US Food Safety Modernization Act: Overview and Impact for Importers and Exporters

In the United States, lawmakers, regulators, consumers and the media are more focused on food safety than ever before. On January 4, 2011, President Obama signed the Food Safety Modernization Act into law, which represents the largest change of the food...


In the United States, lawmakers, regulators, consumers and the media are more focused on food safety than ever before. On January 4, 2011, President Obama signed the Food Safety Modernization Act into law, which represents the largest change of the food safety system since the passage for the Food, Drug, and Cosmetic Act in 1938. The new legislation will bring significant changes to an already shifting food safety landscape, especially in the area of imported foods and ingredients. This paper will outline (1) the current food safety landscape that has impact on the way in which food imports are perceived in the U.S., (2) an overview of the key provisions of the new legislation of importance to importers and exporters, (3) additional considerations, and opportunities.

 

Food Safety Landscape

Changing consumption patterns, large outbreaks of foodborne illness, new food safety science, and identification of new risks all contribute to the shifting food safety system. Consumer demand for fresh food yearround requires global sourcing of fresh food and ingredients. Currently, imports account for 15 percent of the U.S. food supply, including over 75 percent of seafood and 60 percent of fresh produce consumed in the U.S.

Numerous outbreaks over the past several years have made media, consumers, and the United States Congress keep a closer watch on food safety systems.

In response to the changing food safety landscape, United States regulatory agencies are cracking down on food safety violations which will result in faster, more frequent enforcement actions.

The expanding global food supply has resulted in an increased regulatory presence overseas, at the border, and domestically. FDA has opened foreign offices in China, India, Latin America, Europe, and the Middle East (currently based out of Washington, D.C.). FDA is implementing a predictive riskbased screening system at the border to better target field exams and speed up the importation of lowrisk products. FDA is increasing inspections, both in the U.S. and overseas, and is leveraging with federal, state, local, tribal, and territorial partners to provide oversight of the U.S. food system.

 

Food Safety Modernization Act: Key Provisions

The Food Safety Modernization Act (FSMA) contains several provisions that give FDA new authority and place new requirements on those involved in the supply chain.

The primary aim of FSMA is to require food companies to implement preventive controls. In order to do that companies need to understand the risk both in their facility and in their supply chain and develop control systems to control that risk using validated systems, and document that those controls are working and maintain the records showing that the controls are working. One of the most important sections of FSMA is Section 103 that focuses on these preventive controls. Understanding this section is critical to meet the requirements that will be enacted with regard to imported foods.

 

Sec 103. Preventive Controls

One of the most anticipated sections of FSMA for all food manufacturers – whether inside or outside the United States – relates to the new requirement that all facilities that manufacture, process, pack or hold food products have documented preventive control programs in place. The preventive control requirements will go above and beyond a typical Hazard Analysis and Critical Control Point plan, and will include requirements related to recall plans, sanitation, employee hygiene training, environmental monitoring, allergen control program, current good manufacturing practices, supplier approval and verification activities, corrective actions, verification activities, and records. As we move beyond HACCP, preventative control programs should include training programs for managers and/or workers, audit programs, written records (e.g., batch records, sanitation records, etc.), validation of control measures, written sanitation standard operating procedures, food label review and control program, and testing of incoming raw materials, inprocess materials, finished products, and processing environment. Monitoring requirements must verify that controls are working correctly and are effectively and significantly minimizing or preventing the occurrence of identified hazards. Food safety plans will need to be developed, (see food safety plan resource box, next page).

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