Export Controls are laws and regulations that govern the transfer or disclosure of goods, technology and funds originating in one country to persons or entities based or having citizenship in another country. This applies even if the regulated items are not crossing an international border. In the United States, export control regulations are implemented by the U.S. Department of Commerce, Department of State, Department of Treasury through Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), and Office of Foreign Assets Control (OFAC) respectively. These regulations apply to both U.S. and non-U.S. persons within the country. Other countries usually have their own export regulations, such as Germany’s BAFA and the UK Export Control Act.  

Export Control regulations put in place by the U.S. government are designed to safeguard national security interests, protect sensitive technologies, and prevent the proliferation of goods and information that could pose a threat to U.S. and its allies. The different existing U.S. export control regulations can be broadly categorized into three main areas: Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), and Office of Foreign Assets Control (OFAC) sanctions programs.

ITAR is administered by the US Department of State’s Directorate of Defence Trade Controls (DDTC). ITAR regulations specifically cover the export and temporary import of defence articles and services, including firearms, military equipment, and technologies that are inherently military or defensce-related. Key aspects of ITAR include:

• Munitions List: ITAR includes a Munitions List, which details specific categories of defence articles and services subject to ITAR controls. Exporters must obtain licenses or approvals for items on this list.
• Brokering and Manufacturing: ITAR also regulates brokering activities related to defencse articles and requires licenses for manufacturing defence items overseas, even by U.S. companies.
• Registration Requirements: Companies involved in ITAR-controlled transactions must register with the DDTC, and employees handling ITAR-controlled items must receive proper training.

Export Administration Regulations are administered by the Bureau of Industry and Security (BIS) which is governed by the U.S. Department of Commerce. These regulations dictate the export, re-export, and transfer of most commercial items, software, and technology that are not covered by ITAR. EAR regulations are designed to strike a balance between promoting legitimate trade and safeguarding national security interests. Key components of EAR include:

• Export Control Classification Number (ECCN): ECCNs categorize items based on their nature and intended use. Items are classified into different ECCNs, and each ECCN has specific licensing requirements and restrictions.
• Commerce Control List (CCL): The CCL is a comprehensive list of items subject to EAR controls. It specifies which items require an export license and which can be exported without a license under certain conditions.
• End-User and End-Use Controls: EAR regulations also focus on end-user and end-use controls, requiring exporters to screen both the entities and the intended purpose of exports to prevent diversion to unauthorized destinations or uses.

OFAC is part of the U.S. Department of the Treasury and enforces sanctions against targeted countries, entities, and individuals. OFAC’s sanctions programs encompass a wide array of measures that extend beyond export controls. These programs include embargoes, asset freezes, and trade restrictions, among others. They are designed to target not only the export and import of goods and technologies but also financial transactions, investments, and dealings in various sectors. OFAC’s reach extends to virtually all aspects of international trade and financial activities, making it crucial for businesses to thoroughly understand and comply with these sanctions to avoid legal and financial repercussions. Key components of OFAC include:

• Sanctions Programs: OFAC administers various sanctions programs targeting countries like Iran, North Korea, and Cuba, as well as entities and individuals involved in activities contrary to U.S. foreign policy and national security interests.
• Prohibited Transactions: OFAC sanctions prohibit certain transactions with sanctioned entities, including trade, financial dealings, and other interactions. Violating these sanctions can result in severe penalties.
• Compliance and Due Diligence: Businesses must conduct due diligence to ensure they are not engaging in transactions with sanctioned parties. OFAC provides guidance and resources to help entities comply with sanctions regulations.

• Transferring controlled information, such as technical data, to persons and entities across international borders.
• Shipping controlled physical items such as scientific equipment that requires export licenses from one country or jurisdiction to another.
• Verbal, written, electronic, and/or visual disclosures of controlled scientific and technical information related to export-controlled items of foreign persons within a country.
• Provisions of services and/or conducting financial transactions with an embargoed or boycotted country, restricted individuals, or entities.

Some organizations struggle to comply with various export control regulations due to a combination of human error, loosely defined guidelines, and the constantly changing regulatory requirements.

In recent years, the life science and healthcare industry commonly face multiple violations of export controls due to the overlook of security risks and trade sanctions, as seen in Deloitte’s article, “The unseen risks: Export Controls in the Life Science and Healthcare sector”. Organizations are obliged to understand sanction requirements, and are commonly required to comply with more than one country jurisdiction.

The difficulty also lies in the identification of which types of data and document are subject to controls. Data has to be maintained across the business and within the IT landscape, and organizations need to effectively manage the internal and external sharing of files to reduce export control risks.

Export control regulations require organizations to monitor, control and report the transfer or export of controlled technical data. It is prudent for enterprises to automate handling and export compliance of controlled technical data.

NextLabs products and technologies enable enterprises to comply with export control regulations. These solutions include applications that provide best practice policy libraries and reports that are required for showing export compliance, ensuring enterprises are compliant with applicable export control regulations.

These solutions also provide enterprises with the ability to control and audit Deemed Exports of Technical Data by applying policies across servers, applications, and workstations where technical data is managed and stored. NextLabs’ Export Control for Technical Data protects sensitive data within enterprises to ensure appropriate handling of technical data that is in line with regulatory requirements.

NextLabs’ Export Compliance Solution Features

With NextLabs’ Technical Data Export Compliance Solutions, enterprises can keep track of their data, who has access to it, and who has received it by applying policies across servers, applications, and workstations where technical data is managed and stored. This prevents any Conflict of Interest or Improper Disclosure of Technical Data. This allows technical data to be controlled even when it is accessed remotely.

NextLabs’ solutions enable enterprises to ensure they are in compliance with ITAR, EAR, Export License Authorization, German BAFA, UK Export Control Act Regulations, ACECA, and Export Enforcement (EE), protecting them from penalties and fines, all while simplifying and reducing the cost of Export Compliance Reporting and Audits.

NextLabs’ Export Compliance Solutions provides a broad range of benefits to support enterprises, such as:

• Minimizing the Risk of Inappropriate Disclosure/Deemed Export
• Automating Export Control Policies and Procedures to follow export regulations
• Enabling Dual-Use Operations
• Simplifying Users on Policies and Best Practices for Protecting Technical Data

For more information on Export Compliance and Export Controls, please view our Technical Data Export Control and Electronic Export Compliance White Paper.