FDA Report Offers Valuable Insights on FSMA-Driven Shift in the Food Safety Paradigm
By John T. Shapiro and Jason R. Klinowski
Last month, we reported that a federal judge in Oakland,CA, ordered the U.S. Food and Drug Administration (FDA) to submit to the court by May 20, 2013, a schedule to which FDA would adhere in issuing yet-unpublished rules that the Food Safety Modernization Act (FSMA) requires. Rules regarding foreign supplier verification, transport of food and third-party audits are among those important food safety regulations the FDA is tardy in promulgating.
This month, we intended to report on the new schedule. Knowledge of that schedule will allow food companies to better assess and plan for the regulatory changes that will govern their operations. But, on May 17, the court extended until June 10, 2013, the deadline for submission of the new schedule. Both FDA and the consumer watchdog group that brought the litigation asked for an extension when they realized that they would be unable to resolve by May 20 differences regarding the schedule.
FDA’s inability to meet the initial court-ordered deadline for setting a new schedule for issuing rules, however, did not foreclose FDA from meeting—here, only several months late—another FSMA-required milestone. In May 2013, the Secretary of the U.S. Department of Health and Human Services (which includes FDA) submitted to the U.S. Congress a report entitled “Report to Congress on Building Capacity to Implement the FDA Food Safety and Modernization Act (FSMA).” Specifically, FSMA Section 110(a)(1) directs submission by no later than January 4, 2013, of a “comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food and prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities,” including nine particular topics on which FDA is to provide detail.
The report serves as a valuable overview of how FDA intends to direct a seismic shift in the food safety paradigm, from reacting to food safety problems after they occur to preventing contamination and foodborne illness before they happen, holdups and setbacks notwithstanding. Review of the report should help food companies and food-related businesses better understand the food safety rules that currently or are likely to govern the manner in which they do business. A complete copy of the report may be accessed from the FDA website. We highlight here three of FDA’s many reported goals and briefly summarize the FSMA-related accomplishments FDA describes with respect to those goals:
Standard Setting and Guidance. FDA indicates that its most critical task in the initial phase of FSMA is to develop and implement new prevention standards, with three new areas of focus: (1) preventative controls that require food companies to identify potential hazards and develop means by which to prevent those hazards from happening; (2) risk-based guidelines for safe production and harvesting of produce; and (3) verification of the safe nature of imported foods.
In January 2013, FDA proposed the first two rules that set science-based standards for preventing foodborne illness: “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,” and “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.” Given the import of those rules, the period for public comment has been extended until September 16, 2013.
Inspections and Compliance. FDA reports that inspections of food processors is one way in which FDA will ensure that preventive controls are applied across the food supply chain, but that the disparity in number of domestic and international food facilities that require inspection and the facilities actually inspected is of great concern to the government and public alike. To address that disparity, FSMA directs FDA to increase the frequency with which domestic and international facilities are inspected.
FDA notes that it is implementing plans to ensure that all domestic food-producing facilities are inspected with a frequency consistent with the requirements of FSMA. In that regard, all high-risk facilities must be inspected by January 2016 and at least every 3 years thereafter. All non-high risk facilities are to be inspected by January 2018 and at least once every 5 years thereafter. FDA reports that it expects to meet the FSMA-mandated domestic inspection frequency. But, the report indicates that FDA may not meet the needed inspection frequency of foreign facilities due to limited resources. FDA reports that it intends to focus available resources on developing programs under which importers will take greater responsibility for ensuring foreign manufacturer compliance with U.S. safety standards.
Imports. FDA reports that it must implement an entirely new program to ensure the safety of food coming into the United States. Food is imported from more than 110,000 manufacturers worldwide, with many of those foods considered high risk. FSMA provided FDA with new authority to hold importers accountable for verifying that foreign suppliers have adequate preventive controls in place to ensure that foods imported into the United States are safe.
FDA notes that presently it is working on several avenues designed to ensure the safety of imported food, including design of the Foreign Supplier Verification Program; forging partnerships with foreign counterparts to create a global coalition of regulators and strengthen the regulatory capacity of foreign countries; and leveraging public and private third parties to more effectively verify that sufficient preventive measures are taking place at foreign facilities that manufacture food destined for the United States.
John T. Shapiro and Jason R. Klinowski are attorneys and members of the Food Industry Team at Freeborn & Peters LLP (Chicago).