FDA-SENASICA-COFEPRIS Food Safety Partnership

<< International Cooperation on Food Safety

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The FDA-SENASICA-COFEPRIS Food Safety Partnership (FSP) was established in September 2020, through a 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.

The Importance of this Food Safety Partnership

The FSP provides opportunities for collaboration that build upon our pre-existing partnership with SENASICA and COFEPRIS.

1. The scope of the FSP includes the safety of all human food, expanding past the previous focus of just fresh produce.
2. The FSP focuses on increased dialogue around emerging technologies, such as Whole Genome Sequencing (WGS).
3. 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.

1. 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.
2. The Laboratory Collaboration Work Group is enhancing collaboration on laboratory activities, including sharing Mexico’s whole genome sequencing (WGS) data in the GenomeTrakr.
3. 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.
4. 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.

Strategic Priorities Work Group

• 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-SENASICA-COFEPRIS held a virtual technical workshop with bulb onion producers in Chihuahua with 70 participants focused on food safety practices in the FDA’s PSR, SENASICA’s SRRC, and COFEPRIS’ regulatory standard for the safe processing of food, beverages, or food supplements (NOM 251). The International Fresh Produce Association (IFPA) also presented their Best Practice Guide for Bulb Onions and encouraged the Mexican onion industry to share growing and harvesting practices that may differ from U.S. production practices including those that accounted for in the guide.
• SENASICA and COFEPRIS, along with their state partners, utilized FDA’s Bulb Onion Information Collection Tool to gather information on production practices through visits to 45 farms and 15 packinghouses in Chihuahua. The data gathered was shared amongst all 3 agencies to learn about current practices, assess and identify potential knowledge gaps to address. This will guide future education and outreach efforts.

Laboratory Collaboration Work Group

• FDA successfully shipped Cyclospora DNA to SENASICA and COFEPRIS laboratories which facilitates Mexico’s implementation of the new method and support efforts to reduce the presence of this parasite in the food supply. Additionally, in July 2023 FDA delivered an in-person Cyclospora training 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. FDA implemented an in-person WGS laboratory training for SENASICA and COFEPRIS in August 2023 and provided reagents for the agencies to fulfill this commitment. 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.
• FDA developed and delivered a training webinar series for SENASICA and COFEPRIS on a Hepatitis A/Norovirus methodology and provided an informational webinar on the Vibrio methodology.

Outbreak Response Work Group

• FDA conducted an Accompanied Unannounced visit with SENASICA in response to the Hepatitis A outbreak linked to strawberries, and a visit with COFEPRIS at a broccoli producer in Puebla.
• 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 issued the Binational Outbreak Notification Protocol and engaged in information exchange with SENASICA and COFEPRIS related to the Cyclospora outbreak in romaine lettuce.

Food Safety Training Work Group

• FDA partnered with the Produce Safety Alliance (PSA) to deliver 15 Produce Safety Rule Grower Trainings. The trainings have been delivered to over 500 growers in Mexico in collaboration with SENASICA and COFEPRIS for the following commodity groups: Onions, mangos, melon, berries, and papaya.
• FDA partnered with the Inter-American Institute for Cooperation on Agriculture (IICA) to hold informational webinars about the FSMA Proposed Rule on Agricultural Water for SENASICA and COFEPRIS personnel. The three agencies have plans for further outreach on agricultural water to industry in the coming year.
• FDA hosted a Produce Safety Summit and an On-Farm Readiness Review (OFRR) in Guanajuato, Mexico in April 2023, with participation from SENASICA and COFEPRIS. The Summit reached over 200 farmers, Mexican state inspectors, and other industry stakeholders and 25 producers participated in the OFRR. The topics covered in this summit include informational sessions on the FSMA Produce Safety Rule, SENASICA’s SRRC, COFEPRIS’ Sanitary Control for Fresh and minimally processed vegetables, the potential risks surrounding adjacent land use, the FSMA Traceability Rule, and FDA’s Prevention Strategies.
• FDA, SENASICA, and COFEPRIS finalized the Plan for Preventative Training and Training After a Foodborne Outbreak. The purpose of this guide is to ensure that all three agencies are aligned for targeted training to industry 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 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

Resources 

• FSMA Produce Safety Rule
• FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting