FDA Issues Final Rule on Prior Notice of Imported Food, Draft Compliance Guide (Part I - Announcement)
The Food and Drug Administration has issued its final rule, effective 180 days after its November 7, 2008 publication in the Federal Register, on the submission to FDA of prior notice of food, including animal feed, which is imported or offered for import into the U.S.
Sign up for a free preview to unlock the rest of this article
Communications Daily is required reading for senior executives at top telecom corporations, law firms, lobbying organizations, associations and government agencies (including the FCC). Join them today!
This final rule modifies and replaces FDA's interim final rule which implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) on December 12, 2003, to require that prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP) Automated Broker Interface (ABI) or the FDA Prior Notice System Interface (FDA PNSI).
The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held.
(FDA has also concurrently announced the availability of a draft compliance policy guide (CPG) entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The draft provides written guidance to FDA's and CBP's staff on the enforcement of prior notice, etc.)
This is Part I of a series of BP summaries of the FDA's final rule on prior notice. Part I announces its availability, as well as the availability of the draft CPG, and provides some of FDA's examples of significant changes from the interim final rule.
(According to FDA sources, the long lead time before this final rule is effective is due in part to provide time for software to be reprogrammed. See future issues of ITT for additional BP summaries of this final rule.)
FDA States That Final Rule Contains Significant Changes from Interim Rule
In the preamble, the FDA lists some of the changes in the final rule it views as significant. Examples of these changes include:
The term shipper will be revised, by adding the phrase, or express consignment operators or carriers or other private delivery service, after international mail to clarify that a shipper is involved with various types of transactions, and not just international mail shipments.
Prior notice submissions will be allowed to be submitted no more than 15 calendar days before the anticipated date of arrival for submissions made through the PNSI and no more than 30 calendar days before the anticipated date of arrival for submission made through the ABI.
In the interim final rule, a registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage, and export, or further manipulation and export. FDA has removed this from the final rule and will require the registration number of the manufacturer (or the full address of the manufacturer and a reason) in all circumstances.
The final rule also includes a new provision for food arriving by express consignment operator or carrier since certain information may not be available to persons who ship food using an express consignment operator or courier. If the article of food is arriving by express consignment operator or carrier, and neither the submitter nor transmitter is the express consignment operator or carrier, and the prior notice is submitted via PNSI, the express consignment operator or carrier tracking number may be submitted in lieu of the anticipated arrival information.
(See ITT's Online Archives or 10/10/03 news, 03101005, for Part I of BP summaries of FDA interim final rules on prior notice of imported food and the registration of food facilities.)
-final rule effective 180 days after November 7, 2008
FDA contact: Laura Draski (866) 521-2297
FDA final rule (259 page agency version, to be published in Federal Register on 11/07/08) available at http://federalregister.gov/OFRUpload/OFRData/2008-26282_PI.pdf
FDA announcement of draft policy compliance guide (3 page agency draft version, to be published in Federal Register on 11/07/08) available at http://federalregister.gov/OFRUpload/OFRData/2008-26281_PI.pdf