In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.
PREDICT is an important tool that helps entry reviewers target and inspect higher-risk shipments. In parallel, PREDICT also smoothens and accelerates the clearance of any cargo that carries lower risk, so long as accurate and complete data are provided by importers and entry filers.
The new import requirements have now become harsher and effective in unison with the U.S. Customs and Border Protection’s ACE software program. These programs together look for a lot more information from the foreign source of the goods than earlier. Not only are these requirements linked to the FDA’s product codes and U.S. Harmonized Tariff Schedule (HTS); there has to be a match between the information entered on the entry’s commercial or pro forma invoice with the one provided in and entered into PREDICT and ACE software.
In the event of even a minor error or mismatch in the software coding information, importers and shippers can expect expensive delays and a possible refusal of the entry. Those who participate in a voluntary Affirmation of Compliance (AOC) are allowed some lenience by the FDA from the strict requirements. Yet, providing accurate information is imperative for aligning and reconciling the information contained in PREDICT, ACE, Invoice and AOC. Any lapse in adhering to any of these procedures or ensuring the accuracy of the data match has major consequences in the form of fines and delays.
It is critical to get all the procedures in the right order
In the nearly three years that the new import entry filing requirements have been in place, users have been facing problems. What happens when the importer is unable to meet the FDA’s and the Customs and Border Protection’s requirements? There are costly delays. When these delays happen, the importer has to turn to the FDA to resolve the problem. This can be tedious. The only really effective antidote to these issues is paying full and proper attention to how to use the two programs and getting their implementation right to a T.
And then, the importer has to also complete the task of linking the FDA’s and U.S. Custom’s software to an importer’s legal requirements by using the correct Harmonized Tariff Schedule (HTS) code. This is a major determinant of how the FDA will apply its requirements. Importing, however, becomes easier if the information on the manifest, invoice and affirmation of compliance are consistent with each other and correct. So, the crucial task for the importer is to get the harmonization of all these right, because apart from marking out a wrong entry as a problem that requires greater scrutiny for data verification; the FDA will also impose fines for filing incorrect entry data in ACE.
Proper guidance on the ways of meeting these requirements
Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar aimed at helping importers, shippers and others related to these activity get the alignment and matching of the PREDICT, ACE and the HTS right.
Casper Uldriks, who owns the firm, Encore Insight LLC and has worked for over 32 years with the FDA or its divisions at various levels, will be the speaker at this webinar. His having developed enforcement actions and participated in the implementation of new statutory requirements over many years has given him sharp insights into the FDA’s way of thinking. If sharing the insights this expert brings into the FDA’s software programs is relevant to you and interests you, please register for this webinar by visiting Software Screening Program
The intention of this webinar is to explain the benefits from the new requirements of the software programs, which help importers to streamline the import documentation and let them check the status of their entry, as well as the communications between an importer or its broker and U.S. Customs.
Casper will cover the following areas at this webinar:
- FDA’s required information for the PREDICT software screening prior to entry
- FDA product codes
- Custom’s required information for the ACE software system prior to entry
- Custom’s Harmonized Tariff Schedule (HTS)
- Affirmation of Compliance (AOC).