Proposed FDA Regulations Make Already Costly ACE Requirements More Burdensome, Trade Groups Say

Additional data elements required by the Food and Drug Administration for ACE entries are increasing costs and staffing needs for the trade community, companies and trade associations said in comments on FDA’s proposed rule to codify the new requirements (here). FDA’s ACE requirements “represent an economically significant greater burden on the trade community compared to the data required in the previous Automated Commercial System (ACS),” the Express Association of America said (here). One EAA member calculated an increase of 50% in the time required to process an FDA entry in ACE over the time required in ACS, “from 16 to 24 minutes,” the EAA said. “In order to continue to meet the strict delivery deadlines in the express environment for FDA-regulated products, the increased processing time has resulted in a requirement for a 40% increase in staffing for these shipments,” it said.

Though FDA’s proposed rule says submission of these additional data elements can “significantly increase” the chances of getting an automated “may proceed” from the agency, it “provides no details on why this is likely to occur or what processes FDA intends to change to ensure it does occur,” the EAA said. “FDA statistics indicate that 75% of regulated shipments do not receive an automated may proceed, a figure that has remain[ed] at this high level over many years,” despite the optional submission of some of the newly required data elements in ACS for some products, including medical devices, it said. “The conclusion is unavoidable” that the failure to receive an automated “may proceed” is tied not only to data quality, but also the targeting rules in FDA’s PREDICT system, the EAA said. “If FDA believes an automated may proceed will occur more frequently in an ACE environment with the submission of additional information, the agency must commit to reviewing its entire targeting process and working with the trade community to ensure that result is achieved.”

Several of the proposed data elements required under FDA’s proposed rule are unnecessary and duplicative, the Grocery Manufacturers Association said (here). “To the extent additional data are needed to facilitate FDA’s evaluation of the relative risk of food products, GMA generally agrees that they should be included as required data elements for food importers so long as providing this information is not duplicative. We are concerned, however, that several of the proposed data elements required would be duplicative of information importers already provide to CBP,” it said. “In addition, FDA has not explained how certain data elements will improve the efficiency of the agency’s review, including in particular the agency’s review of food, and GMA questions the utility of providing this information in light of the burden it will impose on importers.”

FDA’s proposal to make several currently optional data elements mandatory could make matters worse, said both the United Parcel Service (here) and FedEx (here), echoing earlier comments from the National Customs Brokers & Forwarders Association of America (see 1608250036). Making them mandatory “will cause a pile up of shipments waiting for the additional data” to be obtained by the filer from the importer, FedEx said. Currently these data elements, including intended use, are optional, so CBP can still process the ACE entry and release the goods to the importer’s premises before FDA says the entry “may proceed” into commerce. “This new process may prevent the goods to move to the importer's premise[s] pending a request for information from the filer to the importer if the data is rejected up front,” UPS said. “The very real cost of storage and demurrage incurred waiting to obtain FDA information from an importer can amount to thousands of dollars within a matter of days.”

FDA has “virtually ALL” of the additional information “already within its own database(s),” the American Association of Exporters and Importers said (here). “FDA is now requiring the trade to place, on every single line item, virtually the full FDA database for every single line item,” it said. FDA should instead have a “simple indicator and code” linking to the FDA system ID for that combination of product and importer, which the importer could then reference for FDA to match against its internal systems, AAEI said. “This would be a tremendous relief of reporting requirements for both the trade and the FDA,” it said. AAEI also noted its displeasure with FDA’s “prompt” decision (here) not to grant its request for more time to file comments (see 1608160031). Comments on FDA’s proposed rule were due Aug. 30.