You're right in principle a single system would be great for better risk management and streamlining operations. But there's a huge "but"... The real issue is the FDA/USDA-FSIS split. Imagine the mess: the USDA controls meat, poultry, and eggs with its own specific
HACCP rules and sends inspectors almost every day. The FDA, on the other hand, handles everything else with FSMA Safety Plans and does more sporadic inspections based on risk.
USDA inspectors are practically at home in companies and tend to be super strict, while FDA inspectors come much less often. It makes sense that companies would tailor documents for each. Think about companies that produce food that falls under both regulations: keeping separate plans has become a kind of defensive strategy. The USDA inspector comes in, you just show him the
HACCP plan tailored for him, without risking him starting to poke his nose into the FDA parts and vice versa.
HACCP requires formal validations for all critical points, while FSMA is super strict only on Preventive Process Controls. For the rest - sanitation, allergens, suppliers FSMA focuses more on continuous monitoring than on initial validation. Separating the plans allows companies to follow to the letter what each agency requires, without having to justify to a USDA inspector why an FDA inspection is done in a certain way. Scientifically validating the effectiveness of cleaning is essential, but with separate plans companies can precisely follow the FSMA rules without an inspector, accustomed to the
CCP logic, asking for validations not explicitly requested. It's one of those regulatory subtleties that seem absurd but in practice make the difference during inspections!
What further complicates the situation is the practical aspect of day-to-day management. Many American companies have already developed procedures and staff training based on this division, and changing their approach would require a significant investment. Think about employees who have been working with certain modules for years: some only deal with
HACCP checks, others only handle FSMA documentation. Unifying everything would create operational confusion, at least at the beginning.
There is also the issue of legal liability. In case of problems or disputes, having separate plans allows you to clearly identify which regulation has been violated and which agency has jurisdiction. In a litigious country like the United States, where lawsuits are a daily occurrence, this clarity on responsibilities becomes crucial.
It should be noted that this separation also reflects the different philosophy of the two systems.
HACCP was born for NASA astronauts, with a very technical approach to critical points. FSMA, on the other hand, is a more recent response to problems that have emerged in recent decades, with a broader vision that includes prevention, traceability and supply chain. They are complementary but with distinct origins and goals.
I have noticed that companies that maintain separate systems tend to see
HACCP as the "heart" of daily food safety, while they consider FSMA more as an overall management system. This creates two levels of control that, paradoxically, can reinforce each other.
From the point of view of European efficiency, this all seems like a waste of time, but the American system, however redundant, works in its context. It is like driving on the left in England: it seems strange to those who are used to it differently, but locally it makes sense. In the end, what matters is that food is safe, regardless of the bureaucratic path taken to ensure it. Perhaps someday there will be true harmonization, but as long as federal agencies remain separate with different mandates, this dual management will continue to be the norm in the United States.
