Food Court continues its series discussing the new Foreign Supplier Verification Program (FSVP) rule issued by the US FDA under the Food Safety Modernization Act (FSMA). To read the two previous posts click here and here.
In 175 pages of text the Agency covers a lot of ground and offers a great deal of detail for discussion. Today we look at the basic structure proposed by the FSVP rule. The nuances of how the rule proposes to regulate imports will follow as will the partial exemptions and criteria for full exemptions.
The basic structure of the rule is to require an importer to conduct a range of foreign supplier verification activities. As mentioned in Part 1 the aim of the rule is to fill the gaps missed by the FDA, which currently inspects about 1 to 2% of foreign firms importing into the US. The proposed rule outlines seven (7) required activities under a healthy FSVP. Those are:
- Compliance History Review;
- Hazards Analysis;
- Verification Activities;
- Review of complaints, investigation of adulteration or misbranding, and taking of corrective actions;
- Reassessment of the FSVP;
- Ensuring that required information is submitted at entry; and
- Record keeping.
Among the list two activities stand-out as the core activities required by the rule. The first is the hazard analysis. For most larger firms hazard analysis will be familiar because they follow HACCP already. As with HACCP the proposed rule requires an analysis of unintentional hazards reasonably likely to occur or commonly occurring. The FSVP yet may go further than HACCP and look at intentional hazards, in particular economic adulteration. The Agency states, “some kinds of intentional adulterants could be viewed as reasonably likely to occur, e.g., in foods for which there is a widely recognized risk of economically motivated adulteration in certain circumstances.” Economic adulteration is the intentional addition of cheap ingredients to stretch or enhance a product. The stunning example used by the FDA in the proposed rule is melamine, which was associated with a high profile recall involving a Chinese facility. Its surprising to see the Agency take China to task in the rule and it names no other countries or examples. It’s also interesting to see economic adulteration mentioned and potentially more vigorously regulated. This type of adulteration was the impetus to passing the Food and Drug Act in 1913 and after a long focus on microbial contamination it may foreshadow FSMA II. The hazard analysis is striaght forward and forms the foundation for the next core activity.
The FDA names verification activities in the rule as the “core activity” of the rule and of a FSVP. Verification activities contain two parts – the who and the what. The first step is to identify who controls the hazard identified in the hazard analysis. The rule proposes three potential parties: importer, foreign supplier, importer’s customers. This looks a good deal like the one-up-one-down principle. A hazard controlled by the importer, which is controlled by a preventive activity, requires no foreign verification. It still must be documented and the preventative control reverified on a frequency not yet set in the rule. A hazard controlled by an importer’s customers remain the responsibility of the importer. The rule requires an importer to verify its customer controls the hazard by obtaining written assurance the customer has established and is following procedures that adequately control the hazard. The written assurance would need to briefly state the procedures that the customer has put in place to control the hazard and affirm that these procedures are in fact controlling the hazard. This would be done on an annual basis. This is an important change and potential liability hook for importers. Finally, hazards controlled by the foreign supplier will be subject to one of two options. The first option for hazards controlled by the foreign supplier is based on the type of hazard and the other provides the importer discretion on what verification activity would address the hazard considering the potential risks. Verification activities under both options are sweeping: annual on-site audits, periodic sampling/testing, periodic audits, periodic or lot-by-lot sampling and testing of the food, and periodic review of the foreign supplier’s food safety records. The two options will likely be explored in their own post.
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