FDA Import Requirements and Compliance: Part 5 - Low-Acid Canned Foods and HACCP


Uploaded by RegistrarCorpUS on 26.04.2011

Transcript:
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. class="Apple-style-span" style="color: rgb(34, 34, 34); font-family: 'Helvetica Neue', Arial,
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none; ">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  style="color: rgb(34, 34, 34); font-family: 'Helvetica Neue', Arial, Helvetica, sans-serif;
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 plan into place.
But I'll touch on it here because it does has some implications going forward under
the new safety legislation. So as a refresher for those of you not aware of what style="color: rgb(34, 34, 34); font-family: 'Helvetica Neue', Arial, Helvetica, sans-serif;
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 is, it in essence
is an approach to identify, evaluate, and then control food-safety hazards.
It's acknowledgment that there are hazards in every process. And your Identifying those
hazards and then explaining how you're going to control those hazards. HACCP right now,
is mandatory in the U.S. for basically three sectors: seafood, meat and poultry products,
and juice products. I should also say for canned foods.
So if you're producing any of these products already you'll need to be operating under
HACCP. You've been, or should be operating under HACCP as it is. If you're producing
another type of processed food however, it is not currently required that you operate
under HACCP. I'll talk about that and how that's changing.
So as I said, the focus is on prevention of hazards. HACCP Plan really can be applied
from farm to table, it can be applied to anything, any process. It's applied in all sorts of
manufacturing settings. HACCP itself though, isn't just a stand alone thing. HACCP is really
made up of a number of prerequisites that allow you then to operate under HACCP.  
You can't produce food safely and have a HACCP plan if you
have no good manufacturing processes in place. If you have no employee training. So  class="Apple-style-span" style="color: rgb(34, 34, 34); font-family: 'Helvetica Neue', Arial,
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none; ">HACCP
 is a piece of what you'll to do to be sure that your products
that you're producing are being produced safely. A little bit about some of the voluntary programs
that perhaps you have heard of.
You may have a customer in the US who says "Oh, well, I'd love to buy your products but
are they kosher?" or "Are you operating, can you provide organic products or halal products?
or, " We would like to find a supplier of fair trade products." These are all voluntary
programs, not mandated, not required by FDA.
So operating under ISO 22,000, that's not an FDA requirement. Getting a BRC certificate
for your factory, that's not an FDA requirement. These are customer driven requirements your
buyers will likely want, many of them. But they're not actually required or regulated
by FDA. And private companies typically are, these are all examples of private companies
that are out there doing these various certifications.
So what happens if your shipment's detained? Well FDA basically has three options, they
could just immediately release your product, so you never even hear about it, the product
gets released. They could detain it and sit in their office looking at their laptop and
just review it and then release it.
They could detain it and then send an inspector into the port to actually open the container
and pull out samples to send off for testing, and when the test results come back they could
release the container. They could detain the container, pull samples, test the samples,
and determine there is something wrong with the product and then they could refuse entry
of the product.
So those are kinda of the various options they have. Now you, again as the foreign manufacturer,
you'll be hearing, you'll get an email or a phone call from your buyer in the USA. Bad
news, the shipment's been stopped, I can't pay you or I need my money back, I need you
to take the shipment back, I'm not going to be able to get it, or I can't use it anymore,
if that happens to you, if you get that dreaded phone call or email where your buyer is saying,
you know, the shipment has been stopped.
Well there's really only one way you're going to know what, if that's true, what's really
going on with your shipment. You should ask your buyer for a copy for what's called a
notice of FDA action. This is an official document issued by U.S. FDA. It will say,
right at the top, "U.S. Food and Drug Administration"; it will have the date; it will have the name
of the importer; it will have the container number; and most importantly, it will tell
the status of the shipment.
It will tell the reason it's been stopped. It will indicate how long you have or, I should
say, the importer has, to respond to FDA. And a response might be, depending on the
reason for the detention, might be asking FDA for an extension of time, so that you
can sort out the problem. It might be that you would ask FDA for permission to re-label
a product if the notice of action indicates you have a problem with the labeling.
So, the key thing here is if you have a shipment stop, ask for that document. Look at it because
It's really going to tell you what's going on with your shipment. Whenever we have a
client that comes to us and says, "Oh we have a shipment that's stopped," or, "We've had
problems in the past," first thing we'll say, send us notice of action.
We can't tell you anything until we see that, and FDA will issue subsequent notices, if
you don't respond they'll send notice number two, which will indicate that you will need
to re-export the product or destroy the product within so many days.
If you ask for an extension, they'll issue a second notice, indicating an extension has
been granted. So again, Notice of Action is a key document if you ever have a problem.
I said earlier that there's a a database of detentions. You can go and look, and search
what's called Oasis and the Oasis database will let you search by month.
So you can search by year and month. And then also, you can scroll down and search by country.
And when you search by country you'll see a list of the companies and their products,
the date, and the reason. And if you go online and look at that, it's a public record, so
anyone can see it. And why I emphasize this, is this also means buyers in the U.S. can
see it.
It's a permanent record, it doesn't go away. So if you had a detention five years ago,
if I'm a buyer at Walmart or at Target or at Food Lion or Safeway, I can go into OASIS
and do a search to see if your company has ever had a problem with FDA.
So, it is something to be aware of, that this is permanent record. Which again, really goes
back to why you want be sure you're prepared before you're exporting into the U.S. or if
you're exporting right now already and you feel that you may have things that are not
just right, try and fix them, because this is a permanent record of problems.
Now, FDA also has what's called an automatic detention list. Detention without physical
examination. FDA may put a country, a product category, or a specific manufacturer or a
specific importer on this list, this detention without physical examination list.
So it may be that FDA has determined because of, I'll use an example from a couple years
ago, flooding in Bangladesh. The shrimp ponds became contaminated during the flooding, massive
flooding. And FDA put shrimp from Bangladesh on detention without physical examination.
 They stopped every shipment and required the actual product be tested.
So the reasons they'll put a company, or a product, or a country on this list it varies
dramatically. But that's an example of one reason they might put a company or a country
on a list. Now getting off of this list, this detention without physical examination is
not terribly easy. You'll need to do at least five consecutive shipments of a commercial
size.
So you can't just send over two pounds by FedEx. FDA wants to see five consecutive shipments.
You'll then need to to prepare a petition, a file that you will submit to a specific
office at FDA for review, with the request for them to remove you or your company from
the detention without physical examination list. It's a long process.