Export control, import permits and biosecurity

We screen every order before it ships: destination, end user, end use, and the material itself. We tell you at quotation stage which permits we believe apply to your shipment, and we ask for the permit number before we release goods where one is required. We are not your customs broker, we are not your regulatory consultant, and we cannot obtain a permit issued to your institution on your behalf. What we can do is flag the requirement early enough that you can get one — which is usually the difference between a shipment that arrives and a shipment that does not.

This is not an exhaustive list of world trade law. It is the set of regimes that most commonly stop a real shipment of living or frozen biological material, with an honest note on what each one governs. Naming them here is not legal advice; it is a prompt for your research office.

You hold the import permit. Import permits are issued to the receiving institution, at the receiving address, for a defined material and often for a defined period and quantity. We cannot hold one for you, and a permit issued to us would not cover a shipment to you.

Concretely, you are responsible for:

• determining which import authorisations apply in your jurisdiction to the material described on the quotation;
• obtaining them before the shipment date, and giving us the permit number and a copy where required for the airway bill;
• ensuring the permit covers the actual material, quantity and receiving address on the order — a permit for a different line, a lapsed permit, or a permit naming a different building will fail at the border;
• telling us about any import restriction, licensing requirement or institutional receiving procedure that affects the shipment;
• customs duties, import taxes, brokerage fees and inspection charges in your country, unless the quotation says otherwise.

What we do on our side:

• flag at quotation stage which regimes we believe apply, based on the material and the destination;
• obtain from the supplier the documentation the shipment needs to travel — health certificates, origin statements, serum origin certification, species and strain identification;
• hold the shipment until a required permit number is provided;
• tell you honestly where we do not know the answer for a destination we have not shipped to before, rather than guessing and letting you find out at a border inspection post.

Permit lead times are frequently the longest item on a project timeline — weeks, sometimes months, in some jurisdictions. Start the application when you request the quote, not when you approve it.

The cold chain is itself regulated, independently of the biology inside it. Shipments move under IATA dangerous goods regulations for air transport and the corresponding surface rules.

• Dry ice ships as UN 1845, a class 9 dangerous good. Quantity is declared on the airway bill, packaging must vent, and there are aircraft loading limits. Airlines enforce these strictly and a mis-declared shipment gets refused at the counter.
• Liquid nitrogen dry shippers ship as vapour-phase vessels with the nitrogen fully absorbed into the internal medium. Correctly prepared they are not classed as shipping liquid nitrogen, which is precisely why they exist. A partially charged, over-filled or damaged shipper can be, and will be refused. Dry shippers are also expensive returnable assets with their own return logistics and deadlines.
• Biological substances ship as UN 3373 category B where applicable, in triple packaging, with a trained shipper's declaration. Category A infectious substances are a different and far more restrictive regime, and we do not broker them.
• Packaging and declaration are performed by trained personnel at the supplier or their logistics provider. This is a certification requirement, not a preference.

On your side, your facility must be able to receive these. Dry ice and dry shippers create asphyxiation risk in confined spaces, and some receiving docks, mail rooms and building policies prohibit them outright. The quote form asks what your facility can actually receive for exactly this reason. The operational detail — courier windows, temperature logging, what to do on arrival — is at shipping, cold chain and handling.

Before an order is accepted we screen the destination country, the receiving institution, and the named end user against applicable sanctions and denied-party lists, and we assess whether the material or associated equipment is subject to export control in the jurisdiction it ships from.

Where a licence is required, the shipment does not move until it is granted. Where a destination or party is restricted, we decline, and we will say that we are declining rather than letting an order go quiet.

Screening requires us to know who the end user is. This is one of the situations described in confidentiality and your specification where anonymity is not available: we cannot screen an unnamed party, and a supplier cannot accept an unnamed end user on a controlled line. We will tell you this before circulating anything rather than after.

You must not re-export, transfer or divert material in breach of any applicable export control or sanctions law, and you must not transfer it to a restricted party. If you plan to move material on to a collaborator in another country, tell us — that is a separate export with its own permit requirements, and it is your responsibility once the material is yours.

Brokering biological material carries a responsibility that brokering machined parts does not. We take it seriously without pretending to capabilities we lack.

What we do:

• ask what the material is for, on every request, and read the answer;
• decline requests where the stated or apparent end use is a weapons application, a deliberate-release application, or anything intended to cause harm;
• decline requests for select agents, category A infectious substances, and controlled toxins — we do not broker these at all;
• route requests that touch on dual-use research of concern back to the requester's institutional biosafety oversight rather than sourcing them quietly;
• treat an unwillingness to identify the end user or the end use on a sensitive request as a reason to decline;
• keep records of screening decisions.

What we do not claim:

• we are not a biosecurity authority, and our screening is not a substitute for your institution's oversight;
• we do not run sequence screening of the kind synthesis providers apply to nucleic acid orders — we broker cells, tissues, devices and services, not synthesis;
• we cannot verify what happens to material after delivery, beyond the contractual restrictions that travel with it.

If you are working in an area where these questions are live, tell us early. A researcher who raises the dual-use dimension themselves is not a problem; they are the kind of customer we want. The requests that concern us are the ones that will not say what the material is for.

Stated as a list, so there is no ambiguity. We will not supply:

1. into a jurisdiction where supply would be unlawful, or to a sanctioned or denied party;
2. where a required import permit or export licence is absent, lapsed, or does not cover the material or the address;
3. select agents, category A infectious substances, controlled toxins, or material on a national select agent or controlled pathogen list;
4. where the intended end use is prohibited by no medical, clinical or diagnostic use;
5. where we have reasonable concern about the end use, including weapons or deliberate-release applications;
6. where the receiving facility cannot meet the containment level the material requires, or cannot receive the cold-chain format;
7. where the supplier's own conditions of sale prohibit supply to that destination or end user;
8. where the chain of custody or consent basis for human-derived material cannot be documented adequately.

Where we decline, we tell you why to the extent we are lawfully permitted to, and we refund anything paid for the declined scope. Sometimes the honest answer is that there is a compliant route that takes longer and costs more, and we will describe it.

Five things that remove most of the friction, in the order they matter.

1. Tell us the destination country at quote stage. It changes which suppliers can serve you and which permits apply. It is not an afterthought; it is a routing input.
2. Start permit applications when you request the quote. Permit lead times often exceed production lead times. Applying after you approve a quotation is the single most common cause of a stalled first order.
3. Involve your biosafety officer and your research office early. They know your institution's receiving procedures, its licences, and its committee calendar. We know none of those things.
4. Tell us what your dock can receive. Dry ice, dry shippers, live cultures, material at a given containment level. A building that cannot accept a dry shipper is a solvable problem before shipment and an expensive one after.
5. Send permit numbers as soon as you have them. We hold shipments pending them, and a held shipment of living material is a shipment with a clock running on it.

Nothing on this page is legal or regulatory advice. It is a description of how we operate and of the requirements we most often encounter. Your institution's regulatory affairs function is the authority on your obligations.

Questions before you order: hello@wetwareworld.com. For a live order, quotes@wetwareworld.com with the reference.