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Section 305: Registration of Food Facilities

Section 307: Prior Notice of Import Shipments

On October 10, 2003 the FDA released the Interim Final Rules for 2 of the 4 Sections of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). FDA is responsible for carrying out certain provisions of the Bioterrorism Act, particularly Title III, Subtitle A (Protection of Food Supply) and Subtitle B (Protection of Drug Supply). The Final Rules for Section 303 Detention and Section 306 Records Maintenance are scheduled to be released before the end of 2003.

Section 305: Registration of Food Facilities

Deadline to Register your Company

All companies falling under this jurisdiction must be registered by December 12, 2003. FDA is strongly encouraging electronic registration. Registrations filed by mail or fax will be handled on a first come - first served basis.

Who Must Register

The owner, operator, or agent in charge of a domestic or foreign facility that manufactures/processes, packs, or holds food for human or animal consumption in the U.S., or an individual authorized by one of them, must register that facility with FDA by December 12, 2003. A domestic facility must register whether or not food from the facility enters interstate commerce. A foreign facility must designate a U.S. agent (for example a facility's importer or broker), who must live or maintain a place of business in the U.S. and be physically present in the U.S., for purposes of registration and for the purpose of serving as the FDA communications link.

What Facilities are Exempt from Registration

WBFI submitted a written comment to FDA on the proposed regulations requesting the exemption of Retailers of Animal Food from the registration requirement. WBFI is pleased to report that FDA has exempted Retail Wild Bird Stores and other retailers of animal food from the registration requirement under the Interim Final Rule. The complete list of facilities exempt from Registration is available at the Internet Website noted below.

How Can A Facility Register

A registrant must first Create an Account for the online FDA Industry Systems, and then Register a Food Facility using Form 3537 to register, or to update changes to a registration. Facilities may register online via the Internet at www.fda.gov/furls.

Where to go for more information on Registration of Food Facilities
http://www.cfsan.fda.gov/~dms/fsbtac12.html

Section 307: Prior Notice of Import Shipments

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (the Bioterrorism Act) requires that FDA receive prior notice of food imported into the United States, beginning on December 12, 2003. Most of the prior notice information required by the interim final rule is data usually provided by importers or brokers to the Bureau of Customs and Border Protection (CBP) when foods arrive in the United States. Now, the Bioterrorism Act requires that this information also be provided to FDA in advance of an imported food's arrival to the United States. The timeline for filing is based on the mode of transportation. FDA will use this information in advance of the arrival to review, evaluate, and assess the information, and determine whether to inspect the imported food. FDA and CBP have collaborated on the implementation of the prior notice interim final rule. Nearly all of the current imported food shipments can comply by using CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS). Prior notice can be submitted either through ABI/ACS or FDA's Prior Notice (PN) System Interface beginning December 12, 2003.

When Must Prior Notice be Filed

PN must be received and confirmed by FDA no more than 5 days before arrival and, as specified by the mode of transportation below, no fewer than:

1. 2 hours before arrival by land or road
2. 4 hours before arrival by air or by land by rail
3. 8 hours before arrival by water

In addition, Prior Notice must be received and confirmed by FDA before food is sent by international mail.

How Must Prior Notice be Filed

Prior notice must be submitted electronically either to CBP or FDA.

Who Must Submit Prior Notice

Any individual with knowledge of the required information may submit the priornotice, including, but not limited to, brokers, importers, and U.S. agents.

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.

Where to go for More Information on Prior Notice of Import Shipments

http://www.cfsan.fda.gov/~dms/fsbtac13.html