On June 29, 2007, two siblings in Texas, both children, came down with cranial nerve palsies that progressed into the symmetric, descending paralysis typical of botulism. Both needed a ventilator to breathe. A week later, in Indiana, a married couple fell ill the same way. What the two households had in common was a can of hot dog chili sauce from the same cannery in Augusta, Georgia — made in retorts that, during a five-hour span from the night of May 7 into May 8, the FDA would later find had failed to sterilize what was inside.
Federal rules do not let a cannery decide for itself that a sealed can is safe. A scheduled process, the specific time and temperature a given product and can size needs, has to be established by a qualified person, using methods such as heat-penetration data or an inoculated pack, to show those numbers destroy the spores of Clostridium botulinum, the bacterium behind one of the most lethal toxins known. The plant then files that process with the Food and Drug Administration, which keeps it on record but, by its own regulation, does not approve it: the actual check already happened, in the qualified person's data, before the filing. Neither step runs the retort for you. A retort is a sealed pressure vessel, and its own gauges, alarms, and cooling-water valve are part of how a plant is supposed to know, during the cook, that the filed process is actually happening. At the Castleberry's plant, investigators later found, two of the retorts were not reliably doing that job.
Nobody at the plant caught it. The cans sealed, labeled, and shipped looking like every other can the company had ever made. The first sign anyone had was sick people, states apart, with no reason yet to suspect each other. The Centers for Disease Control and Prevention eventually traced eight confirmed cases, in Indiana, Texas, and Ohio, to the same brand of chili sauce; of twenty-three swollen cans the FDA pulled from the May 8 production run, twenty tested positive for botulinum toxin. The company's initial recall, 39 million cans of chili sauce, grew within days to about 111 million cans once expanded to every product the same line had made over the previous two years. The company permanently closed the Georgia cannery in November 2008. It was the first time in more than thirty years that a case of foodborne botulism in the United States had been traced to a commercial cannery rather than a jar put up at home.
FDA investigators did not find a plant that had done everything right except for one broken part. They found violations of federal canned-food regulations, and something harder to fix: records that could not establish whether anyone had been watching the retorts closely enough, during the cook, to know. A malfunctioning cooling-water valve, a faulty alarm, and miscalibrated temperature-monitoring equipment were all observed on the retorts in question. Investigators could not determine, with certainty, which one had actually let the spores through, because the monitoring record that should have shown the retorts running correctly that day did not exist in a form that could answer the question.
A can does not announce that its retort skipped a step. Somebody still has to be watching the valve.