FSMA – The D.C. acronym for the Food Safety Modernization Act. When I am working with clients or speaking with industry, everyone is familiar with FSMA. But they think of FSMA as the Preventive Controls or Produce Safety Rules. Some are also aware of the Sanitary Transportation Rule, but the Foreign Supplier Verification Programs (FSVP) Rule is relatively unknown.
I’m not going to lie. I have worked 8 years in D.C. on food safety policy and consider myself knowledgeable in this area. Even I was not as familiar with the FSMA Foreign Supplier Verification Programs (FSVP) Rule as I should have been, but that has changed. And frankly, of all the FSMA Rules, the FSVP Rule may cause the most fundamental shift to the day-in and day-out business activities of the industry affected. This Rule has the potential to be seismic in nature to the global food industry.
My support to this claim? I am a lead instructor for teaching the contents of the FSVP Rule to U.S. food importers. During the 2-day course, I watch the participants' faces as the ramifications of this Rule are finally understood. Anyone who has taught knows what I’m talking about – the dawn of understanding. Soon after that realization, I see panic set in as participants begin to recognize the magnitude of what is now required by the Food and Drug Administration (FDA). The scope of documents now required is mind-boggling to many, especially when assessing the complexity of how food is produced – let alone produced in other countries by foreign suppliers. Simply, compliance to the FSVP Rule appears to be overwhelming to many food importers.
So what is the FSVP Rule? The Final Rule was published in November 2015 to ensure the safety of imported food. At its core, the FSVP Rule requires importers to verify that the food they are importing into the U.S. meets the same public health standard as food produced domestically, is not adulterated, and is not misbranded with respect to allergen labeling.
The FSVP Importer must develop a written FSVP program for each foreign supplier and the food produced by the foreign supplier. An FSVP program will include a hazard analysis, evaluation of the foreign supplier, determining and conducting appropriate verification activities, as well as corrective actions. Written procedures for how foreign suppliers are approved based on the evaluation of the risk posed by the imported food and the foreign supplier….among other regulatory requirements….also must be established. Compliance dates are staggered starting on May 30, 2017, through July 2020.
FDA has developed Guidance for Industry on some specific issues and indicated additional guidance documents are being developed.
As my colleagues and I teach the course explaining the FSVP Rule, we answer volumes of questions. In the courses I have taught, the most common questions and discussion are outlined below:
Bottom Line: The FSMA FSVP Rule will impact the food importer industry. The FSVP importer will be held responsible for ensuring the food they are importing into the U.S. meets all regulatory requirements and the public health standards of domestic food. It appears there are significant challenges ahead in developing FSVP Programs as many are unaware of this Rule.