National Grain and Feed Association
& Grain Elevator and Processing Society
Facility Security Site

FDA - Facility Registration Summary

FDA on Oct. 10, 2003 issued interim final regulations implementing the section of the Bioterrorism Act that requires domestic and foreign facilities to register with FDA by Dec. 12, 2003 if they store, manufacture, process or pack food for human or animal consumption in the United States. Facilities are defined as any establishment, structure or structures under one ownership at one general physical location – or, in the case of mobile facilities, one that travels to multiple destinations.

Among the types of facilities covered by the registration requirement are grain elevators, feed mills, flour mills, corn and oilseed processors, pet food manufacturers, feed ingredient manufacturers, renderers and others.

Among establishments that are exempt from facility registration are:

• Farms, feedlots and integrated operations, provided that they are in one general physical location and devoted to the growing and harvesting of crops and/or the raising of animals (including seafood). To qualify for the exemption, such establishments must not further process food or food-producing animals into meat, milk or eggs.
  
• Transportation conveyances (such as rail cars and barges) provided such conveyances hold food or feed only in the “usual course of business as carriers.” Mobile facilities, like trucker-dealers of grain, are not exempt because they store and haul grain beyond the “usual course of business” as transporters.
  
• Retail dealers (such as animal feed dealers, feed stores, pet food stores and farm stores) if the total annual dollar sales to end-consumers exceed the total amount of dollar sales to businesses (such as farms and kennels). If this condition is met, this exemption applies even if the facility stores, manufactures or packs products.

What’s Required

Registration is to be done by the owner, operator or agent in charge of a domestic or foreign facility, or by an individual authorized by one of them. A domestic facility is required to register regardless of whether agricultural commodities stored or handled enters interstate commerce. Foreign facilities are required to designate a U.S. agent (for example, a facility’s importer or broker) who must live or maintain a place of business, as well as be physically present, in the United States.

Registration is free; there is no requirement to pay a third-party provider to register. Registration is required only once, unless required mandatory information changes.

Required facility registration information includes (which must be updated within 60 calendar days of any changes):

• Name, address, phone number for the facility and parent company (if applicable)
  
• Name, address, phone number of owner, operator or agent in charge, as well as an emergency contact number.
  
• All trade names used by the facility (names under which the company does business, not the brand names of its products)
  
• Applicable food product codes (selected from FDA-provided list)
  
• Statements certifying that the submitted information is correct and attesting that the person submitting the information is authorized to do so.
  
• Name of U.S. agent and agent or other designated person’s emergency contact phone number (required for foreign facilities only).
  

Optional facility registration information (not required) includes:

• Fax number, e-mail address of facility.
  
• Preferred mailing address if different from facility address.
  
• Fax number, e-mail address of parent company (if applicable).
  
• Type of activity conducted at facility (such as storage, milling, manufacturing, processing, etc.).
  
• Additional food categories not identified in FDA list (such as animal byproducts, specific grains stored or handled, amino acids, etc.).
  
• Type of storage.
  
• Approximate dates of operation (if seasonal business).
  
• Fax number and e-mail address of owner, operator or agent in charge.
  
• Fax number and e-mail address of individual who authorized facility registration to be submitted.
  
• Foreign facility: 1) emergency contact name, title, phone number and e-mail address; and 2) title, fax number and e-mail address of U.S. agent.

Cancellation of facility registration is required within 60 calendar days of a change in ownership of the facility. The new owner is required to re-register the facility.

Failure to register is considered a prohibited act under the Federal Food, Drug and Cosmetic Act. Offenders are subject to possible civil and criminal penalties.

Registered facilities and registration information is exempt from disclosure under the Freedom of Information Act, as is any information that would disclose the identity, location or type of products stored, handled or manufactured by a specific registered facility or person.

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Disclaimer: The National Grain and Feed Association (NGFA) and The Grain Elevator and Processing Society (GEAPS) make no warranties, expressed or implied, concerning the accuracy, application or use of the information contained on this web site. Further, nothing contained on this web site is intended as legal advice. Competent legal and technical counsel should be consulted.