Three Food Safety Rules Grow Moldy at OIRA, as Import-Related Outbreaks Continue

About 15 percent of all foods we consume are imported. Looking at some particular categories, the numbers are far more striking: imports make up 91 percent of our seafood, 60 percent of our fruits and vegetables, and 61 percent of our honey. Most of these imports come from developing countries that lack any effective health and safety regulation—like China, which has had a seemingly endless run of food safety scandals and yet supplies 50 percent of our apple juice, 80 percent of our tilapia, and 31 percent of our garlic.

Unsanitary practices in these countries are well-documented: Vietnamese farmers are known to send shrimp to America in tubs of ice made from bacteria-infested water; and Mexican laborers are often given filthy bathrooms and no place to wash their hands before gathering onions and grape tomatoes for export. Despite the obvious risks of adulteration and contamination, the resource-strapped Food and Drug Administration (FDA) inspected only 2 percent of food imports and just 0.4 percent of foreign food facilities in 2011. Import-related outbreaks—like the 81 people sickened by Mexican cucumbers just a couple months ago—have become even more frequent in recent years.

The foodborne pathogens that make it to our tables often prove deadly for children, the elderly, and those with compromised immune systems. In 2008, after undergoing chemotherapy and radiation, 67-year-old Raul Rivera was told by his oncologist that he would likely survive non-Hodgkin’s lymphoma. He celebrated by taking his family out for dinner, where they ate pico de gallo. It was later discovered that the jalapeños in the salsa were imported from a Mexican farm that had used Salmonella-tainted water for irrigation. Rivera died two weeks later, not of cancer but of salmonellosis.

In January 2011, President Obama signed the Food Safety Modernization Act (FSMA), a set of sweeping reforms that would be fleshed out in rules issued by the FDA. Two and a half years later, only two proposed rules have been released—one on produce safety standards, and the other on preventive controls for human food. The FDA has drafted three other proposed rules that could significantly improve the safety of imports, but they are currently languishing at the Office of Information and Regulatory Affairs (OIRA), an office inside the White House that is notorious for blocking, weakening, and delaying the rules that it reviews.

These three rules, described below, are already many months beyond their statutory deadlines, and OIRA has held them well past the 90-day limit established by Executive Order 12866. Whenever these rules finally emerge, we should be alert to the ways that OIRA may have undermined their effectiveness, just as it substantially weakened the FDA’s preventive-controls rule before it was released in February.

Foreign Supplier Verification Program (FSVP)

(Final rule was due by January 2012; Proposed rule now stuck at OIRA for a year and seven months)

This rule would hold food importers liable for verifying that their foreign suppliers have adequate measures in place to prevent adulteration and contamination. In other words, U.S. companies that buy food products made in overseas facilities would be responsible for inspecting those facilities, periodically testing their shipments, and evaluating the supplier’s written safety plans. Any company that imports food without having an adequate verification program in place would face penalties.

Americans continue to be sickened by contamination that this rule might have prevented. In recent months, at least 120 people have been infected with hepatitis A after eating “Townsend Farms Organic Anti-Oxidant Blend” of frozen fruit. Despite the pastoral image of an Oregon farm on the package, Townsend actually had many of the blend’s ingredients shipped in from foreign countries. The strain of hepatitis, commonly found in North Africa and the Middle East, suggests that the pomegranate seeds—processed in Turkey—are the likely culprit. With no supplier-verification rule in place, Townsend Farms had no obligation to ensure that the Turkish facility followed sanitary practices or had adequate employee-hygiene policies.

Accreditation of Third Parties to Conduct Food Safety Audits

(Final rule was due by July 2012; Proposed rule now stuck at OIRA for seven months)

This rule will describe the FDA’s “third-party certification” system for foreign food facilities. The general setup is reminiscent of those Russian nesting dolls: the FDA will recognize a number of accreditation bodies, which will then accredit certain third parties to be auditors—including private firms, individuals, and even foreign governments—and these auditors will then be hired by foreign facilities that wish to be “certified” as complying with U.S. standards. (See the diagram on page 13 of this report.)

In several ways, these third-party audits are central to the FDA’s new paradigm: (1) food from certified facilities will qualify for expedited entry into the United States, (2) the FDA may require certain “high risk” foods to be certified before importation, and (3) the FDA will use third-party audit reports to decide which facilities to inspect or which foods to test at the border.

The FSMA’s reliance on third-party auditors is deeply troubling because these companies have a shameful record of incompetence, inconsistency, and conflicts of interest with the facilities they audit. Case in point: a private auditor gave Colorado’s Jensen Farms a “96 out of 100” score in 2011, right before the farm’s listeria-contaminated cantaloupes sparked the deadliest foodborne outbreak in nearly a century, killing 33 people and sickening 147. The same kind of rubber stamps were given to egg, peanut, and ground-turkey facilities either before or immediately after they became the source of major outbreaks and recalls.

In order for the third-party certification program to have any value, the FDA must issue a strict set of standards by which auditors should be judged, and exercise rigorous oversight of both accrediting bodies and auditors. Unfortunately, we have no way of knowing what the FDA has planned until the White House releases the rule from its grip.

Preventive Controls for Animal Feed (including Pet Food)

(Final rule was due by July 2012; Proposed rule now stuck at OIRA for a year and a half)

This rule would require all facilities (domestic and foreign) that produce food or ingredients for animals to develop a written plan describing the steps they will take to identify and prevent contamination or adulteration. Under the FSVP (described above), importers would also be responsible for verifying that foreign suppliers of animal food comply with these requirements.

This rule would hopefully prevent at least some of the worst outbreaks resulting from imported pet foods. Each month the U.S. imports about $40 million worth of pet food, with 70 percent of it coming from China. In 2007, pet food ingredients from China containing melamine and cyanuric acid killed thousands of cats and dogs. And over the past two years, more than a thousand owners have seen their dogs become ill or die after eating Chinese-made jerky treats; the FDA has not yet been able to determine the cause of these reactions.

Contaminated pet food not only endangers pets, but also poses a serious threat to humans, who can be infected from contact with their pets or from handling the food, as several Salmonella outbreaks have demonstrated. The FDA has recently begun sampling domestic pet food for Salmonella—indeed, five brands of dry food were recalled earlier this week after a positive test result—but the same contamination in imported pet food is likely going completely undetected, as the White House continues to sit on this rule that could prevent it in the first place.

When Can We Expect to See These Rules Released?

The Center for Food Safety (CFS) sued the FDA last August over these and other delays, and a judge ordered the parties to agree on a new timeline for rolling out the remaining rules. They were unable to settle on a joint plan, so they each submitted their own timelines. The agency refused to set specific dates, instead promising to release two of these proposed rules by this “summer” and the other one by this “fall,” all of them to be finalized within roughly two years from their proposal. Since the FDA had these proposals fully written when it submitted them to OIRA 7 to 19 months ago, the agency’s reason for insisting on a vague and protracted timeline probably has more to do with how long it expects the OIRA review process to take than with its own ability to get the rules out.

Last Friday, the judge concluded that the FDA’s loose timeframes were inadequate and that new enforceable deadlines were needed—a significant victory for the public. But in setting the new dates, she deferred substantially to the agency’s projected timeline, at least as it applied to these three rules: all FSMA regulations must be proposed by November 30, 2013 and finalized by June 30, 2015. The judge also refused to excuse the rules from review by OIRA, as the CFS had requested, “absent some indication that OIRA is using its authority to unduly delay” the rules. One is left wondering how such “undue delay” might be shown, if 19-month holdups are not enough.

In his confirmation hearing last week, President Obama’s nominee for OIRA Administrator, Dr. Howard Shelanski, emphasized that one of his highest priorities would be ensuring the “timeliness” of OIRA’s reviews. If confirmed, he can begin to make good on his promise by immediately letting these food safety rules see the light of day—well before the FDA runs up against the court-imposed deadlines—and imparting a much-needed sense of urgency to OIRA’s review of regulations that quite literally deal in issues of life and death.

This blog has been updated to include the new timeline set forth by a federal judge for releasing the outstanding FSMA -mandated rules. It is cross-posted on Food Safety News.