Challenges of Implementing FSMA Import Provisions Take Shape

By Ricardo Carvajal –

At FDA’s public meeting on the food import safety provisions of the Food Safety Modernization Act ("FSMA") (see our prior blog posting here), the challenges posed by implementation of those provisions started to take shape.  Presentations by agency personnel, industry representatives, and consumer advocates highlighted the following issues (among many more):

    ◦    limited agency funding and personnel
    ◦    tight statutory deadlines
    ◦    ambiguous statutory terms
    ◦    integration of, or harmonization with, existing standards
    ◦    addressing reliability of third-party audits
    ◦    potential adverse effects on small and medium size businesses
    ◦    impact on competitiveness and efficiency

There was genuine enthusiasm for the possibility that certain aspects of the law, such as the Voluntary Qualified Importer Program, could help smooth the importation process for some importers.  However, there was also concern that the Foreign Supplier Verification Program requirements could prove unduly burdensome for others.  Much will depend on how the agency resolves perhaps the most fundamental issue of all – who qualifies as an importer?

You can read the Deputy Commissioner for Foods' take on the new paradigm for importers here.