In the realm of food safety, the battle lines are drawn, and the stakes are high. Thirty years of experience on the front lines have honed my expertise, and tomorrow's meetings with Boar's Head executives and Frank's class in Michigan State will only add to my insights. The questions I've fielded over the years are a testament to the ongoing challenges in ensuring the safety of our food supply. Here, I present the most pressing inquiries and the answers I've crafted, drawing from my extensive experience in the trenches of the food safety fight.
Operational Change: The Power of Information
The crux of the matter lies in the power of information. Testing products and acting on positive results is paramount. After all, the cases that demand my attention and sustain my team's livelihoods often stem from decisions made by those in the know. A positive swab, a supplier red flag, or a sketchy lot can all lead to dire consequences. With whole genome sequencing, we can now connect a sick child in Indiana to a specific lot in a plant, making it impossible to hide. This realization should prompt a shift in mindset at the C-suite level, where prioritizing transparency and accountability becomes a priority.
Transparency: A Double-Edged Sword
Transparency is a double-edged sword. While it may not directly reduce the severity of an outbreak, it significantly impacts the recovery process. Companies that promptly disclose information, address medical bills, and initiate recalls without delay tend to settle cases quietly and for a fraction of the cost of those that cover up. The cover-up is the true culprit, as it escalates legal fees and punitive damages, which are not incurred by the bacteria themselves.
Spending Priorities: Audits vs. Unannounced Testing
When it comes to spending, third-party audits often take center stage. However, I've witnessed plants earning 'superior' ratings just days before causing harm. The Peanut Corporation and Jensen Farms cantaloupes are stark examples. These audits, funded by the industry, provide a false sense of security and offer plausible deniability. Instead, companies should allocate resources to unannounced testing and address the issues that are uncovered. This approach transforms audits from a liability shield into a genuine safety tool.
Litigation: A Distant Dream
The idea of litigating myself out of business is theoretically possible, given the known pathogens and interventions. However, in practice, this remains a distant dream. The current trend of cutting FDA inspectors and gutting CDC surveillance is detrimental. The Jack in the Box children from 1993 are now middle-aged, and I remain in the fight. This ongoing battle keeps me honest and focused on the goal, even if the ultimate victory seems elusive.
Prior Conduct vs. Severity: The Legal Battle
In legal battles, the severity of the injury and causation are crucial. I must prove that the product caused harm to a specific individual. However, it is the company's prior knowledge and conduct that ultimately determine the outcome. A company that has a history of recalls and ignores test results will face a different legal landscape than one that is a first-time offender. Punitive damages often arise from the cover-up, not the bacteria itself.
Resource Allocation: Surveillance and Inspection
If resources were to be redirected, surveillance and inspection would be the primary beneficiaries. The FDA's inspection capacity is woefully inadequate, with facilities often inspected on a timeline measured in years. The detection of multistate outbreaks relies on the boring yet essential work of federal labs matching strains across states. Cutting these resources would have dire consequences, as outbreaks would continue but go undetected, leading to politically convenient yet morally indefensible outcomes.
Salmonella: A Case for Adulterant Status
The designation of Salmonella as an adulterant in poultry is a complex issue. While we have petitioned for this change, the FSIS denied and then withdrew the framework, missing a crucial opportunity. The solution lies in declaring outbreak-associated, high-load Salmonella scenarios as adulterants, similar to the Big Six non-O157 STECs in beef. Congress can intervene if the agency fails to act, as the natural occurrence of Salmonella is no longer a valid defense when children are at risk.
Adverse Event Reporting: A System in Crisis
The ByHeart outbreak highlighted the flaws in adverse event reporting. The system is voluntary, slow, and structurally blind, often failing to act in time to save lives. Mandatory, time-bound reporting with real teeth is necessary, along with FDA authority to act on early signals. Infants' lives are at stake, and the current system is their voice, which is currently a whisper.
Raw Milk: Labeling vs. Regulation
Raw milk regulation presents a challenge. While labeling is a start, it is not sufficient. Strong, plain-language warnings should be the minimum standard, supported by platforms like RealRawMilkFacts.com. The personal freedom argument collapses when considering the vulnerable toddlers who end up on dialysis with hemolytic uremic syndrome. The freedom to take risks ends where the health of our children begins.
FOIA Exemption 4: A Matter of Public Health
FOIA Exemption 4, which allows companies to withhold records as 'confidential commercial information,' is a cause for concern. While genuine trade secrets deserve protection, plant records that have poisoned people should not be hidden. The public has a right to know who got sick and why. When a company's actions result in hospitalizations, 'confidential business information' is not an acceptable response.
As I prepare for tomorrow's meetings, I reflect on the ongoing battle for food safety. These answers, crafted from years of experience, highlight the challenges and the need for change. It is time for the industry to embrace transparency, accountability, and a proactive approach to ensuring the safety of our food supply.
