FSVP: What Has Changed in the Re-proposed Rule?
In a recent FSMA Fridays webinar, Dr. David Acheson, and Melanie Neumann of The Acheson Group covered some of these changes and its impact on the food industry. Food Safety Tech presents some excerpts:
What is FSVP all about?
Dr. Acheson: The foreign supplier verification program is supply chain risk control for imported foods. Following the melamine in pet foods scandal that originated in China, the legislation was aimed at tightening preventive controls for imported foods. The rule concerns companies that import food from foreign manufacturers, and requires them to ensure that those suppliers are complaint with FDA requirements in the U.S. and thus, you are addressing risks along the supply chain.
How did the re-proposals change FVSP rules?
While there are several changes proposed, the entire substance of the FSVP rules haven’t changed as whole. Overall the changes seem to align the FSVP rule closer to the preventive controls rule in terms of wording and intent. Some of the changes include:
- Approved Suppliers: As long as an importer can demonstrate that they have a process to approve suppliers, and that they follow it, there is no need for them to maintain a list of approved suppliers. However, this raises a question: If you don’t have a list of suppliers, do you know if your supplier is approved or not?
- Supplier Risk: FDA now requires an evaluation of supplier risk along with product risk. Factors that should be considered include regulatory compliance, the history with the supplier (including test results and their willingness to correct problems), and any other relevant factors.
- Audit requirements: In the original rules, FDA asked whether or not an initial audit and subsequent annual audits should be required when an importer identifies hazards that could cause serious adverse health consequences or death to humans or animals. In the supplement, FDA has basically said that yes, audits should be required under these circumstances, but has also given the flexibility in stating that if an importer can demonstrate that the risk can be managed in some other way, and that suppliers can be just as effectively verified through other means, then the importer is free to use other tools, or to decrease frequency of the audits.
- Duplication of efforts: FDA will not require food manufacturing facilities who are subject to preventive controls (and who rely on suppliers to control significant hazards) to keep a whole additional plan in place to comply with FSVP.
- Definition of very small importer: In the re-proposed rule, FDA has set $ 1 million in annual sales as the definition for very small importer, which aligns with the definition in the Preventive Controls rule.
Will food and beverage importers be expected to do onsite audits of foreign suppliers?
As described above, importers are supposed to do onsite audits, but only for significant hazards. Earlier FDA had provided two options. In the re-proposal, FDA seems to going with Option 1, which requires an annual audit for those supplier with significant hazards, but had added flexibility, by which the importer can determine another way of determining risk, or a less frequent audit schedule in lieu of that annual audit. But here’ the concern: While I embrace flexibility and decision making power at the industry or importer level, but there’s no objective bar set. The new requirement seems to say, ‘You have to do this, but you don’t have to do this, if you think you don’t have to do it!’ As a lawyer, looking at this in writing, it raises some flags about enforcement.
Click here for more on this exciting and evolving topic, including answers on where GFSI audits fit in, and what should U.S. importers be doing now to be ready to comply with FSVP requirements.