An international NGO preparing to deliver medical supplies into a conflict-affected jurisdiction faces a sharp legal question on day one: which US government authority controls the shipment, and which controls the funds that pay for it? The answer is not always OFAC. In many cases it is BIS and the Export Administration Regulations. In some cases it is both simultaneously. Getting the analysis wrong means a seized shipment, a frozen payment, or – at worst – a referral to the Department of Justice.
Humanitarian and NGO authorisations under US law are governed by two distinct and partially overlapping regimes: OFAC's sanctions programmes, which restrict financial transactions and dealings with designated persons, and BIS's Export Administration Regulations ("the EAR"), which control the physical export and re-export of controlled goods and technology. Neither regime automatically defers to the other, and a general licence (a standing authorisation that permits a defined category of transactions without a separate application) from OFAC does not satisfy BIS licence requirements for the same shipment, and vice versa.
This analysis sets out the legal basis of each regime, maps where the authorisation requirements diverge, identifies the risk flags practitioners most commonly encounter, and explains when cross-border NGOs and their donors, banks, and logistics partners should involve experienced sanctions counsel.
What is the legal basis for OFAC's humanitarian authorisations?
OFAC administers humanitarian authorisations under the authority of IEEPA and, in certain programmes, the Trading with the Enemy Act ("TWEA"), using a combination of general licences embedded in the relevant thematic sanctions regulations and the specific-licence process for transactions that fall outside those standing permissions.
The key principle is programme-specificity. OFAC's general licences for humanitarian activity are not uniform across all sanctions programmes. A general licence that permits certain NGO transactions under one country-specific programme may be absent, narrower, or differently conditioned in another. Practitioners advising cross-border NGOs note that the first analytical step is always to identify which programme – or which combination of programmes – the proposed transaction engages. An organisation delivering aid in a region subject to multiple overlapping designation orders cannot assume that a licence analysis conducted for one programme carries over to another.
Within programmes that carry humanitarian general licences, OFAC typically authorises NGOs to engage in transactions ordinarily incident to personal remittances, the export and import of certain food, medicine, and medical devices, and activities by non-governmental and international organisations operating in support of humanitarian relief. Each authorisation is bounded: it specifies the categories of persons authorised to transact, the permitted counterparties, the types of goods or services covered, and – critically – whether dealings with SDN List (OFAC's list of Specially Designated Nationals and blocked persons) parties are carved in or carved out.
Where a proposed NGO transaction does not fit within a general licence, a specific licence (a case-by-case authorisation to conduct an otherwise prohibited transaction) is required. The application is submitted to OFAC's Licensing Division, accompanied by a detailed factual description, supporting documentation, and a statement of the humanitarian purpose. OFAC does not publish a standard review period for specific licences as a binding commitment, though our practice experience indicates that complex humanitarian applications are typically reviewed over a period of several months. An organisation that begins an OFAC specific-licence application without sufficient lead time risks programme disruption.
The position above covers the standard case. Your facts – the counterparty, the goods, the route, the regime in play – change the analysis significantly.
For an initial assessment of your OFAC exposure, contact Calder & Vance at info@caldervance.com.
How does the BIS / EAR authorisation regime differ from OFAC?
BIS administers the Export Administration Regulations, which control the export, re-export, and transfer of items – goods, software, and technology – that appear on the Commerce Control List, as well as items subject to the EAR even if not listed there. BIS's jurisdiction is goods-focused; OFAC's is transaction-and-person-focused. That distinction has practical consequences for any NGO shipment.
Under the EAR, an item is given an ECCN (Export Control Classification Number under the Commerce Control List) or falls into the EAR99 category for items subject to the EAR but not specifically listed. Many humanitarian goods – basic foodstuffs, most clothing, and low-technology medical supplies – are EAR99 and require no BIS licence for most destinations. However, medical devices with encryption functionality, certain chemical detection equipment, and specialised field communications gear can carry ECCNs that trigger licence requirements regardless of the humanitarian purpose of the shipment.
BIS addresses humanitarian contexts primarily through licence exceptions rather than through a separate licensing track equivalent to OFAC's specific-licence mechanism. The relevant exceptions permit certain exports to non-governmental organisations, certain shipments of food, medicine, and medical devices, and exports in support of United Nations relief operations. These exceptions are conditioned: the destination, the end-use, and the end-user must each fall within the exception's scope. A shipment of satellite communication equipment to support field coordination, for instance, may not qualify under the standard humanitarian exception regardless of the NGO's bona fides, because the item's technical characteristics place it outside the exception's item scope.
Where a licence exception does not apply, BIS operates a formal licence application process. The application is reviewed on a case-by-case basis, taking into account the Entity List (BIS's list of parties subject to heightened export controls) status of the consignee, the destination, and the assessed end-use risk. In contrast to OFAC's specific-licence process, BIS licence review involves an interagency consultation mechanism that can extend review timelines further. Organisations planning controlled-item shipments to high-risk destinations should build materially longer lead times into their procurement and logistics planning.
A common misconception is that BIS and OFAC licensing are interchangeable or sequential. They are parallel and cumulative. An NGO must satisfy both regimes independently for a shipment that involves controlled items and payments touching a sanctioned jurisdiction.
Where do the regimes diverge on humanitarian and NGO authorisations?
The most significant divergence lies in the subject matter of each regime's permission: OFAC licences the financial transaction and the dealing with persons; BIS licences the item. That structural difference produces four concrete points of friction for cross-border humanitarian operations.
First, scope of the authorisation. An OFAC general licence may authorise an NGO to pay a local implementing partner that is located in a sanctioned jurisdiction, but it does not authorise the export of the goods that partner will distribute if those goods require a BIS licence. Conversely, a BIS licence exception may cover the goods but leave the payment to the local partner exposed under OFAC if the partner is an SDN or is owned 50 percent or more by a blocked person.
Second, the counterparty analysis. OFAC applies the 50 percent rule (OFAC's rule treating entities owned 50 percent or more by blocked persons as themselves blocked) to determine whether a non-listed entity is itself prohibited. BIS applies the Entity List and the denied-parties lists maintained by multiple agencies, and additionally runs a broader "red flags" analysis when there is reason to doubt an end-use claim. The two counterparty tests are methodologically distinct and must each be satisfied.
Third, the treatment of technology. OFAC's humanitarian general licences historically focus on goods, not software or technology transfers. An NGO transmitting field-coordination software, training materials relating to controlled items, or operational data over infrastructure located in a sanctioned jurisdiction may face BIS jurisdiction over the technology transfer even if OFAC's general licence covers the underlying activity. This is a frequently overlooked gap in humanitarian compliance programmes.
Fourth, the geographic scope of each programme. OFAC's general licences are written programme by programme, meaning the humanitarian carve-out in one country-specific programme is not automatically replicated in another. BIS's jurisdiction, by contrast, is item-based: once an item is subject to the EAR, the licence requirement follows the item to the destination regardless of which OFAC programme is in play. A multi-country relief operation encounters a different OFAC licence map at each destination but a single BIS licence framework applied to the item throughout.
In our cross-border practice, we regularly advise NGOs and their banking partners that the divergence between these two regimes is not a compliance technicality – it is a structural feature of US export and sanctions law that requires a coordinated dual-track analysis for every significant humanitarian shipment.
Related practices
- Frozen account management under BIS / EAR – practical guidance on managing accounts and assets subject to export-control holds
- Humanitarian authorisations: OFAC compared with the EU regime – mapping divergences between US and EU humanitarian licensing
- Humanitarian authorisations: OFSI compared with Australia – cross-regime analysis of UK and Australian humanitarian carve-outs
What risk flags do cross-border NGOs and their partners most commonly face?
Financial institutions and logistics providers that support humanitarian operations face a risk profile that differs from that of the NGO itself, and the points at which compliance programmes most commonly fail are predictable.
The first and most persistent risk is the SDN or Entity List hit on a local implementing partner. International NGOs frequently work through local partners for last-mile delivery. Where a local partner is majority-owned by a blocked person or appears on a BIS-maintained restricted-party list, transactions with that partner are prohibited regardless of the humanitarian nature of the end-use. Due diligence on local partners must include ownership-chain analysis under the 50 percent rule, not merely a name-match against published lists.
The second risk is re-export without a fresh authorisation. Goods exported from the United States under a BIS licence exception or OFAC general licence cannot automatically be re-exported by the recipient organisation to a third country. The EAR's re-export rules require a fresh licence or exception analysis at the point of re-export. In our experience, this gap is particularly acute in regional logistics hubs where goods from multiple origins are consolidated and forwarded onward.
The third risk is banking disruption. Financial institutions serving NGOs must navigate OFAC's programme-specific general licences as correspondent banks, payment intermediaries, and account holders simultaneously. A bank that processes a payment for an NGO relying on a general licence that the bank has not independently verified, or that has been misapplied to the wrong programme, faces its own OFAC exposure. De-risking (a financial institution exiting a relationship to avoid sanctions exposure) of humanitarian-sector clients is a real and well-documented consequence of banks concluding that the compliance cost of humanitarian payment processing outweighs the risk.
The fourth risk is the technology-transfer gap described above. NGOs that provide training, software access, or operational-data sharing to local partners may inadvertently create a deemed export or a technology transfer subject to BIS jurisdiction, triggering licence requirements that the organisation has not identified because its licensing review focused on the goods shipment rather than the accompanying knowledge transfer.
If a transaction has already been flagged, or a filing has been refused, an early review can preserve options that narrow with time. Contact Calder & Vance at info@caldervance.com for a confidential review.
How do the UK and EU humanitarian regimes compare with the US position?
The cross-border dimension of humanitarian authorisations does not end with OFAC and BIS. Any NGO operating internationally is likely to encounter at least one other major sanctions regime, and the divergences matter operationally.
Under UK law, the Sanctions and Anti-Money Laundering Act ("SAMLA") and the relevant thematic regulations administered by OFSI establish financial-sanctions prohibitions that parallel OFAC's in purpose but differ in mechanism. OFSI issues specific licences for humanitarian activity on a case-by-case basis. The UK has also introduced a general licence mechanism in a number of its thematic programmes, though the humanitarian general licences available under UK law are not necessarily co-extensive with those under the equivalent OFAC programme. A US-based NGO with UK operations or UK-sourced funding must therefore conduct an independent OFSI analysis in parallel with its OFAC and BIS work.
The EU sanctions regime, administered through Council regulations, similarly provides for humanitarian exceptions and specific-authorisation routes. EU financial sanctions apply to all persons and entities within the EU, all EU nationals, and transactions processed through EU-incorporated entities, including EU-incorporated subsidiaries of US NGOs. The EU's humanitarian derogation provisions are built into the relevant Council regulations and, as with OFAC, are programme-specific. An EU subsidiary of a US NGO cannot assume that the parent organisation's OFAC general licence satisfies the EU Council regulation applicable to the subsidiary's own transactions.
In our cross-border practice, the most common multi-regime gap we encounter is a US-based NGO that has secured an OFAC specific licence for a complex operation but has not separately addressed the EU Council regulation obligations of its European funding partners, or the OFSI licence requirements of its UK correspondent bank. Each regime must be addressed in its own right. Where the stricter prohibition governs under any one applicable regime, that regime sets the floor for the entire operation.
Switzerland's SECO, Canada's Global Affairs Canada, and Australia's DFAT each operate autonomous sanctions regimes that include humanitarian carve-out provisions. These provisions are not uniform and must be analysed separately for operations touching those jurisdictions. For multi-country relief operations, the aggregate licence map can be substantial, and the sequencing of applications – given that some regimes have longer review timelines than others – is itself a programme-planning consideration.
Which regime is stricter on humanitarian and NGO authorisations?
Neither OFAC nor BIS is uniformly stricter: each is more restrictive in its own domain, and the combined effect is more demanding than either regime alone.
OFAC is the primary control on who an NGO may deal with and on what financial transactions may occur. Where a general licence is available, OFAC provides relatively broad coverage for established international organisations engaged in food, medicine, and basic humanitarian relief. The coverage, however, is programme-specific and counterparty-sensitive. For operations in jurisdictions subject to comprehensive sanctions programmes, the general-licence coverage is typically broader; for operations involving designated individuals or entities, even within jurisdictions that carry a humanitarian general licence, the analysis narrows sharply.
BIS is the primary control on what physical items and technology may leave the United States. For EAR99 goods – which encompass a significant proportion of standard humanitarian supplies – BIS imposes no licence requirement for most destinations, and the practical burden is relatively low. The friction arises with dual-use or technically controlled items: communications equipment, certain medical devices with controlled components, water-purification systems with specific technical characteristics, and surveillance or detection equipment. For these items, BIS's licence requirements apply regardless of the humanitarian nature of the use, and the relevant licence exceptions carry conditions that can be difficult to satisfy for operations in high-risk destinations.
The question of relative stringency is therefore less useful than the question of which regime controls the specific chokepoint in a given operation. For a cash-transfer or mobile-money programme, OFAC is the dominant control. For a field-equipment procurement involving technically controlled goods, BIS is the dominant control. For a programme that involves both, the analysis is necessarily dual-track.
What should a cross-border NGO do about this? The practical answer is to run the OFAC and BIS analyses in parallel from the outset of programme planning, not sequentially. An NGO that waits until it has an OFAC licence in hand before beginning its BIS classification and licensing analysis loses time it cannot recover in an operational context.
A common misconception: that one authorisation covers both regimes
The most persistent myth in humanitarian sanctions compliance is that obtaining an OFAC licence – or relying on an OFAC general licence – resolves the US government's requirements for the transaction. It does not. OFAC's authorisation operates within OFAC's jurisdiction: financial transactions and dealings with persons. It does not extend to the physical export of goods, to technology transfers, or to the re-export of controlled items. Those matters remain within BIS's jurisdiction under the EAR.
We regularly advise organisations that have invested considerable effort in obtaining an OFAC specific licence only to discover, at the point of shipment, that the goods require a BIS licence or a qualifying exception that was not identified during programme planning. The reverse also occurs: an organisation that confirms its goods are EAR99 and proceeds on that basis, without completing the OFAC analysis for the financial transactions and local counterparties involved in the operation.
The corrected position is straightforward: every humanitarian operation with a US nexus requires a parallel analysis under both OFAC and BIS from the outset. The two regimes are not sequential checkpoints. They are concurrent obligations, each with its own trigger, its own authorisation mechanism, and its own enforcement authority. Treating them as a single combined clearance is a structural error that no programme scale or humanitarian purpose can cure retroactively.
In a recent matter, a mid-sized international relief organisation sought to deploy field communications equipment and fund a local distribution network in a jurisdiction subject to a US sanctions programme. The BIS classification of the communications equipment had not been completed before the OFAC specific-licence application was filed. The resulting delay – caused by the need to conduct the classification and identify the applicable licence exception in parallel with the OFAC review – extended the timeline of the operation by a period that was material to the organisation's programme commitments. We assisted by coordinating the classification and licensing workstreams simultaneously, with direct engagement with both agencies, and by restructuring the procurement sequence so that EAR99 items were shipped under the OFAC general licence on an accelerated basis while the controlled-item authorisation was completed. The matter resolved without enforcement action.
When should a cross-border NGO or donor involve counsel?
The threshold for involving experienced sanctions counsel is lower than most NGOs assume. The complexity of the dual-regime analysis, the programme-specificity of OFAC's general licences, and the technical demands of BIS classification each create decision points where the cost of an error – in time, funding, and reputational terms – exceeds the cost of early legal input by a wide margin.
Counsel should be involved at programme inception when the operation will touch a jurisdiction subject to a US sanctions programme, when the goods to be shipped include items that are not obviously EAR99, or when the funding structure involves a financial institution that is itself subject to OFAC scrutiny. The earlier in the programme cycle the analysis is completed, the wider the options remain.
Counsel should also be involved when a payment is refused or delayed by a correspondent bank, when a shipment is held at a port of export, when an agency query is received in connection with a pending licence application, or when a local partner's ownership structure raises questions under the 50 percent rule. At each of these points, the window for preserving the operation and managing the regulatory relationship is open but finite.
We have acted for international NGOs, their donors, and their banking partners in licence applications, in agency queries, and in post-shipment compliance reviews across both OFAC and BIS. Our practice covers the full range of US sanctions and export-control authorisation work, as well as the parallel UK, EU, and multilateral regime requirements that cross-border operations routinely engage.
To discuss a licence application, a classification question, or a compliance review of a planned humanitarian operation, contact Calder & Vance at info@caldervance.com.