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Newsletter

FDA's New Registration Requirements For
Food Facilities And Prior Notice For Food Imports

October 27, 2003

On Friday, October 10, 2003, the Food & Drug Administration published new rules that require foreign and domestic food processors, manufacturers, and packers to register with the FDA.  (Click here for a copy of the Food Facilities Registration Rule.)  "Part I" is a discussion of the Food Facilities Registration Rule.

A second, companion regulation requires all importers of food products to provide the FDA with advance notification prior to each importation.  [Click here for a copy of the FDA Prior Notice (PN) Rule.]  "Part II" is a discussion of the FDA PN Requirements.

For imports, facility registration numbers will be required on commercial documentation as part of the PN requirements.  Affected goods will not be admitted unless valid facility registration numbers are provided.  Food products for which a PN has been submitted will receive a PN confirmation number.  Customs entries without the PN confirmation number will be refused admission.

Both the registration and PN regulations go into effect on December 12, 2003.  In order to comply with the registration requirements, food facilities need to begin submitting registrations to the FDA for approval prior to December 12, 2003, to ensure that imports are not detained by Customs for lack of registration information.

PART I:  Food Facilities Registration Rule

I.  Background

On May 22, 2002, Congress passed the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002," also known as the Bioterrorism Act (BTA).  President Bush then signed the bill into law on June 12, 2002.  

Title III of the Act is designed to protect the United States against terrorism implemented through the food supply, so that, in the event of an outbreak of food-borne illness, the source and cause of the illness may be rapidly discovered.

II. Who Must Register?

Owners, operators and/or agents in control of foreign and domestic facilities that manufacture, process, pack, or hold food for human or animal consumption must register their facilities. 

It will likely fall on importers to advise their foreign manufacturers, processors, and packers regarding these registration requirements and to ensure that registration numbers are on invoice documents.  Importers may wish to convey to foreign facilities that beginning on Tuesday October 28, 2003, the U.S. FDA will be holding an explanatory satellite broadcast (with world-wide playback coverage).

The term "food" includes: fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed, pet food, feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages, live food animals, bakery goods, snack foods, candy, and canned foods. 

The terms "manufacturing, processing, packing, packaging and holding" are each defined in §1.227 of the interim final regulations, as follows:

  • "Manufacturing and processing" are essentially any operation that synthesizes, prepares, modifies or manipulates food. 
  • "Packaging" means "placing food into a container that directly contacts the food that the consumer receives." 
  • "Packing" means "placing food into a container other than packaging the food."
  • "Holding" involves "storage of food," including warehousing.

Foreign facilities that process, pack or hold food that is exported for consumption in the U.S. are required to register unless the food undergoes "further processing or packing" at another foreign facility prior to export to the U.S. 

III.  Warehouse Operators, Traders, Brokers and Carriers

Because carriers, forwarders, warehouse operators and brokers are all involved with facilitation of the delivery food, there are instances when such members of the trade community become subject to the registration requirements.

The FDA states that any broker, warehouse operator, or trader who takes possession of food will be required to register if such person is the "owner, operator, or agent in charge of a facility that manufactures/processes, packs or holds food for consumption in the U.S."

VI.  Appointment Of U.S. Agents For Foreign Facilities

Foreign food facilities are required to appoint a U.S. agent.  A U.S. agent can be an individual, corporation, partnership or association who must (1) live or maintain a place of business in the U.S., and (2) be physically present in the U.S. for purposes of registration. 

The U.S. agent will generally serve as a conduit for normal and routine communications (transmitting information clarification requests and notices) and as a contact for emergency communications, unless another alternative emergency contact person is indicated pursuant to §1.233(e).  For this reason, the FDA asks that contact information be provided such that the U.S. agent is accessible 24 hours a day, 7 days per week.

VII.  How To Register With The FDA

Registration has opened as of October 16, 2003.  Registration instructions have been made available in three languages:  English, French and Spanish.  Submissions, however, must be in English.

Each facility must be separately registered, and information must include the name, address and all trade names used by the facility.  For locations with several separate buildings, the FDA recommends registration of each building unless the real estate property-line demonstrates that the several buildings are on the same lot and are, therefore, a single facility.

Once registration is completed, the FDA will provide the registrant with a receipt and assign a unique registration number to the registered facility.

VIII.  On-Line Registration

FDA's preferred method of registration is online at http://www.fda.gov/furls.  This system provides secure (128-bit encrypted) access to allow the facility to establish an enterprise (master) account.  Multiple sub-accounts may be created to allow multiple sub-users to input data.  Generally, the master account allows access to all information input by the sub-accounts; however, there is an option to stipulate that the master account is not to have access to sub-account information. 

The accounts also feature access controls consisting of (1) an account ID, (2) a password and (3) a unique registration number for each facility.

IX.  Other Means of Registration

While Internet registration is preferred, facilities that do not have access to the Internet may file via a paper form.  Additionally, firms registering many facilities may choose instead to submit a CD-ROM with multiple forms in .pdf format.  However, such filings by mail are not recommended, because the FDA does not guarantee timely processing times.  Further, there are numerous requirements, which, if not followed, could result in the FDA simply returning the filing unprocessed.

X.  Requirement to Update Registration Information

Registered facilities must provide updates to the registration information within 60 days of material changes.  For example, if the ownership of a facility changes, then the former owner must submit a cancellation of the prior registration within 60 calendar days, and the new owner must re-register the facility.  The same requirements apply if the facility ceases operations or no long provides food in the United States.  See §§1.234 and 1.235.

XI.  Liability

The FDA states that the failure of the owner, operator or agent in charge of a facility to register, update, or cancel the registration is a prohibited act under the Food, Drug & Cosmetics Act, 21 U.S.C. §331(dd), and 21 U.S.C. §§332 and 333, of the FD&C Act, and that such violations are a basis for civil and/or criminal actions, including agency debarment procedures.

PART II:  FDA PN Requirements

As of December 12, 2003, the FDA will require that U.S. purchasers, importers or their agents submit PN for the importation of food.

I. What “Foods” Are Covered By The PN Requirement?

Almost all forms of foods (including animal food products), supplements and additives are subject to FDA’s new PN requirements.

However, not all food products are subject to the PN requirement. The regulations at section 1.277(b) provide for limited exemptions for certain types of food, such as:

  1. Hand-carried food for personal use
  2. Food made in a home and sent from the home as a gift
  3. Food imported and exported without leaving the port
  4. Meat, poultry or eggs already regulated by certain USDA Inspection Acts.
II. The Timing Requirements to Filing PN

The regulations (section 1.279) provide different filing time requirements depending on the modality used to import the food product:

Modality

Minimum Notice Required Maximum Notice Permissible
Road or Truck 2 hours before port arrival Not more than 5 days before anticipated date of port arrival
Rail 4 hours before port arrival Not more than 5 days before anticipated date of port arrival
Air

4 hours before port arrival Not more than 5 days before anticipated date of port arrival
Sea

8 hours before port arrival

Not more than 5 days before anticipated date of port arrival

International Mail

Notice required prior to mailing of the package

No limit stated

III.  Providing PN and Entry Filing

The FDA has created a PN System Interface to be used to provide notice to the agency (www.access.fda.gov).  This site will be available in December 2003.  

Separately, Customs has said that it will be streamlining the PN requirements by allowing Customs brokers to provide the required information via the ABI/ACS systems already in place.  However, if the ABI system is not operational, the information must be submitted through the FDA's PN system interface.  If the PN system interface goes down, the FDA will be providing fax numbers and e-mail addresses for the trade to have on hand.

IV.  Information Required For PN

The information (§1.281) generally required for PN is to include:

  • Name, address and registration numbers for the persons: (1) submitting the information, (2) transmitting the information, (3) shipper, (4) manufacturer, (5) other originating source, (6) importer, (7) owner, (8) ultimate consignee, and (9) U.S. recipient (as applicable)
  • Description of the food, common name, FDA product code, and HTS code
  • Lot or code numbers required by regulations (low acid canned foods, acidified foods, or infant formula)
  • Entry type; mode of transport; SCAC or IATA code
  • FDA Country of Production and Country of Shipment
  • Quantity (from largest container to smallest package size)
  • Certain detailed planned shipment information, such as the vessel name, flight or trip number, container number, or license plate number.
  • Anticipated date, time and port of arrival (or anticipated date of mailing)

Once the submission of PN information has been confirmed, the FDA will issue a PN confirmation number.  The PN confirmation number must accompany all shipments of food and should be included on the entry.  The FDA will only consider the PN requirement satisfied when the PN confirmation number is issued. 

V.  Modification of PN Information

If submitted information is modified or changed, the FDA will require resubmission of the data and cancellation of the previously submitted information via the same electronic interface.  Thus, if the PN was submitted the ABI/ACS system in the first place, the broker should cancel the PN using ACS by requesting CBP to delete the entry.  There are expected to be further changes to streamline these methods as the electronic systems are more fully developed.

VI.  Refusal of Admission and Detention

Food articles may be refused admission (pursuant to section 1.283(a)) and held at the port for a failure to provide PN or where inaccurate notice is submitted.  While export may be allowed for inaccurate information, export will not allowed where no notice was submitted at all. 

Where the PN filing has been submitted untimely, the shipment may be released if the FDA has completed its review and advised CBP; otherwise, the merchandise must be immediately exported with CBP approval or detained at the port.

Detained food may be segregated and must be moved within 24 hours (see sections 1.283(a)(2) and (3)), under custodian bond, and the FDA notified of its new location.

Please contact George Tuttle, III, at geo@tuttlelaw.com if you have any questions regarding FDA Bioterrorism Regulations or other Customs law matters.

George R. Tuttle, III is an attorney with the Law Offices of George R. Tuttle in San Francisco.  The information in this article is general in nature and is not intended to constitute legal advice or to create an attorney-client relationship with respect to any event or occurrence, and may not be considered such.

 

 

Copyright © 2005 by Tuttle Law Offices. 

All rights reserved.  Information has been obtained from sources believed to be reliable.  However, because of the possibility of human or mechanical error by our offices or by others, we do not guarantee the accuracy, adequacy, or completeness of any information and are not responsible for any errors, omissions, or for the results obtained from the use of such information.

 

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