Interview: Mauricio Castelo – Division of Produce Safety FDA
In an interesting interview for Veggies From Mexico, Mauricio Castelo, PhD, shares with us the significance of the Mexican farming industry for the US; we discussed with him the important subjects to address in terms of food safety and compliance with FDA standards for companies who wish to export their fresh produce into this market.
A native of Culiacán, Sinaloa, Mexico, Mauricio Castelo, PhD has an extensive expertise in the farming industry; he has performed a variety of positions, from research to field work during his over 20 years of professional career. He is able to provide the entire Latin American supply chain the possibility to obtain technical assistance in matters related to the compliance with food safety and the training needed for the necessary compliance with FDA regulations.
1. Could you share your professional experience?
My name is Dr. Mauricio Castelo and I am with the United States Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN) within the Division of Produce Safety (DPS), Fresh Produce Branch. In the US FDA-CFSAN-DPS, the Fresh Produce Branch is the work unit responsible for writing and updating the Produce Safety Rule, developing guidance for industry, leading the development and delivery of FDA-supported produce safety educational initiatives, and providing technical assistance to members of the agricultural community when questions come up about the Produce Safety Rule, the guidance, and the underlying science.
My educational background includes a M.S. and a PhD degree in Food Science and Technology from the University of Nebraska-Lincoln. With over 20 years of experience in the food industry, I have served in a wide variety of roles from conducting applied research to managing compliance programs for leading U.S. food companies. Prior to joining FDA, I worked as a food safety consultant for the produce industry. I worked extensively with the produce industry from farm to processing in US and México. Specifically, I developed and performed training and managed audit programs for certification bodies and customers in compliance with regulations. I also created and performed verification audits for the Foreign Supplier Verification Programs in compliance with the Produce Safety Rule and Preventive Controls for Human Food regulation.
I am a certified lead instructor and have hosted the Produce Safety Alliance Produce Safety Rule Grower Training and the Food Safety Preventive Controls Alliance Preventive Controls for Human Food Regulation courses in US, Mexico, and other countries. My role at the Fresh Produce Branch is to provide technical assistance, outreach and training in Latin America to fully implement and foster industry compliance with the Food Safety Modernization Act (FSMA) Produce Safety Rule
2. What is the FDA and what are its main functions?
The U.S. Food and Drug Administration is a regulatory agency within the U.S. Department of Health and Human Services responsible for protecting public health by assuring the safety, effectiveness, quality and security of human and veterinary drugs, vaccines, biologics and medical devices. The FDA is also responsible for the safety of most of the food supply in the United States, all cosmetics, and dietary supplements. The FDA also regulates tobacco products in the U.S.
You can find more information here: Respuestas a preguntas frecuentes sobre la FDA | FDA
3. How important is Mexico’s agricultural industry for the fresh produce sector in the U.S.?
Roughly one third of all FDA-regulated human food imported into the U.S. is from Mexico, including about 60% of our fresh produce imports.
4. How has the food industry changed since the publication of the FSMA PSR?
The Produce Safety rule established, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Since publication in 2015, the FDA along with our regulatory partners, academia and industry have made significant investments in training, education and outreach to ensure that growers are making meaningful progress toward improving food safety practices on their farms and complying with the produce safety rule.
In addition, with these baseline standards in place the FDA has also been able to focus more narrowly on specific issues such as outbreaks related to Shiga Toxin-producing E.coli and associated leafy greens, Cyclospora cayetanensis on fresh produce , and Salmonella spp. in papayas. The FDA is able to build on the foundation provided by FSMA to identify strategies, actions and research needs to make progress on specific food safety issues. More information on some of these initiatives can be found at:
- FDA Leafy Green STEC Action Plan
- Cyclospora Prevention, Response, and Research Action Plan
- Letter to Papaya Industry
5. What has it been like for the FDA to shift to a preventative approach?
Building this prevention-focused framework has been a tremendous undertaking and is ongoing, however there is no doubt that the work is transforming the food safety system in the United States. I would say one of the most significant changes has been how we think about food safety. While we continue to react to issues as they happen to protect public health, we also put significant effort into figuring out what went wrong so that we can prevent similar issues from happening again.
6. What are the main FDA regulations that apply to farmers who produce fresh produce in Mexico?
Certain farmers that produce covered produce (those products included/covered by the Produce Safety Rule) for export to the United States must comply with the Produce Safety Rule or demonstrate that they are following processes and procedures that offer the same level of public health protection. Domestic growers also need to comply with the PSR. The Produce Safety rule establishes science-based standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. ”Produce” generally includes fruits and vegetables and includes mushrooms, sprouts, peanuts, tree nuts, and herbs. The Produce Safety Rule provides various examples of produce commodities that would be considered “covered produce” for the purposes of the rule. In addition, only produce items that are raw agricultural commodities – meaning a Food in its raw or natural and un-processed state- are subject to the Produce Safety Rule.
The FDA has resources available on its website, including in Spanish, to help farmers understand these requirements. In addition, the agency has made fact sheets for each chapter of the draft guidance with recommendations on how to comply available in Spanish.
In addition, farmers who grow produce for export to the United States should be aware that those importing their products into the U.S. will need to comply with the FSMA Foreign Supplier Verification Program (FSVP) rule. The FSVP rule requires importers to perform risk-based activities to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the produce safety rule, and that the Food is not adulterated or misbranded according to U.S. food safety regulations. Like for the produce safety rule, there are translated fact sheets available on our website.
7. What does the New Era of Smarter Food Safety refer to and what impact will it have on fresh produce?
The New Era of Smarter Food Safety initiative represents a new approach to food safety, leveraging technology, tools and approaches to create a safer and more digital, traceable food system. The goals, as outlined in the New Era of Smarter Food Safety blueprint released in July 2020, build on what has been achieved through implementation of the FDA Food Safety Modernization Act (FSMA).
The New Era goals impact all foods regulated by FDA, including fresh produce. For example, they include advancing food traceability to rapidly identify where contaminated foods were grown or produced and speed recalls when necessary. We are also looking to enhance and strengthen root cause analyses of food contamination and predictive analytics to anticipate risks. Findings of root cause analyses can be an important step in helping industry modify practices to avoid identified risks and can provide more robust data for predictive analytics.
One segment of the produce industry that has been leading in this area is leafy greens. Leafy Greens have been tied to numerous outbreaks over the last several years and so they are highlighted in both the New Era blueprint and the Leafy Greens STEC action plan as an area where we can make progress in meeting the New Era goals. Some of the activities we have been working on collaboratively with industry include a pilot programs on traceability and the creation of a data trust to fuel analytical work to strengthen preventive approaches.
8. What is food safety culture and how does it benefit the agricultural industry?
The creation of food safety cultures on farms, in food facilities, and at home is a New Era of Smarter Food Safety priority. We will not make dramatic improvements in reducing the burden of foodborne disease without doing more to influence the beliefs, attitudes, and, most importantly, the behaviors of people and the actions of organizations.
From the decision a food worker makes about washing their hands before working with food to the decision a management team makes about how to control a food safety hazard, there is a human element to decisions that can make the difference between a food being safe or unsafe.
A strong food safety culture is a prerequisite to effective food safety management and benefits everyone, including the agricultural industry.
9. What would be the main recommendations you would make to Mexican agricultural producers on compliance with FDA regulations?
We recommend farmers that are exporting to the United States become familiar with and implement the applicable FSMA rules and if needed seek out training opportunities to better understand how to comply. We often work with groups like the Inter-American Institute for cooperation on Agriculture (IICA) to host trainings and webinars which are all good opportunities to learn how to better implement the rules.
10. Something else you want to add
The Produce Safety Rule is part of the FDA Food Safety Modernization Act (FSMA) that was signed by President Obama on January 4, 2011. The Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fresh fruits and vegetables, in an effort to prevent microbial contamination and reduce foodborne illnesses associated with produce. The rule is divided into several parts, including standards for:
- Worker health, hygiene, and training
- Agricultural water, both for production and post-harvest uses
- Biological soil amendments of animal origin, BSAAO (e.g., compost)
- Domesticated and wild animals
- Growing, harvesting, packing and holding activities
- Equipment, tools, buildings, and sanitation
- Production of sprouts
Compliance with the FSMA Produce Safety Rule is important in order to be able to export fresh fruits and vegetables to the United States. As part of my role with the DPS-Fresh Produce Branch, I have been reaching out to industry and academia in Latin America to identify collaborative opportunities for educational initiatives in Latin America to support implementation and compliance with the Produce Safety Rule. In the last 10 months, I have completed more than 25 virtual webinars in Mexico. I am also looking to attend conferences, meetings, workshops, and expos in order to share information about the FDA’s work in produce safety.
In addition to supporting the delivery of produce safety educational initiatives in Latin America, please also consider me as a direct resource for technical assistance. I can provide FDA’s perspective to farmers, educators, trade associations and stakeholders on questions about the Produce Safety Rule, the associated guidance, the underlying science, and other related issues and do this in a manner that accounts for Latin America-specific practices, conditions, commodities, and challenges. My focus on Latin America also helps FDA to account for region-specific practices, knowledges gaps, conditions, and challenges in its educational initiatives. More information and resources for the Produce Safety Rule available in Spanish can be found at:
I also want to share with you and your members the FDA’s new Spanish mailbox for any questions you have about the Produce Safety Rule:
Produce Safety Network en Español (ProduceSafetyNetworkEnEspanol@fda.hhs.gov)
Dr. Mauricio Castelo
CFSAN-DPS-FPB
U.S. Food and Drug Administration
Mauricio.Castelo@fda.hhs.gov
