Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!
Regardless of whether you’re trying to transport a collection of biospecimens, bulk biological material, or hazardous chemicals, the impact of additional trade compliance processes and regulations to the clinical supply chain is rising. Trade compliance can be complicated but it does not have to be. Understanding key pieces of information about your product will help open the doors to keep your shipments moving. In this blog we’ll discuss some of the new regulations that have been put in place and the impact to the supply chain.
In 2016, U.S. Customs and Border Protection (CBP) implemented the Automated Commercial Environment (ACE). ACE is the primary system through which the trade community reports imports and exports, and the government determines admissibility. The system offers greater oversight of goods as they enter or leave the United States. ACE features modernize and streamline trade processing across all sectors.
Additional benefits of the ACE system include:
- Streamlined submission of shipment information
- Elimination of paper documentation
- Decreased administrative costs
- 24/7 access to online records
- Enhanced boarder security
However, with these benefits come increased requirements, especially from partnering government agencies, such as the U.S. Food & Drug Administration (FDA) and Environmental Protection Agency (EPA). These agencies have taken the opportunity to coordinate with CBP during the import and export process to ensure legal requirements are met.
Since its implementation, a greater number of shipments have undergone more stringent review by both the CBP and the Partner Government Agencies (PGAs). Prior to 2016, most of our client’s material only required a FDA code to enter the United States. Now, depending on the material, the FDA asks for the name and address of the manufacturer, a processing code, a program code and an intended use code. This increased oversight has added to the work load of the CBP and the FDA officers at the ports. As a result, this has extended the average time client’s material waits for FDA clearance. Before 2016, most packages were cleared the same day the material reached the port. Now the average wait time is two to three days, which could cause an adverse impact to the product. If you are shipping on dry ice, your material could thaw before it reaches its final destination.
The Environmental Protection Agency has also increased their oversight of goods entering and leaving the US. The CBP published a final rule on December 27, 2016 that required the use of the ACE when filing TSCA (Toxic Substance Control Act) imports. The effective date was March 21, 2017. The EPA has provided the CPB with a list of tariff codes to “flag” for TSCA imports. If your material is on this list, you will be required to supply a written certification signed and filed electronically with the CBP stating that your substance complies with the TSCA or that your material is not subject to TSCA.
While the challenge of trade compliance processes and regulations continues to increase, there are ways to alleviate this stress. By partnering with an experienced supply chain provider you can mitigate risk and avoid temperature excursions that could impact your material’s integrity. To learn more about risk management and how to select the correct transport provider to safely move your irreplaceable biospecimen collection, download our InfoPoster!