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  1. Whole Genome Sequencing (WGS) Program

International Whole Genome Sequencing Efforts

In addition to the work FDA is doing 1) to build GenomeTrakr into an extensive international distributed network of laboratories utilizing whole genome sequencing for pathogen identification and 2) to expand the publicly accessible GenomeTrakr reference database of foodborne pathogen genomic and geographic information, FDA is a member of several efforts, with global membership, to establish international standards for the sharing of genomic information. These efforts include work with the Global Microbial Identifier, ISO, and the Global Summit on Regulatory Science. 


Global Microbial Identifier

The Global Microbial Identifier (GMI) is a network of approximately 160 representatives from 32 countries working to develop a global system to aggregate, share, mine, and use microbiological genomic data to address global public health and clinical challenges. GMI’s goal is to deploy a system that promotes equity in access and use of the current technology worldwide, enabling cost-effective improvements in plant, animal, environmental, and human health. 

GMI will use the growing collections of genomic data to conduct worldwide epidemiological surveillance and to perform standardized identification of microbes (including bacteria, parasites, and fungi).  Eventually the genomic information from every new outbreak sample will be able to be compared to the information in this global network of genomic databases to find out where the same type of illnesses are currently occurring, where similar outbreaks have previously occurred, and to determine if new types of pathogens are emerging. However to accomplish this members must agree upon standards for transparency and openness, including rules for data sharing and the appropriate use of any data that is shared. GMI is currently working to address these issues.

GMI’s members include clinical, food, and public health microbiologists and virologists, bioinformaticists, epidemiologists, representatives from academia, industry, funding agencies and data hosting systems, and government health agencies – including FDA. 

ISO

The International Organization for Standardization (ISO) is an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards. It is made up of 163 member countries that are the national standards bodies around the world, with a Central Secretariat that is based in Geneva, Switzerland. ISO’s standards provide a platform for developing practical tools through common understanding and cooperation with all stakeholders on board – from agricultural producers, to food manufacturers, laboratories, regulators, consumers, etc. Out of more than 19,500 ISO International Standards, some 1,000 are specifically dedicated to food, and deal with subjects as diverse as food microbiology, agricultural machinery, logistics, transportation, manufacturing, labelling, packaging and storage.  FDA is part of an ISO effort to develop genomic standards for testing and characterizing foodborne pathogens. 

Global Summit on Regulatory Science

The Global Summit on Regulatory Science (GSRS) is an international conference for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context. The conference provides an opportunity for scientists from government, industry, and academic-research communities to objectively assess the utility of emerging technologies (such as nanotechnology, imaging, omics for translational science, personalized medicine, medical product safety, and food safety) for addressing regulatory-research questions and to discuss the best way to translate these technologies into real-world applications. It also serves as a forum where regulators, policy makers, and bench scientists from various countries can exchange views on how to develop, apply, and implement innovative methodologies into regulatory assessments in their respective countries, as well as harmonizing strategy via global collaboration. To engage the global community to address regulatory-science research and training needs, GSRS is held in different countries on an annual basis. FDA and its global partners in GSRS are working together to develop genomic technologies for testing and characterizing foodborne pathogens.