EAR vs ITAR: Export Controls for Pharmaceutical and Life-Science Shipments
US export control is split across two main regimes with very different reach: the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR). Most pharmaceutical and life-science shipments fall under the EAR, but some materials, technologies and pathogens sit in more tightly controlled territory, and getting the classification wrong carries serious penalties. This guide explains the difference, which regime applies to life-science shipments, and how to classify and screen.
The two regimes
The EAR, administered by the US Bureau of Industry and Security (BIS), controls commercial and dual-use items, things with both civilian and potential military or proliferation uses. The ITAR, administered by the US State Department, controls defence articles and services on the US Munitions List. For a given item the regimes are mutually exclusive: an item is subject to one or the other, not both.
| EAR | ITAR | |
|---|---|---|
| Administered by | Bureau of Industry and Security (Commerce) | State Department (DDTC) |
| Controls | Commercial and dual-use items | Defence articles and services |
| List | Commerce Control List, by ECCN | US Munitions List |
| Typical life-science reach | Most equipment, materials and technology | Certain pathogens, toxins and defence-linked items |
Which applies to life-science shipments
For most pharmaceutical and life-science shipments, the answer is the EAR. Laboratory equipment, most reagents, most biological materials and the technology around them are commercial or dual-use, and are classified on the Commerce Control List by an Export Control Classification Number (ECCN), or fall under EAR99, the catch-all for items not specifically listed. However, certain select agents, toxins and pathogens, and equipment specially designed for them, can attract tighter control, and a small set of defence-linked items can fall under the ITAR. The point is not to assume: classify.
How to classify and screen
- 1Determine the regime: is the item subject to the EAR or the ITAR? Most life-science items are EAR.
- 2Classify under the EAR: find the ECCN on the Commerce Control List, or confirm EAR99 if it is not listed.
- 3Check the reasons for control and the destination: an ECCN plus the destination country determines whether a licence is required.
- 4Screen every party against the denied-party and export-control lists, including the BIS Entity List and Denied Persons List.
- 5Document the classification and screening decision, so the basis for shipping is on the record.
Frequently asked questions
The EAR, Export Administration Regulations, administered by the Bureau of Industry and Security, controls commercial and dual-use items on the Commerce Control List. The ITAR, International Traffic in Arms Regulations, administered by the State Department, controls defence articles and services on the US Munitions List. An item is subject to one regime or the other, not both.