5 FSMA Questions, 5 FSMA Answers with Dr. Hugo: Part 1

AIB’s Global Innovation Manager, Dr. Cornelius Hugo, recently led a webinar about the FSMA Foreign Supplier Verification Program for the International Food Safety and Quality Network as part of their excellent Food Safety Fridays series. 

Questions poured in from attendees following the webinar. We're betting that if someone asked a question, lots of you might benefit from the answer. So, over the next few weeks, we'll be doing a series of FSMA/FSVP questions and answers with Dr. Hugo.  Here are our first five: 

1.     Q: What is the difference between HARPC and HACCP?

A: HACCP is a voluntary food safety approach based on the Codes Alimentarius. It is recognized and used worldwide.  HARPC is a regulation of the US, applicable to all manufactured food products and food contact substances consumed or used in the US, regardless of the origin of such food products and substances.  HARPC and HACCP have some aspects which are identical, others which are similar and others which are unique to HARPC and additional to HACCP.

2.     Q: Do U.S. importers need to go overseas and do facility audits?

A: The audit can be done by the importer, or the importer can rely on an audit done by a third party.  Regardless of who does it, the auditor must be a qualified auditor as defined in the rule.  If the importer relies on a third party for the audit, the importer must review the results of the audit, assess the outcome, make decisions, and sign the review.

3.     Q: What is the difference between FSVP and VQIP?

A: The FSVP applies to all imports of food products, raw materials, ingredients and food contact substances.  The Voluntary Qualified Importer Program (VQIP) is a program that importers can voluntarily participate to make the import process easier and faster. In order to participate, the importer would have to apply, pay an annual fee, and have its foreign supplier “certified” under FSMA/FDA.

4.     Q: If Radiological and EMA is added to my HACCP plan, will that suffice as a HARPC/HACCP plan?

A: The short answer is no.  HARPC requires a few more items such as the documentation of the “knowing or reasonable foreseeable hazard”, that is the scientific evidence, identification of who will control the hazard in the food chain, transport practices, environmental hazard analysis for RTE foods as defined in the rule, cross contact controls for allergen, and supplier compliance history valuation. A good way to find out what more is needed beyond your current HACCP food safety plan is to undertake a FSMA Readiness Assessment.

5.     Q: If a raw commodity is shipped into the US for further processing is it exempt?

A: Under Subpart B - Hazard Analysis and Risk-Based Preventive Controls - of Part 117 - Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Human Food, raw commodities such as cocoa beans, coffee beans, and grains are exempt if you determine and document that the type of food could not be consumed without an appropriate control. Since the FSVP is the equivalent of the Subpart B for domestically sourced materials, I would think that such exemption applies to imported raw commodities. After all, we do not grow coffee or cocoa in the US. 

There you have it! If you found this useful,  check out part 2 and part 3 and stay tuned for parts 4 and 5 of this series. In the mean time, if you have FSMA questions that just can't wait, we have 5 Steps to a FSMA-Ready Facility ready for you! 

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