Opening the Regulatory Floodgates Two Years After FSMA Passage

Some Progress Made

Despite delays in issuing regulations and guidance documents, the FDA did make progress in other areas. It created a mechanism for food facilities to re-register with additional information required by FSMA. Even though the agency has had the authority to order mandatory food product recalls since January 2011, it has not done so. But it did use its enhanced ability to administratively detain food products several times since 2011, Acheson noted. And in November 2012, the FDA suspended the food facility registration of Sunland Inc., the Portales, NM-based nut producer that has been linked to an outbreak of Salmonella bredeney that sickened at least 41 people in 20 states. It was the first time that the FDA had exercised this authority under FSMA.

In addition, the FDA and the nonprofit Institute of Food Technologists completed pilot projects exploring methods of food tracking and tracing. One such program sought to demonstrate tracking and tracing of processed foods and key ingredients, while another dealt with selected fresh fruits and/or vegetables. Both pilots identified and evaluated the types of data that would be useful for tracing cases of foodborne illnesses; connected points along the supply chain from farms to restaurants and grocery stores; and determined how quickly data could be made available to the FDA.

The agency accepted the IFT’s report on the pilots in July and is required to submit its own report to Congress before making the results public. Rules concerning record-keeping regulations for tracing high-risk foods are still to come.

“Some product-tracking work has been done and some hasn’t,” Dr. Acheson said. “The administration has moved forward on some of the easiest stuff. We’re waiting to see what’s contained in the other ton of rules that will likely be very impactful,” he said.

Broad Authority

The FSMA gives the FDA responsibility for mitigating food safety problems by using science- and risk-based approaches to oversee about 80% of the nation’s domestic and imported food supplies. In addition to establishing a comprehensive product-tracing system, the FSMA also requires minimum produce safety standards and the implementation of hazard prevention control plans by food growers and facilities. The agency also has authority to conduct a broad range of food facility inspections and hold imported food products to the same safety standards as domestic products.

In this area, qualified third parties will eventually be authorized to certify that foreign food facilities comply with all U.S. food safety standards, a step that will help facilitate entry of their products into the country. The FDA can expedite review and entry of foods from importers that participate in a voluntary qualified importer program and refuse entry if the agency is denied access by a facility or by the country in which the facility is located.

The FDA faces significant challenges in implementing these requirements, especially for foreign inspections, according to a new report from the Government Accountability Office, the investigative arm of Congress. The GAO report, released in November, notes that in fiscal year 2011, the agency inspected only 0.4 percent of the more than 270,000 registered foreign food facilities and performed tests on less than 0.5 percent of all food entry lines. GAO notes that many foreign governments have also expressed concerns about being evaluated by an organization outside the FDA.