About 15 percent of the food consumed in the United States is imported. Imports make up 91 percent of our seafood, 60 percent of our fruits and vegetables, and 61 percent of our honey. Many of these imported foods come from countries that lack effective health and safety regulation. For example, Chinese food producers have been caught spraying cabbage with formaldehyde and trying to sell baby formula tainted with the mercury, a potent neurotoxin.[i] Yet, that country still supplies approximately 50 percent of our apple juice, 80 percent of our tilapia, and 31 percent of our garlic. Vietnamese farmers have been caught sending shrimp to the United States packed in ice made from bacteria-infested water.[ii] Many farm owners in Mexico provide their workers with only filthy bathrooms and no place to wash their hands before gathering such produce as onions or grape tomatoes for export.[iii]
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. Meanwhile, import-related outbreaks—such as the 84 people sickened by Salmonella-infected Mexican cucumbers in 2013—have become even more frequent.[iv]
The foodborne pathogens that make it to our tables pose a significant threat to children, the elderly, and those with compromised immune systems. The tragic story of 67-year-old Raul Rivera is a case in point. In 2008, after undergoing chemotherapy and radiation, he was told by his oncologist that he would likely survive non-Hodgkin’s lymphoma. Rivera celebrated the positive prognosis by taking his family out for dinner. During the meal, he ate a salsa made with jalapeños, which were later discovered to have been imported from a Mexican farm that had used Salmonella-tainted water for irrigation. He died two weeks later, not of cancer but of salmonellosis.[v]
In part to address this growing threat of contaminated food imports, Congress passed the Food Safety Modernization Act (FSMA). Congress sought to overhaul the U.S. food safety system to focus on preventing foodborne illness outbreaks rather than reacting to them after the fact. The law directs the FDA to issue two key regulations to improve the safety of imported foods: the Foreign Supplier Verification Program and the Accreditation of Third Parties to Conduct Food Safety Audits. The first rule would require food importers to verify that their foreign suppliers have adequate measures in place to prevent adulteration and contamination, while the second would create an independent auditing system through which foreign food facilities could become “certified” as complying with U.S. food safety standards.
What’s the Holdup?
The FSMA instructed the FDA to issue the final Foreign Supplier Verification Program and the Accreditation of Third Parties rules by January 2012 and July 2012, respectively, yet both rules are still a long ways from completion. Despite these deadlines, the FDA failed to issue even the proposals for the rules until July 2013, a full year after they were supposed to be finalized. To make matters worse, the FDA issued in September 2014 a revised proposal of the Foreign Supplier Verification Program rule.[vi] The FDA appears to be treating the two as companion rules, so this revised proposal step will likely result in significant additional delays for the Accreditation of Third Parties rule as well as the Foreign Supplier Verification Program rule.
Interference from economists and political operatives at the White House Office of Information and Regulatory Affairs (OIRA) helped to delay the FDA’s issuance of the initial proposals. The Foreign Supplier Verification Program rule languished at the White House for 20 months, and the Accreditation of Third Parties rule for eight months—both well beyond the maximum four months allowed for OIRA reviews of rules.[vii] Remarkably, OIRA refused to release the rules even after the statutory deadlines for the FDA to issue the final rules had long since passed, causing the agency to violate the clear commands of the FSMA.
What Should the Rules Do?
The FDA should require U.S. companies that purchase food products made overseas to ensure that the foreign suppliers have adequate measures in place to prevent adulteration and contamination. Specifically, the Foreign Supplier Verification rule should direct those companies to inspect foreign supplier facilities, periodically test their shipments, and evaluate their written safety plans. Any company that imports food without an adequate verification program in place should face penalties.
The revised proposal appears to have strengthened many key provisions of the rule, including requiring a more comprehensive analysis of the potential risks posed by imported foods. Some of the provisions in the revised proposal would actually weaken protections as compared to the original proposal, so they should be fixed in the final rule. For example, the revised proposal no longer requires food importers to conduct on-site audits of its foreign suppliers of certain kinds of high-risk foods. (The FDA has yet to assemble a definitive list of foods that fall into this category, but the list will include any foods that pose known safety risks and that are likely to result in severe foodborne illness due to contamination.) Instead, importers would have broad discretion on whether to perform these audits. In the final rule, the FDA should restore the original requirement for conducting on-site audits so that it is mandatory in all cases involving high-hazard foods. The revised proposal also exempts too many “very small importers” and “very small foreign suppliers” because it only applies to firms with annual sales exceeding $1 million. The final rule should only exempt truly small firms, using a cut-off of $500,000 or less.
To be effective, the Accreditation of Third Parties rule should include strict, enforceable standards by which third-party auditors would be judged. Under the rule, foreign food suppliers would hire auditors to inspect their facilities and operations and certify that the suppliers are taking certain minimum steps to ensure the safety of their foods. These certifications would play a key role in the FDA’s new approach to imported food safety under the FSMA: (1) food from certified facilities will qualify for expedited entry into the United States; (2) the FDA may require 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. Under its proposal, the FDA would also recognize certain accreditation bodies that would give a seal of approval to the private firms, individuals, and government bodies that will serve as foreign-based food safety auditors. In addition to strict standards for evaluating auditors, the Accreditation rules will also need to provide for ongoing and rigorous oversight of both the accrediting bodies and the third-party auditors to ensure that the auditing process does not degrade into a “rubber stamp” for certifying foreign food suppliers.
The FDA originally proposed the Foreign Supplier Verification Program and Accreditation of Third Parties rules in July 2013. The comment period for those proposals ended in January 2014. More recently, in September 2014, the FDA issued its revised proposal for the Foreign Supplier Verification Program and the comment period for that continues through December 2014. At that point, the FDA will then work toward developing the final versions of both rules, which it is under a judicial order to complete by no later than October 2015.[viii] Considering that the rules would be more than two years past their statutory deadlines at that point, the FDA should not allow the timeline for completing these crucial safeguards to slip any more. Any further delays will only increase the already high costs—measured in premature deaths, debilitating illnesses, and wasted money—that have already accrued as a result of not having an effective regulatory program in place to address the risks posed by dangerous food imports.
[vii] Exec. Off. of the President, Off. of Mgmt. & Budget, Off. of Info. & Reg. Affairs, OIRA Conclusion of EO 12866 Regulatory Review: 0910-AG64 – Foreign Supplier Verification Program, http://www.reginfo.gov/public/do/eoDetails?rrid=121268 (last visited Oct. 31, 2014); Exec. Off. of the President, Off. of Mgmt. & Budget, Off. of Info. & Reg. Affairs, OIRA Conclusion of EO 12866 Regulatory Review: 0910-AG66 - Accreditation of Third Parties To Conduct Food Safety Audits and for Other Related Purposes, http://www.reginfo.gov/public/do/eoDetails?rrid=122527 (last visited Oct. 31, 2014).