Law Library Articles

Registration of Facilities

Who must register?

• Owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States.
• Foreign facilities must register unless food from that facility undergoes further processing or packaging from another foreign facility before the food is exported to the US.  However, if the subsequent foreign facility undertakes only minimal activity, such as product labeling, both facilities would be required to register.
• All applicable facilities, including facilities that manufacture, process, or hold pet food, pet treats, pet chews and dietary supplements must have registered by December 12, 2003.  A facility is defined as any factory, warehouse or establishment that manufactures, processes, packs or holds food.
• A parent company may register all of its facilities, however, each facility must be registered separately and each will receive a separate registration number. A business with multiple facilities, even if they are located near or adjacent to each other must register each facility separately. If the property records show that the buildings are on distinct lots they each must  have a registration number.
• Exemptions - Exempt from registration are farms, retail food operations, restaurants, non-profit operations that prepare food, fishing vessels that do not process and facilities that are entirely regulated by the USDA, i.e. meat, poultry and egg processors.

How to register?

• The FDA has a Web Page wih all the information required to register your facility. These registrations are done on-line.
• There is no charge to register a facility.

What is included in the registration?

• All contact information for the facility including the name, address, phone number, fax number and e-mail address.
• The name and address of the parent company.
• Emergency contact information.
• All trade names the facility uses.
• A US agent for foreign facilities.
• A certification statement indicating that the information is true, and the contact information of the individual submitting the registration.
• The general categories of food produced at the facility.

What happens if a facility does not register?

• The FDA can bring an action to enjoin persons that do not register and can criminally prosecute violators. If foreign facilities do not register the FDA can hold the food at the port of entry, or direct that it be moved to a secure location.

Prior Notice of Imported Food Shipments

• Prior Notice Must Be Provided To What Imported Food?

  • All food and beverages for human or animal consumption that enter this country must meet proper notification requirements.
  • However, food carried into the US by an individual, in that person's luggage for that person's consumption is exempt. In addition, all meat food, poultry products or egg products that are under the exclusive jurisdiction of the USDA would not be included.
  • The FDA publishes Compliance Guides  and Questions and Answers regarding Prior Notice on its Web Site.

  Who must provide prior notice?

  • Any person with knowledge of the required information may submit prior notice or have it transmitted on their behalf.

  When and how must notice be provided?

  • The interim final rule allows for 2 hours advance notice for ground shipments by road, 4 hours for rail and air shipments, and 8 hours for shipments arriving by sea. The notice may not be submitted more than 5 days before arrival at the US port or border.
  • The notice should be submitted electronically through the FDA's Web based Prior Notice System. The notice may also be sent to the Bureau of Customs and Border Protection (CBP) Automated Broker Interface (ABI) of the Automated Commercial System (ACS). If the Web-based system is not working, notices must be sent to FDA by fax or e-mail.

  What information must be included in the notice?

  • The identification of the submitter, manufacturer, shipper, grower- if known, importer, owner, consignee and carrier. The transmitter must also be included if different than submitter.
  • The identification of the article of food, which includes the complete FDA product code, the common name, the brand name, the quantity described from the smallest package to the largest, and the lot code number if applicable.
  • The originating country, and the country from which the food was shipped.
  • The anticipated arrival date, location and time.
  • US Customs information.
  • Mode of transportation.

   

  Establishment and Retention of Records

  Who must establish and maintain records?

  • Domestic persons that manufacture, process, pack, transport, distribute, hold, or import food, and persons that place food directly in contact with its finished container and that is intended for human or animal consumption in the US and foreign persons that transport food in the US. Pet food, treats and pet chews are all considered food under this law. Dietary supplements are also included.
  • Pet Food manufacturers must keep records for one year after the dates you receive and release the food. 
  • Farms, restaurants, fishing vessels not engaged in processing, and entities under the exclusive jurisdiction of the USDA are exempted from record keeping provisions. Also, exempted are foreign facilities when the food undergoes further manufacturing or processing in the US, except if the further processing is de minimus, such as labeling the exemption does not apply.
  • Retail food establishments are exempted from keeping records relating to the recipient of that food, when sold to consumers.

  What records are required to be maintained?

  • The records that are required for non-transporters include all previous sources, whether foreign or domestic. This must include the name, and contact information.
  • The type of food, including brand name and specific variety; the date received; lot number, if available; quantity and type of packaging, and the name and contact information of the transporter who brought the food.
  • The records must include the specific sources for each ingredient that was used to make every lot, if available.
  • The same information must be recorded for each non-transporter recipient of the food.
  • Transporters must keep records and include the name, contact information of the person who had the food immediately prior to pickup, and the name and contact information of where the food was delivered. Records must also include the identifying information such as quantity, lot identification, the type of food, lot number or other identifier and the type of packaging.

  How must the records be maintained?

  • They can be kept in either paper or electronic form as long as it provides the proper information and meets the access requirements. There is no specified form required.
  • If existing records contain all the required information, they may be used, and duplication is not required.

  How long must the records be kept?

  • For pet food, records would have to be kept for one year from the date the records were created. The records would have to be created when the food was received, released or transported. Records for some other foods must be kept for two years.

  When must the records be made available?

  • If FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, FDA may require that records be made available for inspection and copying.
  • Records must be made available as soon as possible not to exceed 24 hours,from the time of the original request.

  When will these regulations become effective?

  • Unlike the other provisions implementing the Act, when the recordkeeping provision becomes effective depends on the size of the business. Generally most businesses would have 12 months from December 9, 2004. However, small businesses, with less than 500 full-time employees would have 18 months to comply. Very small businesses, with less than 10 full-time employees would have 24 months to comply.

  Questions and Answers on Recordkeeping Requirements

  •  FDA has published a Guidance For Industry on the keeping of records.
  

  Administrative Detention

  When may the FDA detain food?

  • The Act authorizes the FDA to detain an article of food for which there is credible evidence or information indicating that the food presents a threat of serious adverse health consequences or death to humans or animals.
  • The Detention Order must be approved by the District Director of the District where the food to be detained is located.
  • Food governed by the USDA, i.e. meat, poultry and eggs, is not subject to the FDA's administrative detention regulation.
  • FDA has a Guidance Document on What You Need To Know on Administrative Detention of Foods: A Small Entity Compliance Guide

  What happens if food is detained?

  • The detention period cannot exceed 30 days. If after the 30-day period, the FDA has not released the food, the detention order is deemed to be terminated.
  • The detention order will specify where the food is to be held, and may require the food be moved to a secure facility. However, the food may not be delivered to another entity such as its importers, owners or consignees.
  • The owner, operator, or agent in charge of the food may appeal the detention order. For non-perishable food, a notice of intent to file an appeal and to request a hearing must be filed within 4 days of receipt of the detention order. For perishable foods; defined as food that is not heat treated, not frozen, and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 days under normal conditions, the notice of appeal must be filed within 2 days.

   

  ADDITIONAL INFORMATION

  The FDA has numerous resources on its Web Site regarding compliance with the Bioterrorism Act and the Food Safety Modernization Act (FSMA) including Compliance Policy Guides and Guidances for Industry. These guidance documents answer many specific questions as to what your obligations are. If you are in doubt about compliance with this act see the FDA Web site.