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.
CONTACTS
IN THE FOOD AND DRUG ADMINISTRATION |
Phone
numbers and E-MAIL Address |
Leslye
M. FraserLead |
|
Nega
Beru |
|
L. Robert LakeSenior Manager
|
|
HELP
DESK |
|
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? |
|
| 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:
- 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? |
|
| 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
- Once you have created an account, on the left side of the
new page - a series of options will be given to you.
- Click on the section that says: Registration with FDA
- Then choose registration of FOREIGN FACILITY
- Once you have chosen the aforementioned, it is just a matter
of filling in the blanks.
- 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

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