[Market-farming] Re: fda regs

Joan Vibert joan at windwalker-farm.com
Wed Oct 22 14:52:28 EDT 2003

This is the update that I received a few days ago from Kansas State.  You
will notice at the bottom that farms are exempted, so I won't register.

Joan Vibert
Windwalker Farm
Ottawa, Kansas

An update on the FDA food processing regulations:

Overview & Background
The Law:
The Public Health Security and Bioterrorism Preparedness and Response Act of
2002 (the Bioterrorism Act) requires domestic and foreign facilities that
manufacture, process, pack, or hold food for human or animal consumption in
the United States to register with the FDA by December 12, 2003.

Who must register?
Owners, operators, or agents in charge of domestic or foreign facilities
manufacture/process, pack, or hold food for human or animal consumption in
United States are required to register the facility with the FDA.

Domestic facilities are required to register whether or not food from the
facility enters interstate commerce.

Foreign facilities that manufacture/process, pack, or hold food also are
required to register unless food from that facility undergoes further
processing (including packaging) by another foreign facility before the food
is exported to the United States. However, if the subsequent foreign
performs only a minimal activity, such as putting on a label, both
are required to register.

Examples of FDA-regulated Foods
•Food and food additives for man or animals
•Dietary supplements and dietary ingredients
•Infant formula
•Beverages (including alcoholic beverages and bottled water)
•Fruits and vegetables
•Fish and seafood
•Dairy products and shell eggs
•Raw agricultural commodities for use as food or components of food
•Canned foods
•Live food animals
•Bakery goods, snack food, and candy

Is there a registration fee?
No registration fee is required.

What facilities are exempted from registration?
Exempt from registration are farms; retail food establishments; restaurants;
non-profit establishments that prepare food for, or serve food directly to,
consumers; fishing vessels not engaged in processing as defined in 21 CFR
123.3 (k)|; and facilities regulated exclusively throughout the entire
facility by the U.S. Department of Agriculture.

For more information, visit the FDA's registration Web site at

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