FDA Revises Guidance on Prior Notice of Imported Food, Recordkeeping Under the Bioterrorism Act (Part III - Final)

This is Part III, the final part of a three-part series of summaries on these recently revised guidance documents. Part III describes changes made to the second edition of a Q&A document regarding the establishment and maintenance of records under the Bioterrorism Act. (See ITT's Online Archives or 11/29/05 and 11/30/05 news, 05112930 and 05113025, for Parts I and II of BP summary.)

2nd Edition of Q&A Document Contains About 19 Pages of New Questions

The FDA states that this Q&A document responds to various questions raised about section 306 of the Bioterrorism Act and the agency's implementing regulation, which require 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.

In the 2nd edition of this Q&A document, approximately 19 pages of new questions have been added, highlights of which are as follows (partial list):

1. CFR 1.352(a)(6) states that transporters must establish and maintain records that include the route of movement of an article of food in their possession. How detailed should this record of the route be? (Question 39.4)

Must a foreign transporter (transporting within the U.S.) have a place of business in the U.S. to comply with this regulation? (Question 38.2)

A firm's freight brokerage division negotiates freight rates and assigns shipping to independent carriers. Is the brokerage division held liable if an independent carrier under contract is not in compliance with this regulation? (Question 38.3)

A public warehouse releases food to a nontransporter immediate subsequent recipient who makes its own arrangements for transporting the food from the warehouse to the recipient. The receiving firm sometimes does not provide details about the carrier who will transport the food from the warehouse. Is the warehouse now required to obtain information about the carrier? (Question 34.7)

If a lot or code number or other identifier exists, but is not being used by a manufacturer, processor, or packer as part of current business practice, is this business required to include that identifier in the records it establishes and maintains? (Question 32.8)

A firm purchases a food ingredient from a broker who does not take actual possession of the food. Is the immediate previous source of the food the broker or the ingredient manufacturer (from whom the broker obtains the food)? (Question 17.5)

The Prior Notice Rule requires the reporting of specific data elements for the shipper of the food item. FDA defines the shipper as "the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail to the U.S." For direct imports, is the immediate non-transporter the person noted as the shipper on the Prior Notice submission? (Question 17.6)

In addition to adding certain new questions, the FDA lists the following new contact information for questions regarding this Q&A document: Center for Food Safety and Applied Nutrition (CFSAN) at 1(888) SAFEFOOD, fax: 1(877) 366-3322, email: industry@fda.gov.

(See ITT's Online Archives or 09/08/05 news, 05090820, for BP summary of the first edition of this Q&A document.)

FDA Q&A document, second edition (dated 11/10/05) available athttp://www.cfsan.fda.gov/dms/recguid2.html