0520 Attachment A Section 801m of the FFDCA

Attachment A

Section 801(m) of the Federal Food, Drug, and Cosmetic Act

21 U.S.C. 381(m)

(m) Prior notice of imported food shipments

(1) In the case of an article of food that is being imported or

offered for import into the United States, the Secretary, after

consultation with the Secretary of the Treasury, shall by regulation

require, for the purpose of enabling such article to be inspected at

ports of entry into the United States, the submission to the Secretary

of a notice providing the identity of each of the following: The

article; the manufacturer and shipper of the article; if known within

the specified period of time that notice is required to be provided, the

grower of the article; the country from which the article originates;

the country from which the article is shipped; and the anticipated port

of entry for the article. An article of food imported or offered for

import without submission of such notice in accordance with the

requirements under this paragraph shall be refused admission into the

United States. Nothing in this section may be construed as a limitation

on the port of entry for an article of food.

(2)(A) Regulations under paragraph (1) shall require that a notice

under such paragraph be provided by a specified period of time in

advance of the time of the importation of the article of food involved

or the offering of the food for import, which period shall be no less

than the minimum amount of time necessary for the Secretary to receive,

review, and appropriately respond to such notification, but may not

exceed five days. In determining the specified period of time required

under this subparagraph, the Secretary may consider, but is not limited

to consideration of, the effect on commerce of such period of time, the

locations of the various ports of entry into the United States, the

various modes of transportation, the types of food imported into the

United States, and any other such consideration. Nothing in the

preceding sentence may be construed as a limitation on the obligation of

the Secretary to receive, review, and appropriately respond to any

notice under paragraph (1).

(B)(i) If an article of food is being imported or offered for import

into the United States and a notice under paragraph (1) is not provided

in advance in accordance with the requirements under paragraph (1), such

article shall be held at the port of entry for the article, and may not

be delivered to the importer, owner, or consignee of the article, until

such notice is submitted to the Secretary, and the Secretary examines

the notice and determines that the notice is in accordance with the

requirements under paragraph (1). Subsection (b) of this section does

not authorize the delivery of the article pursuant to the execution of a

bond while the article is so held. The article shall be removed to a

secure facility, as appropriate. During the period of time that such

article is so held, the article shall not be transferred by any person

from the port of entry into the United States for the article, or from

the secure facility to which the article has been removed, as the case

may be.

(ii) In carrying out clause (i) with respect to an article of food,

the Secretary shall determine whether there is in the possession of the

Secretary any credible evidence or information indicating that such

article presents a threat of serious adverse health consequences or

death to humans or animals.

(3)(A) This subsection may not be construed as limiting the

authority of the Secretary to obtain information under any other

provision of this chapter.

(B) This subsection may not be construed as authorizing the

Secretary to impose any requirements with respect to a food to the

extent that it is within the exclusive jurisdiction of the Secretary of

Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601

et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),

or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).