4 replies to this topic

[Charles Chew]

Is this going to be a new approach to ensuring safer products being imported into US or just another political cover up for the failure of its past food safety policies? FSMA is going to pile product costing pressure on exporters with additional inspection fees, possible additional certification to meet FDC requirements / standards, etc.

Has anyone been impacted by this new act? Do tell us your experience?

[williamw]

The FDA is just now in the process of publishing the proposed regulations for FSMA, so you are not likely to see significant change for at least a couple of years. The intent of the law is that the regulations for preventative controls etc. would apply to foreign manufacturers as well and the FDA is supposedly going to step up inspections of foreign suppliers but exactly how they are going to that and what kind of enforcement mechanisms are going to be in place and how this is going to work with the regulations in other countries remains to be seen. One of the big issues is going to be funding, as the FDA needs significant funding increases to step up inspections both domestically and abroad and with the current congressional make-up in the US that is not likely to come any time soon.

There is also a provision in FSMA that requires importers to assure that foreign suppliers are complying with the law, but FDA has yet to publish regulations on that so exactly what it is going to entail is anyone's guess at this moment.

Being in the US and working for a company that uses a lot of imported materials (although we are not directly importing them but buying from importers) I am watching what is going on with FSMA very closely and will be glad to answer any question to the best of my ability, but right now there are a lot more unanswered questions than answers.

[Charles Chew]

I have been asked by a client to participate in a facility pre-inspection exercise under the purview of FDA prior to the official inspection but declined due to work commitment. I honestly do not see how FDA is going to make this work but I am very certain that manufacturers are moving their focus away from US market with a view to alternative markets. If this becomes a trend, the US Govt. may have an issue with food security concern to deal with.

So far, I know inspectors are flying everywhere around the world inspecting facilities to meet their targets for review of food safety systems and health data towards preparing guidance documents / regulations. I am also aware that for initial pre-inspection, FDA is charging company hotel accommodation and ground expenses (with airfares fully absorbed by FDA) for a 2-day inspection. As William had mentioned, a lot of areas remain unanswered or pending further FDA advice. Once the pre-inspection at our client's facility is completed, I shall keep this thread updated.

[williamw]

Interesting that they are charging. I see nothing in the law that allows the FDA to charge anything for initial inspection activities, only fees for reinspections when noncompliance issues are found in an initial inspection.

[Charles Chew]

The results of the FDA inspection appeared to point towards a strong attention given to process, product and facility environmental validations during on-site audit. The desk audit certainly focused on reliability and accuracy of all verification activities. Evidence of personnel training was clearly an important concern. Data recording gap is also a big no-no. Mass balance data was also inspected. IMO, facility accredited to a GFSI scheme would have a distinct advantage if thoroughly covered and effectively implemented. The exercise seemed to remain rather inspectorate-based than science-based using risk-preventive approach? Too much uncertainties w/o the guidance documents fully in place.