FDA Issues 3 rd Version of "Q&A" on the Registration of Food Facilities

(On October 10, 2003, the FDA issued an interim final rule to implement the Bioterrorism Act's requirement that domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA by December 12, 2003.)

According to the FDA, this revision (Edition 3) includes answers to new inquiries regarding the implementation of its October 10, 2003 interim final rule on the registration of food facilities.

Highlights of the New Questions in the FDA's Revised Q&A

The following are highlights of the new questions included in the FDA's revision of its Q&A (partial list):

Definition of facility

Do importers of FDA food products need to be registered if the food is not entered for consumption in the U.S. but entered solely for export from a bonded warehouse?

Holding

Is a vessel carrier considered a facility for purposes of this regulation if the vessel is only engaged in transporting food from one facility to another facility?

Must foreign storage facilities that hold finished food products prior to export to the U.S. be registered?

Do the facilities of both the exporter and the importer of food for consumption in the U.S. need to be registered if they each hold food?

Manufacturing/Processing

Is registration required for all of an entity's manufacturing/processing sites even if there is only one involved with food products sent to the U.S.?

Trade Names

Does a distributor of food products need to register the trade names of all products it distributes, or repacks and then distributes, or only the trade names of those products manufactured at its facility?

U.S. Agent

What, if any, involvement will FDA have in the business relationship between a U.S. agent and its foreign principal? Will FDA take any action to enforce or otherwise intervene in that business relationship?

What type of routine communications will occur between FDA and a facility's U.S. agent?

Is a power of attorney required for a U.S. agent to work on behalf of the facility?

May a foreign food processor change U.S. agents after registration?

May the emergency contact for a foreign facility have a phone number outside the U.S.?

What information must the U.S. agent have on the foreign facility? For example, does the U.S. agent need to know and understand the company and product? Or is it sufficient for the U.S. agent to be able to contact the manufacturer quickly in case of emergency, as well as serve as a conduit for the general information flow to and from FDA?

How does a foreign facility "authorize" someone in the U.S. to be their agent (letter to FDA, notarized document)?

May a foreign facility appoint one U.S. agent for part of the year and another U.S. agent for the rest of the year?

Must foreign facilities belonging to the same parent company be registered by the same agent or may each of them use a different agent for registration and emergency contact purposes?

Traditionally, a U.S. broker has been utilized for routine and emergency communications with respect to the disposition of a particular shipment. Will that continue or will only the designated U.S. agent be the facilitator for communications between a shipping facility, carrier, broker, and importer?

If someone agrees to be the U.S. agent for a foreign facility and later wishes to be removed as the U.S. agent, how would this be accomplished?

How can the U.S. agent be accessible 24 hours a day/7 days a week? How can a small company make such an assurance?

Can a person in the U.S., who has not been designated as the U.S. agent for a foreign facility, perform the registration function for that facility?

Availability of Food Registration Information to the Public

Is a registered facility responsible for ensuring that the companies with which they deal are registered?

Can a registration number be revealed to customers?

FDA's list of facilities and registration documents are not subject to public disclosure. How is it known, for instance, that a supplier is registered?

Will FDA require the registration number to be displayed as part of a product label?

(See ITT's Online Archives or 01/12/04 news, 04011210, for BP summary of the FDA's January 12, 2004 Q&A, with a link to its December 2003 Q&A.)

(See ITT's Online Archives or 11/10/03 news, 03111010, for Part XIV (with links to Parts I-XIII) of BP's series of summaries on this interim final rule, as well as on the FDA's interim final rule requiring prior notice of imported food.)

FDA Contact - Melissa Scales (301) 436-1720

FDA's Federal Register notice announcing the February 2004 Q&A (D/N 2003D-0545, FR Pub 02/17/04) available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-3421.pdf

FDA's revised Q&A (Edition 3, dated February 2004) available at http://www.cfsan.fda.gov/dms/ffregui3.html