Bumpy Path to Food Safety: The Implementation of FSMA

The FDA was expected to issue draft regulations covering these plans by the end of 2011. The agency is focused on two areas: conducting hazard analyses for biological and chemical threats, and implementing process controls to prevent, eliminate, or reduce such hazards. Critical areas include sanitation, raw materials and supplier practices, allergen control, environmental monitoring for Salmonella and Listeria monocytogenes, and microbiological and other testing.

The FDA also planned to publish, by the end of 2011, a rule governing production, harvesting, and packing of fresh produce. This is expected to include control of animals, use of manure, water quality, and worker hygiene, among other factors. It is not clear whether assays or other tests will be required to detect foodborne pathogens, although that likelihood has increased following the recent outbreak of listeriosis that was linked to cantaloupes grown at Jensen Farms in Colorado and has been responsible for at least 139 illnesses and 29 deaths in 28 states. But growers must develop plans to minimize the risk of such contamination, and FDA inspectors have the authority to verify implementation of the plans. (There are exemptions for very small farms and producers, as well as certain other food facilities.) Other produce-related outbreaks this year include Salmonella-tainted sprouts and strawberries contaminated with E. coli.

“Although we need testing to validate HACCP and other prevention programs, you cannot test your way to safer foods,” said J. Stan Bailey, PhD, director of scientific affairs for bioMérieux Industry, a manufacturer of assays and other tools for the food industry. “Safe foods will come from implementing appropriate technologies at all phases of production and processing and monitoring the effectiveness of these technologies on a regular basis,” Dr. Bailey told Food Quality.

Import Quandary

About 15% of the U.S. food supply is imported. Nearly two-thirds of the fruits and vegetables and 80% of shrimp and seafood come from outside the U.S., much of the latter from countries with questionable food safety records. “Globalization has presented its own food safety challenges, which must be addressed,” Michael R. Taylor, FDA deputy commissioner for foods, told an audience in Shanghai earlier this year. “It is clear that FDA can’t be everywhere all the time, especially when it comes to the oversight of imported foods.”

FSMA requires imported foods to be held to the same standards as domestic foods, and importers and foreign suppliers must have controls in place to ensure product safety. Over the next several years, assuming adequate funding, the FDA will spend nearly $1.4 billion to hire hundreds of new staff and private contractors to inspect foreign food suppliers, especially for high-risk foods. These will include third-party certifiers such as Bureau Veritas, which plans to hire more inspectors to meet the pending U.S. demand.

The FDA can also expedite review and entry of foods from importers that participate in a voluntary qualified importer program, refuse entry of food if any other country has previously done so, and assess fees to reinspect imports that have been detained for safety reasons. (The fees were to have gone into effect on Oct. 1 but the FDA has delayed them pending further agency review.) The law also requires the FDA to develop plans to train foreign governments and food producers on U.S. food safety requirements.