“I hope President Obama puts the weight of his office behind this,” Senate Agriculture Committee Chairman Harkin says in reference to a regulatory loophole that relieves processors and state inspectors of alerting the FDA to the presence of pathogens in processing plants. The provision allegedly played a role in the PCA outbreak. Further, the FDA reportedly hadn’t inspected PCA’s Blakely plant in nine years.
Assuming it had, the agency’s hands might have been tied, which is why Durbin is forging ahead with legislation that would allow the FDA to initiate food recalls, as well as set uniform safety standards for fresh fruits and vegetables.
DeLauro, chairman of the House Appropriations Committee panel that oversees the FDA’s budget, introduced legislation that would split the FDA into two agencies, one for food safety and the other for drugs and medical devices. “The fundamental issue is the current structure of the agency,” she told reporters.
In years past, DeLauro sponsored even more ambitious measures to restructure the FDA. She and Durbin co-sponsored bills calling for the merger of the FDA, USDA, and a dozen other related departments into a single mega-agency, a concept the National Academy of Sciences’ Institute of Medicine supports, even if consumer groups don’t.
Others believe the concept is symptomatic of an agency that isn’t equipped to do its job, given that the FDA regulates 80 percent of the food Americans eat but receives only a fraction of the funding and staffing of the USDA, which primarily regulates meat, poultry, and egg products.
The results speak for themselves. According to a recent study by the U.S. Government Accountability Office (gao), the FDA inspects only 1 percent of the produce imported into the U.S. When domestic problems are discovered, the agency largely relies on the industry to correct them without benefit of oversight or follow-up, according to the GAO.
The GAO also indicated that the FDA lacked the funding to develop “robust, science-based regulations and risk assessments” for products and processes.
Suffice to say Obama and Congress have several remedial measures to ponder, from the FEAST Act of 2008, a bill that would require foreign manufacturers to meet quality and safety standards set by the FDA, to the FDA Food Safety Modernization Act (FSMA), which would authorize the FDA to set commodity-specific standards for fresh produce, issue mandatory recalls, require imports to meet U.S. safety standards, and mandate food manufacturers to perform risk assessments.
The question is whether the Obama administration is spent, now that it already has allocated hundreds of billions of dollars to keep the U.S. economy afloat. Food-safety measures, including FEAST and FSMA, require funding to support them, and opinions vary on potential sources for the dollars. FSMA, introduced by Sens. Harkin and Chris Dodd (D-Connecticut), would partly rely on user fees. The restaurant industry, by comparison, generally prefers the general appropriations process.
Still, Obama showed his commitment to improved food safety when he tendered his 2010 budget proposal, which would give the FDA $1 billion to improve surveillance and inspections.
As foodservice operators await reform, more of them are taking matters into their own hands, according to Kim Sobotka, a marketer and former data administrator with St. Louis-based food-safety consultant ASI Food Safety Consultants, which performs supplier audits for Yum! Brands and its affiliates.
Audits, Sobotka says, can canvass processing, packaging, warehousing, and distribution, focusing on federally mandated protocols, including the FDA’s 21 CFR 100 and risk-management initiatives, including SOPs, SSOPs, HACCP, and Good Manufacturing Practices.
Risk-management software developed by ASI rates candidate suppliers on the basis of audit scores and lab tests so operators can determine which processor or distributor best meets their standards.
Though price varies in accordance with the operator’s size, it doesn’t necessarily come cheaply.
But the question isn’t who can afford it, Sobotka says. “Who,” she wonders, “can afford not to?”