Posted: April 30, 2012
Raising the bar for the food industry
What you need to know about the FDA Food Safety Modernization ActAntonio Gallegos
The food industry and consumers share a common interest in the safety of America’s food supply. The U.S. Food and Drug Administration (FDA) reports that foodborne illnesses strike 48 million people each year, resulting in 128,000 hospitalizations and 3,000 deaths. In recent years, the United States has experienced large scale contamination outbreaks in peanut butter, eggs, cantaloupe, along with numerous other less publicized cases. By some estimates, the peanut butter recall cost the industry $1 billion in lost production and sales.
Partly in response to these outbreaks, Congress passed the FDA Food Safety Modernization Act (FSMA), which was signed into law on January 4, 2011. The FSMA emphasizes preventative controls that will be imposed on food companies, but also includes expanded authority for FDA.
Preventative Controls. Food facilities must develop written plans that evaluate hazards, implement preventive controls to minimize hazards and monitor the performance of those controls. The plans must also establish procedures to prevent affected food from entering the marketplace if contamination occurs despite implementation of preventative controls.
“Qualified Facilities,” including “Very Small Businesses” (a term yet to be defined) and facilities with sales of less than $500,000 per year are exempt. Qualified Facilities will be required to submit documentation to FDA demonstrating that management has identified potential hazards and implemented and will monitor preventative controls, or compliance with state and/or local food safety laws.
The FSMA requires FDA to issue regulations establishing science-based preventative controls for food facilities, animal feed facilities and fresh produce operations by July 4, 2012. Although FDA has prepared initial drafts, the agency admits that it will not meet the deadline. Businesses, however, are well advised to begin examining their food safety programs now so they can be ready to implement the regulations once FDA issues them.
Facility Inspections. While FDA has long had the authority to inspect food facilities, the FSMA requires FDA to allocate the resources necessary to inspect more frequently. Congress established a timeline for all domestic food facilities to be inspected over the next seven years, with follow-up inspections required at least every three to five years after that. The FDA is also required to inspect at least 1,800 foreign food facilities that supply food to the U.S. within the next five years. Funding will play a critical role in FDA’s ability to meet its inspection requirements, but companies at all levels of the supply chain can expect to be inspected more frequently than in the past.
Inspection of Records. FDA can now demand immediate access to company records relating to a food it reasonably believes presents a serious risk of adverse health consequences or death. Certain types of records are exempt, such as recipes, financial and pricing data, research data and personnel data.
Mandatory Recalls. FDA now has authority to order that all distribution of a food be ceased and that the food be recalled, if FDA determines that there is a reasonable probability that food will cause serious adverse health consequences or death. FDA must first provide the party with the opportunity to initiate its own recall voluntarily. The party is also entitled to a hearing within two days of issuance of the recall order.
Administrative Detentions. The FSMA expanded FDA’s authority to order the detention of a food believed to be unsafe. FDA is authorized to detain the food for twenty days, with the possibility of obtaining a ten-day extension. Depending on findings made during the detention period, FDA may require a corrective action plan or initiate a court proceeding to seize and destroy the food.
Facility Registration. The FDA has long required registration of food facilities, but now those registrations must be renewed every odd-numbered year. FDA can suspend a facility’s registration if the agency determines that a food from the facility has a reasonable probability of causing serious adverse health consequences or death. A suspension prohibits any food from that facility from being distributed, sold, imported or exported. The registrant is entitled to a hearing within two days of issuance of the suspension order.
Other Provisions. The FSMA includes several other provisions, such as requirements for FDA to propose regulations for the safe production and harvesting of certain vegetables and fruit; to initiate pilot programs for enhancing the tracking and traceability of foods; to exercise greater oversight over imported foods; and to issue guidance as to what constitutes a “new dietary ingredient for which pre-market notification must be given to FDA.
Antonio Gallegos is an attorney in the Denver office of Holland & Hart LLP. He has extensive experience representing FDA-regulated businesses in a wide range of legal matters including products liability litigation, government investigations and enforcement actions, and regulatory compliance. www.hollandhart.com/agallegos/