5 FSMA Questions, 5 FSMA Answers with Dr. Hugo: Part 4

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.  Part 1Part 2. Part 3. Here is the penultimate set of five questions: 

1. Q: What about cans and acidified foods? Are those exempt? 
A: These products are not exempt from the FSVP. The importer is not required to undertake a hazard analysis related to biological hazards since manufacturers of such products have already done so to satisfy existing regulations applicable to such products. What the importer has to do is make sure such facilities have also addressed chemical and physical hazards as well.

2. Q: Do you have hazard analysis guidelines fixed for fresh fruits and juices? 
A: Fresh fruits to be consumed as “raw agricultural commodities” such as a mango, banana, strawberry, blueberries, etc., are subject to the Produce Rule. Juices are subject to regulated HACCP for juice and juice pulp. The guidelines for juice HACCP can be obtained from the FDA. The guidelines for the Produce Rule are being developed by the FDA.

3. Q: Can I as a third party auditor in my country help clients? I meet the FSMA regulations for audit services. Or, can only FDA auditors do this?
A: Yes, a third party auditor can carry out the audit of a foreign supplier as long as the auditor is a qualified auditor and the importer assesses and signs off on the results of the audit. If an FDA audit happens within 12 months of the scheduled private audit, the FDA audit can substituted for the private audit.

4. Q: Can electronic records be scanned copies?
A: You can scan a printed record and submit it as a true copy. You also can print an electronic record and submit it.

5. Q: Are English translations required to be done by qualified parties? Can the company do it on their own?
A: The rule does not state qualification requirements for translations. 

And one final bonus question:

Q: If you import from exporters that pack fruits and vegetables, must you check all growers or can you rely on gap certifications obtained by the exporters for their operations? The definition could be interpreted several ways.
A: As an importer you would have done a HARPC or requested such analysis from your foreign supplier for review and assessment. In it your supplier will have identified the hazards needing preventive controls. Assuming we are talking about “produce” - fruits and vegetables to be eaten in their raw state - then the growers of your foreign supplier are subject to the produce rule. You, as an importer, will need to verify that your supplier is verifying compliance with the produce rule by all his local suppliers. GAP certifications, as long as they contain all the requirements of the Produce Rule, would be an acceptable verification activity.

There you have it! If you found this useful, check out the earlier parts and stay tuned for the last installment 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 waiting just for you! 

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