Issue 422, November 18, 2003
Requirement: Domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with the Food and Drug Administration by December 12, 2003. In the event of a potential or actual bioterrorism incident or an outbreak of food-borne illness, facility registration information will help FDA to determine the location and source of the event and permit the agency to notify quickly facilities that may be affected.

Foreign Facilities Require a U.S. Address and Contact: A foreign facility must also provide the name, address, and phone number of its U.S. agent. The foreign facility must also provide the emergency contact phone number for its U.S. agent unless the facility designates another person to serve as the emergency contact.

DHL Danzas acting as a U.S. Agent: DHL Danzas offers the service of acting as the U.S. Agent for Foreign Facilities without a U.S. location through the DHL Danzas, Technical Services Department, Southfield MI. The primary contact for this service is Paul Vroman, Technical Advisor and can be reached by email at Paul.Vroman@dhl.com or phone at (810) 987-0557.

How to Register: Registration is completed via the FDA Web site and can be done by you or with the assistance of DHL Danzas.

DHL Danzas Registration Services: Our services may be utilized to register your facilities through the DHL Danzas, Technical Services Department, Southfield, MI. The primary contact for this service is Paul Vroman, Technical Advisor and can be reached by email at Paul.Vroman@dhl.com.

Self-Registration: The owner, operator or agent in charge may complete the registration. If the person submitting the registration is not the owner, operator, or agent in charge a statement must be included indicating that the person is authorized to submit the registration. Registrants must use Form 3537 to register or update a registration. Facilities may register online via the Internet at https://www.access.fda.gov/.

Information Required: Each registration must include the name, address, and phone number for the facility and its parent company (if applicable); the name, address, and phone number of the owner, operator, or agent in charge; all trade names the facility uses; applicable food product categories as identified in FDA's regulation, 21 CFR 170.3; a statement certifying that the information submitted is true and accurate and that the person submitting the registration, if not the owner, operator, or agent in charge, is authorized to submit the registration.

Registration Changes: Registration must be updated within 60 days when any of the following occur 1) Registration information changes, facility goes out of business, facility acquires a new owner.

Which Facilities Must Register: This new regulation pertains only to facilities that manufacture/process, pack, or hold food, as defined in the regulation, for consumption in the U.S. Examples of "food" include:

	Dietary supplements and dietary ingredients
	Infant formula
	Beverages (including alcoholic beverages and bottled water)
	Fruits and vegetables
	Fish and seafood
	Dairy products and shell eggs
	Raw agricultural commodities for use as food or components of food
	Canned and frozen foods
	Bakery goods, snack food, and candy (including chewing gum)
	Live food animals
	Animal feeds and pet food

Food contact substances and pesticides are not "food" for purposes of the interim final rule. Thus, a facility that manufactures/processes, packs, or holds a food contact substance or a pesticide is not required to register with FDA.

Multiple foreign facilities involved with the manufacturing processing, packing and holding of food sent to the US are required to register as follows: If a foreign facility that manufactures/ processes, packs, or holds food sends it to another foreign facility for further manufacturing/processing or packaging before the food is exported to the U.S., only the second foreign facility is required to register. However, if the second foreign facility performs only a de minimis activity, such as putting on a label, both facilities would be required to register. Also, any foreign facility that packs or holds food after the last foreign manufacturer/processor of the food must register.

Which Facilities Do Not Need to Register: The facility types listed below are not required to register with the FDA. However, Prior Notice of an Import may still be required.

	Multiple foreign facilities involved with the manufacturing processing, packing and holding of food sent to the US are required to register as follows: If a foreign facility that manufactures/ processes, packs, or holds food sends it to another foreign facility for further manufacturing/processing or packaging before the food is exported to the U.S., only the second foreign facility is required to register. However, if the second foreign facility performs only a de minimis activity, such as putting on a label, both facilities would be required to register. Also, any foreign facility that packs or holds food after the last foreign manufacturer/processor of the food must register.
	Private residences of individuals, even though food may be manufactured/processed, packed, or held there.
	Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems.
	Transport vehicles that hold food only in the usual course of their business as carriers.
	Farms, i.e., facilities in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves, and cooling of produce are considered part of harvesting. The term "farm" also includes facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership, and facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
	Restaurants, i.e., facilities that prepare and sell food directly to consumers for immediate consumption, including pet shelters, kennels, and veterinary facilities that provide food directly to animals. Facilities that provide food to interstate conveyances, such as commercial aircraft, or central kitchens that do not prepare and serve food directly to consumers are not restaurants for purposes of the rule.
	Retail food establishments, such as groceries, delis, and roadside stands, that sell food directly to consumers as their primary function, meaning that annual sales directly to consumers are of greater dollar value than annual sales to other buyers. An establishment that manufactures/processes, packs, or holds food and whose primary function is to sell food directly to consumers, including food that the establishment manufactures/processes, from that establishment is a retail food establishment and is not required to register.
	Nonprofit food establishments, which are charitable entities that meet the terms of § 501(c)(3) of the Internal Revenue Code and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S. Central food banks, soup kitchens, and nonprofit food delivery services are examples of nonprofit food establishments.
	Fishing vessels that harvest and transport fish. Such vessels may engage in practices such as heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel and remain exempt.
	Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture, that is, facilities handling only meat, poultry or egg products.

Failing to Register Facilities: Failure of a domestic or foreign facility to register, update required elements, or cancel its registration in accordance with this regulation is a prohibited act under the Federal Food, Drug, and Cosmetic Act. The Federal government can bring a civil action to ask a Federal court to enjoin persons who commit a prohibited act, or it can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act. If a foreign facility is required to register but fails to do so, food from that foreign facility that is offered for import into the U.S. is subject to being held within the port of entry for the article unless otherwise directed by FDA or the Bureau of Customs and Border Protection (CBP). FDA plans to issue enforcement guidance regarding the agency's policies regarding refusals of imported food under section 801(m)(1) or holds of imported food under section 801(l). This guidance document will be available to the public, and FDA will publish a notice of its availability in the Federal Register.

Please note that due to the complex nature of the subject matter, DHL Danzas Air & Ocean cannot be responsible for actions taken by the reader in reliance on the information contained herein without prior consultation with DHL Danzas Air & Ocean.