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Now I'll talk a little bit about a different office at FDA which regulates low acid canned
foods. In the early seventies when the canning industry became very popular, companies,
I should say FDA, realized that if product put in a can or a bottle or a jar isn't produced
properly it can cause people to get very sick, because of botulism.
So they came up with various regulations for thermally processed, acidified, low-acid canned,
bottled, jarred foods.
And there are two aspects of what's required. One is registration of the facility, of the
factory producing the low-acid canned food. And two, the second is submission of process
filing information. So if you are producing canned shrimp you, in four different sizes,
you'll actually submit information to FDA about those four products, and you'll have
a number assigned to each of those products.
So you'd have four SID numbers, plus a factory registration number, or an FCE number. The
FCE number is five digits.
Typically it takes a couple of months to get the FCE number. The process filing is again
required for each product and it's known as an SID, or a submission identifier.
Now some examples of products recently detained from Vietnam, shipped into the U.S.: mixed
vegetables, fish sauce, canned crab, canned clams.
Again, I'll show you a website later where you can actually go and search and see what
products have been detained for this type of registration, or lack of this type of registration.
So how do you know if your product needs this? Well there's a variety of factors, but the
most important factor is pH.
Your acidity level of a product. Acidity in a product kills bacteria. So that's the key
factor, is acidity. Water activity. Is it a dry product? If it's a very dry product,
has a low water activity, bacteria can't form and there's an exemption. Is a product fermented
or carbonated or does it have alcohol in it?
Those are all factors as well. Generally speaking though, acidified and low acid foods will
almost always require this type of registration. Product with pH greater than 4.6 will typically
require the registration. Carbonated or alcohol alcoholic beverages generally will not require
this registration.
On our website, as a resource, you will find a list of probably fifteen or twenty thousand
products by their common name. The names that were actually used by the shippers coming,
exporting to the US.These are products that FDA has detained for violations of the LACF
requirements over the past 10 years.
So you can search like then, just look and see if you oh, canned clams, and you'll see
it in the list. That will give you a somewhat of an idea if your products will need it.
We also have a questionnaire that we can send you, don't charge anything for it. You fill
it out, sent it back and we can tell you if you need to do this particular type of registration.
And you would tell us what's in the product, what's the ph level, etc., and we'll then
tell you "yes we need it", or "no it seems you would not." We do provide a service to
help with this registration.
We act as a liaison between FDA's office of low acid canned food and you as the manufacturer,
to help submit this information to FDA. Now we'll talk a little bit about HACCP. HACCP if you are in the seafood industry or if you are producing
can foods you have likely been operating under HACCP for, you know,
many years.
Whenever you started production you probably put a