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Event Title
Remarks by Mary Lou Valdez to the North American Food Safety and Quality 2019 Conference
June 5, 2019

Speech by
Mary Lou Valdez
Associate Commissioner for Diplomacy and Partnerships - Office of the Commissioner ( March 2019 - January 2020 )


"Global Collaboration: Unifying International Food Safety Systems and Capacity"


It is a pleasure and privilege to join you today to speak about global collaboration to strengthen food safety systems and capacity. 

As you know, the U.S. Food and Drug Administration has been ensuring the safety and quality of foods since its founding in 1906.   But it was not until 2009 that the FDA established foreign posts in strategic locations around the world, recognizing the global nature of our U.S. food supply.  We currently have posts in Beijing, China; New Delhi, India; Brussels, Belgium; Mexico City, Mexico; San Jose, Costa Rica; and Santiago, Chile. 

These posts along with our Office of Global Policy and Strategy headquarters in Maryland, develop, catalyze and support global efforts in strengthening food safety systems, working closely with our Center for Food Safety and Applied Nutrition and other USG Agencies, like the U.S. Department of Agriculture.   

Global Collaboration: Unifying International Food Safety Systems and Capacity.

The phrase “Global Collaboration: Unifying International Food Safety Systems and Capacity” is quite lofty and ambitious.  So, what do I mean exactly?   Our work focuses on three primary areas:

Better data on food safety challenges.  The food industry is a large, complex and multi-faceted industry and U.S. consumers, and indeed consumers everywhere, expect and demand their governments ensure safe and high-quality foods.  National leaders and policymakers need better data and information to understand and appreciate the challenges to food safety and the criticality of strong food safety systems. Our focus is on regulatory authorities.  

Raising the profile within the global policy dialogue.  Food safety does not enjoy a high profile within the global policy dialogue.  It competes with many important public health challenges, such as maternal child health, HIV/AIDS, TB and malaria, and the increasing incidence of noncommunicable diseases, to name only a few.  And yet, per the WHO, one in 10 people fall ill every year from eating contaminated food and 420,000 die as a result.  Children under 5 years are of high risk, with 125,000 children dying from foodborne diseases annually.  Our goal is to bring food safety more central to national and global public health policy discussions.  

Increasing prominence of the Codex Alimentarius Commission.  FDA Centers, along with USDA, US Trade Representative Office, and other USG and private sector experts, actively participate in and provide support to Codex.  Using science as the foundation, Codex international food standards, guidelines, and codes of practice contribute to the safety, quality and fairness of the international food trade.  Consumers can then trust the safety and quality of the food products they buy, and importers can trust that the food they order, will be in accordance with Codex  specifications.  Within an increasing complex 21st century environment, Codex science-based standards are more and more important. 

Along with our areas of focus we work toward a number of expected results. 

Increased investments for food safety systems.  Food safety systems are under-resourced and food regulatory systems even more so.  Small and medium enterprises grapple with ensuring safe product throughout its life-cycle.  Food regulatory authorities are under-resourced in terms of budgets and staff, and may lack strong legislation in which to operate effectively.  We want to see increased investments at national and global levels of governments, and by donors and multilateral organizations.   

Reinforcement of science-based regulations.   Again, science is the essential underpinning to ensuring the safety and quality of the foods we eat.  We are committed to strengthen Codex and other relevant organizations, such as the Asia Pacific Economic Cooperation, to enable the uptake and consistent application of standards, and over time, foster regulatory harmonization and coherence.  

Better information for regulatory (and other) decisions and actions.  While much data and information may exist, regulators need timely, accurate and easily managed data.  WHO’s International Network of Food Safety Authorities (INFOSAN) is a good example in the detection of food-safety events.  Whole-genome sequencing of food borne pathogens is another. 

Stronger food safety systems that can focus on preventing food safety problems rather than reacting to problems after they occur.
Our U.S. Food Safety and Modernization Act or FSMA shifts the focus from responding to foodborne illness to preventing it in the first place.  Congress enacted FSMA in 2011 in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences.  FSMA implementation should result in an effective, preventive approach to food safety. 

Use technology and innovation to ensure safe, nutritious and high-quality foods for consumers around the globe. 

While new regulations and developments have enhanced our oversight of the food supply and its safety, it’s time to look to the future of food safety with a view that builds on the progress we’re making within  our regulatory framework, while also utilizing new and emerging technologies to create a more digital, traceable and safer system.  FDA Commissioner Ned Sharpless and Deputy Commission Frank Yiannis announced last month a “New Era of Smarter Food Safety”.  The goal is to augment our efforts implementing important FSMA requirements while also leveraging the use of new and emerging technologies. 

So, what have we done to champion global collaboration?  A few examples… 

• Collect more robust data for national leaders and policy makers

• Build capacity of national foods regulatory authorities, through Codex, the Asia Pacific Economic Cooperation or APEC, and our foreign posts. 

• Build global network and coalitions, e.g., whole-genome sequencing of foodborne pathogens

Let’s take these one at a time for dive deeper on each…

Collect more robust data for national leaders and policy makers.  The FDA Office of Global Policy and Strategy has commissioned several reports to improve data on what we know about food safety. 

While data does exist, many times it is anecdotal and thus of limited value in making decisions or actions.  The publication of reports can generate more informed discussions, provide additional evidence for better decision-making as well as enable more research efforts, helping to identify new questions and areas where we could benefit from more studies and exploration.  Here are some of the reports we have commissioned.

The WHO Report on the estimates of the global burden of foodborne diseases published 2015.

CFSAN experts actively participated over some years in the development of the global burden report, and the Office of Global Policy and Strategy provided support to WHO to bring the report to publication. 

Regarding the data, the WHO report found that the most frequent causes of foodborne diseases are diarrheal disease agents (e.g., norovirus and Campylobacter spp) – causing 550 million people to fall ill and 230,000 deaths to occur annually.

The report estimated on 31 foodborne hazards – bacteria, parasites, viruses, toxins and chemicals – causing 32 diseases where one in ten people in the world each year fall ill after consuming contaminated food, with children under five years are of particularly high-risk.

The risk of foodborne diseases is most severe in low- and middle-income countries, linked to unsafe water; inadequate conditions in food production and storage; and insufficient food safety legislation or implementation of such legislation. Foodborne diseases are also impediments to economic development globally. 

The World Bank report:  The Safe Food Imperative:  Accelerating Progress in Low- and Middle-Income Countries (October 2018).  Its findings include:

Unsafe foods costs low- and middle-income countries $110B in lost productivity and medical expenses each year.  The annual costs of treating foodborne illness is estimated at $15B annually.

There is a lack of alignment between food safety risks and the capacity to manage them, as countries develop economically, and food systems and diets transform.  And lastly, ppreventive measures can help countries tackle food safety problems.

The National Academies of Science, Engineering and Medicine.  The report “Ensuring Safe Foods and Medical Products through Stronger Regulatory Systems Aboard” released in 2012.

While focusing on the BRIC countries, the Study identified the main characteristics of successful regulatory systems.   These characteristics included the responsiveness and predictability of a system, a focus on outcomes, and an ability of a regulatory system to respond appropriately to new science, innovation, and ideas.

It also identified common problems that cut across developing countries’ product safety systems.  Problems include the ability to adhere to international standards, a lack of capacity in controlling supply chains, the need for more and better trained personnel, poor or non-existent surveillance systems, and a lack of a strong legal underpinning in which to regulate. 

We have commissioned the National Academies for a new report to be released in 2020.  The report will expand past the BRIC countries.   It will identify and analyze progress made since 2012 as well as the gaps that remain or new gaps that have emerged. 

Another area where we champion global collaboration is in the building of capacity of national foods regulatory authorities

World Health Assembly Resolution - WHA 63.3 Advancing food safety initiatives. (passed in 2010). The resolution called upon Member States to establish or improve the evidence base for food safety, to contribute to international risks assessments, and to develop and maintain sustainable preventive measures.   It also asked the WHO Secretariat to help countries improve cross-sectoral collaboration along the food production chain, including assessment, management and communication of foodborne and zoonotic risks. 

Two International Food Safety Conferences of global importance have occurred this year.

The first was the WHO/FAO/AU International Food Safety Conference (Addis Ababa February 2019).  The second was the International Forum on Food Safety and Trade (Geneva April 2019).

These conferences brought together governments and their technical and regulatory experts, and experts from industry, academia and civil society.  They encompassed technical panels to address key food safety issues and strategic actions. These include:

• The burden of foodborne disease and the benefits of investing in food safety systems;
• Better use of science, innovation, and digital transformation in support of food safety; and
• Empowering consumers to support sustainable food systems. 

Codex Alimentarius Commission.  The Codex Alimentarius, or "Food Code" is a collection of standards, guidelines and codes of practice.  These are standards for all the principal foods, whether processed, semi-processed or raw, for distribution to the consumer.  Codex was established by FAO and WHO to protect consumer health and promote fair practices in food trade. It held its first meeting in 1963 and now has 188 Member States. 

It tackles tough public health issues such as contaminants, nutrition and labeling, antimicrobial resistance and biotechnology issues (including genetically modified food).    To date, Codex has produced 223 Standards, 78 guidelines, and 53 codes of practice.  And when developing these, Codex analyzes risk and relies on independent scientific advice provided by expert bodies of the World Health Organization and the UN Food and Agriculture Organization (WHO/FAO) expert bodies. 

Our FDA Centers and other US Agencies contribute significant scientific and regulatory expertise to Codex Working Groups and Task Forces.  We also provide funding to enable and expand the participation of low- and middle-income countries so that they too can more fully participate in standards development and be able to apply Codex standards at national levels. 

Building global networks and coalitions.

Ensuring the safety and quality of the foods that U.S. consumers demand and expect is a primary driver in FDA’s efforts to build global networks and coalitions.  After all, 32% of the fresh vegetables, 55% of the fruit and 94% of the seafood that U.S. consumers eat is imported.  Coalitions can help leverage our efforts and expand our regulatory reach.  I’ll highlight a few. 

Whole-genome sequencing.

To ensure food safety and security, foodborne diseases need to be detected quickly and monitored globally.   Whole genome sequencing (WGS) has the potential to change the way we detect, characterize, and monitor microbiological food safety hazards as well as to improve the treatment of people suffering from foodborne diseases.

In contrast to current technologies that can be imprecise, time consuming and resource-intensive, whole genome sequencing technology is rapid, precise, universal across organisms (humans, plants, microbes, etc.), inexpensive, and easy to use.   The rapidity of detection and precision of identification offered by whole genome sequencing can mitigate outbreaks and alleviate economic losses. 

Currently, public health labs from ten or more countries participate in a network that collects and shares genomic and geographic data to help globally track and prevent the spread of foodborne pathogens.  Effective use of WGS, however, requires global implementation and data sharing. 

Work with the Inter-American Institute for Cooperation on Agriculture.

As a key element of FSMA’s preventive approach, Congress mandated FDA to establish science-based, minimum standards for the safe growing, harvesting, packing, and holding of produce on farms to minimize contamination that could cause serious adverse health consequences or death.

With many countries in Latin America shipping fresh produce to the United States, building   competency, knowledge and capacity of foreign regulators and industry are essential.  An FDA objective is to ensure that industry and importers along complex supply chains embrace FSMA’s preventive approach, and fully implement FSMA food safety standards.

While much training occurs in the Americas at various levels, many times the impact of such training is unknown or unmeasured.  So we in FDA thought that working with a multilateral institution in the Region, such as the Inter-American Institute for Cooperation on Agriculture, which is well respected for their knowledge and capacity building, is a good way to build capacity through sustainable and evidence-based training curriculum based on FSMA principles and concepts.  This effort began in 2017.

Work bilaterally, especially where FDA has foreign posts.

As I’ve stated, our foreign posts, strategically located around the globe, engage directly and effectively with regulatory counterparts, Industry, and relevant academic and other institutions, including USG agencies that are part of the Embassy family. 

Our objectives include:
• building our own knowledge base about the regulatory system and capacity of a country or subregion, the robustness of the industry that exists there and the intersections between the two. 

• actively sharing information about FDA regulatory requirements, to help ensure that the products these countries export meet our standards.  And over time, FDA information may contribute to countries building their food safety capacity domestically.  

• and wherever appropriate, we engage in system strengthening and capacity building efforts across relevant stakeholders, including regulatory authorities, to bolster existing food safety systems. 

For example:   our foreign posts in Latin America are working to build capacity and knowledge for On-Farm Readiness so that farmers have the information and tools they need to minimize risk of contamination, especially of products heading to the USA. Also, FDA experts from time to time join World Bank assessment teams as countries explore potential food safety investments.

Which takes us back to our Expected Results:

• Increased investments in food safety systems
• Science-based regulations – adopted and implemented
• Better information – shared and utilized
• Stronger food safety systems exist
• Better utilization of Technology/innovation to ensure safe and high-quality foods

As FDA looks ahead to the future, we ask ourselves the following:

How do we operationalize the issues of the Int’l Fora of 2019?

The WHO/FAO/AU and WTO conferences engendered much momentum and we want to continue moving key concepts that emanated forward.  The European Commission and others are exploring the governance venues of WHO and FAO to bring food safety back to the discussions. 

How do we optimize the reports, including the upcoming 2020 reports?

The reports FDA commissioned contain a wealth of information and data.  We are working to actively push out or disseminate the information to national policy leaders.  For example, a dissemination conference will accompany each Academies Report.  And new data is emerging so keeping the information flow will be critical to support better evidence-based decisions and actions.  

How can we increase investments and maximize existing investments?

The World Bank Report not only has an external audience but an internal one as well.  We are hopeful that with this Report, World Bank experts can and will engage with national policy makers around the benefits of investing in food safety systems – which can be additive and good value for money. 

Most importantly… How do we create a shared responsibility for food safety?

Regulators or their governments cannot ensure the safety and quality of food on their own.  As the WHO Director-General Dr. Tedros, stated at the food conference in Addis in February, food safety is a shared responsibility.  And this is similar to the theme of the 2019 Food Safety Day to be celebrated Friday, June 7, which is “Food Safety, Everyone’s Business.”  Industry and businesses at all levels of the product life cycle, academia, the research community and others must be part of the overall solution.  Consumers are equally important as the power of their voice and advocacy can have profound effects at local, national and global levels. 

FDA is working with multilateral institutions, other governments, and the industry to help create a shared responsibility that is transparent, robust, and sustainable over time.  The United Nations in a recent report projected that our world population will reach 8.5 billion by 2030 – so there is certainly not a moment to lose. 

Thank you so very much for allowing me to spend some time with you today.

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