FDA sugar house registration

[JoeJ]

Has anyone else seen the latest VMSA newsletter about having to register by Dec 31, 2012 with the FDA as a food production facility?

[rchase]

someone told me this yesterday and i told them they where crazy. now i dont think so. hope someone knows anout this on here.

[Bucket Head]

This is an interesting post. I'm sure producers in every state are wondering about what I'm going to ask. What happens after the 31st if you don't register- you can't make or sell syrup? And more importantly, what regulations accompany the registration and when do the inspections start?

Steve

[markcasper]

Unless you get something registered mail, you should not worry about it. There are alot of scams floating around preying to rip people off.

[JoeJ]

Mark,

I was trying to find out what other people have heard about the FDA registration. I received the VMSMA newsletter via email on Dec 6. The heading of the column was "Urgent: FDA Food Facility Registration Due"
The column states that the Food Safety and Modernization Act was signed into law in Jan 2011 to protect the American food supply. According to the column, if you boil sap to make maple syrup, you must
register with the FDA as a food production facility. There is an exemption for syrup boiled for personal consumption only and if you collect sap but do not boil it. I emailed the executive director of the VMSMA
twice with questions for clarification and he stated both times that if you boil sap and make syrup, you must register with the FDA (except for the above exemptions). Unfortunately, I do not think that this is
a hoax. Time will tell

[happy thoughts]

Has anyone else seen the latest VMSA newsletter about having to register by Dec 31, 2012 with the FDA as a food production facility?

JoeJ- I found this on the net- laws specific to your state of Vermont. It's a pdf file from UVM. There is contact info there and you might get a better response from your local Ag extension. As I read it, if you sell any amount of syrup in VT you have to be registered in your state. If you sell outside the state you must also be FDA registered.

It's all part of the US food modernization and safety act that a lot of states have already used to update their state regs. It's purpose is to help improve food safety and make it possible to trace food products if there are problems. When written in 2002 it's purpose was supposedly tracing acts of bioterrorism.

http://www.uvm.edu/extension/food/pdfs/foodprocessingregs_nov2012.pdf

Hope that helps.

[markcasper]

I don't know....something seems real strange. I was on this page reading through the posts, clicked on the back browser and was redirected to the fda website instead of the maple topics for the day. They are probably bugged into this thread b/c why would I be directed to their web site?

[Meridian Maples]

We were registered with the FDA over a year ago. We actually had an FDA inspection last year during the season. It was actually a USDA inspector that came out. They do your basic inspection, but you also have to show them your recall plan and ect. If you go to the Wisconsin Maple Syrup Producers website they have a link about this requirement. Its actually been on there for quite a while.
We were worried about this inspection, but it wasn't much. I think we were the first inspection they did in our area. We just went through their list of requirements and made sure we abided, everything went well.

[Spanielslovesappin]

Below is the link to the CFR's Part 110 that pertain to the FDA Safe food practices. It is not overly restrictive. Though they seem to want running water, a hand washing sink and procedure, hoods or covers (not tightly fitting) over open containers and the most troubling part... a bathroom. I am using the bathroom in my mom house across the street to meet that one as i do not have and could not reasonable be expected to install a septic system for a sugarhouse. Running water could come from condensation?

My take on this... i hate it...the man keeping down the little guy, this is affecting so many little people far beyond our little click.

BUT, we all already live and die by the CFR's as they pretty much regulate everything that occurs in our lives AND if you familiarize yourself with the regs, you will find that if you are making a clean quality product you are already doing 90% of what is called for.

In my 10 years of answering questions for government inspectors, i have found that for the most part if you are familiar with the reg's, you wont be caught off guard and you can tell them why you think that your process meets their reg's. Showing that you are simply aware of this law will help.

Meeting the reg's will make it easier to sell your syrup to packers, the local dinner and stores thus increasing the size of the market. And if your a back woods brewer who is keeping a low profile and consuming, gifting or selling to close friends and family then your not really on the radar of this issue.

A final thought... Everyone these days seems to be willing to trade freedoms for security, (think about that last trip to the airport) unfortunately in the eyes of Ben Franklin, we deserve neither!

The FDA Link as promised:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110

[DrTimPerkins]

...you must register with the FDA (except for the above exemptions). Unfortunately, I do not think that this is a hoax. Time will tell

Joe and all....This is not a hoax. Maple producers are required now to register with the FDA unless they fall under certain exemptions. The process is neither hard, nor terribly time consuming. Unfortunately, there are some companies out there mailing/calling with offers to get you registered for some exorbitant amount of $. You probably don't need their services....the process of registering online is really not too bad. The UVM PMRC registered the first time around....back in 2002 I think. Only thing this has resulted in so far is an email every couple of years asking us to update our registration, which we have done.

[red maples]

There is quite alot of speculation of this whole thing if you get the maple news there a very good article on this subject. Even the big producers aren''t really sure whats going to happen but they are getting ready for what ever may be coming our way.

A few quotes that I see from the article,

(maple news) Judith McGreary, director of the farm and ranch freedon alliance says: her understanding of the FSMA is that small scale producers would be exempt who both 1) make less than $.5 million adjusted gross income annually and 2) sell more than 1/2 of there product to qualified end users(direct to consumer retail, restantants, in state retailers or retailers with in 250 mile radius of the producer). Internet sales would included as a direct sale as its easy to track.

The FSMA(food safety modernization act) is not written yet. So know one really knows what to expect. Thats why so many farmers were against it because it was signed into law basically as a blank check kinda *** backwards!!! So they can write anything they want to into the act.

(maple news)Basically what they are saying it will include 5 key points, preventive controls, inspection and compliance, imported food safety, response(mandatory recall authority for the FDA)and enhanced partenership amoung the US a foriegn food safety organizations.

I still need to learn what is required for the FDA but again this is really unclear as to the size of the operation that needs to comply with registering your sugarhouse with the FDA. Its a good idea for all of us to try our very best to meet these standards anyway as it looks good with customers, and covers your butt incase of any inspection. and you need to have a paper trail. in some form a bar code system is nice but not economical for a small producer. Supermarkets require it. but a sharpie and a piece of paper works just fine. I have a hose at this point form the house but my house is only 200 ft away? Its coming.... in my opinion its best to plan for it over the next few years just to be on the safe side.

[Bucket Head]

Possibly a dumb question; All states are required to register by the 31st, or only Vermont and Wisconsin are required at the moment? I did'nt see anyone from other states chiming in. If my state Assn. "reminded" everyone to register, I must have missed it.

Does anyone know of a producer that was forced to cease operations from this? If so, what requirement(s) could not be met?

Steve

[NH Maplemaker]

Were can we find the requirements? I went to the USDA web page and FORGET IT! You could read that all day long and not find what you are looking for. Also wondering how maney here have registered? I really don't know what to do! But time maybe running out, or maybe not.

[DrTimPerkins]

Were can we find the requirements? I went to the USDA web page and FORGET IT!

Information on the FDA/FSMA can be found at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm#FAQs

I suggest you contact your state association if you have questions. The Vermont association is encouraging maple producers to register. The text of the message in the VMSMA email newsletter follows:

URGENT: FDA Food Facility Registrations Due
The Food Safety and Modernization Act (FSMA), signed into law in early 2011, aims to protect the American food supply through regulations that prevent contamination rather than responding to it. Under the old Bioterrorism Act, many maple sugar makers were exempt from registering their facility with the FDA. However, that law has been superseded by the FSMA and the way the regulation impacts the maple industry has changed.
All maple sugar facilities that process and/or package a food product must register with the FDA. The FDA makes the distinction that any sugar maker who collects and boils sap is undertaking the step of processing sap and therefore must register. The system for registering has changed to a biennial registration; in order to conform all registrations must be updated and submitted to FDA by 12/31/2012. For more information or to register, please check out the Food Safety and Modernization Act page here http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm#FAQs or contact VMSMA at XXX-XXX-XXXX.

[DrTimPerkins]

Were can we find the requirements? I went to the USDA web page and FORGET IT!

It is not the USDA. It is the FDA, which is a branch of the U.S. Dept of Health & Human Services. Website is: http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm#FAQs

[NH Maplemaker]

It is not the USDA. It is the FDA, which is a branch of the U.S. Dept of Health & Human Services. Website is: http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm#FAQs
Thank you for that clarification. Just wrong choice of Letters on my part! That is the web page I was on. There is alot of explanations ,But I don't find the registration form that can be filled out.
Thanks again

[happy thoughts]

Thank you for that clarification. Just wrong choice of Letters on my part! That is the web page I was on. There is alot of explanations ,But I don't find the registration form that can be filled out.
Thanks again

Of course you can't find it. What else do you expect from a federally mandated program? :)

It took me a while to find it but look here... you need to create an account and log in.
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/default.htm

[DrTimPerkins]

... I don't find the registration form that can be filled out.

It is part-way down that page. Section IC.3.5.

IC.3.5 What form do I use to renew a food facility registration?
Registrants must use Form 3537 to register, update, or renew a registration. Facilities may register online via the Internet at www.fda.gov/furls, which operates during business hours from 7:00 am to 11:00 pm U.S. Eastern Time. Facilities may also register by mail or fax or for multiple submissions, by CD-ROM.

Registration by Paper (Mail or FAX) or CD-ROM4

Step by Step Instructions

[Sunday Rock Maple]

I just went to the link and did it --- took about 15 minutes.

[MapleChaser]

Thanks Dr. Perkins for the on line link to register very easy to do.
MC

[twitch]

What if you don't do it

[GeneralStark]

What if you don't do it

Big Brother comes knocking. Then, the much feared "FDA Sugarhouse Cliff".:o

[lakeview maple]

Big Brother comes knocking. Then, the much feared "FDA Sugarhouse Cliff".:o LOL, not the feared Sugarhouse cliff

[AdirondackSap]

I thinks this all about the big producers who can afford all these regulations trying to push out the mom and pop guys just like the big dairy farmers did

[Thad Blaisdell]

Yes thats it.... nothing to do with just the govt wanting their hand in everybodies cookie jar.

[lakeview maple]

Its ALL ABOUT THE GOV ,wanting to stick there nose in ,its just a matter of all of us making sure that our equipment is were it should be ,and our product safe.This is were everyone from 10 taps to 10 thousand needs to just quit pointing fingers and get your equipment at the level the GOVT wants.

[delivron]

Finally a clear definition from the FDA.

9.14 Q: Are maple syrup producers “farms” and, thus, exempt from registering?

A: The response to this question depends upon the activities of the maple syrup producer. The activities of maple syrup producers customarily consist of two types: gathering sap from sugar maple trees and concentrating the sap through the application of heat to make syrup. Gathering sap is "harvesting," which is included in the definition of farm (21 CFR 1.227(b)). The “farm” is exempt from registration. However, concentrating sugar maple sap by heating is a form of manufacturing/processing (21 CFR 1.227(b)). Accordingly, a facility that concentrates sugar maple sap is performing a manufacturing/processing activity and is required to be registered, unless all of the concentrated sap is consumed on the farm or another farm under the same ownership.

So if you boil you must register.

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm331959.htm?source=govdelivery

15.3 Q: Most sugar makers in Massachusetts operate from their own property, on which their private residence is also located. Are these sugar makers required to register the facility that is on their property and used for sugar production?
A: Under 21 CFR 1.227(b)(2), a private residence is not a "facility" and thus, is not required to be registered. A private residence must meet customary expectations for a private home and does not otherwise include commercial facilities in which a person also happens to reside. A private residence includes the parcel of real property on which the residence is located. Accordingly, if the sugar production occurs in the private home or in a detached building that meets customary expectations for use as part of the private home, such as a detached garage that has not been modified for manufacturing and processing so that it can no longer practically be used as customary for a garage, the home or building would not have to be registered. If, however, a separate building located on the real property of the private residence site is used as a sugar manufacturing or processing facility and does not have a use as customarily expected for a private residence, that facility must be registered, unless that facility qualifies for another exemption (e.g., as a retail facility; 21 CFR 1.227(b)(11)).

[tuckermtn]

Accordingly, a facility that concentrates sugar maple sap is performing a manufacturing/processing activity and is required to be registered, unless all of the concentrated sap is consumed on the farm or another farm under the same ownership.

So if you boil you must register.

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm331959.htm?source=govdelivery


So if I boil using 15 % red maple sap I don't need to register? Just sugar maple sap?

[twitch]

there you go tucker you found loophole all I have to know if find some more reds to tap lol


Accordingly, a facility that concentrates sugar maple sap is performing a manufacturing/processing activity and is required to be registered, unless all of the concentrated sap is consumed on the farm or another farm under the same ownership.

So if you boil you must register.

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm331959.htm?source=govdelivery


So if I boil using 15 % red maple sap I don't need to register? Just sugar maple sap?

[maple flats]

I just got an email stating the the FDA has extended the registration deadline until 1/31/13 because they were not ready until 10/22/12 to process, 3 weeks after the designated start date.

[maple flats]

I just went to the FDA link Dr Tim posted. I created an account and set a password. After that I don't find what to do. Is that it? I did not find any details and did not enter any products I produce. Where is this info entered?

[lakeview maple]

I recieved a phone call today telling me they were sending me a survey and I should have it in the next week,Al

[NH Maplemaker]

There is about 11 steps before you are done! After you set your ID and pass word there is a line that said register your facility. Had the same problem, I also got half done and the link shut down ! Had to back a few hours later to finish.

[red maples]

I just got an email stating the the FDA has extended the registration deadline until 1/31/13 because they were not ready until 10/22/12 to process, 3 weeks after the designated start date.

Yes I did see that too. there was a red box on when I went to the site.

[maple flats]

Sounds like typical government operation. They impose something and then make it difficult to see how to adhere and follow.

[3% Solution]

Hey guys,
I maybe all wet here but ......... if you sell directly to the comsumer you do not have to register.
So the smaller producers, such as myself, are not effected by this regulation.
It also states that if you sell more (dollar wise) to comsumers than you do to other buyers (selling your bulk), you are exempt.
So many of you are not required to register.

[farmall h]

Dr.Tim, how does one get a printed form. I went online (without registering) and was able to get to the printed version of the form but was not able to open the file icon. Says it requires Adobe Acrobat 6. Pretty sure I have that...how do I open the file?

[DrTimPerkins]

I didn't do it that way, so not sure. If you click the file icon it should open. If it doesn't, try right-clicking on it and saving it to your hard drive, then open it from there. If neither of those work, try upgrading your Adobe Acrobat Reader.

[SevenCreeksSap]

Hey guys,
I maybe all wet here but ......... if you sell directly to the comsumer you do not have to register.
So the smaller producers, such as myself, are not effected by this regulation.
It also states that if you sell more (dollar wise) to comsumers than you do to other buyers (selling your bulk), you are exempt.
So many of you are not required to register.

Okay, so which of the thousands of lines in the FDA document are you reading this? about selling directly to consumers. I would think that would mean gate sales, farmers markets, flea markets ect. I'm having trouble with all the information and picking out something to our benefit. Its hard to imagine they left a loophole.

I had heard about this when it was being rammed through and there was talk about the input from people who grow vegetables to sell at farmers markets. I wonder if this is the same exemption as for them.

[3% Solution]

Good afternoon 7,

Well when we are dealing with standards and rules we need to look at all of the info that is given to us (no offense to anyone here) and not just look at the first scary part.

So with that said, let's start digging into this matter.

Go to Post # 27 ..............
Look at the answer to question # 15.3 ...............
Specifically, read the last sentence slowly .................
The key here is to refer to 21 CFR 1.227 (b) (11)). ..... you can highlight and copy this to your search on your web browser ...............
Now when you get to this page, you will find this is a list of definitions .........
Scroll down to where you find "Retail Facility" .........
Read this and it tells you (in between the lines) that many "maple producers" are operating in this capacity ....... a "Retail Facility"

So now that we have read that, Food Safety is alive and well in this act and I don't think the feds are trying to shut any one down.
They are just trying to clean up the messy operations out there and I bet we all know at least one!!

Being retail ...... if I sell syrup to someone and their family gets sick because of it, they know right where they got it from .... ME.
Now if I wholesale, I need to register so my bad syrup can be traced back to me, however they may do that.
That is all that is being done here.

And no I do not work for the federal government.
However, I do work with federal standards in my job.

I hope this helps

dave

[Jeff E]

I orignally registered in 2008. It requires updating every 2 years, so I went back in and did the update.
Hang onto your registration Account ID and password, you will need it in the future.

I originally registered when I started selling bulk syrup and wholesale to local stores. A few of the stores asked for my FDA registration information for them to carry my syrup.

If you set aside 30 minutes, you will get registered, and won't have to worry about it, and to be able to provide that information to your customers, as well as inspection dates, seems like a good marketing tool. It has made a difference in acceptance of my product as legitimate and safe.

I have not had a USDA inspection, but have had several State inspections.

[SevenCreeksSap]

Good afternoon 7,

Well when we are dealing with standards and rules we need to look at all of the info that is given to us (no offense to anyone here) and not just look at the first scary part.

So with that said, let's start digging into this matter.

Go to Post # 27 ..............
Look at the answer to question # 15.3 ...............
Specifically, read the last sentence slowly .................
The key here is to refer to 21 CFR 1.227 (b) (11)). ..... you can highlight and copy this to your search on your web browser ...............
Now when you get to this page, you will find this is a list of definitions .........
Scroll down to where you find "Retail Facility" .........
Read this and it tells you (in between the lines) that many "maple producers" are operating in this capacity ....... a "Retail Facility"

So now that we have read that, Food Safety is alive and well in this act and I don't think the feds are trying to shut any one down.
They are just trying to clean up the messy operations out there and I bet we all know at least one!!

I hope this helps

dave

3% - That really did help, thanks. I read further and found this to either muddy or clarify the sap tank a little more

5.1 Q: [Added December 2012] How did FSMA clarify the definition of “retail food establishment?”

A: FSMA requires FDA to amend the definition of the term "retail food establishment" in 21 CFR 1.227(b) to clarify that, in determining the primary function of an establishment or a retail food establishment, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include:

The sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed;
The sale and distribution of such food through a community supported agriculture program; and
The sale and distribution of such food at any other such direct sales platform as determined by FDA.
5.2 Q: [Added December 2012] What does “community supported agriculture program” mean for purposes of the “retail food establishment” definition?

A: The term “community supported agriculture program,” which is used in the definition of “retail food establishment,” means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. State agencies may purchase shares or subscribe to a community supported agriculture program on behalf of individual Senior Farmers’ Market Nutrition Program (SFMNP) participants (7 CFR 249.2).

So- If I am reading the monstrous code of federal regulations right, and I do not assume I am, then for those of us that do NOT wholesale pack and send to another syrup dealer for repackaging, may not have to register (at this time, I'm sure it's coming)

If I'm reading this right, then gate sales, farmers markets, flea markets, or give aways would not cause me to have to register.

I know I may seem kind of dense here but come on, the CFR seems to be written specifically to be unclear. I'll register if I have to, and I am building the cleanest safest operation I can, following the food safe advice by most of you here, and just standard logic and cleanliness in a food operation. but I really dont have the slightest interest in the fed Gov coming to see me for any reason. its almost never a good thing and always, always costs money somehow. There is no way you could convince me that my supposed representative actually read or understood a word of this before they voted, except maybe the safety minded title.

[3% Solution]

And again it is direct sales of the product.
No registration needed for a lot of us.

[Homestead Maple]

For any one that has had a FDA inspection<
What are they looking for when an inspection is done and what questions do they ask you?

[red maples]

to add somemore confusion to this its for everyone. if you harvest boil and bottle sap / syrup you are a food production facility and you must register you facility. period.

Posted in the gather tanks...NHMPA news letter.

I am not typing the whole thing...
"Accordingly, a farm that both gathers and concentrates sugar maple sap is a "mixed-type" facility that is required to be registered, unless all sap is consumed on the farm or another farm under the same ownership"

I just have a question....There isn't a specific catagory for maple syrup what does it go under or do we just type it in the "other" section?

[JoeJ]

When I registered, I typed "Maple Syrup" into the "other" section.

[NH Maplemaker]

Im the other section I put pure maple syrup and pure maple candy! JimL.

[red maples]

OH pure....forgot pure!!! :) I forgot to do the honey and eggs too. but it says that you have 15 days to edit the registration as well as the dead line was extended to january 31 anyway.

[SWEETER CREATIONS]

Once you put in all your info and have a confirmation number do you get a written certificate?

[red maples]

Once you put in all your info and have a confirmation number do you get a written certificate?

I got an email. that was about it. I just printed out the filled out registration. no certificate.

[tuckermtn]

just registered with the FDA, filled out my USDA agCensus report, and filed my business update with the New Hampshire Secretary of State...

get em all done at once- good thing to do on a Sunday night with no football. Rooting for the Packers and Patriots...

[red maples]

FDA Done just have to do the other 2. Eric how long did the Ag census take you? envelopes a little THICK!!!

[johnallin]

Just finished the FDA registration also. Thanks to the help from all of you; it was pretty straight forward and if it helps us promote product so much the better.

[SeanD]

A few quotes that I see from the article,

(maple news) Judith McGreary, director of the farm and ranch freedon alliance says: her understanding of the FSMA is that small scale producers would be exempt who both 1) make less than $.5 million adjusted gross income annually and 2) sell more than 1/2 of there product to qualified end users(direct to consumer retail, restantants, in state retailers or retailers with in 250 mile radius of the producer). Internet sales would included as a direct sale as its easy to track.



I don't get the Maple News, but I appreciate your citing this, Brad. Does anyone know if McGreary's understanding of the FSMA is accurate? I can't find this in the FDA regs.

Based on all of the stuff I can find, everyone who boils sap in a sugar house that is not part of their house needs to register, but this part she has about the size of the operation would make a huge difference for many of us.

Sean

[steve J]

Well I had not registered did not realize I had to and here it is March 6th I am going to try and register now hopefully they do not give me grief.