NCBFAA Applauds FDA Efforts, Suggests Further Procedural and Operational Refinements in Recently Filed Comments

Kenneth Bargteil
Phone: (410) 768-9000
For Immediate Release

Washington, DCOn May 14, the National Customs Brokers and Forwarders Association of America, Inc. (NCBFAA) submitted comments to the Food and Drug Administration (FDA) requesting changes in 10 areas of its prior notice proposal. The NCBFAA’s remarks were in connection with the Interim Final Rules on Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), and the Registration of Food Facilities under the Bioterrorism Act, published in the October 10, 2003, Federal Register.
        The NCBFAA applauded the FDA’s efforts to date to craft "a more highly reasonable and workable scheme for protecting the integrity of the food supply chain yet with much less impact on trade and commerce than the industry had originally feared." Notwithstanding these tremendous strides "as is often the case with the introduction of a highly complex group of regulations, there are still procedural and operational weaknesses that need to be addressed." These include:

  1. Requiring separate prior notices for each FDA line on an entry is unduly burdensome. To address this issue, the NCBFAA suggested amending the definition of "article of food" in the PN Final Rule to eliminate quantity and product code as distinguishing factors that require a separate PN. Further, differences in the food product "quantity" and product code should not require separate PNs; rather, submission of separate PNs should be based on the uniformity of entry-level food data.
  2. FDA should adopt reduced time frames in the prior notice final rule that mirror CBP’s time frames for advanced electronic reporting of manifest information. It is impossible to obtain a uniform system if certain procedural basics, such as submission deadlines, are not consistent. Such an approach will lead not only to confusion in the industry, but also to documentation and systemic problems.
  3. FDA’s prior notice system interface (PNSI) requires significant improvement. While use of "copy web entry" somewhat facilitates the use of PNSI, filers are still experiencing technical difficulties in the processing and filing of PNs. Currently, it takes a customs broker approximately 30 minutes to input a PN using PNSI. Problems associated with PNSI crashes, slow processing speed and limited system capacity need attention.
  4. Food product categories should be considered as criteria for expedited processing of prior notice. Expedited procedures should be instituted for certain fresh and perishable foods. Foods including baked goods, produce and fresh fish or seafood are often packed and shipped as soon as possible to ensure freshness of the food. As such, the exact variety and quantity of such products are often not determined until well after the current PN deadlines.
  5. The FDA should notify the filer when an entry is refused due to inadequate prior notice. As there is a narrow window within which interested parties may refile an adequate PN before goods are moved to General Order, the duty to report the refusal should lie with FDA, so that the interested parties are timely informed of the refusal and are not prejudiced by any delay in the reporting.
  6. It is unduly burdensome and duplicative for the "submitter" to complete all contact information fields when the submitter is a registered facility. To facilitate efficiency and minimize duplicate reporting of information, FDA should revise the PN form. A facility’s registration contains all necessary contact information for the submitter, which FDA can easily access and cross-reference. This will significantly reduce the amount of time necessary to complete the PN while still providing FDA will all required information
  7. FDA should provide an electronic method through WP for curing a "reject" due to a defective prior notice.
  8. FDA should allow prior notice amendments within the applicable period for submission, without having to cancel and resubmit an entry, if the amendment does not affect the integrity of a certified entry. For FDA to be able to track and deter suspect shipments all material shipment and food information must be accurate and updated within the PN Systems, otherwise the system will never achieve its purpose. FDA should revamp the PN Systems to allow room for human error and change in shipment or food information, so long as such PN revisions are timely.
  9. Prior notice confirmation should include the entry identifier number for which FDA is acknowledging receipt. The NCBFAA recommends that the WP software and/or PNSI system be redesigned for filers to receive the relevant entry identifier information with the PN confirmation.
  10. The factory name for "gray market" food shipments should be sufficient for the PN where a submitter does not know the factory’s registration number. 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.

        In conclusion, the NCBFAA expressed it confidence in the FDA’s ability to address these issue and urged it to incorporate these recommendations into the final PN rule. "We believe that these comments will aid both FDA and CBP," the NCBFAA said, "in achieving their goal of developing a truly joint and uniform system with respect to enforcement of the Bioterrorism Act and its subsequent regulations."
        With headquarters in Washington, DC, the NCBFAA ( represents nearly 700 member companies - the nation's leading freight forwarders, customs brokers, ocean transportation intermediaries (OTIs) and air cargo agents. Established in 1897 in New York, NCBFAA is the strong, effective national voice of the industry. Through its various committees, counsel and representatives, the Association maintains a close watch over legislative and regulatory issues that affect its members. It keeps them informed of these and other related issues through its weekly Monday Morning eBriefingQuarterly NCBFAA Bulletin, and various meetings and conferences throughout the year.


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