I. Introduction

     On October 10, 2003, the Food & Drug Administration (FDA) published in the Federal Register "Interim Final" regulations requiring (1) Registration of Food Facilities, both domestic and foreign, which manufacture/process, pack or hold food for human or animal consumption in the United States; and (2) Pre-Import Notification to FDA of all arrivals of imported food into the United States.

     Both requirements become effective on December 12, 2003. FDA will begin accepting on-line facility registrations on October 16, 2003.

     FDA's final regulations differ significantly from those proposed for comment several months ago. In particular, the "advance notification" requirements for imports have been substantially revised, to require shorter periods for pre-import notification, and to allow most notifications to be submitted electronically via Customs and Border Protection's Automated Commercial System/Automated Broker Interface (ACS/ABI).

     This Memorandum describes the new regulations, and assesses their possible impact on food producers and importers. Neville Peterson LLP stands ready to furnish any additional information or assistance which your company or its suppliers may require in analyzing or complying with these important new regulations. [Neville Peterson LLP is available to act as United States registered agent for foreign food facilities].

II. Registration of Food Facilities

1. Requirement to Register With FDA
   
        Any domestic or foreign facility that "manufactures/processes, packs or holds food for human or animal consumption in the U.S." must be registered with FDA by December 12, 2003. FDA will make its on-line registration system available for public use beginning October 16, 2003.
   
        The registration must be filed by the owner, operator or agent in charge of the plant, or by an individual authorized by one of those persons. A foreign facility must designate a U.S. agent, who must live in or maintain a place of business in the United States and be physically present in the United States, for purposes of registration.
   
        Domestic facilities must register, whether or not food from the facility enters interstate commerce.
   
   
2. Types of Facilities Which Must Register
   
        As noted above, all foreign and domestic plants which "manufacture/process, pack or hold" food for domestic consumption must register with FDA.
   
        For purposes of the registration requirement, "manufacturing/processing" is defined as "making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients". Manufacturing/processing activities include, but are not limited to, "cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling or packaging" food or food ingredients.
   
        "Holding", for purposes of the regulations means "storage of foods". Holding facilities required to register with FDA include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
   
        "Packaging" of foods means placing food into a container that directly contacts the food and that the consumer receives. "Packing" means placing food into a container other than packaging the food.
   
   
3. Facilities Exempt from Registration Requirements
   
        For purposes of the Registration of Food Facilities regulations, food contact substances and pesticides are not considered "food", and facilities producing or handling those substances are not required to register with FDA.
   
        Certain types of facilities are exempted from registration. These include private residences of individuals, non-bottled drinking water collection and distribution facilities (e.g., municipal water systems), transport vehicles that hold food only in the course of their business, carriers, farms, restaurants, retail food establishments, non-profit food establishments, fishing vessels, and facilities which are regulated exclusively by the United States Department of Agriculture (e.g., facilities handling only meat, poultry or egg products).
   
        If one foreign facility manufactures/processes, packs or holds food and 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 labeling, both facilities would be required to register. Accordingly, food importers must inquire concerning the various facilities engaged in the production of the goods which they import, in order to determine which facilities are required to register.
   
   
4. Procedure for Registration of Facilities with FDA
   
        Registrants must use FDA Form 3537 to register or to update a registration. Beginning October 16, 2003, FDA will accept these registrations over the internet at www.fda.gov/furls, which will operate 24 hours a day, 7 days a week. Internet registration is the preferred method of registration.
   
        In addition to internet registration, facilities lacking reasonable access to the internet can register by filing a paper copy of form 3557 with FDA, or by faxing the form to FDA at (301) 210-0247.
   
        FDA will accept multiple registrations submitted in CD-ROM format, if the files are submitted in Portable Document Format (PDF) and are accompanied by one signed copy of the certification statement that appears on the registration form.
   
        FDA encourages electronic registration over the internet as the least costly and most efficient means of filing the registration. In electronic format, all required information must be entered before the system will accept the submission. Registrants receive immediate confirmation of registration and a registration number for the facility is issued immediately upon electronic acceptance.

   Required data elements for each FDA facility registration include the following.
   
   (a) The name, full address, and phone number of the facility;
   
   (b) The name, address, and phone number of the parent company, if the facility is a subsidiary of the parent company;
   
   (c) For domestic and foreign facilities, the names, addresses, and phone numbers of the owner, operator, and agent in charge.
   
   (d) For a foreign facility, the name, address, phone number, and emergency contact phone number of its U.S. agent (if there is no other emergency contact designated under Sec. 1.233( c));
   
   (e) For a domestic facility, an emergency contact phone number;
   
   (f) All trade names the facility uses;
   
   (g) Applicable food product categories as identified in Sec. 170.3 of this chapter, unless [the applicant checks] either ``most/all human food product categories,'' according to Sec. 1.233(e), or ``none of the above mandatory categories'' because [the] facility manufactures/processes, packs, or holds a food that is not identified in Sec. 170.3 of [the FDA's regulations];
   
   (h) The name, address, and phone number for the owner, operator, or agent in charge;
   
   (i) A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate. If the individual submitting the form is not the owner, operator, or agent in charge of the facility, the registration must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, and telephone number, the individual who authorized submission of the registration. Each registration must include the name of the individual registering the facility submitting the registration, and the individual's signature (for the paper and CD-ROM options).

   Optional data elements included in the registration form include the following:
   
   (a) Fax number and e-mail address of the facility;
   
   (b) Preferred mailing address, if different from that of the facility;
   
   (c) Fax number and e-mail address of the parent company, if the facility is a subsidiary of the parent company;
   
   (d) For a domestic facility, emergency contact name, title, and e- mail address;
   
   (e) For a foreign facility, an emergency contact name, title, phone number and e-mail address. FDA will consider the facility's U.S. agent the facility's emergency contact unless the facility chooses to designate another person to serve as an emergency contact under this section;
   
   (f) For a foreign facility, title, fax number, and e-mail address of the U.S. agent;
   
   (g) Type of activity conducted at the facility (e.g., manufacturing, processing or holding);
   
   (h) Food categories not identified in Sec. 170.3 of this chapter, which are provided in Form 3537 sections 11a (e.g., infant formula, animal byproducts and extracts) and 11b (e.g., grain products, amino acids);
   
   (i) Type of storage, if the facility is primarily a holding facility;
   
   (j) A food product category of ``most/all human food product categories,'' if the facility manufactures/processes, packs, or holds foods in most or all of the categories identified in Sec. 170.3 of this chapter;
   
   (k) Approximate dates of operation, if the facility's business is seasonal;
   
   (l) The fax number and e-mail address of the owner, operator, or agent in charge; and
   
   (m) The fax number and e-mail address of the individual who authorized submission of the registration.

5. Updating/Amending the Facility Registration
   
        Facility registrations must be updated if a required element of the registration information changes. Changes should be submitted through the internet or through FDA's paper update process.
   
        If the new owner acquires an already registered facility, the former owner must cancel the facility's registration within 60 days of the change, and the new owner must register the facility. If a facility goes out of business, its registration must be cancelled.
   
   
6. Sanctions for Failure to Register a Food Facility
   
        Failure of a domestic or foreign facility to register with FDA, to update required data elements, or to cancel its registration in accordance with the new regulations is deemed to be a "prohibited act" under the Federal Food, Drug and Cosmetic Act. The Federal Government can bring civil actions to ask a Federal Court to enjoin persons who commit prohibited acts, or, in extreme cases, can bring a criminal prosecution against persons responsible for commission of the prohibited act.
   
        If a foreign facility which is required to register fails to do so, food from that facility which is offered for import into the United States will be denied admission into the United States and held at the port of entry. As noted below, facilities registration codes will be required to be submitted to Customs in connection with pre-import notifications of food imports.
   
   
7. Public Comment Period: FDA Enforcement Policy
   
        Although these new regulations go into effect on December 12, 2003, FDA is providing a 75-day comment period on specific issues related to its interim final rule on Registration of Food Facilities.
   
        During the initial months following the effective date, FDA will follow an enforcement policy which emphasizes assisting covered entities in understanding and complying with registration requirements. FDA intends to publish a Compliance Policy Guide which will generally outline how FDA intends to exercise its enforcement discretion regarding registration of food facilities.

     

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