FDA Revises Guidance on Prior Notice of Imported Food, Recordkeeping under the Bioterrorism Act (Part I)
The Food and Drug Administration (FDA) has recently issued notices announcing the availability of a revised compliance policy guide on prior notice (PN) of imported food as well as the second edition of a questions-and-answers (Q&A) document regarding the final rule on establishment and maintenance of records under the Bioterrorism Act.
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This is Part I of a three-part series of summaries on these recently revised guidance documents. Part I announces the availability of, and briefly highlights, these documents. See future issues of ITT for more detailed summaries.
FDA's Revised Compliance Policy Guide on PN of Imported Foods
In its announcement of the availability of this revised compliance policy guide, the FDA states that this document provides written guidance to FDA's and U.S. Customs and Border Protection's (CBP's) staff on enforcement of section 307 of the Bioterrorism Act and the agency's implementing regulations, which require PN for food imported or offered for import into the U.S.
Finalized sections pertaining to routine shipments of food that are transshipped through the U.S. According to the FDA, this compliance policy guide has been revised to finalize the sections pertaining to routine shipments of food that are transshipped through the U.S., arriving from and exiting to the same country, and regarding the Harmonized Tariff Schedule (HTS) code that is part of the planned shipment information. (See ITT's Online Archives or 03/07/05 news, 05030715, for BP summary of the previous version of this compliance policy guide.)
This revised compliance policy guide is available at http://www.cfsan.fda.gov/pn/cpgpn6.html
Revised Q&A's on Establishment/Maintenance of Records Under Bioterrorism Act
The FDA also announces the availability of the second edition of its Q&A document regarding the final rule on establishment and maintenance of records. The FDA states that this guidance responds to various questions raised about section 306 of the Bioterrorism Act and the agency's implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the U.S. According to the FDA, such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food.
Deadlines for compliance with records requirements. FDA adds that persons covered by the regulation must be in compliance by December 9, 2005, June 9, 2006, or December 11, 2006 depending on the size of the business. (See ITT's Online Archives or 09/08/05 news, 05090820, for BP summary of the previous version of this Q&A document.)
(See ITT's Online Archives, 05011495, for full BP summary of the final rule on recordkeeping under the Bioterrorism Act.)
The second edition of this Q&A document is available at http://www.cfsan.fda.gov/dms/recguid2.html
-written or electronic comments on FDA guidance documents may be submitted at any time
| Laura Draski (PN compliance policy guide) | (866) 521-2297 |
| Denise Beavers (Q&A document) | (301)436-1721 |
FDA Notices on availability of these guidance documents available at:
Revised compliance policy guide notice (D/N 2003D-0554, FR Pub 11/14/05) available at http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-22500.pdf
Q&A document second edition notice (D/N 2005D-0356, FR Pub 11/22/05) available athttp://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-23062.pdf