Current Issues / Bioterrorism Act  

Bioterrorisme Act

U.S. Food and Drug Administration

U.S Food and Drug Administration website
http://www.fda.gov

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Secretary of Health and Human Services to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply. To carry out the provisions of the Bioterrorism Act, FDA published, on October 10, 2003, an interim final regulation, Registration Of Food Facilities, which 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. Under this interim final regulation, all affected facilities must register by December 12, 2003. In the event of a potential or actual bioterrorism incident or an outbreak of food-borne illness, facility registration information will help FDA to determine the location and source of the event and permit the agency to notify quickly facilities that may be affected. Facilities can register online via the Internet, by completing a paper form, or submitting to FDA a CD-ROM with relevant registration information. The online registration system is available for use since October 16, 2003. For assistance with online registration: in the U.S call 1-800-216-7331 or 301-575-0156; from elsewhere call 301-575-0156; or send a fax to 301-210-0247. Requests for assistance also may be emailed to furls@fda.gov. Beginning October 16, 2003, the Online Registration Help Desk is staffed on business days from 7 AM until 11 PM U.S. Eastern Time.

This new regulation pertains only to facilities that manufacture/process, pack, or hold food, as defined in the regulation, for consumption in the U.S. Examples of "food" include:

  • 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 (including chewing gum)
  • Live food animals
  • Animal feeds and pet food

Official link to:
http://www.cfsan.fda.gov/~dms/fsbtac12.html

FAQS :
http://www.cfsan.fda.gov/~furls/ffrmqa.html
http://www.cfsan.fda.gov/~furls/acctqa.html

We strongly advise you to get familiar with the information above (see links) before beginning the following stages:

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1- Create an account:

To create an account : https://www.access.fda.gov/oaa/
See steps by steps instructions by clicking on SEE INSTRUCTIONS inside the box on the left menu “new users” or go directly to “Create New Account”.

If your account creation was successful, the following message will be displayed: You have successfully created an Account. Your account ID is... and a button to login to the FDA Industry Systems home page

1.A
Before login to register your facility, you must have a U.S agent to complete the registration. A U.S. agent means a person residing or maintaining a place of business in the U.S. whom a foreign facility designates as its U.S. agent for purposes of the registration regulation. The U.S. agent acts as a communications link between FDA and the foreign facility. A firm's commercial business in the U.S. need not be conducted through the U.S. agent designated for registration purposes.

A U.S. agent cannot be in the form of a mailbox, answering machine or service, or other place where an individual acting as the foreign facility's U.S. agent is not physically present.

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2- Register your facility:

https://www.access.fda.gov/oaa/
http://www.cfsan.fda.gov/~furls/ffquick.html

Choose the LOGIN button from the FDA Industry Systems page, or the Registration of Food Facilities Home Page to get to the Login page. Login with your account ID and Password. (For help with creating an account see the Create New Account Quick Start Guide.)

Choose Food Facility Registration from the list of FDA Unified Registration and Listing Systems. Select "Register a Food Facility" from the menu buttons.

Help desk: http://www.cfsan.fda.gov/~furls/helpol.html

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3- PRIOR NOTICE

The Act requires that FDA receive prior notice before food is imported or offered for import into the United States. Advance notice of import shipments allows FDA, with the support of the Bureau of Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies.

On October 9, 2003 the Department of Health and Human Services (HHS) issued two new FDA rules to enhance the security of the food supply (See press release.) Under the prior notice regulation issued, prior notice must be provided for food products entering the United States beginning December 12, 2003.

Prior Notice official webpage: http://www.cfsan.fda.gov/~pn/pnoview.html
General information on Prior Notice: http://www.cfsan.fda.gov/~pn/cpgpn5.html
Fact sheet on Prior Notice : http://www.cfsan.fda.gov/~dms/fsbtac13.html
Help desk: http://www.cfsan.fda.gov/~furls/helpf.html

Reference
When must prior notice be submitted? Prior notice must be received and confirmed electronically by FDA no more than 5 days before arrival and, as specified by the mode of transportation below, no fewer than:

  • 2 hours before arrival by land by road
  • 4 hours before arrival by air or by land by rail
  • 8 hours before arrival by water
  • The time consistent with the timeframe established for the mode of transportation for an article of food carried by or otherwise accompanying an individual if it is subject to prior notice (The food must also be accompanied by the FDA confirmation.)

In addition, prior notice must be received and confirmed electronically by FDA before food is mailed by international mail. (The parcel must be accompanied by confirmation of FDA receipt of prior notice.)

What food is subject to the requirement for submitting prior notice? Prior notice applies to food for humans and other animals that is imported or offered for import into the United States.

What foods are excluded from the prior notice requirement? Foods that are excluded from the prior notice requirement are:

  • food carried by or otherwise accompanying an individual arriving in the United States for that individual's personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution);
  • food that is exported without leaving the port of arrival until export;
  • meat food products, poultry products and egg products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act;
  • food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States.

What are the consequences of failing to submit adequate prior notice information of an imported food shipment? Food that is imported or offered for import with inadequate prior notice is subject to refusal and holding at the port or in secure storage. FDA will provide its staff with enforcement guidance containing the Agency's policies on injunctions, prosecution, and debarment related to failure to provide timely and accurate prior notice, as well as the Agency's policies regarding refusals under 801(m)(1) and holds under 801(l).

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