A fee-driven model
At the same time, funding will drive how the FDA implements the new regulations. The FDA lacks financial and human resources to manage all the tasks assigned to it under the statute and is shifting to a fee-driven model, similar to that used in the medical devices arena and with EPA and OSHA. This will become the new normal in the food industry. Any increase in the agency budget is likely to be fee-generated. FDA now has the authorization to charge for re-inspections, along with the financial incentive to do so. Registration, which is currently free, may eventually provide a new revenue stream. Indeed, registration has historically been a precursor to a new fee following taxation schemes predating the Roman Empire. The proposed fee-based voluntary qualified importer program will be the preferable alternative to government-to-government partnership programs for imported foods because it will generate revenue. Memorandums of Understanding (MOUs) recognizing foreign inspection systems under the “Seafood HACCP” regulation for over 15 years now have been slow in coming, and similar arrangements under FSMA will be slow as well.
Ultimately, the new requirements under FSMA will lead to higher costs, considering there will be pressure to conduct greater product testing, environmental monitoring and audits. Although the HACCP requirement in FSMA should increase overall food safety, many provisions in FSMA are redundant and confusing. The prospect of full Congressional funding is also highly unlikely, forcing the agency to become fee-driven and creating a conflict of interest and undermining the food safety mission.
There is a long road ahead for all of us, and if the “Seafood HACCP” provides any indication, it will take five to 10 years for things to shake out.