FDA-SENASICA-Cofepris Food Safety Partnership
<< International Cooperation on Food Safety
The FDA-SENASICA-Cofepris Food Safety Partnership (FSP) was established in September 2020, through a new Statement of Intent (SOI) between the US Food and Drug Administration (FDA) and Mexico’s National Service of Agro-Alimentary Health, Safety and Quality (SENASICA) and the Federal Commission for Protection against Sanitary Risk (Cofepris).
Through its Latin America Office, the FDA and Mexico’s food safety regulators have been working collaboratively on fresh produce safety since 2014.
The goal of the 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.
Roughly one third of all FDA-regulated human food imported into the U.S. is from Mexico, including 60% of our fresh produce imports.
The FSP aligns with the aims of the FDA’s New Era of Smarter Food Safety Blueprint through its core elements of tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and business modernization, and food safety culture. In addition, the FSP facilitates important work on increased data-sharing to improve outbreak response communications between Mexico and the U.S.
What’s New about this Food Safety Partnership
The FSP provides new opportunities for collaboration that build upon our pre-existing partnership with SENASICA and Cofepris.
- The scope of the FSP has been expanded beyond fresh produce to include the safety of all human food.
- The renewed FSP focuses on increased dialogue around emerging technologies, such as Whole Genome Sequencing (WGS).
- FDA, SENASICA, and Cofepris have emphasized their shared interest in collaborating with academia, industry trade associations, and consumer groups in the U.S. and Mexico for a comprehensive approach to prevention of foodborne diseases in human foods.
To accomplish the aims of the FSP, there are four content-specific workgroups that focus on shared priority topics as agreed upon between FDA, SENASICA, and Cofepris.
- The Strategic Priorities Work Group is establishing and implementing information exchange and communication mechanisms between agencies on strategic issues, that can potentially pose a risk to the health of consumers in both countries, identified through outbreaks and other for-cause events, and during routine import and export processes.
- The Laboratory Collaboration Work Group is enhancing collaboration on laboratory activities, including sharing Mexico’s whole genome sequencing (WGS) data in the GenomeTrakr.
- The Outbreak Response Work Group is enhancing the effective and timely response for the identification of outbreaks associated with human foods traded between both countries.
- The Food Safety Training Work Group is facilitating training and dissemination mechanisms on food safety issues of interest and agreed upon by the FSP to help improve compliance with applicable requirements and regulations, especially under the Produce Safety Rule, Preventive Controls for Human Food Rule, and Foreign Supplier Verification Programs (FSVP) Rule.
Progress and Accomplishments
Working groups established at the start of the FSP reported tangible progress toward better protections for public health – particularly in the areas of exchanging analytical methods to improve detection and reduce exposure to food contaminated with Cyclospora cayetanensis. In addition, important work on increased data-sharing to improve outbreak response communications and targeted training and outreach continues between the three agencies.
- In response to the 2021 Salmonella outbreak, linked to bulb onions from the State of Chihuahua, MX, the three agencies collaborated to exchange information on their respective onion plans and to guide efforts, such as SENASICA’s mobile laboratory for assessing field samples from inspections, FDA’s Foreign Supplier Verification inspections for onion importers, and hosting technical meetings with Mexican onion growers and packers to learn more about their production practices and share lessons learned from the previous U.S. onion investigations.
- FDA and SENASICA engaged with the papaya industry on the verification of the papaya checklist, a tool to further encourage the adoption of food safety best practices for papaya. The agencies also supported papaya industry's implementation of a supplemental FSVP training for suppliers.
- This workgroup continues a technical dialogue around SENASICA’s Systems for the Reduction of Contamination Risks (SRRC), the Mexican government’s voluntary audit standards for produce safety, and FDA’s Produce Safety Rule (PSR) to better understand each other’s standards.
- FDA implemented a Cyclospora methodology distance training plan for SENASICA and COFEPRIS based on the BAM Chapter 19b method for detecting Cyclospora cayetanensis in produce samples. Competency in the methodology will expand international capacity for detecting Cyclospora cayetanensis.
- SENASICA uploaded 5 historical Salmonella oranienburg isolates to the GenomeTrakr network to support the outbreak investigation linked to bulb onions imported from Mexico.
- In a new commitment for Whole Genome Sequencing (WGS), SENASICA and FDA reached a data sharing agreement to upload 100 sequences (food and environmental) to the GenomeTrakr network. This is an important contribution to the GenomeTrakr network and allows both countries to identify and respond to outbreaks much quicker and with more precision, helping to mitigate the impact on consumers. As a next step, FDA and SENASICA plan to collaborate on advanced data analysis and use of GalaxyTrakr. FDA and COFEPRIS hope to establish a similar agreement in the coming year.
- This work group revised the Binational Outbreak Notification Protocol between the three agencies to include improvements in the document to allow for more timely and effective communication by:
- Providing whole genome sequencing data.
- Including a reference to the laboratory methodology for detection.
- Using the FDA CORE Investigation Table to share publicly available epidemiologic information.
- Drafted and finalized the standard operating procedure for accompanied, unannounced inspections which allows SENASICA and FDA to conduct inspections on the same farm. As a next step, FDA, SENASICA, and COFEPRIS are working on a new model for conducting inspections involving participation by all three regulatory agencies where a food safety issue is suspected.
- In July, SENASICA and FDA piloted an accompanied, unannounced inspection using the standard operating procedure. This provided a first-hand look into how each agency implements inspections and created a foundation for stronger coordinated responses in for-cause situations.
- SENASICA and COFEPRIS participated in the FDA ¨Traceback Investigation¨ course to strengthen the technical understanding of FDA's process and methodologies FDA uses to carry out a traceback investigation during outbreaks. Both agencies conducted internal traceback trainings as a result.
- FDA, SENASICA and COFEPRIS empowered Mexican lead trainers by facilitating participation of Mexican Trainers in the Produce Safety Alliance (PSA)'s Spanish-language Educators Call.
- FDA partnered with JIFSAN to deliver Produce Safety Rule trainings to over 400 growers in Mexico in collaboration with SENASICA and COFEPRIS including:
- Cilantro growers in Puebla
- Avocado growers in Jalisco
- Onion growers in Chihuahua
- Guided by FDA’s efforts to prevent food safety issues in mangos, all three agencies engaged the mango industry in food safety training. They worked with a mango association, EMEX, to train mango producers in Sinaloa, Nayarit, and Jalisco on the Produce Safety Alliance’s Grower Training curricula.
- FDA held informational webinars about the FSMA Proposed Rule on Agricultural Water for SENASICA and COFEPRIS personnel and the three agencies have plans for further collaborations on agricultural water in the coming year.
News & Announcements
- 8/23/2021 - The Food Safety Partnership Between the U.S. and Mexico Reports Progress at First Annual Meeting
- 3/17/2021 FDA Voices Blog - FDA’s Partnership with Mexico’s Regulators Strengthens Food Safety Protections
- 10/2/2020 Press Release - FDA, Mexican Counterparts Enhance Food Safety Partnership
- 10/5/2020 CFSAN Constituent Update - FDA and Mexico Sign Statement of Intent Forging Food Safety Partnership
- 6/25/2020 FDA In Brief - FDA Redoubles Call to Action for Papaya Industry to Keep American Consumers Safe from Foodborne Illness