Health and Human Services issued final interim rules on two Food and Drug Administration regulations under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. These two rules address the registration of domestic and foreign food facilities and the prior notice that must be submitted to Food and Drug on all shipments of human and animal food imported or offered for import after December 12, 2003.
Registration may be done by completing a paper form, submitting a CD-ROM to FDA with all relevant registration information or online via the Internet. The paper form is available on the internet. To print a copy please click on the following:
http://www.cfsan.fda.gov/~furls/papercd.html
The online registration will be available on October 16, 2003. Registrants will have access to the online registration 24 hours a day 7 days a week.
Whatever method of registration is chosen, it must be done by December 12, 2003. Failure to register is a prohibited act and the Federal Government can bring a civil action to ask a Federal court to enjoin persons who commit a prohibited act, or it can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act. If a foreign facility fails to register imports of food from that facility is subject to being held within the port of entry for the article unless otherwise directed by FDA or Customs. FDA plans to issue enforcement guidelines. These guidelines will be available to the public and FDA will publish a notice of availability in the Federal Register.
The registration only pertains to facilities that manufacture/process, pack, on hold food, as defined in the regulation, for consumption in the United States.
Prior notice for all shipments of food must be submitted to Food and Drug beginning on December 12, 2003. The notice can be submitted through ABI/ACS or FDA's Prior Notice (PN) System Interface. The notice can be sent no more than 5 days before arrival but must be submitted at least 2 - 8 hours prior to arrival. The following gives the times for the different modes of transportation.
Arrival by land by road - 2 hours before arrival
Arrival by Air or by land by rail - 4 hours before arrival
Arrival by water - 8 hours before arrival
Mail shipments can not be mailed until prior notice has been received
and confirmed electronically by FDA. A confirmation of the FDA receipt
of prior notice must accompany the parcel.
The prior notice systems will be available 24 hours a day, 7 days a week for information submissions beginning December 12, 2003.
The food subject to prior notice requirements is food that is imported, or offered for import, to the United States for humans and other animals. Food is defined by section 201(f) of the Federal Food, Drug, and Cosmetic Act. That section defines food as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article. Some more examples of "food" are:
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 and frozen foods
Bakery goods, snack food, and candy
Live food animals
Animal feeds and pet food
The prior notice can be submitted by any individual with knowledge of the required information, including, but not limited to, brokers, importers, and U.S. agents.
You can obtain the required information to complete the prior notice from the fact sheet on that subject on the FDA website. To access that fact sheet please click on the following:
http://www.cfsan.fda.gov/~dms/fsbtac13.html
Failure to submit adequate prior notice information on an imported food shipment will cause the shipment to be subject to refusal and holding at the port or in secure storage. It appears from reading the information made available by Food and Drug,at this time, they will use discretion in enforcement of the above.