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FDA REGISTRATION

Taken from The Leaflet, newsletter of the Mass Maple Association
As reprinted from Maple Syrup Digest June 2004

There was much confusion last fall about the requirement for maple producers to register with the FDA and about possible exemptions that the producer may qualify for. The FDA has since specifically addressed the maple syrup industry and has ruled the following:

The 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.

(See question 2.15 at http://www.cfsan.fda.gov/~dms/ffregui3.html)
Also see: Question 1.4 at the same FDA website, which says:

Under 21 CFR §1.227(b)(2), a private residence is not a "facility" and thus, is not required to be registered. Importantly, such an establishment 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 in question is produced in a private residence or a detached building that would be considered part of the residence, such as a detached garage, the facility would not have to be registered. If, however, there is a separate sugar manufacturing/processing facility that is located on the private residence site, the establishment would be considered a mixed-type establishment and the manufacturing/processing facility would have to be registered, unless that facility qualified for another exemption (e.g., as a retail facility, 21 CFR §1.227(b)(11).).

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