Some food products require the FDA’s prior notice to export to the USA

This is the case of canned tuna, ready-made sauces, preserves, cheese sauces, mushrooms and truffles, among other foods. The FDA’s prior notice for import is meant to ensure that products are sterile and avoid the risk of botulism, which may grow in environments without oxygen with a ph above 4.6.

Below we offer you an excerpt from an email exchange between ExportUSA’s FDA specialist (a technician who holds a graduate degree in food preparation sciences) and a client firm. The firm in question was certifying the production process and requesting the SID to import some food specialties into the United States.

It is an example aimed to shed light on the complexities of the process and the professionalism of ExportUSA New York Corp.’s FDA consulting work.

Modifying a request for an SID certification already submitted to the FDA

"Please find attached the documentation regarding the rejected SID requests (and for the third SID, the extra one whose certification process we are beginning now). I made some edits in red to the pdf file you had sent me as a starting point. It will be sufficient to open your two SID (‘edit’ mode) to modifying them as indicated and submit everything again to the FDA. The aim is to reply to those questions asked in the “returned SID” (field: ‘comments to firm’).

Some important notes:

I think it would be best to rename the two products [the ones we are requesting the SID number for] as “shelf stable potato gnocchi” e “shelf stable whole wheat gnocchi.” To this end, I distinguished the temperature of the final thermal treatment (85°C) from the parameter F70=18 (this was contested in the SID).

I inserted in English the description of the first phase of the pasteurization process. This is the translation  for your review: ‘the pre-packaged product is placed on a pasteurizing belt hot air oven. The center reaches a temperature of 85°C (the temperature is monitored through a data logger in the product).”

Scientific pubblications aimed at corroborating the validity of the sterilization process and evaluate the autoclavi by FDA technicians.

It is frequent that firms must provide scientific studies to prove the validity of the methods used in their plant to sterilize the foods intended for export to the United States. ExportUSA’s FDA consulting services for food exports to the United States include researching and evaluating scientific publications to find the ones that are most appropriate for the products for which the SID is being requested.

“Please find attached the scientific support GDL requested by the Food and Drug Administration to support your SID application. It will substitute the prior one regarding the cooking process for gnocchi and become the new process source establishment.

The publications you had proposed are not appropriate (one of the even claims that botulism can emerge when the ph level is below 4.6). I found instead a scientific journal article that explains that acidifying to a level below 4.6 prevents the germination of Botulinum spores. It was impossible to find a publication in Italian or English specifically on the gnocchi production process. We believe, however, that a generic study on the sterilization process of vegetable preserves should be enough (please refer to the other article I attached).

In this case the client firm decided to fill out the form for the SID request to the FDA on its own and ExportUSA provided the necessary consulting service to assist the company’s in-house technician. Below are some excerpts from email exchange between the ExportUSA technician and the firm in which some of the steps in the SID request process are clarified.

“Please find attached the text you will have to insert in the comment fields to describe the final pasteurization process for the product you are requesting the SID from the FDA for (please check that I described the process accurately, I included a copy of the text in English and Italian for your review).

The corrected SID can be used for the two returned SIDs (of course please take care to change the names) as well as the third (as long as it’s the same process, obviously). I have not received any information regarding the third SID yet—I will need a list of ingredients and the product description.

I also noticed some discrepancies in the names of the instruments used for the final pasteurization (hot air oven) in the returned SID application and the diagram of the process you sent; I used the information from the latter to fill out the section regarding the autoclave validation.

Once you get to step 8 (the confirmation) you’ll have the option to ‘save as a draft’ with the bottom left bottom. The SID will be saved in the DRAFT folder until the next edit. You can send me a scanned copy of the SID once you reach this step and I can evaluate if you can proceed with the final submission or not and if further edits are required.

You have to open one of any of the two SID contained in the folder called “returned” (just click on the number) and from there in the upper right-hand side of the summary screen use the function ‘edit’ to access the seven screen sections.

It’s basically the norm for FDA technicians to request extra information aimed at supporting the validity of the production processes or sterilization methods used.

Below we include an email exchange between a client firm and the ExportUSA technician discussing how to respond some of the FDA requests in the course of an SID number request procedure.

“The email is pretty clear, all you need to do is forward the 2541a forms. Since you already did this before I suggest you do not send other documents. I remind you that before sending food products into the United States you must wait that the product status in the SID authorization process is changed to ‘FILED.’

You will have to wait for a response by mail for the SID you submitted  (just like when you sent the first FCE form), alternatively the FDA may alert you by email. The email will announce that “THE FILE HAS BEEN PROCESSED.’ You will then have to verify by accessing your account whether the status of the SID was changed to ‘FILED’ (indicating that it was approved) or ‘RETURNED’ (meaning that will need to provide further details).

When the SID is ‘FILED’ the unique identification number (FCE+SID) will also be confirmed. However the problem right now for you is gaining approval, since we cannot exclude that they will not request further documentation on the production process/product sterilization [of course whenever possible we have tried to anticipate these kinds of requests].

The processing time for a SID request to import food products into the United States is about 20 days from the moment the Food and Drug Administration receives the SID request.