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Protocol Specific Considerations

Marine Research and Technology

Research involving marine technologies and related data often intersects with export control regulations, particularly in fields like marine defense, navigation, environmental monitoring, and underwater exploration. Technologies and data collected during marine research may fall under regulations like ITAR or EAR if they have national security, defense, or dual-use applications. Investigators developing protocols for marine research must carefully consider and integrate export control compliance measures into their research planning and execution.

Examples of Export-Controlled Marine Research and Technologies

  • Sonar Systems: Technologies used in underwater mapping, navigation, and communication (e.g., multi-beam sonar systems) can be ITAR-controlled if they have military applications. For civilian uses, they may fall under EAR if they have dual-use capabilities (e.g., mapping, research, or resource exploration).
  • Underwater Drones and Remotely Operated Vehicles (ROVs): These vehicles, used for deep-sea exploration or military reconnaissance, are often subject to both ITAR and EAR, especially when they include sensitive technologies like cameras, sensors, and propulsion systems.
  • Subsea Cables and Communication Systems: Technologies used for underwater communications, including fiber optic cables and other sensitive transmission systems, may be controlled if their applications extend to military or strategic purposes.
  • Geospatial Data: Environmental and geological data collected from the ocean floor, including bathymetric maps or oceanographic surveys, may fall under EAR controls, especially if the data could have defense or security applications.
  • Oceanographic Instruments: Instruments used to measure ocean currents, temperatures, or other environmental data, particularly those with dual-use applications (civilian and military), could be export-controlled.
  • Marine Surveillance Equipment: Equipment used for monitoring and tracking vessels, such as radar systems or satellite tracking devices, is often subject to export control due to its military applications.

Marine Research Related Technology with ECCN:

1. Underwater Drones (AUVs, ROVs) and Related Technologies (ECCN 8A001/9A012/9A991): Covers autonomous underwater vehicles (AUVs), remotely operated vehicles (ROVs), and associated control systems, sensors, and payloads. AUVs and ROVs with certain specifications, such as high endurance, large payload capacities, and sophisticated sensors, may require export licenses if transferred to specific countries or entities.

2. Sensors, Sonar, and Acoustic Systems:

  • ECCN 6A001: Includes advanced high performance underwater sensors, such as environmental monitoring systems, hydrographic survey systems, and underwater imaging technologies. Sensors used in military applications (e.g., detection of underwater mines or submarines) are subject to export controls.
  • ECCN 6A003: Covers high resolution imaging and sonar systems, including both passive and active sonar systems, used in marine research for mapping the ocean floor, detecting objects, and conducting environmental assessments. These systems are frequently used by both military and civilian researchers. Sonar systems that exceed specific frequency ranges or have dual-use capabilities (military and scientific) are subject to export control.
  • ECCN 6D001: Includes acoustics software.
  • ECCN 6E001/6E002: Includes production and development technology for acoustics.

3. Marine Survey Equipment (ECCN 6A002): Includes underwater acoustic components such as transducers, hydrophones, and arrays that can be used for both civilian environmental research (e.g., marine biology studies) and military applications (e.g., submarine detection). Covers underwater sensors equipment used in seismic surveys of the seafloor, marine geology, and resource exploration. Seismic equipment used in military applications for anti-submarine warfare, mapping, and other defense-related activities.

4. Oceanographic Research Equipment:

  • ECCN 8A002: Covers marine systems, equipment, and related parts and components, including but not limited to propulsion systems, sonar systems, navigation systems, and remotely operated vehicles (ROVs) designed for military, defense, or dual-use applications.
  • ECCN: 8A992: Includes vessels, marine system or equipment not controlled by 8A001 such as: underwater equipment (life jackets, inflation cartridges, compasses, wetsuits, masks, fins, weigh belts, and dive computers).
  • ECCN 8D992: Includes underwater equipment software.
  • ECCN 8E992: Includes development, production, use of technology for underwater equipment.

5. Submarine Components and Propulsion Systems (ECCN 9A004): Covers equipment designed for marine research such as: data loggers, sensors, and monitoring equipment used in to study temperature, salinity, ocean currents, and ecosystems. Covers submarine propulsion systems, including advanced nuclear or non-nuclear propulsion components, as well as materials used in the construction of submersible vehicles or platforms. Military-grade submarine components, such as propulsion systems with advanced energy efficiencies or stealth capabilities, are heavily regulated and require licenses for export. When these instruments are designed for high-precision applications or used in national security-sensitive environments, export controls may apply.

6. Marine Satellite Communication Systems (ECCN 5A991): This includes communication equipment and systems used for remote communications with marine vessels, particularly in scientific expeditions or military operations. Satellite communication systems with encryption capabilities used in marine research (or dual-use applications) may require export licenses if they are used for military purposes or in sensitive environments.

7. Marine Energy Technologies (ECCN 9A991): Includes energy harvesting systems, such as underwater turbines or other advanced renewable energy technologies used for marine research or military purposes (e.g., power generation in remote locations). Marine energy systems with military applications, such as energy systems for unmanned underwater vehicles or naval assets, are subject to export control.

Drones, Unmanned Vehicles (UAV), Remotely Operated Vehicles (ROVs), and Related Technologies

Research involving drones, unmanned aerial vehicles (UAVs), and remotely operated vehicles (ROVs) presents unique challenges related to export control compliance due to the sensitive nature of the technologies involved. These vehicles can have military, dual-use (civilian and military), or defense-related applications, making it essential for investigators to understand and comply with ITAR and EAR requirements. These regulations aim to control the dissemination of technologies that could impact national security.

Examples of Export-Controlled UAVs and Technologies

  • Military-Grade UAVs & ROVs: ROVs & UAVs designed for defense, surveillance, reconnaissance, or military operations are generally subject to ITAR due to their direct application in defense-related use.
  • Dual-Use Technologies: UAVs with both civilian and military applications, such as those used for environmental monitoring or infrastructure inspection, may be subject to EAR if they are equipped with sensitive technologies (e.g., high-resolution cameras, advanced sensors). ROVs used for civilian and military purposes, such as subsea oil exploration or search-and-rescue missions, may be controlled under EAR if equipped with advanced sensors, cameras, or communication systems.
  • Navigation and Control Systems: Technologies used in UAV flight control systems, autopilot software, and GPS or inertial navigation systems that could be adapted for military use fall under ITAR or EAR controls. Technologies such as sonar, inertial navigation, or autonomous guidance systems used for deep-sea or defense-related applications may be subject to ITAR or EAR restrictions.
  • Specialized Payload Technologies: High-performance payloads such as high-resolution cameras, sonar systems, or manipulators designed for ROVs could be controlled if they are adaptable for military applications. Sensors or surveillance equipment designed for UAVs, such as radar, infrared cameras, or communications interception devices, could be controlled if they have military applications.

Specific UAV with Export Control Classification Numbers (ECCN):

  1. Complete ROV Systems (ECCN 9A004): Covers complete ROV systems designed for military, dual-use, or sensitive applications, such as deep-sea exploration or underwater surveillance.
  2. Complete UAV Systems (ECCN 9A001): Covers complete UAV systems (e.g., aircraft, payloads, and control systems) that are specifically designed for military, dual-use, or sensitive applications such as surveillance and reconnaissance. UAVs in this category require export licenses when they are transferred to certain destinations.
  3. Navigation and Control Systems:
    • ECCN 9A012: This covers systems like flight control, navigation, and autopilot systems that manage UAV operations. This ECCN is crucial for both military and civilian drones with autonomous flight capabilities.
    • ECCN 7A002: Includes inertial navigation systems and autonomous guidance systems used in ROVs for precise underwater positioning and control.
    • ECCN 6A001: Relates to advanced sonar systems or imaging technologies for underwater navigation.
  4. Payloads (Sensors, Cameras, and Other Equipment):
    • ECCN 6A003: Applies to high-resolution imaging systems and sensors (e.g., infrared, multispectral, radar) used for surveillance or reconnaissance, often found on UAVs. This classification impacts both civilian and military UAVs that carry sensitive imaging equipment.
    • ECCN 6A001: Includes sonar systems, side-scan sonar, or bathymetric mapping tools often mounted on ROVs.
    • ECCN 5A991: Covers telecommunications and broadcast equipment used for UAV communication systems. This includes telemetry systems that transmit data from the UAV to ground control.
    • ECCN 8A992: Applies to non-sensitive tools, such as basic manipulators or cameras with limited resolution, used in civilian applications.
  5. UAV Ground Control, Components, & Systems (ECCN 9A515): Includes components of the UAV such as high-performance onboard sensors, radar systems, and communication equipment. Covers ground control stations and systems used to manage UAV operations, including remote piloting and communications infrastructure. These systems are necessary for controlling UAV flight and managing mission data and can be subject to EAR regulations when used for military or dual-use.
  6. Communication Systems (Data Link Systems):
    • ECCN 5A001: Relates to data communication systems used in UAV/ROV operations, including data link systems that transmit mission and sensor data to ground stations. High-performance communication systems are often restricted under EAR, especially when they enable real-time military reconnaissance or surveillance operations.
    • ECCN 5B991: Includes transmission and receiving equipment used for controlling UAVs/ROVs. This could include systems for sending operational data back to the operator, including telemetry data.
  7. Related Software
    • ECCN 4D003: Covers software related to the operation and control of UAVs, ROVs, and RPVs. It includes mission planning, autonomous operation, real-time data analysis, flight control, and communications, which are integral to both UAV and ROV systems. It also covers software that may include encryption for securing communications, navigation, or data storage, as used in sensitive or dual-use technologies.
    • ECCN 6D001: Covers software used for controlling payloads on UAVs, ROVs, and RPVs, including surveillance software, targeting software, and systems that handle high-performance sensors and cameras.
    • ECCN 6D003: Covers software for processing and enhancing payload data, such as sonar data for ROVs or UAV imaging systems. This could include interpretation and analysis software for environmental, geophysical, or oceanographic data, especially in military applications.
  8. UAV Data Storage Systems (ECCN 5A001): Relates to data storage devices used in UAVs for storing sensitive mission data, such as images, video, or telemetry. These devices may be subject to export restrictions depending on the level of encryption or sensitivity of the stored data.
  9. Specialized UAV Components (e.g., Radar, LiDAR, Advanced Sensors) (ECCN 6A002): High-performance radar, LiDAR, or imaging systems used on UAVs for military reconnaissance or monitoring sensitive areas may have both commercial and defense applications, export licenses Is required for military or dual-use applications.
  10. ROV Sensors and Imaging Systems (ECCN 6A001): Covers specialized sensors such as LiDAR, sonar, or multi-beam imaging systems used in ROVs for underwater exploration or military reconnaissance.

Notes Specific for Drones:

  • Drones may automatically send flight telemetry data to the manufacturer. Sending this data to the manufacturer could be a prohibited export. The best way to prevent an unauthorized export is to manually disable this feature upon receipt of the drone, prior to first use.
  • If the drone is classified as EAR “600 series”, merely operating the device can trigger a deemed export, such that the technology transfer is deemed to occur through this activity alone.
  • DJI (Da-Jiang Innovations), a well-known drone manufacturer headquartered in China, is on the U.S. Bureau of Industry and Security (BIS) Entity List. Depending on the scenario, the shipment of items to DJI, including drones for return or repair, may be prohibited. While there is not a prohibition on the purchase or use of DJI drones at SIU, it is recommended to purchase alternative equipment, preferably from a U.S. manufacturer, whenever possible.

Notes for UAV Flight Operations and Federal Compliance:

In addition to export control compliance, UAV research must adhere to federal regulations governing the operation of unmanned aircraft. This includes ensuring that flight operations comply with the Federal Aviation Administration (FAA) rules and guidelines.

  • FAA Approval: Investigators must obtain the necessary FAA approvals for UAV flights, especially if the UAVs are being used for research in controlled airspace, beyond visual line of sight, or in other regulated areas.
  • Flight Logs and Monitoring: Researchers must maintain detailed flight logs, including the locations, times, and purposes of each flight. UAV operations should be monitored to ensure compliance with FAA regulations and export control laws.

Note: ROV Compliance with Maritime Regulations:

  • Adhere to maritime laws and guidelines for underwater vehicle operations, particularly in international waters or environmentally protected zones.
  • Obtain permissions for operations in restricted areas, such as military zones or marine conservation areas.

NASA-related data and technologies may be subject to strict export control regulations due to their potential military, national security, and commercial applications. These technologies, including those used in space exploration, satellite systems, and aerospace manufacturing, may require export licenses under ITAR or EAR. ITAR governs defense-related technologies and military applications, such as rocket systems and related technologies. EAR covers commercial and dual- use technologies that may have both civilian and military applications, such as satellite communication systems, aerospace components, and GPS technology.

Examples of Export-Controlled NASA Data and Technologies

  1. Spacecrafts, Satellite Technology, and Components (ECCN 9A004): Includes spacecrafts, satellites, satellite components, and associated technologies such as communications systems, propulsion, and navigation equipment. Spacecrafts, satellites, and components intended for military or sensitive government use are heavily controlled to prevent unauthorized access by foreign entities.
  2. Rocket Propulsion and Launch Vehicle Systems (ECCN 9A008): Covers rocket propulsion systems, launch vehicles, and related technologies. These systems have applications in both space exploration and military sectors. Exporting these technologies without proper licenses could violate U.S. national security interests.
  3. Spacecraft and Space Exploration Technologies (ECCN 9A010): Includes spacecraft, space exploration vehicles, and technologies used for space exploration, including propulsion systems associated with launching or operating in space.
  4. Aerospace Systems and Equipment (ECCN 9A099): Covers various aerospace technologies not specifically listed elsewhere, including advanced sensors, avionics, and control systems used in aircraft and spacecraft. These systems are dual-use (civil and military) and can be restricted under both ITAR and EAR regulations depending on their use.
  5. Space-Based Remote Sensing Technologies (ECCN 9A515): Includes remote sensing technologies used for propulsion systems related to orbital platforms or space-based sensors used for environmental monitoring or military purposes.
  6. Aerospace Manufacturing Technology (ECCN 9B001): Covers the technology, processes, and equipment used in the manufacturing of aerospace components. These technologies, especially those related to military-grade aerospace parts, are export-controlled to prevent the spread of advanced manufacturing capabilities.

Note: NASA-sponsored projects come with specific terms and conditions that outline what can be shared and what must be restricted. Researchers must adhere to these terms to ensure compliance with export control laws. The project agreement often specifies the types of data and technology that are restricted from distribution, especially when foreign national involvement is involved. For projects involving foreign collaborators, the nationality of all parties must be verified to ensure that export-controlled data is not transferred to non-U.S. persons without the appropriate licenses. NASA sponsored projects may include specific clauses regarding the participation of foreign nationals.

Supercomputers, high-performance computing systems, advance chips, and semiconductors are subject to U.S. export control regulations due to their potential military applications, dual-use capabilities, and strategic importance to national security.

Key Considerations for Supercomputers

  1. Control Framework: Supercomputers are subject to export control regulations based on their Adjusted Peak Performance (APP). APP is a measure of the system's performance, which influences whether the technology is restricted for export. Exportability depends on various factors, including the system’s APP, the destination country, and the intended end-use (military or civilian). Supercomputers with high APP capabilities may require licenses for export to certain countries, especially those subject to U.S. sanctions or embargoes. Chips and Semiconductors are also subject to export controls, restrictions apply to advanced processors (e.g. GPUs, AI accelerators) and semiconductor manufacturing equipment, given their role in powering supercomputers and other technologies.
  2. Export Control Regulations: The ITAR may apply to supercomputers used for military purposes, especially those designed for defense-related applications such as simulations for weapons systems, military training, and nuclear research. The EAR typically govern the export of supercomputers and components used for civilian or dual-use applications (e.g., weather modeling, aerospace, AI or energy sector research). Supercomputers that meet specific processing power thresholds may fall under the EAR’s CCL.
  3. ECCN Classification: Supercomputers, as well as components like processors, software, and storage systems, may be classified under specific ECCN system, which determines the level of restriction on exports based on the technology's sensitivity and end-use. Examples include ECCNs that restrict high-performance computing systems based on their processing capabilities or their potential for military use. Super computers typically have codes such as 4A003 (systems for processing advanced encryption or decryption technologies). Chips and Semiconductors typically have ECCNs such as 3A001 (electric devices and components) and 3B001 (equipment for semiconductors) govern advanced chips and semiconductor manufacturing tools. Items exceeding specific thresholds (e.g., FLOPS, power efficiency) are subject to licensing requirements.
  4. Deemed Export Concerns: While access to supercomputers by foreign nationals within the U.S. typically does not trigger a "deemed export" under the EAR, there are concerns if technical details, algorithms, or operational information related to the supercomputer are shared with foreign nationals. Disclosure of such information—especially if it involves non-public, military, or restricted-use technology—may result in compliance violations. Researchers should be cautious when sharing operational details, as it may trigger export control restrictions even within the U.S.
  5. National Security and Foreign Policy Interests: Supercomputers with advanced capabilities for processing large amounts of data (e.g., machine learning, climate modeling, scientific simulations) may be subject to export restrictions to safeguard national security and foreign policy interests.

 

Emerging Technologies and Compliance Risks

  1. Advanced Chips for AI & Machine Learning: Supercomputers are increasingly used in AI and machine learning applications. As these technologies advance, they may become dual-use technologies, meaning they can enhance both civilian and military capabilities. High-performance GPUs, TPUs, and AI-accelerated chips are dual-use technologies subject to tighter controls due to their potential for military applications. The U.S. has imposed targeted export restrictions on AI chips to countries such as China and Russia to safeguard national security.
  2. Quantum Computing & Advanced Semiconductors: Quantum chips and advanced semiconductors which enable quantum computing have the potential to surpass traditional supercomputing capabilities, which may lead to new regulations for both hardware and software due to its implications for encryption and national security.
  3. Semiconductor Manufacturing Equipment: Lithography machines (e.g., EUV tools), deposition equipment, and etching systems are tightly controlled, especially for nodes at 7nm and below. These tools are critical for producing chips used in supercomputers and AI systems.
  4. Cybersecurity Threats: Chips and supercomputers play a critical role in cybersecurity research and defense. Close monitoring of access and careful management of data encryption, decryption, or network defense must be carefully managed to avoid compliance violations.

Encryption software and technology are heavily regulated due to their dual-use potential, serving civilian, commercial, and military applications. Under the EAR, encryption-related items are classified under Category 5, Part 2 of the CCL. These controls aim to prevent the misuse of advanced encryption technologies for unauthorized purposes, such as cybersecurity threats or military advancements.

Classification and ECCNs:

Encryption items, including software, hardware, and technology common ECCNs include:

  1. 5A001: Telecommunications systems, equipment, components, and accessories which includes encryption hardware or equipment designed for information security, including encryption functionality in communication devices.
  2. 5B001: For encryption hardware components.
  3. 5D001: Encryption software that exceeds basic capabilities and is not publicly available or mass-market.
  4. 5D002: Specific cryptographic software, including that used for secure communications in government systems.
  5. 5E001: Technology required for the development, production, or use of encryption software or hardware.
  6. Mass-Market Exception: Certain encryption products, if publicly available and mass-market (ECCN 5A992 or 5D992), may qualify for relaxed controls. For example, consumer-level products like home routers or smartphones with basic encryption may fall under these exceptions if they are widely available to the public.

Examples of Export-Controlled Encryption Technology:

  1. Encryption Source Code (ECCN 5D002): Advanced encryption algorithms, such as those used in secure communication systems, cybersecurity applications, or military-grade encryption.
  2. Cryptographic Hardware (ECCN 5A002): Devices implementing hardware-based encryption, such as network security appliances or secure USB drives.
  3. Satellite Communication Encryption (ECCN 5A002/5D002): Technology used in secure satellite links or ground stations.
  4. Quantum Encryption Technology (ECCN 5E002): Cutting-edge encryption techniques involving quantum key distribution for secure communications.
  5. Custom Encryption Algorithms (ECCN 5D002): Non-standard or proprietary algorithms used for specialized applications, especially if they are not publicly available.

Emerging Trends in Encryption Compliance

  • Post-Quantum Cryptography: The development of encryption resistant to quantum computing decryption methods is subject to stringent controls due to its implications for national security.
  • Blockchain and Cryptocurrency: Encryption technologies underlying blockchain systems and cryptocurrency wallets may face increased scrutiny due to their financial and security implications.
  • Export Control Modernization: Regulatory updates are expected to address emerging technologies, including AI and machine-learning-driven encryption applications, creating new compliance challenges.

Controlled biological agents, including certain pathogens, toxins, and biological equipment, are regulated under the EAR and, in some cases, the ITAR due to their potential dual-use applications. These materials can be used for legitimate scientific and medical purposes but may also pose significant risks if misused for biological warfare or other nefarious purposes.

Regulatory Framework

  1. Commerce Control List (CCL), Category 1 Biological agents and related equipment (Materials, Chemicals, Microorganisms, and Toxins):
    • 1C351: Human, animal, and plant pathogens, including bacteria (e.g., Bacillus anthracis), viruses (e.g., Ebola), and toxins (e.g., botulinum toxin).
    • 1C352: Animal pathogens (e.g., Foot-and-mouth disease virus).
    • 1C353: Plant pathogens (e.g., Puccinia graminis).
    • 1C354: Biological toxins not included in 1C351 (e.g., abrin).
  2. 1E001-1E998: Technology and technical assistance required for the development, production, or use of controlled biological agents. This includes any technology necessary for manipulating, producing, or disseminating biological agents and related equipment.
  3. Deemed Exports: Disclosing technical data or research related to controlled biological agents to foreign nationals within the U.S. may constitute a deemed export and require licensing unless exclusions (e.g., Fundamental Research Exclusion) apply.
  4. Dual-Use Concerns: Certain biological agents, while essential for scientific progress, are also of concern due to their potential for weaponization. Researchers working with controlled biological agents must be aware of dual-use risks and ensure compliance with regulations.

Examples of Controlled Biological Agents & Equipment

  1. Pathogens (ECCN 1C351)
  • Bacillus anthracis (anthrax)
  • Yersinia pestis (plague)
  • Variola virus (smallpox)
  • Brucella spp. (brucellosis)
  • Mycobacterium tuberculosis (tuberculosis)
  • Salmonella enterica (certain strains)
  • Vibrio cholerae (cholera)
  • Listeria monocytogenes (listeriosis)
  • Shigella spp. (dysentery)
  • Hepatitis B and C viruses
  • Rabies virus
  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
  • Dengue virus
  • Zika virus
  • West Nile virus
  • Coccidioides spp. (coccidioidomycosis)
  • Histoplasma capsulatum (histoplasmosis)
  • Blastomyces dermatitidis (blastomycosis)
  • Plasmodium spp. (malaria)
  • Toxoplasma gondii (toxoplasmosis)
  • Trypanosoma spp. (African trypanosomiasis)

2. Toxins (ECCN 1C351)

  • Botulinum toxin
  • Ricin
  • Shiga toxin (produced by Shigella and E. coli)
  • Cholera toxin (produced by Vibrio cholerae)
  • Tetanus toxin (produced by Clostridium tetani)
  • Staphylococcal enterotoxins (causing food poisoning)
  • Exotoxins (produced by various Gram-positive bacteria)

3. Animal Pathogens (ECCN 1C352)

  • Foot-and-mouth disease virus
  • Newcastle disease virus
  • Bovine spongiform encephalopathy (BSE) – “Mad cow disease”
  • Scrapie (affecting sheep and goats)
  • Chronic wasting disease (CWD) (affecting cervids like deer and elk)
  • Plague (carried by fleas)
  • Lyme disease (Borrelia burgdorferi, carried by ticks)
  • Chikungunya virus (transmitted by mosquitoes)

4. Plant Pathogens (ECCN 1C353)

  • Puccinia graminis (wheat stem rust)
  • Xanthomonas oryzae (bacterial blight of rice)
  • Fusarium oxysporum (wilt disease in plants)
  • Puccinia spp. (rusts on various crops)
  • Alternaria spp. (producing plant diseases)
  • Cucumber mosaic virus
  • Tomato spotted wilt virus
  • Tobacco mosaic virus
  • Banana bunchy top virus

5. Biological Equipment (ECCN 2B352)

  • Fermenters capable of cultivating microorganisms under controlled conditions
  • Centrifugal separators designed for handling microorganisms or toxins
  • CRISPR-Cas9 systems, TALENs, and ZFNs for gene editing
  • PCR thermocyclers (Polymerase Chain Reaction)
  • Electroporators (used to introduce DNA into cells)
  • Gel electrophoresis equipment (for separating nucleic acids or proteins)
  • Export Control & International Trade Compliance Program Guidelines
  • Class III Biosafety Cabinets (for high-risk pathogens requiring Biosafety Level 4 containment)
  • econtamination chambers (for sterilizing biological materials and equipment)
  • High-efficiency particulate air (HEPA) filters for controlled environments
  • Autoclaves (used for sterilizing biological waste and equipment)
  • Bioreactors specifically designed for viral propagation or biopharmaceutical production

Emerging Risks and Considerations

  1. Synthetic Biology: Advances in synthetic biology raise concerns about the development of novel pathogens or toxins that may not yet be listed under existing export control regulations.
  2. Gene Editing: Technologies like CRISPR could be used to enhance pathogenicity or develop resistance to treatments, necessitating additional compliance monitoring.
  3. Global Health Collaborations: While international collaborations are essential for combating diseases, they also require careful export control oversight to prevent misuse of shared biological agents or technologies.

The use of foreign-supplied equipment or technology in research can introduce significant compliance risks under U.S. export control laws, particularly if the equipment or technology originates from countries subject to embargoes or restrictions or involves dual-use or military applications. Foreign-supplied equipment or technology may be subject to U.S. re-export controls under the ITAR or the EAR, even if it was not originally developed in the United States. Foreign suppliers may impose additional restrictions on the use, modification, or transfer of their equipment or technology. These must be reviewed and honored as part of any research protocol.

Key Considerations:

Documentation Requirements

  • End-User License Agreements (EULA): Researchers must review and comply with the terms of any license agreements associated with foreign-supplied technology.
  • Technical Data Restrictions: If the foreign-supplied equipment involves technical data, researchers must ensure compliance with local restrictions on dissemination to unauthorized parties.
  • Import Permits: Certain technologies or equipment may require import permits or customs declarations when entering the U.S.
  • Licensing: If the equipment or technology involves dual-use or military applications, an export license may be required for sharing, modification, or incorporation into new technologies.
  • Insurance Coverage: Secure adequate insurance for high-value or sensitive equipment to mitigate financial losses in case of damage or delays.

Risk Assessment

  • Supplier Country of Origin: Identify whether the supplier is located in a country subject to U.S. sanctions, embargoes, or export restrictions.
  • End-Use Verification: Ensure the equipment or technology is being used only for permissible purposes and will not be diverted to prohibited activities.
  • Cybersecurity Risks: Evaluate whether the equipment or technology poses cybersecurity vulnerabilities or risks of unauthorized data access.
  • Supply Chain Security: The growing focus on supply chain security means researchers must ensure that foreign-supplied equipment does not have vulnerabilities or embedded technologies that could compromise security.

Cloud computing enables seamless collaboration, reduced infrastructure costs, and greater accessibility for research teams. However, improper use of cloud storage and transmission can inadvertently lead to an export control violation, like:

  • Data being stored in countries subject to U.S. embargoes or trade restrictions can indeed constitute an illegal export if not handled with the proper licensing or government authorization.
  • Shared access with foreign nationals could breach regulations without proper licenses, if data is deemed controlled.

Requirements for Using Cloud Services Safely:

To ensure compliance, data stored or transmitted via cloud computing must meet the following conditions:

  1. Unclassified Data: The data must not involve classified or sensitive military technologies.
  2. End-to-End Encryption: The data must be encrypted from the sender to the recipient, preventing third-party access. End-to-end encryption ensures that even if data is intercepted during transmission, it remains protected. The encryption must cover the entire process, ensuring data privacy and security.
  3. Cryptographic Modules: Encryption methods must comply with U.S. federal standards (e.g., FIPS 140-2).
  4. Prohibited Locations: Cloud storage should not be used for classified or sensitive military technologies, which are governed by stricter export control regulations. Data must not be intentionally stored on servers located in embargoed countries or regions.

Definition of End-to-End Encryption:

End-to-end encryption ensures that data is encrypted during the entire transmission process, from the sender to the recipient. Decryption keys must not be provided to third parties or stored in insecure locations.

Embargoed and Restricted Countries:

The U.S. government maintains a list of countries subject to military embargoes and trade sanctions. Data storage or transmission to these countries is prohibited unless explicitly authorized under a government license.

Researchers must avoid:

  • Transmitting research data via servers located in these countries.
  • Collaborating with institutions or individuals based in these locations.

Guidelines for Data Retention and Storage:

  • UMass Dartmouth requires researchers to store research data in secure, university-managed systems.
  • Avoid using personal devices or unapproved storage services for export-controlled data.
  • Work closely with UMassD CITS and DIEC to implement any project-specific security requirements.