FDA Issues 4th Version of "Q&A" on the Registration of Food Facilities
The Food and Drug Administration (FDA) has posted to its Web site a fourth version of its Questions & Answers (Q&A) document regarding the registration of food facilities, which is effective immediately.
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
(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 4) includes answers to several 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:
Nonprofit food facilities
Is an establishment operated by a public or other not-for-profit organization in which food is prepared, such as food for a school lunch program, or for a food service program, a "nonprofit food establishment" that is not required to be registered?
U.S. Agent
What does a foreign facility need to do to "designate" a person as a U.S. agent?
What is the status of a foreign facility's registration where the person listed as the U.S. agent for the facility has not affirmatively agreed to serve as the facility's U.S. agent?
What will happen to an article of food that is imported or offered for import into the U.S. from a facility with a registration that FDA considers to be invalid because it does not include a U.S. agent who has affirmatively agreed to serve in that capacity?
(See ITT's Online Archives or 02/18/04 news, 04021810, for BP summary of the February 2004 version of this "Q&A" , with a link to the January 2004 version.)
(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 August 2004 Q&A (D/N 2003D-0545, FR Pub 08/06/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-18057.pdf
FDA's revised Q&A (Edition 4, dated August 2004) available at http://www.cfsan.fda.gov/dms/ffregui4.html