Global Defense of the Food Supply
More than 16 percent of the food consumed in the United States is imported, and it’s the job of the Food and Drug Administration (FDA) to make sure those imports are safe and properly labeled. There are protections in place to inspect and govern the flow of imported food, but contaminated goods still enter the national supply chain.
One in six people are affected by food-borne diseases in the United States each year, and contaminated food leads to an average of 3,000 deaths annually, according to the Centers for Disease Control and Prevention. Through numerous laws and regulations the government is attempting to mitigate threats and keep the food supply safe.
After a jump in incidents of food-borne illnesses in the 2000s, President Barack Obama signed the Food Safety and Modernization Act (FSMA) in 2011, which aims to develop a global approach for ensuring the safety and security of the food supply. The act aims to give the FDA greater oversight of the food being imported into the United States.
The FSMA continues to evolve, and the FDA is currently focused on protecting food against intentional adulteration—acts intended to cause large-scale public harm through contamination of food. The proposed rule, which was made public at the end of 2013, has undergone a series of revisions and is on schedule to be finalized this year.
The rule would require at-risk food facilities to create and implement food defense plans that address areas of vulnerability the FDA identifies within its food operation, says Zak Solomon, a former FDA employee. Solomon is now the director of analysis at Food Sentry, an organization that provides ongoing analysis of risks to the food supply.
Under the new regulations, facilities would devise actionable procedures to reduce the risk of adulteration during bulk liquid transportation, liquid storage and handling, secondary ingredient handling, and mixing. Implementing focused mitigation strategies, monitoring the procedures, verifying that all processes are being conducted correctly, training, and recordkeeping would also be required.
“These focused mitigation strategies would protect food against intentional adulteration, which is where the FDA is hanging its hat from the food security standpoint,” Solomon explains. “That refers to economic adulteration or adulteration by disgruntled employees, or someone with something against the companies.”
Solomon notes that food adulteration with the intent to harm the public—an act of terrorism—is unlikely. However, economic adulteration, where cheaper ingredients or extra preservatives are added to a product, is one of the biggest problems he sees in the food supply chain.
“When it comes to risks for food, adulteration is a big deal,” he says. “The economically motivated adulteration is very real and it is powerful. People look for opportunities within their supply chains all the time, whether they’re a manufacturer or a farmer, and I don’t know that there’s any other risk that provides such a clear and real danger as that does.”
Solomon says that building a food defense plan is currently optional for manufacturers and distributors under the FDA, so a mandatory requirement would be a good first step to strengthen food safety. But he notes that the global food system is extremely dynamic, and a more proactive approach that considers the evolving threat landscape would be more effective. There is also no oversight mechanism, which FDA officials or other federal regulators would use to make sure that facilities are complying with the rule.
“I’m not sure about the ability of a written food defense plan as outlined in the legislation to handle such a dynamic system, simply because even if somebody submits a food defense plan, who’s going to be there to check that they’re actually doing what they put forward in the plan?” Solomon says.
To proactively identify risks in the food supply chain, Food Sentry analyzes the political and social situation in the country exporting the food, the reputation of the company, and whether workers would have any reason to adulterate the supply. Solomon says he thinks the FSMA rule can do more to promote this type of forward thinking.
“Having a plan in place is great, but if you’re not out there looking for risks as they exist in the real world, then you’re going to have to wait to see if something happens and hopefully your plan will catch it,” Solomon says.
The likelihood of a terrorist tainting the global food supply is small, but the potential is there, Solomon stresses. “Even though we haven’t seen it happening, there’s a reason we’re incorporating it into our risk assessments because it’s possible, and if it happens it would be terrible, especially if nobody was paying attention,” he says.
The FDA works with U.S. Customs and Border Protection at ports of entry to scan targeted or high-risk products, but when it comes to imported food, the first line of defense is overseas. Over the past decade, the FDA has set up 13 foreign offices in high-export regions to oversee the facilities that manufacture and process food.
The FSMA has enhanced the FDA foreign offices’ oversight of imported food. Under the act, each foreign office is required to build working relationships with local regulatory agencies, gather and assess information to better understand the regional regulatory landscape, and conduct inspections at high-risk food facilities. The FSMA required the FDA to inspect at least 600 foreign facilities by the beginning of 2012, and to inspect at least twice the number it inspected during the previous year.
But a recent Government Accountability Office (GAO) report found that the FDA has not been able to keep pace with the FSMA targets. In 2011, the agency conducted 1,002 foreign food inspections, exceeding the FSMA requirement. However, the number of inspections has not doubled over the following years—in 2012, 1,343 inspections were completed (a 34 percent increase); 1,403 inspections were conducted in 2013 (a 4 percent increase over 2012); and 1,323 inspections took place in 2014 (a 6 percent decrease from 2013). The FDA should conduct at least 2,806 inspections of foreign facilities in 2014, the report notes.
“While the FSMA has set certain targets, the actual inspections that FDA is conducting is much lower,” says J. Alfredo Gomez, the director of GAO’s Natural Resources and Environment division. “It’s actually why we recommended FDA really needs to do an assessment to determine what should be the annual number of foreign inspections that would be sufficient to ensure that the imported food is safe.”
The report found that foreign officials cited the cost of inspections and lack of funding for not being able to meet the FSMA mandate. “FDA officials told us that the agency has not met—and is not planning to meet—the FSMA mandate,” the report states. “They questioned the usefulness of conducting the number of inspections mandated by the FSMA.”
A Congressional Budget Office assessment found that the FSMA mandate needed $580 million in funding to be effective, but Congress has doled out less than half that amount to the FDA.
The lack of funding and low number of inspections aren’t the only problems the FDA’s foreign offices are facing. The GAO report also found that 44 percent of positions at the nine remaining foreign offices—four offices have been closed in the past three years—are vacant. Gomez points out that the problem is not new.This GAO report is a follow-up to a 2010 report on the FDA, in which the GAO recommended that the FDA develop a workforce plan to fill the vacancies.
“We do note that the FDA has not done a great job there, because there are large numbers that are still vacant,” Gomez explains. “FDA has not yet developed this workforce plan, and we call out the need for that.”
Foreign food facility inspections are primarily conducted by FDA officials based in the United States, although there has been a rise in the number of inspections performed directly by the foreign office staff, Gomez notes. These inspections by overseas staff barely make a dent, though, because a large portion of the vacant positions are for food inspectors.
Does the subpar performance of the overseas FDA offices spell disaster for food safety in the United States? It’s hard to say, according to Gomez: “Essentially, we don’t really know the extent to which the foreign offices contribute to the safety of imported food because FDA has not developed performance measures that can demonstrate the contributions to the safety of food,” he says.
The report found that FDA officials determined that conducting foreign inspections was not the best use of agency funds and instead focused on helping manufacturers comply with FSMA rules as well as developing relationships with foreign officials.
“FDA has not conducted an analysis to determine whether either the required number of inspections in the FSMA mandate or the lower number of inspections it is conducting is sufficient to ensure” the safety of imported food, the report notes.
“We point out FDA has asked for fund‑ing for about 1,200 inspections each year,” Gomez says. “Reading between the lines, the FDA is saying they don’t have enough funding, but only requests flat funding for three years. You have to square those two statements and say, perhaps you should do a study to determine whether those 1,200 inspections are indeed what you should be doing.”
The majority of FDA’s foreign offices listed building relationships as a top priority, while only four considered conducting inspections as a top priority. Gomez says FDA officials were able to list a number of times where relationships with foreign food officials contributed to the safety of imported food, but the results are not easy to quantify.
“If you’re not going to keep up with the FSMA, it should be on solid analytical ground for not doing so,” Gomez explains. “Our recommendation is tied to them getting on solid ground for the number of foreign inspections that they do. We’re not going to trade this problem away, as there’s an increasing number of food imports. We’re not going to grow out of this problem.”