New Food Regulations take effect December 12. Honey is on the list.

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.
New Food Regulations take effect December 12. 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

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

 

FDA Corrects Errors on Charts for Bioterrorism Act. Review the corrections.

"Public Health Security and Bioterrorism Preparedness and Response Act of 2002" -(pdf)

FDA - Food Facility Registration Questions and Answers - Explains general and technical information about what you need to know and what to do about it. -(pdf)

Fact Sheet on FDA'S New Food Bioterrorism Regulation:Interim Final Rule - Registration of Food Facilities

Instructions for Food Facility Registration Form 3537 -(pdf)

Food Facility Registration Form 3537 -(pdf)

National Honey Board's Information - Keeping Food Safe - How the New Bioterrorism Regulations May  Impact Your Honey Business -(pdf)

Instructions for Cancellation of Food Facility Registration Form 3537a -(pdf)

Cancellation of Food Facility Registration Form 3537a -(pdf)

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Department of Entomology, Cornell University, Ithaca, NY 14853 

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