| Comment Record|
Mr. Robert Collette ||
2002-08-30 12:44:02 |
National Fisheries Institute |
| Comments for FDA General |
1. General Comments
August 29, 2002
Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Re: Docket No. 02N-0278: Comments on Section 307, Prior Notice of Imported Food Shipments Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188)
Dear Sir or Madam:
President Bush signed Public Law No. 107-188 into law on June 12, 2002. The law made significant changes to, among other things, the Federal Food, Drug, and Cosmetic Act (¡§FDC Act¡¨) and enhanced controls to better protect the safety and security of the United States food supply. Among these changes, Section 307 of the Public Law imposed new requirements upon the importation of food into the U.S.
The Food and Drug Administration (¡§FDA¡¨) summarizes the new import provisions of Section 307 as follows:
„h Amends Section 801 of the FDC Act to require prior notice of imported food shipments. The notice is required to provide the article, the manufacturer and shipper, the grower (if known within the specified time in which notice is required), the country of origin, the country from which the article is shipped, and the anticipated port of entry. If notice is not provided, the article shall be refused admission.
„h Requires the Secretary, after consultation with Secretary of the Treasury, to issue regulations that specify the period of advance notice. The advance notice shall be no less than the minimum amount of time necessary for the Secretary to receive, review, and appropriately respond to such notification. The period may not exceed five days.
„h Requires the Secretary to promulgate proposed and final regulations by December 12, 2003. If the Secretary fails to meet the deadline, the default period of notice will be no less than 8 hours and no more than five days until the regulation takes effect.
„h States that if an article of food is offered for import and prior notice has not been provided, such article shall be held at the port of entry until the importer, owner, or consignee complies. The Secretary, in carrying out this requirement, shall determine whether there is any credible evidence or information indicating that the article presents a threat of serious adverse health consequences or death to humans or animals.
„h Amends Section 301 of the FDC Act making it a prohibited act to import or offer for import an article of food in violation of these requirements.
Prior to initiating a complex rulemaking, FDA¡¦s Center for Food Safety and Applied Nutrition (¡§CFSAN¡¨) wisely called for comments from interested parties regarding factors the agency should consider as it proceeds to draft the regulations implementing Public Law No. 107-188. The National Fisheries Institute appreciates the opportunity to offer preliminary comments on the implementation of Section 307 of Public Law No. 107-188, Prior Notice of Imported Food Shipments. The NFI is a member of the National Coalition of Food Importing Associations (NCFIA), a coalition of trade associations that represent different segments of the United States food importing community. The other members of the NCFIA are: American Spice Trade Association; Association of Food Industries; Cheese Importers Association of America; and The Cocoa Merchants Association of America Inc. NFI supports and incorporates by reference the comments submitted by the NCFIA concerning the implementation of prior notice requirements of the Act. In addition, NFI offers the following observations relevant to the development of reasonable provisions that are harmonious with existing systems and procedures of U.S. Customs and FDA. We place particular emphasis on the importation of perishable fish and seafood.
As noted in the NCFIA comments, there is a great deal of redundancy between the information gathered through existing systems and the notification requirements of Section 307 of the Act. Therefore, FDA, in close consultation with U.S. Customs, should look to the existing systems and make minor modifications where necessary.
NCFIA points out that FDA personnel have a long history of reviewing electronic submissions for fresh shipments contemporaneous to an article¡¦s arrival into U.S. ports. Flexibility in setting minimum notice requirements is necessary because the amount of notice that is feasible to provide depends upon the type of goods (quota versus non-quota class merchandise) and the mode of transport (truck, air, maritime). A single period of minimum notice may be reasonable in some instances, but impossible in other situations. NFI represents many firms that import highly perishable fresh fish and seafood products. These products are particularly susceptible to damage and loss should import entry procedures lead to lengthy delays in the processing and disposition of shipments. Fresh fish and seafood enters primarily via air shipments and truck from Mexico and Canada. The timeframes for notice, therefore, must be flexible and reflect the current commercial realities and practices of the importing business for these commodities.
Buying and selling of fresh fish is unique, in many situations the fish arriving today was still swimming as recently as yesterday. Obviously, this makes collection and submission of all the relevant information needed for importation a challenge and places restrictions on the ability to provide prior notice. In general, NFI supports the comments of NCFIA in regard to air shipments and cargo by truck as well as its comments about ocean cargo. In addition, we wish to point out that the existing Customs¡¦ ¡§wheels up¡¨ policy places further restriction on air cargo. Specifically, shipments arriving in the morning on one day that were actually shipped the evening of the previous day cannot be entered into the ABI system until the date of arrival, thus entry notification is actually the day of arrival rather than the shipment date. This illustrates the complexity of submission of data in advance of arriving shipments. These issues should be carefully studied along with the intricacies of seafood and other food commerce before FDA finalizes the regulations to implement prior notice requirements.
Thank you for the opportunity to provide these preliminary comments regarding the implementation of Section 307.
Robert L. Collette
V.P of Science and Technology
Enclosure: NCFIA Comment Letter