Do you need a to Register with FDA? Some Answers

[delivron]

Here are a few answers from the FDA web site.

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.

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)).
.
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.


Source: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm331959.htm

Complete PowerPoint Presentation available on request.

[red maples]

So basically yes. if you make maple syrup and plan to sell in any market yes you need to register. But if you harvest it and sell it as sap according to 9:14 you are a farm and not a processor/manufacturer and do not need to register. what ever.

[delivron]

While I am not an expert on the topic. I agree with your conclusion with the exception of local Farmer's Markets or similar community sanctioned markets could be considered an exception.

Should you not register a buyer has the right to reject your product because you might create a problem in the buyers protection of the food chain. Likewise if you sell barrels to packers you should register in my opinion.

Also I have corrected the repeated paragraph to read as follows
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)).

[SeanD]

Delivron,

Thanks for posting these so clearly. There's one more I have been using to determine whether or not to register. It's the one about the amount of sales being less than .5 million or something about the percentage of product sold in direct sales. Of course, now I can't find it! Do you know that one?

I've been focusing in on that last line of 15.3Q:

that facility must be registered, unless that facility qualifies for another exemption (e.g., as a retail facility; 21 CFR 1.227(b)(11))


At the time I found it and read it, it seemed like I (and most of us) were exempt. Do you know where that one was?

Thanks,
Sean

[wiam]

Henry Marcus, Vt dept. Ag was a speaker at Caledonia County Association meeting Thursday night. He said he had talked with FDA and they told him if you make maple syrup you need to register.

[The Sweet Spot]

When did this start? Last year here in Michigan you did not have to do anything unless you sold more then $10,000.00 worth or something like this. You could put on your lable (not inspected by the dept. of ag.) and you were good, if you produced under this set amount. Is this registration only in certin states? I am inspected by the DEPT. of AG. so I know I'm covered.

[shane hickey]

The sweet spot the inspector of ag is totally different
Then the fda inspectors everyone that process syrup
Has to register its federal so it means the nation
You just have a health inspector now correct?
Now you'll have a fda inspector mine already came out.

[markct]

so who do we contact to register? or is there a form we request or can find somewhere?

[shane hickey]

My health inspector had the form so i would start
There. There is a web page but it was to confusing
for me.

[markct]

I went and registered online, page after page asking almost the same info over and over, but its done atleast so im legal and dont have to worry now

[Flat Lander Sugaring]

so i dont have to register, which I dont care because I wasnt going to in the first place!!

[farmall h]

I have completed the form....have not faxed it in yet because I cannot find any vocabulary regarding Maple Syrup production. Do I write it in on page 6of 10 or write it in on page 8 of 10??

[wiam]

Henry Marcus (Vt dept of Ag) said to use category "other"

[hounder]

Can someone explain this a little more for me. I thought that if you sold from your farm, and you labeled it properly with name, address and phone you did not have to do anything else. I claim the income on taxes, but want to register with the state or feds if I have to. We plan on adding on each year, so I am sure we will sell to restaurants and put in markets somewhere down the line. We are in NY if that makes any difference.

[gmcooper]

Hounder,
From everything I have read and heard on the FDA registration maple producers are required to register. It does not matter where the syrup is sold from the issue is the syrup was processed.
As far as New York you probably need a license from the state to produce and sell maple syrup. Other from NY can answer that better.
Mark

[sjdoyon]

Latest from the Maple mainline:

Information for Vermont Maple Producers:

Producers may be aware that the FDA is requiring maple operations to register before the
end of 2012. Here is information that the FDA has shared regarding maple:
“FDA believes that 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" as defined in the Interim Final Rule (21 CFR
§1.227(b)(3)). However, concentrating sugar maple sap by heating is a form of
manufacturing/processing. (21 CFR §1.227(b)(6)). Accordingly, a farm that both gathers and
concentrates sugar maple sap is a "mixed-type" facility that is required to be registered, unless all
of the concentrated sap is consumed on the farm or another farm under the same ownership.”
(Henry Marckres interprets this as meaning people who only sell sap don’t need to register).

Even if you have previously registered your facility with FDA (at any time before Oct 22, 2012),
you are required to re-register your facility every 2 years (in Oct- Dec 31 of the even numbered
years- 2012, 2014, etc). Even if you are already inspected by FDA you still need to do this food
facility registration with the FDA. The Registration information is available from:
http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm

[spencer11]

it also says if you process the sap on you own property(like where your house is) ans thats where your sugar house is, you dont need to register, and if your sugar house can be used a another building(garage or shed etc) in the off season you do not need to register, or if you sell over half your sryup retail you dont need to register

[SeanD]

Spencer,

Do you know where you found the info about retail sales? I know I read it somewhere, but now I can't find it again. I am beginning to think I imagined it.

It is the big exemption I think many of us hobbyists will have, but I want to go right to the source to be 100% sure.

Sean

[spencer11]

someone posted it in another thread about the fda, they might of had a link to it or pasted it in the reply

[Teuchtar]

Thanks for posting these guidelines. I've been registered for years, without requiring renewal, so this was my first time facing that new 2-year renewal cycle. It was actually a snap to renew. Just a couple of pages of addresses for the farm and for residence to review and update. Like everybody else, I despise the grasping reach of needless bureaucracy, but in-fact the renewal only took a couple of minutes.

[hounder]

Teuchtar, what is required for NY specifically then? What is expected from FDA inspection? My only concern is we do not have running water at the building that we produce in nor have any plans for it. Sugarhouse is on the property, but not at the house. Also, we sell Christmas trees from those buildings where we boil syrup? Certainly sell more than half retail, but what does that mean if you sell bulk? As long as less than half of what we produce goes to bulk we still are good?

[325abn]

Don't need to, no no no dont need to. :)

[SeanD]

Found where I got it. It was the posting by Red Maples where he quoted the Maple News, who was quoting Judith McGreary from the Farm and Ranch Freedom Alliance. So, the source is not the FDA. I don't know if it is accurate.


(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.

This came from Post 11 in this thread: http://mapletrader.com/community/showthread.php?17996-FDA-sugar-house-registration

Again, I have no idea if it is accurate. If anyone can officially debunk or verify this, I'd appreciate it.


Sean

[Teuchtar]

I'm still learning the updated NY requirements, so can't comment. Hoping not for bad news :-(
FDA inspection was a new box to check, not in the original registration process circa 2005. We had to declare the months operation for the 'harvest', so I said feb/mar/apr. I honestly don't know what to expect there. I'm sure someone from the govt will stop by to "help" me understand. Last weekend I evicted all the mice, and swept the sugarhouse nice and clean. The NY regs describe cleanliness expectations. What else could the Feds object to ? Evidence of improper chemical storage ? Evidence of adulteration ? Blatenly wrong or missing labelling ? Inconsistencies in your declaration ? Not sure.
I sell all retail in small containers and don't bulk, so can't comment on the bulk/retail mix.