NCBFAA Submits Comments on FDA's Prior Notice and Food Facility Registration Interim Final Rules

On October 10, 2003, the FDA published two interim final rules under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) on prior notice (PN) and facility registration. NCBFAA states that although FDA has made tremendous strides with educational and outreach programs, there are still procedural and operational weaknesses that need to be addressed.

Highlights of NCBFAA Recommendations for PN and Registration Requirements

In its comments, NCBFAA makes ten observations and recommendations regarding these interim final rules, of which seven are summarized below (partial list):

Separate PN for each FDA line on an entry is burdensome. The FDA's interim final rule requires that a PN must be provided for each "article of food" and states that an article of food refers to a single food that is associated with the same complete FDA product code, the same "quantity" (i.e. amount and package size) and the same manufacturer/grower.

NCBFAA asserts that this requirement has been unduly burdensome on importers/filers and believes the FDA's ability to contact the necessary parties or track down a contaminated shipment will not be compromised if they do not have a separate PN for each different type of food product or amount of such product that arrive on the same bill of lading from the same manufacturer. NCBFAA recommends that PN submissions mirror the U.S. Customs and Border Protection (CBP) entry, and states that the PN final rule should eliminate quantity and product code as distinguishing factors that require a separate PN.

PN timeframes should mirror CBP's. NCBFAA states that streamlining FDA's PN submission timeframe with CBP's timeframes for advanced electronic reporting of manifest information is essential in order for CBP and FDA to achieve their goal of creating a uniform, integrated system with respect to enforcement of the Bioterrorism Act. (See ITT's Online Archives or 04/14/04 news, 04041405, for BP summary of the Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of PN Timeframes.)

NCBFAA recommends that FDA keep its vessel timeframes intact, yet adopt CBP's guidelines on air, land/rail and land/truck PN submission, including the 30 minute expedited submission procedures in place for Free and Secure Trade/Customs-Trade Partnership Against Terrorism (FAST/C-TPAT) participants.

Many difficulties remain in using PNSI. NCBFAA cites, among other things, technical difficulties experienced by filers and notes that it currently takes a customs broker approximately 30 minutes to input a PN using the FDA's PN System Interface (PNSI). NCBFAA states that problems associated with PNSI crashes, slow processing speed, and limited system capacity also need attention.

Filers should be notified when an entry is refused for inadequate PN. Under the FDA's interim final rule, only the carrier is required to be notified when goods are refused at the border due to inadequate PN. NCBFAA believes that the filer who transmitted the PN should be notified and notes that all information needed to contact the filer is readily available on the ABI submission and/or PN for any given shipment. NCBFAA also believes that the importer of record and/or consignee, if different from the filer, and if known, should also be notified.

Electronic method to cure a reject through WP should be provided. According to NCBFAA, the only method for a filer to resubmit a PN when goods are refused at the border is to transmit solely through PNSI. NCBFAA states that requiring ABI filers to retype all PN information into PNSI is time-consuming and unduly burdensome. As a result, NCBFAA recommends that the final rule be revised to allow post-refusal PN submission to be transmitted via either PNSI or WP.

FDA should allow PN amendments without cancellation or resubmission of entry. NCBFAA states that PNSI and WP do not currently allow the filer to correct or amend the PN submission after it is filed. NCBFAA contends that FDA should allow room for human error and change in shipment or food information, so long as such PN revisions are timely.

Manufacturer's name for "Gray Market" food shipments should be sufficient. The NCBFAA states that when a buyer purchases food products from a middleman or other entity, rather than directly from the manufacturer, the facility's registration number is often unknown, cannot be obtained from the manufacturer, or does not exist. Under these circumstances, when the submitter can only provide the manufacturer's name, PN should nevertheless be considered adequate and complete.

NCBFAA press release available at http://www.ncbfaa.org/whatsnew/pressreleases/2004/fdapriornotice.htm

NCBFAA recommendations (dated 05/14/04) available via email by emailing documents@brokerpower.com