FSMA’s Next Steps
Since the Food Safety Modernization Act (FMSA) was signed into law earlier this year on January 4, 2011, U.S. FDA has already implemented significant changes to structural processes and consumer outreach. As mandated by Congress, U.S. FDA has begun the process of establishing and setting re-inspection fees, created a consumer-friendly website focused on food recalls, and submitted a report to Congress concerning State and local recall authority. While these are, without question, important changes, many more considerable changes are coming that will impact industry.
Later this week, on May 4, 2011, U.S. FDA is mandated to issue interim final rules concerning Administrative Detention of Food and Prior Notice of Imported Food Shipments. These rules will be published in the Federal Register and Registrar Corp will analyze and post key points of the regulations in future articles.
A month later, on July 3, 2011, U.S. FDA has a long list of items to have completed. On this date, U.S. FDA will be empowered to suspend food facility registration for facilities that created, caused, or were responsible for food having a reasonable probability of having adverse health consequences to humans or animals, as well as facilities that knew or had reason to know of such probability yet still packed, received, or held such food products. No person is given permission to ship food from facilities with suspended facility registration nor introduce such food into United States commerce. U.S. FDA may extend suspension of food facility registration until it has been determined by U.S. FDA that adequate grounds for suspension no longer exist. These facilities may have further requirements to meet because of their suspension, such as possibly needing to submit corrective action plans to U.S. FDA.
On July 3, 2011, U.S. FDA must also issue multiple guidance documents and update older guidance documents. U.S. FDA must issue a small entity compliance guide for facility registration as well as contaminant-specific and science-based guidance documents regarding action levels, tolerances, or regulations, based on studies to be conducted at least every two years moving forward. The “Fish & Fisheries Products Hazards and Controls Guidance” must also take these changes into account, in addition to technology advances that have occurred since its previous publication. U.S. FDA must publish a guidance document that clarifies when a new dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor must document the new dietary ingredient, and the appropriate methods for establishing the identity of the dietary ingredient.
In addition to the guidance documents required on July 3, 2011, U.S. FDA must complete several other tasks. U.S. FDA must report on the progress made in implementing a national food emergency response laboratory network in conjunction with efforts by the United States Department of Agriculture (USDA), Department of Homeland Security (DHS), and State, local, and tribal governments and must be made available on the U.S. FDA website. The U.S. FDA and USDA must also establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance. A diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, including food retailers, food manufacturers, consumer organization, and academia, must be established to make recommendations to the Secretary of Health and Human Services regarding designations of the Centers for Excellence, which must be established later in the year. U.S. FDA must also develop and implement, by this date, a strategy to better identify smuggled food and prevent the entry of such food into the United States in conjunction with DHS.
FSMA imposes several important tasks upon U.S. FDA within a relatively short deadline.
Registrar Corp will keep you abreast of these issues as they develop. For specific questions about FSMA, contact Registrar Corp’s team of knowledgeable Regulatory Specialists via Live Help 24/7.