Passionfruit - FDA Bioterrorism

FDA Bioterrorism Act Fact Sheet

prepared by NZ Horticulture Export Authority, 7 July 2003

On the 12th December 2003 the Bioterrorism Act comes into effect impacting all fruit, vegetables, beverages, fish, canned products and dairy products entering the United States.
These requirements include:

1. Registration

All food handling facilities must register.
Exporters, unless they own or operate coolstores and packhouses, are not required to register but need to ensure that each facility in their supply chain does.

All facilities that manufacture, process, pack, distribute, receive or hold food for consumption in the US must register with FDA from 12 October 2003 to 12 December 2003.You cannot register before this date.An online registration system is being developed and available from 12 October.
Keep checking the FDA website: www.fda.gov/oc/bioterrorism/bioact.html

We recommend all packhouses, coolstores, depots and freight forwarders, packing and holding product for the US register.

It is free and it avoids the possibility of product being detained or refused entry.When you register online you will get a bounce-back email with your registration number attached.This will need to appear on prior notice submissions but not on packaging

If foreign facilities fail to register by 12th December 2003 and attempts to
import food into the U.S., the product will be held at the port of entry

FDA may direct that it be moved to a secure location. The owner, importer, consignee or agent will be responsible for covering transportation and storage costs

FDA anticipates around 410,000 domestic and foreign facilities to register in the eight week period. We recommend that facilities are prepared to register from 12 October 2003.

2.Prior Notice

From 12 December 2003 the FDA must be advised of all shipments destined for the US, including transhipments. Prior notice timeframes are very specific:

Not more than 5 days from arrival

Not later than noon the day before arrival

Changes can be made up to two hours prior to arrival

The purchaser or importer (or their qualified agent e.g. customs broker) who resides or maintains a place of business in the United States, is required to submit prior notice of the importation of food. Note:the NZ exporter cannot submit prior notice and does not need to appoint an agent.

If a consignment is being transhipped through the US the arriving carrier or in bond carrier is responsible for submitting prior notice

One prior notice must be submitted for each product in the shipment i.e. if a consignment included cherries, apricots and plums three prior notices would have to be submitted.

Where a shipment that arrives at a US port with no prior notice or inadequate notice, it will be refused entry to the US. The purchaser, owner, importer or consignee would be responsible for transportation and storage expenses.

The NZ exporter will be responsible for ensuring all necessary information is provided to the importer.We recommend that you talk to your importers in the US to establish appropriate systems.

FDA anticipates over 20,000 new prior notices per day.

3.Records Maintenance

FDA requires all facilities involved in the supply chain to keep records of where a consignment came from and where it went (one up and one down). For perishable products these records must be held for one year.

Required information includes name, address, phone number of the firm and contact person, the brand and type of product, batch number or other consignment identifier, and the date the product was received/despatched.

There is no audit process for record keeping requirements. An Amercian firm can be prosecuted if FDA requests this information and is not available. A New Zealand company cannot be prosecuted under American law but the US government could seek assistance from the NZ government.

Existing systems may be adequate to meet these requirements and FDA do not require the establishment of new systems.

Timeframes are different to registration and prior notice. Companies with less than 11 employees have 18 months to put appropriate systems in place (12 May 2005); companies with 12 to 500 employees have 12 months (12 December 2004); and, companies with more than 500 employees, six months (12 May 2004)

4.Administrative Detention

Allows FDA to "impound" food, both domestic and foreign, in the United States market.Currently they have this power on imported product, they can refuse entry and direct the consignment to secure storage.Where a product is already in the US market they can detain and investigate consignments that they believe pose a threat to human or animal health.

New Zealand exporters do not have to do anything in terms of meeting administrative detention requirements.

The information contained in this fact sheet is based on the US regulations and information distributed by FDA.Some portions of the regulation are open to interpretation. We will continue to further clarify operational requirements under the Bioterrorism Act.