PDA

View Full Version : FDA Inspection



Meridian Maples
03-28-2012, 11:14 AM
Anyone ever go through an FDA inspection of their syrup operation? I guess we were randomly selected and they are coming tommorow. I'm curious as to what they will be looking for. We've been inspected by the USDA before but not the FDA.

Brandy Brook Maple Farm
03-28-2012, 02:41 PM
No and it doesn't sound like fun. I hope it goes ok for you. Let me know if you find out what prompted them to be interested in observing how you make maple syrup....

Meridian Maples
03-28-2012, 02:57 PM
The inspector called and said we were randomly picked off of the USDA's list. Looking at the FDA's list of requirements they want a recall plan and a whole bunch of other items above and beyond the USDA's. Boy it's going to be interesting. We have a very clean building and all of our equipment in the sugar house is new within the last 5 years so I've got my fingers crossed.

Brandy Brook Maple Farm
03-28-2012, 03:17 PM
I hope it goes smoothly for you. I'm sure it will be fine. Just makes you wonder "why" sometimes. What we don't need is more and more regs, etc. I know that a lot of it is for food safety, etc...but most farmers (besides maple producers) don't heat their product to the sterilizing temperatures we do. Anyway, keep me posted and good luck! :)

argohauler
03-28-2012, 06:50 PM
Check this thread out at sugarbush.info.

http://www.sugarbush.info/forums/showthread.php?t=851

markcasper
03-28-2012, 09:53 PM
WOW, This is getting too close to home! My neighbor was telling me of someone he knew that lost his syrup license not too far from us, but I can't remember who he said it was. When the inspector came to my place he gave me a check for not having a double wash sink and one for not having hot running water.

Maplewalnut
03-29-2012, 06:58 AM
Meridian- I work with FDA weekly and have been thru numerous site inspections at work,

Answer only the questions they ask as clearly but concisely as you can. Don't get into story telling. It is uncomfortable at times but let them lead. Refrain from using words such as 'generally' 'most of the time' 'occaisonally' 'usually' etc. They are looking for consistency of manufacture which in turn provides consistent product. Cleanliness obviously is huge and first impressions go along way. They may check how you calibrate instruments such as hydrometers, thermometers, refractometers. I would expect them to check your label and you may need to explain your cleaning process of both the sugarhouse and RO. They also tend to see if you have pest prevention such as mouse traps. Good Luck PM with any questions or observations they cite you for and I can look up code of regulations for you.

Newfvt
03-29-2012, 07:56 AM
Can someone with experience at this clarify "who is in charge"? Are these inspections limited by regulation or even custom to just the bigger producers? It would seem that smaller operations, let's say less than 500 or 1000 gallons of syrup, and those not selling wholesale to retail outlets, would not be targeted by FEDERAL inspectors. The posts in this discussion talk about USDA and FDA, both of which are Federal, but do not mention State regulators. How is the Nanny-Nation creeping into your maple syrup:>) When I sugared in Vermont, years ago, using old lead-soldered pans, we did get a lead check on syrup we had in a general store by VT Agency of Ag folks. They didnt do much more than say we needed to upgrade equipment, which was done immediately. When I moved to WI and got a new sugarbush and new equipment, by the second year I was ready to go retail. My understanding of "retail" means any middle-man sales to anyone, i.e. sales where you are not handing your product to the end customer at what amounts to the "farm gate". To put our syrup in 1 convenience store and 1 little town bakery, we had to go through the license process with the County Health department for 3 wash pans, hot water etc for the filtering, jugging etc. And pay them something like $100 for the inspection.
I am at a loss to see how USDA and FDA are getting into Maple - unless it is at the big-boy end!
Steve

markcasper
03-29-2012, 10:44 AM
I have never heard of the FDA doing maple inspections. The Wisconsin Department of Agriculture, Trade, and Consumer Protection requires a food processing plant license be issued on operations that produce and sell more than $5,000 per year. It seems that sales direct from the farm do not have to count towards the $5,000. This would be state.

To me it would be unconstitutional for the FDA to be involved. In relating to dairy plants....my father has had the federal goons at the farm, but the only reason is because where he ships milk does from time to time move milk out of state to another of their facilities in Ohio, therefore putting Con-Agra, and any milk patrons under federal rules.

RollinsOrchards
03-29-2012, 12:15 PM
A recall plan is really quite simple. I have had to work on one for our apple cider.

You make up a "recall notice/press release" Look at the big companies word-usage to get a feel of the "we want to take precautions, no need to panic, return unused portion for complete refund. . ." idea.

You post the notice at any location where you normally sell the product in question, and make a list of media outlets to send a copy to. I have two such lists, depending on where the batch in question was sold. If any of the batch in question was sold at farmers markets or any off-site sales I will include the big city media, radio, and tv. Ninety-nine percent of our product is sold at our farm stand to regular customers, so my recall notice will go there and to the local newspapers where we advertise. With cider it really is just a formality, since the product will be completely consumed or spoil before the recall machinery can spring into action.

Batch codes or dates will allow you to recall only specific amounts of production. If you don't have that you will have to recall your entire production, which could be costly for maple syrup.

This is coming for all food production, from being able to track which tree produced and which picker touched an Apple to the field location where each Zuchinni came from. The FDA suffered a big embarrassment between the Tomato and Spinach contamination, spending weeks tracking down the problem. This tracking is better for us really if you look at it right. If there is some tainted maple syrup out there don't you want to be able to isolate the damage? You don't want people to be scared to consume your product, it takes five years for sales to return to normal after any "e-coli in cider" outbreaks in our region of the country.

Newfvt
03-29-2012, 07:17 PM
Guys,

I don't claim to be an expert here, but by way of background, I have been a teaching contractor for Homeland Security on the food safety and security side since 2002, including a week long course in Food Risk Assessment and Mitigation (CARVER+Shock) and another in HACCP (Hazard Analysis-Critical Control Points) methods. I can quote you a list as long as your arm on food scares that go way beyond spinach. e.coli and Jalapeno peppers. Many food scares never make the media, or for regulatory or market-reaction reasons, are not made public.

As a retired Vermont cow doctor, most of my interest has been on processed foods containing beef or poultry.

In general FDA has little if any true enforcement power. They go to great lengths not to write a lot of things down. They prefer to call their findings "guidance'. Similarly I don't think USDA has the interest, and I know not the manpower, to be chasing Maple Syrup all the way back to a sugarhouse on some Mountain in Vermont. FDA and USDA cant even figure out who should regulate eggs-in-the-shell and who should regulate liquid eggs in a carton. If your chicken pot pie has less than 2% chicken in it, FDA inspects; go to 2.000001% - and it is regulated by USDA!

I think as long as a maple producer is "careful" within the generally accepted meaning of the word, and is within whatever his own State's laws and regs say about maple production and sale - they do differ, I don't see how we have much to worry about as far as the Feds suddenly syping over someone's wood pile. Although it wouldnt hurt to have your sugarhouse scanned for bugging devices :>)

I appreciate RollinsOrchards comments, but I think we need to be careful that this discussion doesn't get the entire Maple Industry's panties-in-a-yank over "batch codes, dates and recall notices".

Are we looking at the day when a guy with 100 taps making 25 gallons of syrup and selling it off the back of his F-150 in town needs a HACCP Plan. As Tim Sample, the Comic Laureate from the Great Sate 'o Maine says, "Not too hardly likely, chummy"

If someone from Proctor sees this, perhaps they can give us a "definitive" answer?

Steve

markcasper
03-29-2012, 10:24 PM
In general FDA has little if any true enforcement power.

I beg your pardon. With the passage of Senate bill # S510, it appears we are seeing the rollout happening. It is very sad to see what is happening to this country.

http://www.farmtoconsumer.org/s510-revised-fda-coming-kennedy.htm

From other sources I have previously read, S 510 is designed to shut down small farms and ranches.

Rhino
03-30-2012, 06:06 AM
Meridian Maples, This is just a total guess why you might be on "the list" of the FDA. Don't know if this is true but i thought i heard you got a grant for equipment???? I think anytime you get more involved with government/paperwork you put your name out there as to what you are doing and how you are doing it. Getting "free" money sometimes isn't getting "free" money. Hope it goes good for you, keep us posted.

Meridian Maples
03-30-2012, 06:33 AM
Had the guy come out yesterday, he was actually from the USDA but he was doing and FDA inspection along with a USDA. Actually 2 inspections. We were randomly picked, so anyone can get this. He said this was his 2nd one this year. Yes they want a recall plan. We fortunately have a daily record of what we did each day and all of our barrels are labeled. This is for everyone producing syrup and selling it. He went through the syrup shack and wanted an explanation of how we process the syrup from how we get it out of the woods to the syrup shack, through the RO and throught the evaporator. He wanted to know how we sanitize stuff, and he wanted to see that all of our tanks were stainless or food grade and covered. The whole thing only lasted an hour.

Maplewalnut
03-30-2012, 06:39 AM
Had the guy come out yesterday, he was actually from the USDA but he was doing and FDA inspection along with a USDA. .

Glad eveyrthing went well, doesnt sound like anything more than a state inspector would ask. Not sure what he told you about the inspection but its against the law to fill out reports for USDA and FDA by one inspector!!!!