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Updated FDA Interpretations Now Include Maple Registration

Registration part of effort to protect food supply from terrorism

February 2004

Note: The information provided has been gathered from information provided by the FDA on their website. Producers should consult with their legal adviser and the Food and Drug Administration regarding their individual situation.

 

In response to differing interpretations as to wheter or not maple syrup producers were required to register with the Food and Drug Aadministration as part of the bioterrorism legislation, the FDA has now specifically included maple syrup making. In its most recent interpretations (February 2004), the FDA has stated that it will require maple syrup producers to register unless all syrup produced is consumed on the farm.

This clarification was published by the FDA in February 2004 in the "Guidance for Industry,Questions and Answers Regarding Registration of Food Facilities (Edition 3)"

Maple syrup makers can register with the Food and Drug Aadministration by filing Form 3537. Registration can be through the Internet, by surface mail (paper or CD-ROM), or by fax.

Full information is available at the FDA's web site at http://www.cfsan.fda.gov/~dms/fsbtact.html

Earlier, it appeared that maple syrup making would be exempt as part of farming activity. However, FDA now considers the sugar house as a "mixed-type" facility. The text of the interpretation as quoted from the FDA website is as follows:

2.15 Q: [Added February, 2004] Would maple syrup producers be exempt from registering as farms?
A: The response to this question depends upon the activities of the maple syrup producers.  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.

 

Information about Form 3537 is available at http://www.cfsan.fda.gov/~furls/papercd.html and the actual form may be downloaded as a pdf file at http://www.cfsan.fda.gov/~furls/frm3537.pdf

Copies of Form 3557 are also available from the secretary of the Indiana Maple Syrup Association.

Because maple syrup makers may be involved in other activities such as roadside sales, following is additional selected information taken from the FDA website, http://www.cfsan.fda.gov/~dms/fsbtac16.html and

Further explanation of the regulations is also presented at the FDA website http://www.cfsan.fda.gov/~furls/ffrmqa.html#requirement which follows immediately after.


Who Must Register? (from http://www.cfsan.fda.gov/~dms/fsbtac16.html )


Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food (subject to FDA's jurisdiction) for human or animal consumption in the U.S.
Domestic facilities are required to register whether or not food from the facility enters interstate commerce

What Facilities Are Exempt?

Non-profit establishments
Retailers
Farms
Restaurants
Fishing vessels, except those that engage in processing as defined in FDAs seafood HACCP regulations (21 CFR 123.3(k))
Facilities regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture (USDA)
Note: USDA regulates meat products, poultry products, and egg products


Definitions

Farm: a facility in one general physical location devoted to the growing and harvesting of crops for food and/or the raising of animals for food (including seafood)
Washing, trimming outer leaves, and cooling produce are considered part of harvesting when done on a farm
E.g., apple orchards, dairy farms, feedlots, and aquaculture facilities

Farm includes a facility that . . .


Packs or holds food if all food is grown or raised on that farm or consumed on that farm or another farm under the same ownership; or
Manufactures/processes food, if all of the food used in such activities is consumed on that farm or another farm under the same ownership

 

Further definition of the above terms, which may also be viewed at the FDA website http://www.cfsan.fda.gov/~furls/ffrmqa.html#requirement, is quoted below:

Do I need to register?

If your facility manufactures, processes, packs, or holds food for human or animal consumption in the United States, you must register the facility with FDA by December 12, 2003. The only exemptions are:


* A foreign facility is exempt from registering if food from the facility undergoes further processing (including packaging) by another facility outside the United States. The first facility is not exempted from registration if the processing or packaging activities of the subsequent facility are limited to affixing a label to a package or other de minimis activity. The facility that conducts the de minimis activity also must register.

* The following domestic and foreign facilities also do not need to register:

* Private residences of individuals, even though food may be manufactured/processed, packed, or held there.

* Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems.

* Transport vehicles that hold food only in the usual course of their business as carriers.

* Farms, i.e., facilities in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves, and cooling of produce are considered part of harvesting.

The term "farm" also includes facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership, and facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

A farm-operated roadside stand that sells food directly to consumers as its primary function would be exempt from registration as a retail food establishment.

* Restaurants, i.e., facilities that prepare and sell food directly to consumers for immediate consumption, including pet shelters, kennels, and veterinary facilities that provide food directly to animals. Facilities that provide food to interstate conveyances, such as commercial aircraft, or central kitchens that do not prepare and serve food directly to consumers are not restaurants for purposes of the rule.

* Retail food establishments, such as groceries, delis, and roadside stands, that sell food directly to consumers as their primary function, meaning that annual sales directly to consumers are of greater dollar value than annual sales to other buyers.

An establishment that manufactures/processes, packs, or holds food and whose primary function is to sell food directly to consumers, including food that the establishment manufactures/processes, from that establishment is a retail food establishment and is not required to register.

* Nonprofit food establishments, which are charitable entities that meet the terms of § 501(c)(3) of the Internal Revenue Code and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S. Central food banks, soup kitchens, and nonprofit food delivery services are examples of nonprofit food establishments.

* Fishing vessels that harvest and transport fish. Such vessels may engage in practices such as heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel and remain exempt.

* Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture, that is, facilities handling only meat, poultry or egg products.