OT: US FDA Regulations: Public Health Security and Bio-terrorism Preparedness and Response Act of 2002

[Guest guest]

Being that this is a global list I thought this might be important info

for anyone here who exports any kind of food stuffs to the US or imports

it into the US .... got this from DHL ... regulations are going to be

strictly enforced now ....

 

*Smile*

Chris (list mom)

 

http://www.alittleolfactory.com

 

 

<http://www.dhl-usa.com/images/blank.gif>

<http://www.dhl-usa.com/html/art/contentImages/pix.gif>

<http://www.dhl-usa.com/images/blank.gif> US FDA Regulations:

Public Health Security and Bio-terrorism Preparedness and Response Act

of 2002

 

NOTE: The following information is relevant for DHL Express customers

only. DHL Danzas Air & Ocean customers should contact their local office

for further details.

 

General: As a follow up to our communication of 19 November 2003, we

would like to update you on some important developments that will

shortly take effect with regards to new importation requirements for the

United States.

 

On June 12, 2002, the USA's " Public Health Security and Bio-terrorism

Preparedness and Response Act of 2002 " , (also known as the bio-terrorism

Act or BTA) was signed into law. This included provisions designed to

protect the United States against bio-terrorist threats to its food

supply including food from foreign sources. These provisions were

implemented on December 12, 2003 but not fully enforced in order to

allow for a period of education and information exchange on the

technicalities.

 

 

The FDA has announced that effective immediately, US Customs can return

or abandon all shipments that do not comply with the new provisions and

that as of August 12, 2004, the US government will enforce all

fines/penalties described for non-compliance.

 

 

This law has two major provisions impacting DHL Express Customers:

 

 

 

* Registration of Facilities: The FDA will require that domestic

and foreign facilities that manufacture, process, pack, or hold food for

human or animal consumption in the United States register with the FDA.

US based farms, retail facilities, restaurants and non-profit food

facilities in which food is prepared for or served directly to the

consumer are exempt from these requirements.

 

* Prior Notice of Importation of Food: The FDA will require that

U.S. purchasers or U.S. importers or their agents submit to the FDA,

prior notice on the importation of food. Prior notice must be submitted

no less than four hours before flight arrival but may not be submitted

more than five days prior to shipment arrival.

 

Registration and Prior Notice has a significant impact on the trading

community. This document aims to provide an overview of the relevant

provisions that may impact on you as customers of DHL Express.

 

Further guidance on the relevant requirements and the assistance that

DHL can provide are contained in the attached document. Further details

on the Act and the Notices of Proposed Rulemaking are available on the

FDA Web site at <http://www.fda.gov/oc/bioterrorism/bioact.html>

www.fda.gov/oc/bioterrorism/bioact.html.

 

Should you have any questions regarding this change, please do not

hesitate to contact your local DHL Office. Additionally, please find

enclosed list of questions and answers which may also be of assistance.

 

 

 

 

<http://www.dhl-usa.com/images/blank.gif> GUIDELINES FOR SHIPPING

FOOD TO THE UNITED STATES

 

 

 

 

1. What types of commodities are covered?

 

Examples of commodities the FDA consider to be food include:

 

 

 

 

* Dietary supplements and dietary ingredients

 

* Infant formula (baby food)

 

* 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

 

* Live food animals

 

* Bakery goods, snack foods, candy and chewing gum

 

* Animal feed and pet food

 

 

The FDA has the sole authority to determine the scope of the

covered commodities. Further details are available on the FDA website at

<http://www.fda.gov/> www.fda.gov.

 

 

2. What types of commodities are exempted?

 

The following are exempt from Prior Notice requirements

 

 

 

* 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.

 

* Meat food products, poultry products and egg products that are

subject to the exclusive jurisdiction of the U.S. Department of

Agriculture (USDA) and comply with the USDA rules and regulations.

 

 

The FDA has the sole authority to determine the scope of the

covered commodities. Further details are available on the FDA website at

<http://www.fda.gov/> www.fda.gov.

 

 

3. Who needs to register?

 

All facilities that manufacture, process, pack, or hold food for human

or animal consumption in the United States register with the FDA.

 

 

 

4. What information is required?

 

Each registration must include:

 

 

 

 

* The name, address and phone number for the facility and its

parent company (if applicable);

 

* The name, address and phone number of the owner operator or

agent in charge;

 

* All trade names the facility uses;

 

* Applicable food product categories; and

 

* A statement certifying that the information submitted is true

and accurate and that the person is authorized to submit the

registration.

 

 

All non-US facilities must also designate a U.S. Agent 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.

 

 

5. When should any changes to a previous facility application be

submitted?

 

When any required element of a facility's registration changes, an

update must be submitted within 60 days of the change.

 

 

 

6. How can customers register their company facilities details with

the FDA?

 

Customers can register either through DHL or as self registration.

 

 

 

 

* Registering through DHL :

DHL Danzas Air & Ocean US is offering two separate services to our

customers via the DHL Technical Services Department in Southfield

Michigan. The contact for Facility Registrations ONLY is Paul Vroman

paul.vroman or phone +1(810)987-0557.

 

 

 

* DHL would file the application and any subsequent changes on

behalf of the customer. Charges for these services will be as follows:

 

 

* Facilities Registration: $ 75.00 per facility registered

 

* Subsequent Changes: $ 75.00 per change registered

 

* DHL can also act as the U.S. Agent for Foreign Facilities. This

service includes providing updates on the BTA act but is in addition to

the facility registration fee without a U.S. location. Charges for this

service will be as follows:

 

 

* Agent Service annual fee $ 600.00

 

 

* Self registration :

 

 

* This can be done directly by each customer through the FDA

website at <http://www.fda.gov/> www.fda.gov.

 

 

 

 

7. How can customers ensure that the FDA receives timely prior

notice?

 

DHL will require submission of a Prior Notice confirmation number or the

required data elements to submit a Prior Notice application on the

shipping documentation at the time of pick up.

 

Prior Notice requirements apply regardless of:

 

 

 

 

* The quantity imported (samples, full orders, etc.)

 

* The purpose of importation (testing, consumption, etc.)

 

* The type of transaction (commercial or gift).

 

 

 

The FDA and Customs & Border Protection (CBP) have announced

that they intend to allow food importers to provide the required

information on imports to both agencies using an integrated process.

Prior notice must be submitted electronically at

<http://www.access.fda.gov/> www.access.fda.gov. DHL will accommodate

both options.

 

 

8. Are there any other information requirements?

 

In addition to standard invoice requirements, the following elements

must be included on the shipping invoice and be available at the time of

pick up:

 

 

 

 

* Identification of each article of food, including the common or

usual name or market name, the quantity described at the smallest

package size, and the lot or code numbers or other identifier.

 

* In order to be able to submit a proper Prior Notice DHL requires

English language description of each food item shipped. The FDA product

code, if known (available from

<http://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM>

www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM), will speed up the

process.

 

* Complete name and address of the manufacturer or grower and

their FDA registration number (if available)

 

* Country of production

 

* Complete name and address of shipper and their FDA registration

number (if available)

 

* Complete name and address of the importer, purchaser or ultimate

consignee and their FDA registration numbers (if available)

 

 

 

Note that a separate prior notice is required for each article

of food when any of the above items varies or changes. This also

includes changes in the size or kind of packaging or container.

 

DHL has instituted an additional fee for this service of $20.00 per

shipment. Fee includes the PN submission for all applicable products and

will be charged to the importer or purchaser.

 

 

9. What information does DHL require if customers choose to submit

prior notification directly to the FDA?

 

DHL will require a copy of the prior notice confirmation to accompany

the shipment. The confirmation number must also be clearly identified on

the shipping invoice. The DHL airway bill should state food or

foodstuff.

 

 

 

10. What will occur if customers do not follow the above

requirements?

 

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, seizure, destruction, fines, and

penalties related to failure to provide timely and accurate Prior

Notice.