On January 4, 2011, President Obama signed into law the Food Safety Modernization Act (“FSMA”) (Pub. L. No. 111-353, 124 Stat. 3885 (2011)), representing the most substantial overhaul of food safety law in decades. FSMA increases oversight at various points along the supply chain, including production, storage, distribution, and importation. Because the supply chain is essential to efficiency, costs, and ultimately revenues, retailers should stay apprised of developments in FSMA’s implementation.
FSMA mandates that the Food and Drug Administration increase the number of inspections of all facilities, with more frequent inspection of high-risk facilities. Along with more inspections, facilities must evaluate threats to food safety and establish risk-based preventive controls in response to such threats. Additionally, FSMA gives the FDA one year to establish science-based standards for safe production of fruits and vegetables.
FSMA requires increased awareness for retailers, as it seeks to equalize the standards for foreign and domestic food facilities. To do so, FSMA requires importers to enforce foreign suppliers’ compliance with new and existing regulations, including risk-based preventative controls and science-based produce standards. Among the suggested supplier verification activities are the following: monitoring records for shipments, annual on-site inspections, and lot-by-lot certification of compliance.
To further ensure compliance by foreign suppliers, the FDA may condition the entry of food on certification that imports comply with FSMA’s provisions. FSMA also authorizes the FDA to enter into agreements with foreign governments to facilitate the inspection of foreign facilities. If such a facility refuses inspection, its imports will be refused admission into the United States. Because of the FDA’s ability to condition and restrict the entry of food into the country, retailers that import large volumes of food face an increased risk of supply chain issues. For that reason, these retailers should take steps to ensure that their suppliers are positioned to comply with the developing food safety regulations.
For additional information, see the following links:
http://www.crowell.com/NewsEvents/Article.aspx?id=1919
http://www.crowell.com/PracticeAreas/PracticeArea.aspx?id=123
http://www.crowell.com/PracticeAreas/PracticeArea.aspx?id=56
http://www.fda.gov/Food/FoodSafety/default.htm
Content for this post was provided by Andrew Kaplan, a counsel, and Derek Mullins, an associate, in the Washington, DC office of Crowell & Moring.