In celebration of One Health Day this November 3, we’ve included this special section to highlight One Health activities.
How OGPS Contributes Globally through a One Health Lens
Many centuries ago, Tibetan wisdom-keepers recognized that the health of people, animals, and the environment are fundamentally intertwined. Today, that way of thinking is reflected in a concept known as One Health, which recognizes the importance of looking across disciplines and sectors to solve public health challenges. In today’s precarious world, this approach has never been more important. The FDA has a global role to play through the activities of its foreign offices.
What is the aim of One Health?
One Health acknowledges the interconnectedness of human, animal, plant, and environmental health. This interface becomes more important as humans continue to expand into previously undisturbed lands and habitats, and as international trade and travel increase exposure to pathogen-transmitting vectors and speed the spread of disease outbreaks.
Consequently, a One Health approach is gaining traction for its holistic perspective in addressing the complex health challenges facing our society, such as ecosystem degradation, food system failures, infectious diseases, and antimicrobial resistance. This transformative approach can be embraced to promote food security, health equity, sustainable development, and integrative and innovative approaches to challenges.
Applying the One Health concept to public health replaces piecemeal approaches with comprehensive solutions. This means collaborating across disciplines by bringing together physicians, veterinarians, environmental scientists, social scientists, engineers, public health professionals, regulators, and policymakers to collectively forge a path forward for the best chance of sustainable success.
How is the FDA getting involved?
At the FDA, the Office of Chief Scientist, within the Office of the Commissioner, together with the Director of the Center for Veterinary Medicine, oversee the FDA’s One Health Initiative in collaboration with nine FDA centers and offices. Leveraging science, technology, and innovation, the FDA One Health initiative seeks to: create a multidisciplinary mindset for internal and external FDA stakeholders; provide infrastructure to sustain the effort; engage governmental partners in coordination, communication, outreach, and inclusivity; and reach globally to expand the FDA’s One Health impact.
As we prepare to observe One Health Day on November 3, it is worth recognizing that the FDA’s Office of Global Policy and Strategy (OGPS) — often working with other FDA centers and offices, U.S. and foreign government agencies, and international, regional, and industry organizations — has been influential in shaping a diverse portfolio of global FDA activities that address One Health concerns at fundamental levels.
How do OGPS activities contribute to global One Health?
The OGPS foreign offices in Europe, India, Latin America, and China are involved with many activities that have a One Health component. For the staff, it’s not only about keeping imported food or medical products safe, but about how we, as regulators, approach our relationships with our global counterparts and strive together, mindfully, toward solutions. A small sampling of the broad range of our foreign offices’ endeavors is highlighted below.
- WGS networks and capabilities. Our foreign offices have been at the forefront of promoting international participation in the GenomeTrakr network, which allows government agencies, laboratories, and academia across the globe to share and compare whole genome sequencing (WGS) data from food and environmental samples. The broader the participation, the better public health agencies can perform surveillance on emerging pathogenic threats and mount an appropriate response to outbreaks.This August, the Latin America Office facilitated bilateral engagements between the FDA and food agencies in Mexico to increase their participation in the GenomeTrakr network. This is an important step and will allow the agencies to identify and respond to outbreaks faster and with more precision. Similarly, the India Office is currently working to facilitate transfer of WGS instrumentation to India’s Marine Products Export Development Authority (MPEDA) and to provide training so MPEDA can upload the genetic information on isolates to the GenomeTrakr network. This will be the first use of WGS for food safety purposes by a regulatory body in India. [For more, please see our preceding article on the India Office’s WGS activity with MPEDA.]The Europe Office has led and coordinated several bilateral discussions with key EU entities involved in foodborne pathogen surveillance and foodborne outbreak response, in part to better understand the application of WGS in the EU’s food safety system. Building on these bilateral efforts, the FDA is bringing together experts in food, the environment, and human health for a broader discussion on WGS. The FDA is currently planning a U.S.-EU dialogue involving the U.S. Centers for Disease Control and Prevention and key EU agencies to discuss challenges and opportunities for WGS data sharing and public access through the GenomeTrakr network; the workshop is scheduled for January 12-13, 2023, and will be hosted by the Europe Office.Looking ahead, the development of stronger WGS networks and surveillance and a focus on supply chain traceability are important next steps to broadening our approach to food safety beyond the walls of the manufacturing facility and preventing disease outbreaks at the source.
- Produce safety. The Latin America Office has been at the forefront of outreach regarding education on safe produce practices that include awareness and mitigation of disease vectors from wildlife, the surrounding environment, byproducts of nearby human activities, and improper human handling (e.g. unclean hands). Through a cooperative agreement with the Inter-American Institute for Cooperation on Agriculture, the Latin America Office (with the FDA’s Center for Food Safety and Applied Nutrition, or CFSAN) helped facilitate numerous trainings on produce safety aimed at reducing foodborne outbreaks, such as those involving leafy greens or fresh fruit and vegetables from pathogens including salmonella and cyclospora.
- Seafood safety. The amount of seafood consumed in the United States and throughout the world is growing. With this increased consumption, aquaculture products have become a more important source for people’s nutritional and food security needs. Aquaculture often occurs in or near large bodies of water where the farm may share a contiguous environment with nearby wildlife. The Latin America and India Offices are supporting the FDA’s One Health approach to ensure a safe supply of aquacultured seafood. Together with CFSAN, these offices are helping to provide training for regulators and industry in these regions on Seafood HACCP and good aquaculture practices (GAqP) — which address natural hazards, food safety, and proper use of veterinary drugs, including antimicrobial stewardship.
- Pandemic readiness and vaccine equity. The India Office supported global pandemic response efforts by conducting inspections at a vaccine manufacturer in India on behalf of the European Medicines Agency (EMA) to facilitate regulatory assessment of vaccines being considered for Emergency Use Listing by the World Health Organization and inclusion in COVAX (short for COVID-19 Vaccines Global Access, a worldwide initiative aimed at equitable access to COVID-19 vaccines). In support of the India Office efforts, the Europe Office facilitated discussions, as needed, through their dedicated FDA Liaison to the EMA.The Latin America Office provided regional outreach opportunities and worked closely with regulatory partners to share information on the FDA’s regulatory pathways related to emergency response and Emergency Use Authorizations, which was utilized by many Latin American countries to streamline their own respective approval processes of essential medical products and to create regulatory pathways for making decisions in response to public health emergencies.
- Antimicrobial resistance. Over the past three years, the Europe Office has facilitated discussions between the FDA and the EMA and participated in interagency discussions with the European Commission (EC) while the EU was developing new legislation about the use of antimicrobials. This legislation lists antimicrobials reserved for treating infections in humans only, and therefore these products are not authorized for use on animals (for example in farming). The EU finalized its legislation in July 2022. Although the list itself presents no concerns (i.e., no drugs approved for food animals in the United States are on this EU list) the Europe Office is currently monitoring the adoption of a delegated act (a non-legislative act by the EC to supplement or amend certain non-essential elements of a legislative act) that will clarify the application of specific provisions affecting third countries.
- Participation in international organizations and events. All of the OGPS foreign offices routinely and extensively attend, help facilitate, or present at meetings, conferences, and events in their respective regions on One Health-related topics; and some staff may even participate in technical working groups along with international regulatory counterparts. This engagement inspires new insights and provides opportunities for the FDA to better understand our global counterparts and stakeholders.
The COVID-19 pandemic has been an unrelenting reminder that a One Health approach is critical if we want to effectively combat future outbreaks before they turn into a pandemic. Our global world today cannot afford to ignore animal diseases and their risk to public health, as over 60% of emerging infectious diseases globally are zoonotic. Moreover, produce outbreaks and recalls occurring over the last several decades have shown many causes to be of animal origin.
The direct toll on human health is only part of the global effect, which also puts a strain on medical product resources and impacts local and international food supply chains.
As we have recapped, the FDA’s foreign offices remain ever alert to these interconnections and are diligently applying the agency’s broad array of regulatory tools to protect public health.
On October 17, four international agencies — the Food and Agriculture Organization of the United Nations (FAO), the United Nations Environment Programme (UNEP), the World Health Organization (WHO), and the World Organisation for Animal Health (WOAH, founded as OIE) — announced the launch of their first joint plan on One Health.
Their cooperation on One Health was formalized in March 2022 when the four signed a Memorandum of Understanding for joint One Health activities, forming the Quadripartite Collaboration for One Health. The MOU provides a legal and formal framework for the agencies to use a more integrated approach when confronting challenges at the human, animal, plant, and ecosystem interface.
The Quadripartite agencies’ One Health Joint Plan of Action “aims to create a framework to integrate systems and capacity so that we can collectively better prevent, predict, detect, and respond to health threats,” the WHO said in a press release. “Ultimately, this initiative seeks to improve the health of humans, animals, plants, and the environment, while contributing to sustainable development.”
The plan extends for five years, through 2026, and focuses on building the agencies’ strengths across the most critical of global One Health concerns:
- One Health capacities for health systems.
- Emerging and re-emerging zoonotic epidemics.
- Endemic zoonotic, neglected tropical, and vector-borne diseases.
- Food safety risks.
- Antimicrobial resistance and the environment.
The four collaborating agencies seek to provide a framework for adoption of a One Health approach to coordinated, multisectoral action and partnership that can be embraced by all organizational levels — governments and international agencies, industry organizations and professional associations, and academia and research institutions.
According to the WHO, the plan sets out operational objectives to include “upstream policy and legislative advice and technical assistance to help set national targets and priorities” and to promote “multinational, multisector, multidisciplinary collaboration, learning and exchange of knowledge, solutions and technologies.” At the core of the plan are the values of cooperation and shared responsibility; a set of values that the world is now at a crossroads to address.
The World Bank Calls for Moving Away from Pandemic Containment to Pandemic Prevention
In advance of One Health Day on November 3, the World Bank has issued a report urging policymakers, governments and the international community to invest in pandemic prevention and move away from what it calls “the business-as-usual approach” based on containment and control after a disease has emerged. The report estimates that prevention guided by a One Health approach — sustainably balancing and optimizing the health of people, animals, and ecosystems — would cost anywhere from $10.3 billion to $11.5 billion per year. In contrast, the G20 Joint Finance and Health Taskforce has estimated that it costs about $30.1 billion per year to manage pandemics. Moreover, actions to prevent disease outbreaks carry an estimated rate of return of up to 86% and most of these actions will result in significant co-benefits, the World Bank says.
“Prevention is better than cure. COVID-19 has shown that a pandemic risk anywhere becomes a pandemic risk everywhere. The economic case for One Health is powerful — the cost of prevention is extremely modest compared to the cost of managing and responding to pandemics,” said Mari Pangestu, World Bank Managing Director of Development Policy and Partnerships.
To make its point, the report, “Putting Pandemics Behind Us: Investing in One Health to Reduce Risks of Emerging Infectious Diseases,” includes case studies of Liberia, Vietnam, and the Assam State in India.