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

now I'll talk a little bit about a different office at FDA which regulates low acid canned foods in the early 70s when the canning industry became very popular companies I should say FDA realized that of a product put in a pan or a bottle or jar isn't produced properly it can cause people to get very sick 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 finding information so if you are producing panned shrimp you in four different sizes you will actually submit information that the about those four products and you will have a number assigned to each of those products so you have four s ID numbers plus a factory registration number or an FCE number the SE numbers five did cook typically it takes a couple months to get the FCE number the process filing is again required for each product and it's known as an S ID or submission identifier now some examples of products recently detained from Vietnam shipped into the US mixed vegetables fish sauce canned crab and 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 that well there's a variety of factors but the most important factor is pH you are a cinnamon level of the product acidity and the product kills bacteria so that's the key factor is acidity water activity is it a drying product if it's a very dry product as a low water activity bacteria can form and there's an exemption as a product event it carbonated or does it have alcohol in it those are all factors as well generally speaking no acidified at low acid foods will almost always require this type of registration product with pH greater than 4.6 would 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 is detained for violations of the LA CF requirements over the past ten years so you can search by then just look and see if you co Klan and clams you'll see it in the list that will give you a sort of an idea if your products will need it we also have a questionnaire that we can send you don't charge anything forward you fill it out send it back tell you if you need to do this this particular type of registration and you would tell us what's in the product what did the age level etc and will then tell you yes you need it or no it seems you with no we do provide a service and 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 passive passive if you are in the seafood industry or if you're producing canned foods you have lately been operating under asset for you know many years whenever you started production you probably put a has a plan into place but I'll touch on it here because it does have some implications going forward under the new food safety legislation so as a refresher for those of you not aware of what has it is in essence is a approach to identify evaluate and then control food safety hazards it's an acknowledgement that there are hazards in every process and you are identifying those hazards and then explaining how you're going to control those hazards hasip right now is mandatory in the US for basically free sector seafood meat and poultry products and juice products I should also say for demand foods so if you're producing any of these products already you'll need to be operating under house event or should be operating under hasip as it is if you're producing another type of processed food however it is not currently required that you operate on her house so I'll talk about that how that's changing so as I said the focus is on prevention hazards passive plan really can be applied from farm to table it can be applied to anything any process it so it's applied in all sorts of manufacturing settings passive itself though isn't just the standalone thing passive is really made up of a number of prerequisites that allow you then to operate under hazard you can't produce food safely and have an asset plan if you have no good manufacturing processes in place if you have no employee training so hasip is a piece of which we'll have to do to be sure that your products are being led to products that you're producing are being produced safely a little bit about some of the voluntary programs that perhaps you have heard of oh you may have a customer in the US who says oh well I would 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 product these are all voluntary programs not mandated not required by FDA so operating under ISO 22000 that's not an FDA requirement getting a PR scene 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 private companies that are out there doing these various certifications so what happens if you ship taine well FDA basically has three options they could just immediately release your product so you never even hear about it the product that's 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 since an inspector into the port to actually open the container pull out samples to send off for testing and when the test results come back they could have released 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 kind of the various options that they have now you again as the foreign manufacturer you will be hearing but we have an email or phone call from your buyer in the USA bad news the shipments been stopped I can't pay you what I need my money back I need you to take the ship in fact 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 buyers saying you know I'm shipments been stopped well there's really only one way you're going to know what is that if that's true what's really going on with your shipment you should ask your buyer or copy of what's called a notice of FDA action this is an official document issued by US FDA it will say right at the top US Food Drug Administration it will have a date it'll have the name of the importer it will have the container number and most importantly it will tell the status of the shipment it'll 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 for the detention might be asked the 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 relay all the product if the notice of action indicates you have a problem with the labeling so the key thing here is if you have a ship in stock 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 say oh we have a shipment that stopped and we've had problems in the past first thing we'll say send us a notice of action we can't tell you anything until we see that an FDA will issue subsequent notices if you don't respond they'll send notice number two which will indicate that you'll 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 a notice of action is a key document if you ever have a problem I said earlier that there's 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 a month and then also you can drill 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 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 US can see it it's a permanent record doesn't go away so if you had a detention five years ago from the buyer at Walmart we're targeted where it fine or Safeway I go into a wases and do a search to see if your company has ever had a problem with FDA so it is something to keep to be aware of that this is a permanent record which again really goes back to why be sure you're prepared before your exporting into the US 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 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 of this detention without physical examination list so it may be that is determined because of I use an example from a couple years ago flooding in Bangladesh the shrimp ponds became contaminated during flooding massive flooding an MTA put shrimp from Bangladesh on detention without physical examination they stopped every shipment and require that actual product be tested so the reasons they will put a company or a product or a country on this list it varies dramatically but that's an example of one means they might put a company or country on the list now getting off of this list this detention without physical exam is not terribly easy you'll need to do at least five consecutive shipments of the commercial side so you can't just send over two pounds by the FedEx the FDA wants to see five consecutive shipments you'll then need to prepare a petition a file that you will submit to a specific office at FDA for review with the request for them to renew you for your company from the detention without physical examination list it's a long process

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