2002N-0278 - Small Entity Compliance Guides on Registration of Food Facilities and Prior Notice of Imported Food; Availability
FDA Comment Number : EC479
Submitter : Miss. Marisol Figueroa Date & Time: 05/17/2004 06:05:31
Organization : FEPACH A.G.
Food Association
Category :
Issue Areas/Comments
GENERAL
GENERAL
2002N-0278 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Reopening of Comment Period
FR Type: Interim Final Rules
Action: Extension/Reopening of Comment Period

[Docket No. 2002N-O278]: Interim final rule; reopening of comment period.

Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.


Specific comments


Sec. 1.281 What information must be in a prior notice? / (a) General

The FDA notes:

,???The estimated quantity of food that will be shipped, described from largest container to smallest package size; ??.
???
???The anticipated time of that arrival;?..?


It is a problem to indicate in this part ?estimated quantity?, and in the Section 1282 (a)(1) to put only ?quantity?, because in the first section gives an idea of relatively and in the second section (1282) gives a very exact parameter.

Also is a problem for food arriving by ocean vessel or arriving as containerized cargo by water, to indicate an anticipated time, because in these cases the indication of a specific date is already difficult. So to give an exact hour of arrival is impossible.


Sec. 1.282 What must you do if information changes after you have received confirmation of a prior notice from FDA?

The text notes:

?(a)(1) If any of the information required in Sec. 1.281(a) except the information required in:
(i) Sec. 1.281(a)(5)(iii) (quantity),
(ii) Sec. 1.281(a)(11) (anticipated arrival information), or
(iii) Sec. 1.281(a)(17) (planned shipment information) changes after you receive notice that FDA has confirmed your prior notice submission for review, you must resubmit prior notice in accordance with this subpart unless the article of food will not be offered for import or imported into the United States??.?

FDA does not specifies what happens with the food if the information of quantity, anticipated arrival information and planned shipment information changes.





During the ?Embassy Training Seminar?, in Washington at 6 - 7 November, it was explained that :

?If change is to estimated quantity, anticipated arrival information, planned shipment information or estimated date of mailing ? no action required?.

But that no action is required from the submitter or the transmitter does not clarifies if the food will be ?accepted?. As ?accepted?, we mean that the prior notice will be considered adequate.

Therefore the requirement of ?estimated quantity? and ?anticipated time? become more important.