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.
Organization
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.
- FDA, SENASICA, and COFEPRIS held a meeting in Chihuahua, Mexico in March 2023, with about 50 onion producers and communicated our unified message of the importance of food safety including the FSMA Produce Safety Rule and the International Fresh Produce Association (IFPA) Best Practices Guide for Bulb Onions.
- SENASICA and COFEPRIS are integrating the FDA’s Bulb Onion Information Collection Tool into their internal protocol to gather information on production practices when visiting onion farms and packinghouses. This summer, SENASICA and COFEPRIS will share information gathered among the three agencies. This information could be used to broaden our understanding of potential sources and routes of contamination at the farm or packinghouse, as well as identify potential training needs for onion producers.
- 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 successfully shipped Cyclospora DNA to SENASICA and COFEPRIS laboratories. Additionally, FDA delivered a Cyclospora webinar on the BAM Chapter 19b methodology to support SENASICA and COFEPPRIS in demonstrating competency.
- In a new commitment for Whole Genome Sequencing (WGS), SENASICA, COFEPRIS, 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 faster to outbreaks and with more precision, helping to mitigate the impact on consumers.
- SENASICA and COFEPRIS will host FDA for laboratory assessments in April 2023. Using the knowledge gained through these assessments, FDA will be able to tailor WGS trainings to each agency’s needs and competencies. These in-laboratory WGS trainings will be planned and executed at SENASICA and COFEPRIS in August 2023.
- The Standard Operating Procedure for Accompanied Unannounced Visits was finalized between the three agencies. This SOP allows SENASICA, FDA, and COFEPRIS to conduct inspections on the same firm under each agency’s jurisdiction and according to their respective inspection protocols. By conducting the visits unannounced, the regulators have the ability to observe typical production practices.
- FDA issued the Binational Outbreak Notification Protocol and engaged in information exchange with SENASICA and COFEPRIS related to the Hepatitis A outbreak linked to imported frozen strawberries from certain farms in Baja, Mexico.
- FDA partnered with the Produce Safety Alliance (PSA) to plan 15 Produce Safety Rule Grower Trainings. To date, five trainings have been delivered to over 150 growers in Mexico in collaboration with SENASICA and COFEPRIS for the following commodity groups: Onion growers in Chihuahua, Mango growers in Nayarit and Jalisco, and Melon growers in Sonora.
- FDA partnered with the Inter-American Institute for Cooperation on Agriculture and held informational webinars about the FSMA Proposed Rule on Agricultural Water for SENASICA and COFEPRIS personnel and the three agencies have plans for further outreach on agricultural water in the coming year.
- FDA will host a Produce Safety Summit and an On-Farm Readiness Review (OFRR) in Guanajuato, Mexico in April, 2023, with participation from SENASICA and COFEPRIS, over 200 farmers, Mexican state inspectors, and other industry stakeholders. The topics covered in this summit include informational sessions on the FSMA Produce Safety Rule, SENASICA’s Systems of Risk Reduction of Contamination, the potential risks surrounding adjacent land use, the FSMA Traceability Rule, and FDA’s Prevention Strategies.
- FDA, SENASICA, and COFEPRIS will work together to finalize the Post Adverse Food Safety Event Training Guide. The purpose of this guide is to ensure that all three agencies are aligned for targeted training response following a foodborne outbreak.
News & Announcements
- 8/25/2022 - FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting
- 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
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