The Food Safety Modernization Act of 2010 (FSMA) brings forth major changes in food regulations. The Act focuses on preventive food safety measures and increased regulatory enforcement authority. Congress included both domestic and imported feed and food in the requirements of the Act. The Act places emphasis on preventing foodborne illnesses by developing systems based upon the latest science to design and build food safety into a product throughout the complex food distribution channels. It also attaches food safety responsibility to everyone throughout the movement of food ingredients, food processing, distribution and food in consumer packages.
The Act gives FDA the ability to detain questionable products and stop the production and distribution of products where FDA has “reason to believe” that the use of the item presents a threat of serious adverse health consequences or death to humans or animals. The Act also provides FDA with mandatory recall authority if a firm refuses to voluntarily recall a product when FDA presents information that indicates the product maybe adulterated. The fees section of the Act allows FDA to charge all of their costs associated with a mandatory recall to the recalling firm, thus making it an economic incentive for a firm to do a voluntary recall when evidence supports the need to remove product from the market place.
The Mandatory Recall Authority given to FDA by this Act is not expected to increase the number of recalls. Instead, the number of recalls will be impacted by the advances of the Center of Disease Control Prevention PulseNet DNA technology and efforts of the epidemiologists, as well as the FDA Reportable Food Registry that was established by the 2007 FDA Administrative Amendments Act. The FSMA also requires FDA to increase the frequency of inspections.
Portions of the FSMA went into effect on January 4, 2011 at the moment President Obama’s pen left the document upon his signing. Other portions require FDA to develop guidance documents, proposed regulations and interim final rules to implement various sections of the Act. The FSMA also requires FDA to conduct three tracking and tracing of food pilot projects and report the results to Congress by July 2012.
The management of food facilities registered with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 should become familiar with the requirements of the FSMA.
In light of the new Act it is important to become familiar with the law and those things that went into effect upon the signature of the President. It is also important that to review your current procedures for handling regulatory inspections and update their guidance documents as needed. In addition, efforts should include a review the requirements of the new law with the facility management staff and your regulatory inspection guidelines with those responsible for working with the regulatory inspectors during their visit to your facility.