FDA Adds Info to FSMA FAQ on Identifying High Risk Domestic Facilities
The Food and Drug Administration has updated its Food Safety Modernization Act (FSMA) frequently asked questions (FAQ) document to add a Q&A on how the agency identifies a high-risk (HR) domestic facility. The answer to the question refers readers to another document, which states that the agency identifies a HR domestic facility based on the risk factors identified in section 421(a)(1) of the Food, Drug, and Cosmetic Act. HR domestic facilities must be inspected at least once in the first 5 years following enactment of the FSMA and then once every 3 years thereafter.
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Non-HR domestic facilities must be inspected at least once in the first 7 years following enactment and then once every 5 years thereafter. These inspection frequencies are minimums and some firms may be inspected on a more frequent basis. Referenced document, "FSMA Domestic Facility Risk Categorization (FY 2012)" listing those identification factors, and other information available here.
The FSMA reforms U.S. food safety laws and was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The FSMA includes new importer requirements and fees, certification for high risk food imports, verification of foreign suppliers, etc. See ITT's Online Archives 11010426 for comprehensive summary of the FSMA.)