At the Outsourcing in Clinical Trials Conference in New England, the CBP warned attendees of the common legal pitfalls researchers make in transporting material for clinical research. Credit: Jonathan Weiss via Shutterstock

The incorrect transport of biological materials opens the US up to risk of infectious disease and biological threats, says Sean Smith, a biological threat exclusion coordinator at the US Customs and Border Protection (CBP). In 2023, the agency seized 549,238lbs of drugs. While narcotics and illegal substances made up the majority of this number, other drugs accounted for 107,510 lbs.

“We are seeing more and more non-compliant biological materials coming in,” said Smith at a talk at the Outsourcing in Clinical Trials Conference in New England held 23-24 October.

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Many of the non-compliant materials are research materials and some finished products, said Baljeet Kaur, the agriculture operations manager from CBP. On the research material side, these items are often regulated by multiple agencies, she added. Confiscated items have included plasmids, preserved animal tissue, and cryo-containers, said Kaur. Often people have legitimate uses for these materials, but if people transport them without the correct paperwork, the CBP must assess them as potential threats, said Smith.

The US CBP has agricultural and biological programs to keep dangerous biological threats out of the US for national security reasons.

A common misconception is that people rule out certain products as US Department of Agriculture (USDA)-regulated. “Just because the US Food and Drug Administration (FDA) has approved something it does not mean it’s approved to come into the country. A lot of products that we see are regulated by more than one agency, and they all have to be satisfied,” said Smith. He listed the primate material as something that is often incorrectly transported due to this misconception. Primate, fish and wildlife products require a declaration before the product has left the country.

The Department of Transportation also has strict requirements on the importation of certain materials, added Smith. To import biological materials, individuals should sign up for a permit from the USDA and/or the Centers for Disease Control and Prevention (CDC), said Smith. Medications can only be carried if they are to be taken by the individual transporting the drugs, he added. If individuals go through the proper processes, we can ensure the safe transport of necessary materials whilst protecting the borders, said Smith.

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The Outsourcing in Clinical Trials Conference in New England event held talks on several aspects of the US clinical research space with topics ranging from rare disease recruitment to international trial opportunities.