of the produce safety rule, the LGMAs seem to be leading the charge in ensuring adequate food safety. Canada’s import requirements allow for LGMA-handled produce to be imported, and the CFDA sees LGMA compliance as compliance with the Produce Safety Rule.


For more information regarding the Produce Safety Rule, click here.

For more information regarding FDA’s Leafy Green STEC Action Plan, click here.

For more information regarding the FDA’s investigation of 2019 E. coli outbreaks associated with leafy greens, click here.

To read FDA Commissioner Hahn’s remarks on the Action Plan, click here.

For more information regarding the Food Traceability List, click here.

To review the FSMA Proposed Rule for Food Traceability, click here.

For more information regarding the California LGMA, click here.

For more information regarding the Arizona LGMA, click here.

For more information regarding Canada’s Importation Requirements, click here.