Docket Management
Docket: 02N-0278 - Bioterrorism Preparedness; Prior Notice of Imported Food Shipments, Section 307
Comment Number: EC -14

Accepted - Volume 2

Comment Record
Commentor Mr. Bob Bauer Date/Time 2002-08-30 12:37:29
Organization Association of Food Industries
Category Association

Comments for FDA General
Questions
1. General Comments 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 President Bush signed Public Law No. 107-188 into law on June 12, 2002. The Association of Food Industries, Inc., an association of 300+ U.S. companies in the international food trade, commends FDA’s Center for Food Safety and Applied Nutrition for its wise decision to call for comments from interested parties regarding factors the agency should consider as it proceeds to draft the regulations implementing Public Law No. 107-188. AFI offers the following comments on implementation of Section 307 of Public Law No. 107-188, Prior Notice of Imported Food Shipments. Regulations Promulgated “In Consultation with the Secretary of Treasury” Section 307(a), to be codified at 21 U.S.C. § 381(m)(1) requires FDA to promulgate regulations implementing the requirements of Section 307 “after consultation with the Secretary of Treasury,” that is, the U.S. Customs Service. Primary responsibility for administering U.S. laws relating to the import of goods, including food, into the U.S. lies with Customs. FDA is responsible for determining whether or not an article offered for importation is in compliance with or in violation of the laws FDA enforces. Section 307 is essentially overlaying requirements upon an existing system for the notification, inspection, handling, and processing of imported articles, including food. The existing system has arisen from a considerable body of Customs laws, regulations, policies, notices, and rulings and has been honed through decades of real world, practical experience. FDA should follow the letter and spirit of the exhortation to consult with Customs in promulgating rules to implement Section 307; AFI urges that FDA not try to “reinvent the wheel.” For instance, terms such as “importer,” “port of entry,” “date of entry,” “date of importation,” “time of entry,” and “shipment” are all defined in Customs regulations. The existing procedures governing the importation of articles, including food, into the U.S. are well-known and well-established in the importing community. FDA should look first to established Customs regulatory definitions and procedures as it promulgates the Section 307 regulations. New Regulations Should Rely Upon Existing FDA/Customs Notification Procedures The Section 307 notification requirement is redundant of information gathered through existing procedures. Importers of articles that fall within the jurisdiction of FDA already must submit notification to FDA before goods can enter domestic commerce. The notification importers must already make to Customs and FDA includes everything Section 307 would require, except for the identification of the grower, if known. This information could easily be provided as an additional line on the OASIS interface. Other Aspects of the Notice Currently, the customs broker completing the information screens within the ABI/ACS/OASIS system assigns a Customs entry number to the merchandise. For ease of tracking the food articles, AFI recommends FDA track the imports using the Customs entry number. The Customs entry number is available to FDA through the OASIS system. The electronic notification system should provide for an automatic reply from FDA. In this way, the submitting broker will immediately receive confirmation that the imported food articles are in compliance with the Section 307 notice requirements. Timing of Notice Section 307 states: notice [shall 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. As a general matter, AFI urges FDA to be very flexible in its notice requirements. The existing ABI/ACS/OASIS system of interface and notification has worked well. FDA personnel have a long history of reviewing these electronic submissions contemporaneous to an article’s arrival into U.S. ports. FDA is able to determine at the time of submission of Customs documentation which imported articles should be sampled and inspected and which should be given a “May Proceed.” The current system has provided for adequate oversight over imported goods without unnecessarily disrupting the orderly movement of goods in commerce. AFI believes any new regulations implementing Section 307 should respect these current practices and customs. In the spirit of flexibility and consistency, AFI urges FDA to look to the upper limits for notification prior to importation stated in Section 307 and that Customs has adopted. Section 307 prohibits FDA from requiring an importer to give more than five days notice prior to importation. Similarly, Customs permits filing of entries up to five days prior to the estimated arrival date of the merchandise. FDA surely has no objection to a similar maximum notice of five days. The issue of minimum notice is more difficult. The statute says FDA may not require prior notification in excess of five days. The import community wishes to aid FDA in its mission of keeping the U.S. food supply safe, pure, and abundant. In the view of industry, however, the current ABI/ACS/OASIS notification system is working well. Upon receipt of the electronic notification, FDA can issue a Notice of Sampling and halt the further movement of an imported article until the agency can review the imported article more closely. Any tinkering with the current system may create delay and expense, without necessarily enhancing oversight of imported goods. AFI urges FDA to look most closely at how the existing system already accommodates the letter and spirit of Public Law. No. 107-188. Flexibility in setting minimum notice requirements is necessary because the amount of notice that is feasible to provide depends upon the type of goods (tariff versus non-tariff class goods) and the method of transport (truck, air, maritime). A single period of minimum notice may be reasonable in some instances, but impossible in other situations. The timeframes for notice discussed below reflect the current commercial realities and practices of the importing business. Air Freight Generally, for merchandise traveling by air, Customs dictates that the ABI/ACS electronic submission of information must be made on a “wheels up” basis. That is, the broker may not enter the merchandise into the ACS system until the shipping plane’s wheels are up at the point of departure. While most international flights into U.S. ports of entry are longer than four hours in duration, this is not true of many international flights originating in Canada, Mexico and the Caribbean. AFI requests FDA follow the Customs “wheels up” rule as to merchandise traveling by air. An importer should notify FDA of the shipment at least four hours prior to the plane’s estimated time of arrival, or once the plane leaves the ground at the point of departure, and ending with the expiration on the date of importation (as defined in 19 C.F.R. § 101.1). This is consistent with current practices of filing Customs entry documents for air freight and provides FDA sufficient notice to make decisions regarding admissibility of merchandise. Ocean Cargo Several unusual factors need to be considered when establishing minimum notification periods for ocean-going vessels. These are discussed below. Ocean voyages are longer, and therefore could, potentially, accommodate a longer notice period. However, ocean voyages are also potentially subject to great variability and changes in arrival schedules. Weather, mechanical failures and similar problems can significantly delay trans-ocean shipments. The five-day maximum for filing entries with the Customs is measured from the estimated time of arrival (ETA) into port that the steamship company provides to the piers where the boat will dock. This information, in turn, is reported to Customs and Customs brokers. If the vessel’s arrival is delayed, then the steamship company modifies the reported ETA and the importer modifies its entry to the ACS system. Any minimum prior notice needs to be sufficiently flexible to allow for these types of changes in ETA. Also, while some ocean journeys are very long, significant traffic into U.S. ports originates from Canada, Mexico, and the Caribbean. Journeys from these ports could be as short as eight hours. For such shipments, brokers typically do not have all the documentation necessary to make the ACS/OASIS entry until a few hours prior to the vessel entering the U.S. port. For these reasons, AFI urges FDA to adopt a notice requirement of four hours prior to estimated time of importation for non-tariff class maritime cargo. The complex issues raised by tariff class goods is discussed below. Much imported food is subject to a tariff rate quota, such as dairy products, peanuts, sugar, and sugar-containing products. Such quota products are subject to Customs “live entry” regulations, 19 C.F.R. § 132.11a. Under these regulations, the importer may not submit the information on the merchandise into the ABI/ACS until the “date of importation” -- the date on which the vessel actually arrives within the limits of a port in the United States with intent then and there to unlade such merchandise. 19 U.S.C. § 101.1. Thus, if the Section 307 notification to FDA is to occur concurrently with the ABI/ACS/OASIS submission, the notification for food subject to quotas cannot be made until after the vessel arrives within the port’s limits. Practically speaking, it will be at least four hours, and likely much longer, from the time the vessel enters the port’s limits, until the time the vessel actually docks and is able to begin unloading. AFI recommends the Section 307 notification period for foods subject to quotas follow the Customs requirements for live entries. The Section 307 notification should be made concurrently with the filing of the entry documents, after the time the vessel enters the port’s limits and before the vessel is unloaded. Cargo by Truck Currently, it is common business practice in the case of products entering the U.S. from Canada and Mexico for the driver to present the Customs entry forms at the border crossing/port of entry; there is generally no advance notice of the shipment through the ABI/ACS/OASIS system. It will be a severe burden upon commerce if shippers are forced to abandon this system. Advance notice is especially unworkable for highly perishable items, such as fresh fish and seafood, and fresh fruits and vegetables entering the U.S. from Canada and Mexico. Furthermore, a significant percentage of truck traffic from Canada and Mexico into the U.S. involves short journeys, often less than four hours. AFI urges FDA to continue this practice and permit importers to comply with Section 307 notification requirements by presentation of the notice at the border simultaneously with the requisite Customs documentation. If, however, FDA demands prior notice of truck shipments from Canada and Mexico, then the agency should consider the following factors: · Under the Customs-Trade Partnership Against Terrorism (C-TPAT), shipments from participating importers are entitled to expedited processing at the border. Customs designates participating importers as “low-risk status,” if they have a demonstrated a history of regulatory compliance and supply chain integrity. FDA should adopt these determinations and permit a shorter notification window for importers Customs has designated as low risk status. · FDA should permit a shortened notification window for any shipments of highly perishable goods, such as fresh fish and seafood, and fresh produce. · FDA should permit a shortened notification window for routine truck shipments that are repetitive and regularly scheduled. AFI thanks FDA for the opportunity to submit these comments. Sincerely, Robert Bauer, President Association of Food Industries




EC -14