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Questions Remain for PGA Treatment of 321 Entries; Exemptions Unlikely to Apply to TTB, ATF, Some FDA Regulated Products

With CBP expected to allow for multiple options for filing Section 321 entries, some significant uncertainty remains for how the partner government agencies will treat goods imported at values under the $800 de minimis threshold, said Lenny Feldman, a lawyer with Sandler Travis. Still, there have been some indications for what to expect from the PGAs on the issue, he said. "Goods that the Alcohol and Tobacco Tax and Trade Bureau and the Bureau of Alcohol, Tobacco, Firearms and Explosives regulate would seem to be excluded from section 321 processing because the customs regulations already mention alcohol and tobacco as exceptions to de minimis processing," Feldman said in a May 20 email. Pharmaceuticals and medical devices regulated by the Food and Drug Administration also seem unlikely to receive Section 321 filing exemptions, he said.

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Feldman, who is also a member of the Commercial Customs Operations Advisory Committee, noted that the FDA announced in July 2017 (see 1707030044) that there are "five regulated items that could be released under section 321. Notably, absent from this list were pharmaceuticals and medical devices," he said. "We are still waiting to receive confirmation from other PGAs including the Consumer Product Safety Commission, National Highway Traffic Safety Administration and Directorate of Defense Trade Controls that in the past have been known to express that additional data is critical for their admissibility determinations."

A number of other agencies have not provided any formal indications on the issue, he said. "Other PGAs where the trade community really seems to need section 321 policy guidance because they cover a wide variety of merchandise include the Agricultural Marketing Service, the Animal and Plant Health Inspection Service, Food Safety and Inspection Service, National Marine Fisheries Service, Environmental Protection Agency and the Fish and Wildlife Service," Feldman said. "While some of these PGAs have informally expressed an interest in admissibility data for section 321 shipments, the question is if they need that data, whether it can be provided through manifest, an enhanced manifest process, or an ACE process, and what does that mean for the duties," he asked. "If the PGAs are saying they need the data for release regardless of the value of the shipment, does that mean that you owe duties on that merchandise as well -- or is it just really more about having the admissibility data at the time of cargo release."

While CBP released a strategic plan earlier this year (see 1803060038), CBP has yet to officially announce its plans for Section 321 entry policies due to the ongoing NAFTA negotiations (see 1712050025). De minimis continues to be a contentious issue within NAFTA negotiations (see 1805180023).