1. Understand FDA’s Objectives in the Pacific Island Region: Attendees will gain a clear understanding of the specific goals and objectives of the FDA Guam Pilot Project, including its aims to improve food safety, enhance regulatory oversight, and address unique challenges faced by the Pacific Island communities.
2. Recognize Key Challenges and Solutions: Participants will be able to identify the primary challenges encountered during the pilot project, such as logistical issues, resource constraints, and cultural considerations. They will also learn about the solutions and strategies implemented to overcome these challenges.
3. Evaluate the Impact on Local Food Systems: Attendees will learn how the FDA Guam Pilot Project has impacted local food systems, including improvements in food safety practices, regulatory compliance, and overall public health in the region.
4. Assess Collaborative Efforts and Stakeholder Engagement: Participants will understand the importance of collaboration between the FDA, local public health agencies, community organizations, and other stakeholders. They will learn how these partnerships contributed to the success of the project and its implementation.
5. Apply Lessons Learned to Future Projects: Attendees will be equipped with insights and best practices derived from the FDA Guam Pilot Project that can be applied to similar initiatives in other regions. They will be able to discuss how these lessons can inform future projects aimed at improving food safety and regulatory frameworks in diverse and remote areas.
In April 2022, Food and Drug Administration (FDA) and Guam Division of Public Health and Social Services (DPHSS), Division of Environmental Health (DEH) initiated a pilot to increase medical product safety and supply chain security related to the importation of fraudulent, misbranded, or adulterated imported goods. In Guam, 95% of items are imported, including medical products, food, dietary supplements, cosmetics, and tobacco products. Since June 2022, FDA has maintained a continuous presence in Guam, with temporary FDA personnel (i.e., detailees) engaging with local customs and health authorities. Funded by the US Department of Health and Human Services (HHS) Health Care Fraud and Abuse Control Program (HCFAC), pilot goals included: • Improve intelligence on imported goods entering the US mainland, Hawaii, and US Pacific territories. • Build sustainable regulatory capacity and capability for Guam and enhance support for the other US Pacific territories (the Commonwealth of the Northern Mariana Islands (CNMI) and American Samoa). • Provide a conduit for FDA laboratory engagement to support the analysis of imported products. • Inform FDA Office of Criminal Investigations (OCI) operations through direct engagement in the Pacific region. • Broaden FDA’s international presence and engagement. FDA designed the Guam Project to be executed in different phases. The goal of Phase I (i.e., pilot) was to understand and assess current levels of regulatory operations, enforcement, and public health risk in Guam. This information gathering and assessment helped inform requirements, opportunities, and limitations of establishing FDA operations in Guam. In March 2023, FDA initiated Guam Project Phase II to test and assess different processes and procedures to determine the design, feasibility, and organization of a long-term FDA presence in Guam. The results of the FDA’s initiatives in Guam encourage a more collaborative and streamlined regulatory environment that could be adopted by other federal agencies, leading to faster innovation and better alignment of regulatory practices across the government. Guam has a population of about 160,000 residents and about 30,000 military members and their families.