New FDA regulations to combat bioterrorism
Gonul Kaletunc
  

Let me start by saying this article is for informational purposes only and is not intended to constitute legal advice. Please contact proper authorities with your specific questions.

As a result of the federal Bioterrorism Act of 2002, the Food and Drug administration (FDA) has more responsibilities to prevent terrorists from contaminating our food supply, and to act quickly if contamination is suspected. As a food consumer you will applaud these measures. As a food producer you may be concerned about more paperwork.

The good news is that only a small percentage of the readers of this column are required to manage their business any differently. Keep reading and I'll try to help you decide if you are one of the few, and what to do if you are.

The new FDA rules are in the following four categories:

• Registration of Food Facilities

• Prior Notice of Imported Food Shipments

• Establishment and Maintenance of Records

• Administrative Detention of Adulterated Food

The new rules affect both domestic and foreign persons who manufacture, pack, distribute, or hold food.

Registration of food facilities
The new regulation requires that any domestic or foreign facility, regardless of size, that manufactures/processes, packs, or  holds food for human of animal consumption in the U.S. must register with the FDA.

Facilities exempt from registration include private residences and "farms devoted to growing and harvesting of crops, the raising of animals, or the farms process, pack, or hold the food provided that the food is consumed on that farm."

The main goal of the registration rule is to enable the FDA to determine the location and source of an actual or potential bioterorism event or an outbreak of food-borne illness so that affected facilities can be notified quickly.

Registration of a facility is usually a one time process and does not require a fee.

Prior notice of imported food shipments
If you are importing food, the FDA should be notified in advance. The purpose of the rule is to enable the FDA to decide whether to inspect the food prior to arrival at the port of entry as well as to enable the FDA to conduct inspections, prevent entry of potentially high risk shipments, and facilitate the tracking of products that could threaten public health.

Food exempt from prior notice includes food carried by individuals for personal use and food made by an individual in resdence and sent to a person in the U.S. as a gift.

Establishment and Maintenance of Records
Businesses with 10 or fewer workers have until December 2006 to comply. This rule requires that persons who manufacture, process, pack, transport, distribute, receive, hold, or import food for human or animal consumption, must establish and maintain records.

Those exempt from the regulations include among others: farms, restaurants, persons who manufacture for personal consumption, and retail food stores employing 10 or fewer employees.

The records have to identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, and identify the immediate non-transporter subsequent recipients of all foods released.

Records may be kept in any format, paper or electronic, and must be kept for 6 months to 2 years. Recipes, financial data, pricing data, personnel data, research data, and sales data are excluded from these requirements.

Administrative Detention
The FDA has the authority to administratively detain food to prevent adulterated food from entering commerce. This gives consumers even more protection than previously existed. If the detention is for perishable foods, the FDA will react as quickly as possible in case of an appeal.

Go to my website, and you'll find links to FDA sites that you can easily click on to reach FDA pages including: Registration of food facilities, prior notice of imports, administrative detention of food, and maintenance of records.
http://www.ag.ohio-state.edu/~fabe/SC2004/ws2004new.html

Gonul Kaletunc, Associate Professor and Extension Food Safety Engineering Specialist, can be reached at 614-292-0419, or kaletunc.1@osu.edu.

This column is provided by the OSU Department of Food, Agricultural, and Biological Engineering.