FDA Issues Corrections to its Interim Final Rule on Prior Notice of Imported Food

(In its notice, the FDA states that the interim final rule was published with some errors, which this document corrects. See ITT's Online Archives or 10/30/03 news, 03103020, for the final part of BP's highlights of the interim final rule's regulations, with links to earlier summaries.)

Samples of Corrections Made to Interim Final Rule

The following are samples of the types of corrections the FDA has made to its interim final rule on prior notice of imported food (partial list):

No registration required for "storage and export." The FDA has amended 21 CFR 1.281(a)(6) to state, among other things, that 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.

(The interim final rule had mistakenly included a comma between the words "storage" and "export" which is now removed.)

Adding omitted phrase "and the submitter does not know." The FDA is also amending the second sentence of 21 CFR 1.281(a)(7) to state that "if the submitter does not know the identity of the grower, or if the article has been consolidated and the submitter does not know the identity of any of the growers, you may provide the name and address of the firm that has consolidated the articles of food from different growers or different growing locations.

Changing "owner" to "importer". The FDA is amending 21 CFR 1.281(a)(12) so as to state that "the identify of the importer is not required for an article of food that is imported or offered for import for transshipment through the U.S. under a Transportation and Exportation entry."

(The interim final rule had mistakenly referred to the identity of the "owner.")

Changing "owner" to "importer." The FDA is amending 21 CFR 1.281(c)(13) to state that if an article of food has been refused under section 801(m)(1) of the Federal Food, Drug, and Cosmetic Act and this subpart, the submitter must submit, among other information, the name and address of the owner, if different from the importer or ultimate consignee.

In addition, this paragraph is further revised to state that the identity of the importer is not required for an article of food that is imported or offered for import through transshipment through the U.S. under a Transportation and Exportation entry.

(The paragraph had mistakenly used the word "owner" instead of importer.)

"Held" as opposed to "refused" foods. The FDA is amending 21 CFR 1.285 (d) and (f) by, among other things, replacing the words "refused" and "refusal" with the words "held" and "hold".

eCFR Contains Changes Made to Interim Final Rule on Prior Notice

Subscribers should note that the e-CFR, which is available at http://www.gpoaccess.gov/ecfr/, has been updated to reflect the changes the FDA has made to its interim final rule on prior notice of imported food.

(BP has previously reported that the Office of the Federal Register (OFR) and the U.S. Government Printing Office (GPO) maintain an e-CFR prototype beta test site which contains a version of the CFR and is updated daily. According to a set of Frequently Asked Questions (FAQ) on this site, the e-CFR will be in beta test mode for a while, depending on testing results.

The FAQ states that once testing is finished, it is anticipated that beta status will be removed from the e-CFR; however, the e-CFR will not be legal until approved by the Administrative Committee of the Federal Register.)

FDA Contact - Deborah Ralston (301) 443-6230

FDA correction notice (D/N 2002N-0278, FR Pub 02/02/04) available athttp://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-1592.pdf

FDA interim final rule (D/N 02N-0278, FR Pub 10/10/03) available at http://a257.g.akamaitech.net/7/257/2422/10oct20030800/edocket.access.gpo.gov/2003/pdf/03-25877.pdf