Prior Notice Requirement

What is Prior Notice Requirement?

As of December 12, 2003, The U.S. Food and Drug Administration (FDA) must be notified in advance of any shipments of food for humans and other animals that are imported into the U.S., unless the food is exempt from Prior Notice.

 

Why Prior Notice Is Required?

Prior Notice of Imported Food Shipments will give FDA time to:

• Review and evaluate information before a food product arrives in the U.S.

• Better deploy resources to conduct inspections.

• Help intercept contaminated products.

 

US FDA Prior Notice Requirement

Which Industry Sectors Are Affected by Prior Notice?

If you export, transport, or import food into/through the United States, FDA must be given Prior Notice of imported food shipments.

 

Industry Sectors Affected?

• Domestic and foreign cross-border transporters (rail, truck, ship and air).

• Domestic and foreign importers.

• Domestic and foreign exporters.

• Domestic and foreign filers and brokers.

• Domestic and international manufacturers and growers.

 

How “Food” Is Defined for Prior Notice?

For purposes of Prior Notice, “food” is defined as:

• Articles used for food or drink for man or other animals.

• Chewing gum.

• Articles used for components of items listed in the 1st and 2nd bullets.

Note: "Food" does not include food contact substances or pesticides.

 

Examples of “Food.”

• Fruits

• Vegetables

• Fish and seafood

• Dairy products

• Eggs

• Raw agricultural commodities for use as food or as components of food

• Animal feed (including pet food)

• Food and feed ingredients

• Food and feed additives

• Dietary supplements and dietary ingredients

• Infant formula

• Beverages (including alcoholic beverages and bottled water)

• Live food animals

• Bakery goods

• Snack foods

• Candy

• Canned foods

 

Which Food Imports Require Prior Notice?

Prior Notice is required for imports of all foods that are subject to the regulation. However, certain exemptions apply.

 

The following chart lists food imports that require Prior Notice.

If the food you are importing falls under one of these requirements, be sure to review the Exemptions box (on the following page) to see whether any exceptions apply.

 

Food Imports Requiring Prior Notice (Unless Exemptions Apply)

 

• Food imported for use, storage, or distribution in the U.S. (including gifts and trade and quality assurance/quality control and market research samples)

• Food transhipped through the U.S. to another country

• Food imported for future export, or food for use in a Foreign Trade Zone, unless it is on the list of exemptions on the following page

 

The following chart lists exemptions from the Prior Notice rule. If any of these exemptions apply to a food shipment you are importing, you do NOT have to submit Prior Notice for that shipment.

 

Exemptions

• Food carried by or otherwise accompanying (e.g., baggage) an individual arriving in the U.S. for that individual's personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution)

• Food made by a person 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 U.S.

• Food that is exported without leaving the port of arrival until export

• Meat food products, poultry products, and egg products that at the time of importation are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act

• Food in diplomatic bags/pouches based on the authority in Art. 27(3) of The Vienna Convention on Diplomatic Relations (1961)

 

Who Can Give Prior Notice?

Any individual with knowledge of the required information can submit Prior Notice. The Prior Notice includes individuals, manufacturers, exporters, brokers, importers, and U.S. agents.

 

How to Give Prior Notice?

Prior Notice must be submitted electronically through either of the following systems:

· FDA PNSI

· ACE system

· GeTs FDA PN System

 

PNSI Benefits:

· The FDA Prior Notice System Interface (PNSI) is available 24 hours a day, 7 days a week.

· FDA’s and CBP’s computer systems enable you to submit Prior Notice as part of the entry process.

· This will avoid duplication of information.

 

What If You Fail to Provide Adequate Prior Notice?

Food that is imported or offered for import with inadequate Prior Notice is subject to refusal and, if refused, must be held at the port of entry unless directed to another location. The importing or offering for import into the U.S. of an article of food in violation of Prior Notice requirements is a "Prohibited Act" under the laws FDA administers. FDA has provided its staff with enforcement guidance containing the agency's policies on refusals, holds, injunctions, prosecution, and debarment related to failure to provide timely and accurate Prior Notice or otherwise comply with FDA Prior Notice regulations.

 

Note: Prior Notice guidance documents are available to the public and posted on the FDA website.

FDA will continue to update these as appropriate.

 

GIVING PRIOR NOTICE OF AN IMPORTED FOOD SHIPMENT.

 

How to Give Prior Notice?

Prior Notice must be submitted electronically through either of the following systems:

• FDA PNSI

• ACE system

• GeTs FDA PN System

 

The FDA Prior Notice System Interface (PNSI) is available 24 hours a day, 7 days a week. FDA’s and CBP’s computer systems enable you to submit Prior Notice as part of the entry process. This will avoid duplication of information.

 

If a broker's or filer's Automated Broker Interface (ABI) system or the ABI/Automated Commercial System (ACS) interface is not operating, Prior Notice must be submitted through the FDA Prior Notice System Interface.

 

If the FDA PNSI is not operating, or if the Operational and Administrative System for Import Support (OASIS) is not operating, FDA will post prominent notification and instructions on the System Status web page. FDA will accept Prior Notice submissions in the format it deems appropriate during the system(s) outage.

 

When to Give Prior Notice of a Shipment?

Note: Unless the Prior Notice is for food arriving by international mail or is carried by or otherwise accompanies an individual, Prior Notice submitted by ABI/ACS does not require additional documentation (although it may be prudent for the carrier to have a copy of Prior Notice confirmation or the associated entry number in his/her possession when arriving at the port of arrival).

 

FDA must electronically receive and confirm Prior Notice before a food shipment arrives at the first port in the United States (port of entry). The deadline for submitting Prior Notice depends on the mode of transportation used for shipment.

 

Except in the case of food arriving by international mail, FDA must receive and confirm a Prior Notice:

1) no more than 30 days before a shipment arrives, if Prior Notice is submitted via ABI/ACS; or

2) no more than 15 days before a shipment arrives, if Prior Notice is submitted via FDA’s PNSI. 

 

For shipments arriving - when prior notice must be submitted

 

Information Required for Prior Notice

Importers or brokers already provide most of the information required for Prior Notice to CBP when goods arrive in the U.S.

According to the Bioterrorism Act, FDA must receive the required information before a shipment of food arrives.

 

Some Highlights of Required Information

       Name, business address, telephone, and email of the individual submitting Prior Notice, as well as firm name and address (if applicable)

       Name, firm name (if applicable) and business address, telephone, and email of the individual transmitting Prior Notice (if someone else is transmitting Prior Notice on behalf of the submitter)

       Entry type and CBP identifier (if identifier is available)

       Identification for each article of food in the shipment:

o   (1) FDA product code

o   (2) Common product name or market name

o   (3) Estimated quantity (from smallest package size to largest container)

o   (4) Lot, code number or another identifier (if food is required to have one)

       If the food is no longer in its natural state: manufacturer’s name and either

o   (1) the registration number, city, and country of the manufacturer or

o   (2) both the full address of the manufacturer and the reason the registration number is not provided (reasons listed in the Compliance Policy Guide for Prior Notice of Imported Food)

       If the food is in its natural state: name of grower and growing location, if known

       FDA Country of Production

       Shipper’s (sender’s, if food is mailed) name and full address

       Country from which food is shipped; or, if food is imported by international mail, the anticipated date of mailing and country from which food is mailed

       Anticipated arrival information (location, date, and time); or, if food is imported by international mail, the U.S. recipient’s name and address

       Name and full address of importer, owner, and consignee, unless the shipment is imported or offered for import for transshipment through the U.S. under a transportation and exportation (T&E) entry; or if food is imported by international mail, the U.S. recipient’s name and address

       Carrier and mode of transportation (except for food imported by international mail)

       Planned shipment information (except for food imported by international mail)

       Any country to which the article has been refused entry. (2011 IFR)

 

 

 

 

Related Pages:

ACE Highway

ACE ABI for US CBP

ACE Air

ACE Ocean

ISF “10+2”