Improving the Safety of Imported Papayas

Numerous outbreaks associated with fresh imported papaya occurred between 2011 and 2019; however, since implementation of the U.S.-Mexico public-private partnership in 2020, no Salmonella outbreaks linked to Mexican papayas have been reported.  The U.S.-Mexico public-private partnership serves as a model for sustained collaboration and science-based interventions to improve public health. This model serves as a blueprint for enhancing food safety in other commodities and regions and shows that meaningful and lasting improvements in produce safety are achievable when regulators and industry work together toward shared goals. 

This case study provides a replicable blueprint for improving food safety in other commodities and global supply chains—showing that collaborative, science-based approaches can protect public health while supporting industry growth and sustainability.

Executive Overview

Approximately 85% of all papayas imported into the United States are from Mexico, serving as the primary supplier to meet year-round U.S. consumer demand. However, from 2011 to 2019, repeated Salmonella outbreaks associated with fresh papayas revealed food safety vulnerabilities in production, packing, and supply chain controls. These outbreaks resulted in hundreds of illnesses and two deaths and underscored the urgent need for a coordinated, risk-based preventive approach to papaya safety.

To improve the safety of imported papayas, the U.S. Food and Drug Administration (FDA) partnered with the Mexican government—through the National Service of Agri-Food Health, Safety and Quality (SENASICA) and the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS)—as well as industry stakeholders including ProExport Papaya and the Texas International Produce Association (TIPA). This collaboration represented a shift from enforcement-driven approaches towards structured cooperation between government and industry.  The public-private model for food safety establishes a collaborative framework that responds to a food safety issue identified by regulatory agencies. It mobilizes a diverse set of key stakeholders to further analyze and characterize the food safety issue, understand underlying causes, and develop coordinated action plans. These plans include verification measures as well as establishing systems to develop and disseminate improved production practices and food safety educational resources. Since 2019, this collaboration enabled shared responsibility between public and private sectors, improved communication, and supported preventive, risk-based food safety management across the Mexican papaya industry. Prioritizing preventive efforts not only helped reduce risk of another outbreak but also allowed regulatory resources to be shifted to areas of greater risk while leveraging proactive prevention efforts led by industry that had more meaningful and long-term positive impacts on papaya safety.

Problem Identification: FDA Immediate Regulatory Actions

• Between 2011 and 2019, FDA and CDC investigated eight outbreaks of Salmonella infections linked to imported papayas. The 2019 outbreak—resulting in hundreds of illnesses and two deaths—served as a critical inflection point for governments and industry alike, underscoring the need for a coordinated, preventive, and sustainable approach to papaya safety.  
• FDA issued Import Alert (IA 21-17) for whole, fresh papayas from Mexico due to widespread Salmonella contamination.

Characterizing the food safety issue

• FDA conducted inspections of papaya farms and packinghouses and increased border sampling and monitoring of papaya imported to the U.S. from Mexico.
• FDA Issued a public call to action letter to all papaya industry segments, urging:
  • Risk assessments and root cause analyses
  • Improved agricultural water management practices
  • Enhanced traceability
  • Investment in preventive research
• In 2020, FDA posted the FDA In Brief FDA Redoubles Call to Action for Papaya Industry to Keep Consumers Safe from Foodborne Illness building on its 2019 call to action by outlining additional steps the papaya industry could take to prevent Salmonella outbreaks.

Mobilizing Key Stakeholders

• Following FDA’s calls to action, FDA, the Texas International Produce Association (TIPA), the International Fresh Produce Association (IFPA), SENASICA and papaya importers met regularly to develop systematic approaches to address this food safety issue.  These stakeholders worked together to identify both short-term and long-term goals, fostering unprecedented transparency from papaya growers and packers and active participation from industry, government, and academic partners in both Mexico and the United States. These efforts mobilized the papaya industry in Mexico to organize and form ProExport Papaya.
• The FDA-SENASICA-COFEPRIS Food Safety Partnership (FSP), established in 2020 through a Statement of Intent (SOI) was leveraged to support these efforts, specifically industry training. The goal of FSP is to protect public health through the prevention of foodborne diseases in human foods, by using modern approaches and preventive practices based on technical and scientific evidence, health surveillance, and verification measures.

Industry taking action with support from government:

From 2020 through 2023, industry leadership played a critical role in translating regulatory expectations into practical, on-the-ground implementation. In collaboration with FDA and SENASICA, ProExport Papaya—with support from TIPA and the International Fresh Produce Association (IFPA)—developed and disseminated tools to promote consistent food safety practices, including:

• Papaya Best Practice Guidelines (Mexico Papaya Best Practices Document - Texas International Produce Association), created to establish standardized best practices for the commercial production, harvesting, post-harvest handling, and marketing of papaya to ensure food safety compliance. The “Food Safety Best Practices Guide for the Growing & Handling of Mexican Papaya” was developed through a collaborative effort between ProExport Papaya, TIPA, and IFPA primarily to improve food safety, support market exports, industry self-regulation and raise production standards. An industry-led study on papaya harvesting methods was conducted to make improvements to the best practices guide.
• Guide to Develop and Implement Foreign Supplier Verification Programs (FSVP) for Importers of Mexican Papaya to help growers and importers meet FSVP regulations, which require importers to verify that foreign suppliers meet U.S. safety standards
• Conducted research to inform the best practices guide for papaya production
• Self-audit verification checklists for food safety
• Standardized root cause analysis (RCA) protocols
• Joint training programs and educational outreach for industry stakeholders
• Grower trainings for papaya growers hosted by ProExport Papaya in collaboration with Produce Safety Alliance (PSA), (Grower Training Course | CALS)
• Emphasis on FDA Food Safety Modernization Act (FSMA) compliance: Produce Safety Rule (PSR), FSVP, and the Food Traceability Rule.

SENASICA also supported industry’s efforts through the establishment of a Papaya Action Plan (Plan de Acción Papaya | Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria | Gobierno | gob.mx).  As part of SENASICA’s action plan, SRRC (Systems for the Reduction of Contamination Risks) certification program (SENASICA - SIAS | Sistema de Reducción de Riesgos de Contaminación y Buenas Prácticas) was updated to include papaya-specific best practices and audit certification benchmarks for papaya operations.

Verification, Capacity Building and Ongoing Engagement (2024-2025)

From 2024 onward, the partnership focused on verification activities, strengthening local expertise and ensuring long-term sustainability:

• Verification and Monitoring Activities by both FDA and industry:
  • FDA prioritized papaya operations in Mexico for regulatory inspections.
  • ProExport Papaya hosted Educational Farm Visits (EFVs) for FDA officials to observe improved practices and foster collaborative relationships across the supply chain.
  • ProExport Papaya partnered with international food safety harmonization organizations to recognize the papaya specific audit program so that producers could use as way demonstrate their food safety practices to the U.S. retail industry. These verification activities grew to include audits of numerous papaya farms and packing facilities, while efforts continued to bring other Latin American countries into the program. Several retailers require papaya producers to adhere to these best practices standards.
  • ProExport Papaya is planning to implement a continuous food safety improvement system by conducting unannounced visits to farms and packinghouses to verify implementation of the best practices guide.
  • ProExport Papaya routinely monitors and shares information with FDA on recent industry trends/findings from audits, results, and needs related to trainings and site visits with papaya growers.

Continued support to industry and dissemination of food safety educational resources:

• Papaya industry food safety professionals participated in the International On-Farm Readiness Review (iOFRR) training in Mexico. A commitment was made by industry participants to provide multiple on-farm readiness reviews to farms annually.
  • The About On-Farm Readiness Review - NASDA is a voluntary, educational program originally developed for produce growers in the U.S. that was later adapted for foreign farms exporting to the U.S.  The program helps to determine readiness of farming community align their practices to comply with the PSR, such as by providing on-farm learning experiences, and helping to identify knowledge gaps.
• FDA provided targeted technical assistance to the papaya industry on critical issues (e.g., industry sampling protocol, root cause analysis protocol in response to Salmonella spp. sample result).
• ProExport Papaya coordinated webinars on emerging regulatory topics, including the Final Agricultural Water Rule and Adjacent and Nearby Land Use (ANLU).
• ProExport Papaya engaged in strategic outreach with retail partners to communicate progress, demonstrate accountability, and share its food safety story.
• SENASICA supported industry training on the updated papaya-specific SRRC standards.

Partnership Model and Key Interventions

The public-private partnership model for papaya safety cultivated a synergistic alliance that took significant action when a food safety issue was identified by regulatory agencies. This dynamic framework mobilized a diverse set of key stakeholders, weaving together their collective expertise to meticulously characterize the food safety issue, determine its root causes, and forged coordinated action plans. These comprehensive strategies encompassed robust verification measures while simultaneously establishing systems to develop and disseminate improved production practices and food safety educational resources, thereby nurturing a culture of continuous improvement and shared knowledge across the food safety landscape.

Key interventions of the papaya safety model included:

• FDA’s actions that mobilized an entire industry to organize and create change. The agency’s 2019 and 2020 calls to action played a critical role in shaping what ProExport Papaya is today.
• SENASICA’s Papaya Action Plan, which recognized industry best practices, supported industry training, and incorporated certification benchmarks for papaya operations (Plan de Acción Papaya | Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria | Gobierno | gob.mx)
• ProExport Papaya developed and disseminated practical food safety resources including root cause analysis and self-assessments protocols, which allows papaya firms in Mexico to better understand the source or cause of a food safety issue and implement preventive measures.
• Remote and in-person training models by ProExport Papaya to share latest food safety information across industry members.
• Strong verification program by regulators and industry that provides a continuous loop for feedback and improvement.

Outcomes

• No Salmonella outbreaks linked to Mexican papayas since 2020.
• Improved compliance with FSMA requirements for growers and U.S.-based FSVP importers of Mexican papayas across the supply chain.
• Strengthened communication, trust, and transparency among regulators, industry, and trading partners.
• Created a sustainable model to enhance international food safety.

Key Lessons Learned

• FDA and counterpart government agencies’ oversight in Mexico, SENASICA and COFEPRIS, together with effective collaboration with industry, is essential to achieving sustainable food safety outcomes.
• Preventive, science-based measures and tools, including root cause analysis, are more effective than reactive enforcement alone.
• Sustainable food safety improvements require durable systems that disseminate resources broadly across an entire industry, not just to individual growers.

Conclusion  

The U.S.–Mexico papaya safety collaboration demonstrates that meaningful and lasting improvements in produce safety are achievable when regulators and industry work together toward shared goals. By aligning regulatory expectations, investing in capacity building, and fostering industry ownership of prevention, this effort transformed the Mexican papaya sector and delivered measurable public health benefits.

This case study provides a replicable blueprint for improving food safety in other commodities and global supply chains—showing that collaborative, science-based approaches can protect public health while supporting industry growth and sustainability.

The success of the papaya safety model was built on shared responsibility, transparency, and continuous improvement. This model can be replicated for other FDA regulated commodities with promising results. The public-private food safety model creates a collaborative framework that addresses food safety issues identified by regulatory agencies through mobilization of diverse stakeholders to analyze, characterize, and develop coordinated action plans, including verification measures and systems for disseminating improved production practices and educational resources.