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:
- “Do I really have to do this? I’m just a small business and this will bankrupt me.” As the regulatory requirements are fully understood, many importers realize that they may not have the technical expertise or staffing to develop a FSVP program for each food product and foreign supplier. The Rule allows flexibility for FSVP importers to use external subject matter experts in developing and maintaining their FSVP programs.
- “Does everyone know about this Rule? What is FDA doing to communicate their expectations domestically and globally?” Importers tell me there is a general lack of understanding or awareness of the FSVP Rule; not only among their foreign suppliers, but also here in the States. Those sitting in these courses are at least aware of the FSVP Rule, but how many are not? This Rule has been published for almost 18 months and yet many in the affected industry are unaware of it.
- “I will not be able to get this information.” Over and over again, I hear a version of this statement. Importers are concerned that they will be unable to get the necessary information from their foreign suppliers due to sharing of proprietary business data. Many course participants state their customers in other countries are not aware of this Rule, and as such, getting information will be challenging.
- “How will FDA inspect? What should I expect during an inspection?” This is the big unknown. The first compliance date is May 30, 2017. What we do know is FSVP inspection will likely be review of the FSVP programs, primarily the documentation and supporting materials of each program. Because the implementation date is still a month out, the fear of the unknown inspection is great.
- “How do I know when I need to be compliant?” Answering this question is challenging for many importers, but OFW Law has developed flow diagrams to assist FSVP Importers. More to come in future blog posts.
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.