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BIOTERRORISM ACT OF 2002

Summary Of Mandatory Requirements That Need To Be Met Before 12 December 2003

The Belize Agricultural Health Authority was given the mandate to develop an action plan to facilitate compliance with the USA Bioterrorism Act of 2002 that was passed by the Food and Drug Administration. This Act has certain requirements which need to be complied with before the 12 December 2003.

The requirements are as follows:

Before 12 December 2003 Registration with FDA
All facilities that store, hold, pack, process, transport or export food to the United States.
Five days before and after Prior Notice of Consignments being exported or through the United States of America.
12 December 2003  
On and after 12 December 2003 Record Keeping and Maintenance for traceability

BAHA has spearheaded a series of workshops, seminars and public awareness campaigns to ensure that all stakeholders were fully informed about the requirements that need to be met.

INFORMATION
SOURCE
Compendium of Public Health Preparedness and Response Act Against Bioterrorism of the U.S.A.

OIRSA Regional Organization for Plant and Animal Health.

Copies can be obtained at BAHA offices countrywide

Website for Registering online with FDA
Available at the following websites:www.baha.bz (click here) and www.belizeinvest.org.bz or direct at the following address:(1) www.cfsan.fda.gov/~furls/ovffreg.html
USA Customs new tariff numbers www.cfsan.fda.gov/guidance.html

CONTACTS IN THE FOOD AND DRUG ADMINISTRATION
Phone numbers and E-MAIL Address
Leslye M. FraserLead
Nega Beru
L. Robert LakeSenior Manager
HELP DESK
Phone: 301-575-0156
800-216-7331
Fax: 301-210-0247
furls@fda.gov


FREQUENTLY ASKED QUESTIONS

QUESTION
RESPONSE
What are the major components of the Bioterrorism Act that will affect us?
  • Need to register with FDA before 12 December 2003
  • Submission of Prior Notice for all food being exported to the United States on the 12 December 2003 and thereafter.
  • The need to comply with Record Keeping and Maintenance in the event that FDA requires information on any product that has been exported to the US.
Why register with FDA?
  • Failure to register with FDA will result in consignments not being allowed entry into the United States.
  • Failure to comply with the Bioterrorism Act will be classified as a federal offense by the USA.
Is there is a cost to Registering with FDA?
  • It is free to register online with FDA.
Who needs to register with FDA?

Owners, operators, or agents in charge of domestic or foreign facilities that

  • Manufacture
  • Process
  • Pack
  • Hold or store food for human or animal consumption in the US.
Can a facility delegate responsibility to register with FDA to someone else? Yes. Owners, operators or agents in charge may choose to authorize an individual to register on behalf of the facility.
Where can you register with FDA?
What is a foreign facility?
  • Any facility not located in any of the States or territories of the United States of America, in the District of Columbia or the Commonwealth of Puerto Rico.
When should a foreign facility register with FDA?
  • Before 12 December 2003.
What do you need to comply with in the registration process?
  • US Resident FDA Agent (any person: an individual, partnership, corporation or association, that resides or maintains a place of business in the United States of America and is physically present in the USA)
  • Fill in the form with accurate information.
What foods are included under FDA?
  • All fruits and vegetables
  • Fish and Seafood
  • Dairy products and shell eggs
  • Raw agricultural commodities for use as food or components of food
  • Live food animals
  • Infant formula
  • Bakery goods, snack food, candy and chewing gum
  • Canned and frozen foods
  • Beverages (including alcoholic beverages and bottled water)
  • Animal feeds and pet food
  • Food packaging
  • Additives such as colour, preservatives and flavours
  • Dietary supplements and dietary ingredients
Foods exempted
  • Bulk shipments of chicken and beef or commodities regulated strictly by the United States Department of Agriculture (USDA).
What facilities are included?
  • All foreign facilities that manufacture, store, hold or transport food
What facilities are exempted?
  • Non-profit establishments
  • Retailers
  • Farms
  • Restaurants
  • Fishing vessels, except those that engage in processing as defined in FDA's seafood HACCP regulations (21 CFR 123.3(k))
  • Facilities regulated exclusively throughout the entire facility, by the U.S Department of Agriculture (USDA): who regulates meat products, poultry products, and egg products
When should prior notice be given to The Food and Drug Administration of the USA?
  • Five (5) days or eight (8) hours before the consignment arrives in the United States of America, since it comes into effect on the 12 December 2003
  • Except for food arriving by international mail, prior notice cannot be submitted more than five (5) days before arrival
    • ARRIVAL BY LAND via ROAD: prior notice must be given no less than two (2) hours before the food arrives at the port of arrival
    • ARRIVAL BY AIR and LAND via rail: prior notice must be given no less than four (4) hours before the food arrives at the port of arrival.
    • ARRIVAL BY WATER: prior notice must be given no less than eight (8) hours before the food arrives at the port of arrival.
    • FOOD CARRIED BY OR ACCOMPANYING AN INDIVIDUAL: time is based on manner of transportation.
    • FOOD ARRIVING BY INTERNATIONAL MAIL: the prior notice must be submitted before the food is mail.
When will Prior Notice be implemented?
  • Prior notice will be implemented on 7th December 2003 due to the fact that Registration becomes effective on 12th December 2003.
What are the components of Prior Notice?
  • Receipt:
    • E-mail/Fax
  • Review:
    • Central location (not FDA districts), 24 hours/day/seven days a week; separate from and occur prior to [801(a) admissibility review
  • Response:
    • Prior Notice review will determine what shipments require a response at the border. Response will be accomplished by either FDA or CBP
    • Response may consist of cargo examination/verification, sample collection, direction of shipment to a secure facility or storage of the port of arrival or port of entry if prior notice is inadequate.
Does Prior Notice apply to food being transported through international mail?
  • Yes.
What is international mail?
  • International mail is any foreign national mail services, which does not include express carriers, express consignment operators, or to the private delivery services.
What are the requirements for food arriving by international mail?
  • Anticipated port, date, and time of arrival
  • Importer, owner, or ultimate consignee
  • Mode of transport
  • Carrier and planned shipment information
  • HTS Code
  • Date of shipment
  • US recipient
Does information from FDA indicating that prior notice was received guarantee entry of such commodities into the US?
  • NO. It simply means that your information was received by FDA.
Who should submit prior notice to FDA?
  • All exporters of food that will be entering the United States of America on the 12 December 2003 and thereafter.
How should this prior notice be submitted?
  • It is recommended that it be done electronically.
How often should prior notice be given?
  • Every consignment entering the United States of America must be notified to FDA eight (8) hours or five (5) days before the shipment arrives. Ensure that the prior notice is adhered to as stipulated above.
Who can we contact in Belize for further information?
  • Scroll down and view list of contacts below.

MEMBERS OF THE TASK FORCE AND CONTACT NUMBERS

Name of Officer
Organization/Address
Telephone/Fax Number
E-mail Address
Michael DeShield BAHA, Belize City Tel: 011-501-224-4794
Fax: 011-501-224-5230
foodsafety@btl.net
Delilah A. Cabb BAHA, Central Farm Tel: 011-501- 824-4899/4872
Fax: 011-501-824-4889
bahasps@yahoo.co.uk
Marnie Santana BELTRAIDE, Belmopan Tel: 011-501-822-3737
Fax: 011-501- 822-0595
marnie@belizeinvest.org.bz
Felix Tzul MAF, Belmopan Tel: 011-501-822-2241-43
Fax: 011-501-822-2409
felixtzul@belizemail.net
Jose Mai MAF, Belmopan Tel: 011-501-822-2241-43
Fax: 011-501-822-2409
abelardomai@yahoo.com
Ruth Kantun BELTRAIDE, Belmopan Tel: 011-501-822-3737
Fax: 011-501-822-0595
ruth@belizeinvest.org.bz
Melanie Gideon BELTRAIDE, Belize City Tel: 011-501-223-5219 Ext. 23
Fax: 011-501-223-4702
melanie@belizeinvest.org.bz
Carlos Itza BAHA, Central Farm, Cayo Tel: 011-501-824-2131
Fax: 011-501-824-3773
klositza@yahoo.com
Margarito Garcia BAHA, Central Farm Tel: 011-501-824-4899
Fax: 011-501-824-4889
baha_quarantine@yahoo.co.uk
Roberto Manzanero BAHA, Central Farm Tel: 011-501-824-4899
Fax: 011-501-824-4889/3773
baha_quarantine@yahoo.co.uk
Hernan Zetina BAHA/Belmopan Tel: 011-501-822-0197
Fax: 011-501-822-0271
ernzetina@yahoo.com
Adib Bejos BAHA, Central Farm Tel: 011-501-824-4899
Fax: 011-501-824-4889
foodsafety_bz@yahoo.com
Endhir Sosa BAHA, Belize City Tel: 011-501-224-4794
Fax: 011-501-224-5230
foodsafety@btl.net
Marcos Osorio OIRSA, Belmopan Tel: 011-501-822-0521
Fax: 011-501-822-0522
vifinex@btl.net
Teresita Chacon BAHA, Belmopan Tel: 011-501-822-1378
Tel: 011-501-822-0818
Fax: 011-501-822-0271
terrisweeter@yahoo.com
Harold Westby MAF, Orange Walk Town Tel: 011-501-322-2149
Fax: 011-501-322-
hhnn71@yahoo.com
Andrew Mejia MAF, 9 Miles Stann Creek Valley Road Tel: 011-501-522-2514
Fax: 011-501-522-2514
daoscreek@btl.net
Fay Garnett MAF, Central Farm Tel: 011-501-824-2079/2191
Fax: 011-501-824-2079
fgarnett83@yahoo.com
Emilio Perez MAF, Corozal Town Tel: 011-501-422-2297
Fax: 011-501-422-3131
daocorozal@btl.net
Marvin Blades
MAF, Elridgeville,Toledo
Tel: 011-501-722-2689
Fax: 011-501-722-2689
daotoledo@btl.net, marvin_bz@yahoo.com
Gary Ramirez MAF, Belize City Tel: 011-501-227-7492/2685
Fax: 011-501-227-4979

daobelize@btl.net, GRamirez@belizeweb.com

Guideline For Registering Facilities Online With The Food And Drug Administration Of The United States Of America

The following is the procedure for registering online with FDA.
Computer Specifications:

  • Microsoft Internet Explorer Version 5.5, 6.0
  • Netscape Navigator Version 7.1
  • Opera 7.0

(1) LOG ON THE website: www.cfsan.fda.gov/~furls/ovffreg.html

(2) The first thing you are advised to do, once you are at the homepage, is to create an ACCOUNT with FDA.
a. PROCEDURE FOR CREATING A NEW ACCOUNT WITH FDA

i. Select Number 2: Create an Account
ii. Then click on Login/Create Account
iii. Click on Create New Account
iv. Tick on the section that corresponds to Food Facility Registration
v. Once you do that, FDA will give you an ACCOUNT ID: EXAMPLE - bel30775.

(3) ACTUAL REGISTRATION OF FACILITY

  1. Once you have created an account, on the left side of the new page - a series of options will be given to you.
  2. Click on the section that says: Registration with FDA
  3. Then choose registration of FOREIGN FACILITY
  4. Once you have chosen the aforementioned, it is just a matter of filling in the blanks.
  5. Remember to use the guide which is available at the following website: www.cfsan.fda.gov/~furls/ins3537.pdf

    i. Title of Guideline: Instructions for Filling Out DHHS/FDA Forms 3537 and 3537a, Food Facility Registration and Registration Cancellation, Instructions for Form 3537, Food Facility Registration Form


 

 

 
Copyright 2006 Belize Agricultural Health Authority. All Rights Reserved.
 


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