Hi all,

I'm forwarding this from organic bee list:

What is your take on this?

Clay
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Food facilities must register with the FDA. Read carefully to see if you
qualify. If you do, don't wait. These guys aren't kidding.Honey is on the
list. Most hobby outfits will be exempt. Some sideline and most all
commercial outfits need to heed this message. Don't bet you are exempt. Read
the rules.
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New Food Regs take effect in 6 weeks. Honey is on the list.


Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002; Interim Rule

The U.S. Food and Drug Administration (FDA) has issued an interim final
regulation for the registration of food facilities. Domestic and foreign
facilities that manufacture, process, pack or hold food for human or animal
consumption in the United States are required to register with the FDA by
December 12, 2003. Registration is one of several tools that will enable FDA
to act quickly in responding to a threatened or actual terrorist attack on
the U.S. food supply. In the event of an outbreak of food-borne illness,
registration information will help FDA and other authorities determine the
source and cause of the event. Registration will also allow FDA to more
quickly notify facilities to protect themselves against terrorist activity.
All facilities processing food regulated by the FDA are subject to this
regulation. Section 305 of the Public Health Security and Bioterrorism
Preparedness and Response Act (Bioterrorism Act) of 2002 defines a food
processing facility as any establishment, structure, or structures, such as
a factory or warehouse, which manufactures, processes, packs, or holds food.
The registration requirement does not apply if a facility is a private
residence, farm, restaurant, retail food establishment, nonprofit food
establishment, and fishing vessel. A facility is exempt from registering
only if all of its activities are included in one or more exemption. As an
example, a farm that raises vegetables and sells the produce to consumers as
its primary function, i.e. retail, is exempt from registration. However, a
farm that raises vegetables for packing and sale to a distributor must
register.
The regulation requires the registration of the location of any facility
involved in the manufacture/processing of food. It does not require the
registration of individuals involved in food production or processing.
Information derived from the registration database may be shared with States
and other federal agencies. The registration information contained in the
database of food processing facilities is not subject to disclosure under
the Freedom of Information Act. Any information derived from the list of
facilities or registration documents that would disclose the identity or
location of an owner, operator, agent, or registered facility is not subject
to public review.
If you are an owner or operator of a food processing facility and it is not
exempt from the registration regulation, the facility must be registered
with the FDA. Failure to register, update, or cancel a registration as
required is a prohibited act. The FDA can bring civil or criminal action,
cancel a registration, or hold food articles for those in violation of this
regulation.
Owners or agents of appropriate facilities may register electronically over
the internet (http://www.cfsan.fda.gov/~furls/ovffreg.html), by mail with
Form 3537 or a CD-ROM containing multiple submissions, or by FAX. There is
no fee for this registration. Registration is a one-time requirement for
each food processing facility. Change in mandatory information or
cancellation of registration must be submitted to FDA within 60 days of the
reason for the event.
Written or electronic comments on the interim regulation may be provided to
the FDA by December 24, 2003. Written comments should be submitted to the
Division of Dockets and Management, Food and Drug Administration, 5630
Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Current information on FDA's efforts
under the Bioterrorism Act and an electronic copy of the regulation may be
viewed at http://www.fda.gov/oc/bioterrorism/bioact.html.

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Kim Flottum
Editor, Bee Culture Magazine http://www.beeculture.com/beeculture/index.html