Customs Update: FDA's New Food Import Measures
(Published Apr 8, 2003 - Journal of Commerce Online)

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 resulted in sweeping changes to the legal and regulatory framework under which food importers will now operate.
 
The Act mandates that by Dec. 12, 2003:

(1) All U.S. and foreign facilities that manufacture, process, pack, or hold human or animal food for consumption in the U.S. (including storage facilities such as grain elevators) must register with the Food and Drug Administration (FDA), and that a...

(2) Notice of importation, prior to arrival, must be submitted for all imported food products, human and animal, including in-bonds, regardless of whether those products are intended for consumption in the U.S.

These requirements go into effect on the stated date whether or not the FDA has issued final rules. The agency is creating a new computer system to handle the incoming data.
 

Registration provisions

Highlights of the FDA proposed rules regarding registration include:

1) All foreign and domestic facilities with operations that have an affect or impact on food must register unless subject to specific exemptions such as farms, fishing vessels that merely transport and harvest fish, or facilities regulated exclusively by the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.

2) FDA anticipates having a computer system built and operational by Oct. 12, 2003 so that registration takes place electronically. FDA will not accept registrations before the computer system is operational. Registration is a one-time event, requires no fee and must be submitted in English. A foreign facility subject to registration may designate a U.S. agent to register on its behalf. FDA encourages U.S. agents to have written agreements with their foreign vendors which clearly delineate the responsibilities of the parties.

3) Mandatory registration information includes the full name and address of the facility, phone and fax numbers and e-mail address, emergency contact information, trade name(s) used by the facility, name and address of U.S. agent, information about food categories processed, packed or stored at the facility; accompanied by a statement that the information is truthful and the person submitting it as the agent has proper authorization.

4) All changes must be updated within 30 days.

5) If a facility fails to register and is not exempt, that failure to register is considered a prohibited act which allows the government to file civil and/or criminal charges in federal court against the violator. If a felony conviction follows, FDA now has the power to request debarment, meaning that person would be denied the right to import. Similarly if a facility fails to register by Dec. 12, 2003, food from that facility is subject to detention.

6) The obligation to register under these new procedures is separate and apart from any current registration requirements of the FDA or any other government agency.

7) Registration and assignment of a number means only that the facility is properly registered with FDA. Facilities may not claim that a registration number means an approval or endorsement of that facility by FDA. Any such representation in the labeling of a food product will be deemed to misbrand the product.

8) Proprietary information, such as the identity or location of a facility, is protected by the Freedom of Information Act.

9) In these new rules, FDA is not changing the definition of food as previously defined in the Food Drug and Cosmetic Act, but does include some examples: raw agricultural commodities for use as food or components of food; animal feed, including pet food; food and feed ingredients and additives; substances that migrate into food from food packaging and articles that contact food; dietary supplements and dietary ingredients; beverages, including alcoholic beverages. In other words, even those who make goods used in food production may be affected.


Prior notice

Highlights of the prior notice proposed rules include:

1) "Originating country" is defined as the country from which the article of food originates, e.g. for fresh food, the originating country is where it is grown and harvested; for processed food, such as canned corn, the originating country is where the corn is canned. This rule ignores Customs' substantial transformation principles. "Port of Entry" is the port of first arrival and not where the entry is filed, so again Customs' definition differs.

2) All food that is imported or offered for import into the U.S., whether for consumption by people or animals and regardless of whether destined to stay in or move in-bond through the U.S., must have a prior notice filed. The four (4) exceptions are food carried by an individual traveler for personal consumption, and foods that are subject to the exclusive jurisdiction of USDA under the meat, poultry or eggs protocols mentioned above.

3) The purchaser or importer of an article of food who resides or maintains a place of business in the U.S. is the person authorized to submit prior notice.

4) As proposed, prior notice must be submitted no sooner that five (5) days prior to, and no later than noon the calendar day before the day of arrival.

5) As with the new registration system, FDA is proposing that prior notices be submitted electronically through the computer system to be developed and called FDA's Prior Notice System. As previously indicated, it is expected to be fully operational by Oct. 12, 2003.

6) Prior notice includes the name and address of the submitter and facility registration number if required, Customs entry type and Automated Commercial System (ACS) entry line number, product identity information, originating country, shipper, country of shipping, anticipated arrival information, including port of entry, date of arrival, and time of arrival, Customs entry port and date of Customs entry, plus the identity of the importer or owner and the carrier.

7) Once transmitted, information may only be changed in one of two ways: amendment or update. "Amendments" are allowed for clarification of product identity and "updates" for revision of arrival information. If a different food is added to the shipment, the prior notice process must be restarted. Both types of notice must be submitted at least two (2) hours prior to arrival and must be filed electronically. By way of example, an update would consist of changing the time of arrival of the vessel or other conveyance, whereas an amendment would clarify the number of cans per size of food previously reported.

8) If an article of food is imported or offered for import with no prior notice or inadequate prior notice, it will be refused admission under section 801(m) of the FDA Act. A Prior Notice is inadequate if it is inaccurate, incomplete, or not timely submitted. As with refused admission for failure to be properly registered with FDA under Section 801(l) of the FDA Act, a food that is refused admission under Section 801(m) will be detained at the port of entry. There is no appeal process if an importer contends his prior notice is complete but FDA disagrees. The only option is to start the prior notice process all over again.

9) Refused admission under the prior notice provisions has nothing to do with whether or not food "may proceed" or will be refused admission under the "regular" FDA procedures.

10) Failure to provide adequate prior notice is also a prohibited act and carries with it the same consequences as the failure to register, including criminal or civil proceedings or debarment.
 
For more details, review the FDA's Federal Register publications:
Registration: Feb. 3, 2003 Fed. Reg. Vol. 68, No. 22, Pages 5378-5427.
Prior Notice: Feb. 3, 2003, Fed. Reg. Vol. 68, No. 22, Page 5428-5468.
Comment deadline: April 4, 2003.

Look also for additional regulations in the refused admission and record-keeping area which FDA is expected to propose in the coming months.