FDA Issues Second Edition of Q&A on Prior Notice Requirement for Imported Food
The Food and Drug Administration (FDA) has issued a notice announcing that it has issued the second edition of its Questions and Answers (Q&A) on the prior notice requirement for imported food. This revised guidance is entitled "Questions and Answers Regarding the Interim Final Rule on Prior Notice of Imported Food (Edition 2)" and is dated May 2004.
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In its Q&A, the FDA states that revisions/additions since the first edition are noted by date (i.e., April 2004). In addition, the Q&A numbering system and Table of Contents have been revised for clarity. (See ITT's Online Archives or 12/15/03 news, 03121505, for BP summary of the first December 16, 2003 edition, as well as an update on the FDA compliance policy guide for enforcing the prior notice requirement.)
According to the FDA, this guidance responds to various questions raised about Section 307 of the Bioterrorism Act and the FDA's interim final rule, which requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the U.S.
This is Part I of a two-part series of summaries on this Q&A, and lists the 25 new Q&As and highlights new Section IV. See future issue of ITT for Part II.
25 new Q&As added. According to the FDA's guidance, 25 new Q&As have been added to Section IIsince the first edition. The question portion of these 25 Q&As are as follows:
| A 1.4 | How do I comment on the interim final rule? |
| A 1.5 | What if I have a question about or need clarification on the interim final rule? |
| A 2.5 | How do I arrange for a presentation by FDA on prior notice requirements to my trade group? |
| B 4.1 | Are seeds subject to prior notice requirements? |
| C 7.2 | If I submit prior notice before a food is admitted into a Foreign Trade Zone (FTZ), do I need to submit prior notice again before a food is withdrawn from the FTZ? |
| C 8.2 | Does prior notice apply to food in its natural state, grown by an individual, and sent to an individual in the U.S. as a gift? |
| C 8.3 | Is prior notice required if an individual purchases a food product, made by a third party, and sends it to an individual in the U.S. as a gift? |
| C 9.2 | Are foods included with my household goods subject to prior notice even if the move is covered by the military? |
| C 12.2 | Is prior notice required for meat intended for animal feed or pet food? |
| C 14.1 | Is produce that is inspected by the Animal and Plant Health Inspection Service's (APHIS') Plant Protection and Quarantine (PPQ) or graded by USDA's Agricultural Marketing Service (AMS) subject to FDA's prior notice requirements? |
| C 15.2 | I plan to drive back to the U.S. from Canada with my trunk full of food I purchased there to serve at a family picnic. Is prior notice required? |
| C 15.3 | I plan to drive back to the U.S. from Mexico with my trunk full of shellfish that I plan to sell at a flea market on the U.S. side of the border. Is prior notice required? |
| C 15.4 | I plan to drive back to the U.S. from Canada with my trunk full of samples of finished packaged foods for testing. Is prior notice required? |
| C 17.2 | Are samples of food that are intended for analytical testing for contaminants exempt from prior notice? |
| D 2.2 | What is the deadline if the food is transported by truck, but the truck arrives via ferry due to a water crossing? |
| D 2.3 | What is the deadline if the food walks across the border, such as livestock that are driven across? |
| D 5.1 | What food facility registration numbers must I provide as part of my prior notice submission? |
| D 6.1 | If a food from a known grower is commingled with food from unknown growers, may the submitter still identify only the consolidator instead of the grower? |
| D 6.2 | Does a grower need to be identified if an article of food can no longer be associated with a particular grower? May growing location be used instead? |
| D 7.1 | If my shipment consists of just one type of food in the same size container but under different brand names, do I have to submit a separate prior notice for food labeled with each brand name? |
| D 7.2 | How many prior notice submissions are required and what is the estimated quantity of food shipped if I sell fish to grocery stores in the U.S., who will order the fish in bulk, and the fish is packed and shipped to the U.S. in one of four manners (described in the guidance)? |
| D 10.2 | My food is being shipped in several different containers. Does the Prior Notice System Interface (PNSI) accept multiple container numbers? |
| D 11.5 | Do I need to submit samples to accompany my prior notice submission or to accompany the shipment? |
| E 2.3 | What enforcement discretion is described in FDA's Compliance Policy Guide \"Guidance for FDA and CBP Staff/Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002"? |
| E 2.4 | Does the enforcement discretion described in FDA's Compliance Policy Guide mean that registration of foreign food facilities is not required until August 2004? |
Section IV added on where to get additional information. In addition, the FDA has added a Section IV entitled "Where to Get Additional Information." In this section, the FDA lists contact telephone and fax numbers, as well as a contact email address, for the Prior Notice Help Desk.
The FDA also provides links to "Useful Web sites" on (partial list): the Bioterrorism Act, PNSI, the Compliance Policy Guide, a document on Prior Notice and Sending Food Gifts Through International Mail, the form for submitting questions on Prior Notice, the U.S. Customs and Border Protection (CBP) home page, the CBP Broker Management Handbook, the CBP Web site on becoming a broker, etc.
FDA contact - Domenic Veneziano (866) 521-2297
FDA notice (D/N 2004D-0065, FR Pub 05/03/04) available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-10023.pdf
FDA Q&A on prior notice (Edition 2, dated May 2004) available at http://www.cfsan.fda.gov/pn/pnqagui2.html