FDA issues new rules on produce, turns its attention to spices

The Food Safety and Modernization Act (FSMA) was signed into law by President Barack Obama in January 2011. The purpose of the legislation was to reduce food safety risks and foodborne illness. Since that time, there has been a consistent march of new regulations implementing that legislation from the Food and Drug Administration, covering various aspects of the food and temperature-controlled supply chains.
The impetus for passage of FSMA was an outbreak of salmonella in peanut butter in 2008 and 2009, which left nine people dead and over 700 sick. That incident led to criminal prosecutions and convictions of peanut suppliers.

An estimated 48 million people get sick each year from foodborne diseases, according to recent data from the U.S. Centers for Disease Control and Prevention; 128,000 are hospitalized, and 3,000 die each year. Most recently, a multistate outbreak of salmonella in imported cucumbers killed four in the U.S. and hospitalized 157.

It is therefore probably not coincidental that the latest regulations to emerge from the FDA involve the growing, handling, and importing of produce. The FDA has also been studying the adulteration of imported spices, which may result in new rules.

The produce regulations—referred to as the Produce Safety rule, the Foreign Supplier Verification Programs rule, and the Accredited Third-Party Certification rule—released last November, establish safety standards for produce farms and make importers accountable for verifying that imported food meets U.S. safety standards. The rule also established a program for the accreditation of third-party auditors to conduct food safety inspections of foreign food facilities.

“The recent salmonella outbreak is exactly the kind of incident these rules can help prevent,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine. “The FDA is working with partners across the government and industry to prevent foodborne outbreaks.”

The Produce Safety rule establishes science-based standards for growing, harvesting, packing, and holding produce. The rule includes requirements for water quality, employee health and hygiene, and standards for compost and manure.

The rule applies to raw agricultural commodities (RACs) and not to those not normally eaten raw. There are exemptions to the rule for small farms.

“Those farms and RACs that are covered by the new rule are now required to implement a series of controls, processes and procedures that historically have been optional,” said Diane Romza-Kutz, a food and drug attorney with the St. Louis law firm of Thompson Coburn LLP. “The new Produce Safety rule is expansive and contains many exceptions, as well as some narrowly written requirements.”

The Foreign Supplier Verification Programs rule requires food importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards and that they are achieving the same level of food safety as domestic farms and food facilities. In 2013, USDA estimated that imported food accounted for about 19 percent of the U.S. food supply, including about 52 percent of the fresh fruits and 22 percent of the fresh vegetables consumed by Americans. The final rule ensures that importers conduct verification activities, such as audits of a supplier’s facility, sampling and testing of food, or a review of the supplier’s relevant food safety records, based on risks linked to the imported food and the performance of the foreign supplier.

The FDA has also finalized a rule on Accredited Third-Party Certification, which is part of FSMA’s new food import safety system. This rule establishes accreditation of third-party certification bodies, or auditors, to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.

The FDA will likely next turn its attention to imported spices. The agency announced last month that it completed a two-year, nationwide study to collect data on the presence of salmonella in retail spice packages and stated it is working on ways to tighten controls, including through FSMA. As part of the effort to learn more about the public health risks associated with spices and help develop plans to improve the safety of spices, the FDA developed a draft risk profile, which was released in October 2013.

That document showed that the presence of pathogens such as salmonella and filth in spices is a “systemic challenge” and that the problem relates in part to poor or inconsistent use of appropriate controls to prevent contamination. Studying spice shipments from 79 countries, the FDA found that 37 of the 79 countries had Salmonella-contaminated shipments. Spice shipments offered for entry into the U.S. had an overall prevalence for salmonella of 6.6 percent between 2007 and 2009, twice the prevalence of all other imported, FDA-regulated foods. Around 12 percent of spice shipments offered for entry to the U.S. during the same period were adulterated with filth such as insects and animal hair.

The FDA has reached out to international partners to discuss implementation of FSMA.

Howard Sklamberg, the FDA’s deputy commissioner for global regulatory operations and policy, recently visited India, a major exporter of spices—and the seventh largest supplier of food—to the United States.

“These goods come from thousands of different companies,” noted Sklamberg, “making FDA’s close engagement with our Indian counterparts necessary, especially on the export-related parts of FSMA. We explained that FSMA mandates a food safety system that is preventive, rather than reactive. FSMA requires that foreign food producers meet U.S. safety standards.”

During the visit, Sklamberg signed a memorandum of understanding with the government of India to engage in regulatory, scientific, and public health protection matters related to food products.

“As the food system grows more global and trade-driven every year,” said Sklamberg, “we grow more dependent on collaboration and partnership between government and industry across national boundaries.”

“The ultimate success of FSMA depends on full funding of the president’s budget request,” Taylor added. “This will help us train FDA food safety staff, fund work with farmers on produce safety, provide technical assistance to small farms and food businesses, and implement the new import system that Congress envisioned.”