Determine
Chemicals have a lookup.
Biological material does not,
and the regulations say so.
You have a sample to send and nothing to look it up in. Determine asks you the questions the rules actually turn on, tells you what the material is and how it has to travel, and keeps a record of how that answer was reached. It does not decide for you. It makes sure the decision was made properly, and that somebody can see how a year later.
The tool is the demo. It is free, ungated, and it shows the clause behind every step.
The problem
What usually happens instead.
A sample has to be somewhere by Thursday. Nobody in the room is a dangerous goods specialist, because hardly anybody is. So you ask the colleague who did it last time. Or you find the paperwork from the last shipment that went out fine and copy it across. Or you pick the answer least likely to start an argument, and get on with the day.
Most of the time that works. The times it does not are the expensive ones, and they do not look like a compliance problem when they happen. They look like a bad week.
The courier says no at the counter
The package comes back or it sits at the depot. Somebody repacks it, somebody rebooks it, and the sample loses a day it may not have had to lose.
It goes out under-declared
An under-declared consignment usually travels perfectly well. You find out later, when an auditor, a regulator or an incident asks how the call was made, and nobody can remember.
It goes out heavier than it needed to
The strictest packaging, a signed declaration, and a carrier who had to agree the route in advance. Cost and delay for a sample that never needed any of it. Over-classifying is also how a compliance process quietly gets routed around.
The question comes back a year later
The person who made the call has moved teams. The reasoning was in their head, or in an email thread nobody kept. There is nothing to show.
Almost none of that ever appears as a line in a budget. It appears as a study visit rescheduled, a shipment sitting at a depot over a weekend, a set of samples that arrived too warm to use, and somebody senior spending a week rebuilding a decision out of an old inbox.
Who it is for
Built for the person who has to ship the thing.
Three people tend to arrive at this page, and the product is built for all three, for different reasons.
The person shipping it
In a lab or a logistics team, with a sample to get out this week and no dangerous goods qualification, because almost nobody has one. You need to know what this material is, what it has to be packed in, and what has to be on the paperwork.
The person who owns the consequences
Trade compliance, QA, or a biosafety officer. You cannot be on every shipment and you know it. What you need is that the calls made without you were made the same way you would have made them, and that you can see how.
The person evaluating it
At a large organisation, or at a courier, LIMS or biobank vendor. You are asking whether this can sit inside what you already run, on your own infrastructure, against your own question set.
Who it is not for
A tool that will not say what it does not do is a tool you have to test yourself. So, plainly:
- It is not for anyone who wants the answer without the questions. It will ask you about the material and about where it came from, and where you cannot answer it says so instead of picking something.
- It does not replace a biosafety officer or a dangerous goods adviser. If you have one, this makes their judgement reusable by people who are not them. If you do not have one, this does not become one.
- It is not a courier booking tool, a packaging supplier or a training course.
- It will not sign anything. The shipper remains the duty holder, and that is a legal position no software can take on.
- If you ship one well-characterised material on one lane every week, and that determination is already written down, you may not need this at all. The value is in variety, in volume, and in being able to show the working.
Using it
You answer questions about the material. That is the whole interaction.
It asks about the sample in front of you, in the order the rules depend on: what is in the tube, where it came from, what has been done to it, how much there is, what is keeping it cold. You get back what the material is, what that means for packing and paperwork, and the reasoning behind it. That reasoning is saved, so the answer is still explainable when you are not in the room.
You answer
Questions about the material in front of you, not about regulations. Each one says why it is being asked and what turns on it. Where an answer is not known, it escalates rather than guesses, because that is what the rules direct.
You get an answer with its working
What the material is, what that means for packing and paperwork, what has to happen next, and the clause behind every step. Including the outcomes your answers ruled out, and why they were ruled out.
You keep the record
Stored with the basis, the rule that fired, the answers it read, the dated rule set version and the person who answered. This is the part you show somebody a year later.
What it will not do
Determine does not make the decision for you, and it never issues a certification, an approval or a clearance. The shipper is the duty holder under IATA DGR 1.3 and ADR 1.4.2.1, and stays the duty holder. What changes is that the decision was put against the right questions, evaluated against a rule set with a date on it, and written down well enough that a person can stand behind it afterwards.
The free classifier on this site does the first two of those three steps for the infectious question and then stops. It does not keep the record, version the rules or carry your own configuration. Those are the product.
Why it is hard
No database can solve this, and that is written into the rule.
For chemicals this is a solved problem. A structure goes in, software returns a controlled-substance answer, because the answer is a property of the molecule. Biological material is not like that. The rule that decides whether a sample sits in the most restricted tier turns on who or what it came from, what they had, and where they were at the time.
Assignment to UN 2814 or UN 2900 must be based on the known medical history and symptoms of the source human or animal, endemic local conditions, or professional judgement concerning individual circumstances of the source human or animal.
The facts are local
Medical history, presenting symptoms and endemic conditions are facts about one patient, one animal or one site on one day. Nothing static holds them.
The same organism classifies differently
A culture and a patient specimen of the same pathogen are not the same consignment. The test applies to the form being shipped.
So the incumbents stop
Every page ranking for these questions reproduces the clause and refers the reader to their biosafety officer. The advice is correct and it is not an answer.
What exists instead is people. The specialist couriers all perform this determination as a human advisory service, and they do it well. The trouble with headcount is that it does not scale, it is hard to evidence consistently, and it leaves when the person leaves. Determine turns that expertise into something a system can hold, run and reconstruct, which is why those couriers read as the most motivated channel in the market rather than the threat they first appear to be.
The record
An answer is not a record. This is what a determination carries.
An outcome on its own is worth very little the moment somebody asks how it was reached. The engine cannot produce one without all five of these. Not as a policy somebody can switch off, as a constraint the code will not compile around.
- The basis
- Declared, derived or absent. Whether a human asserted it, the rules concluded it, or nobody has answered.
- The rule
- The identified rule that produced the outcome, not a model score. Rules are readable rows, and you can see the ones that did not fire.
- The answers it read
- The specific elicited answers the rule depended on, cited. This is what turns an outcome into a reconstruction.
- The rule set version
- The dated edition it was evaluated against. A determination reached in 2026 still reads as it did in 2026 after the rules move.
- The person and the moment
- Who answered, when, and under which question set. The determination stays theirs; the engine records it rather than replacing it.
Unanswered is not the same as no
A consignment with no infectious status answered is not a non-infectious consignment. It is one nobody has classified. Systems that default the blank to “not dangerous goods” produce a clean-looking record of a decision that was never made. The engine reports those separately, because the difference between asking and defaulting is the entire point.
What it covers
If you already know this area, here is exactly what it covers.
Everything above is deliberately plain. This part is not, because anyone evaluating the tool needs the real scope rather than a summary of it. Nine things decide how a piece of biological research material is treated, with roughly thirty attributes underneath them. Any one of the nine can regulate a shipment on its own, which is why settling the infectious question alone does not settle the shipment.
- 01
What the material actually is
A culture grown on purpose, a specimen taken from a patient or an animal, an environmental or food sample, or a finished product. This is asked first because the same organism is treated differently depending on which of those it is. It is also the gate that decides whether the infectious cascade runs at all.
- 02
How infectious it is, and to whom
Category A means capable of causing permanent disability or life-threatening disease in an otherwise healthy human (UN2814) or animal (UN2900). Category B, UN3373, is infectious material below that threshold, which is most of what a research operation ships. Also here: the named exemptions, waste for disposal (UN3291), licensed biological products, and toxins separated from the organism that made them (UN3172, Class 6.1).
- 03
How much of it, and how it is packed
Quantity drives which packing instruction applies, PI 620 or PI 650. The 4 litre and 4 kg outer package limit under PI 650 excludes the mass of the refrigerant, and counting the dry ice toward it is one of the most common reasons a package is turned away.
- 04
Whether it has been modified
Genetically modified material carries UN3245 and PI 959 for transport. Separately, the movement itself can be a transboundary movement of a living modified organism under the Cartagena Protocol, with the documentation content requirements at Article 18.2. Two different obligations with two different triggers, and meeting one does not discharge the other.
- 05
What species it is, and where it came from
Endangered species listing under CITES, access and benefit sharing under the Nagoya Protocol where the material is a genetic resource, and veterinary or animal health certification.
- 06
Whether it is human material
The consent and ethics basis it was collected under, licensing by the Human Tissue Authority in the UK, and the equivalent regimes elsewhere.
- 07
What it is sitting in
Formalin and ethanol can introduce an independent hazard, and can also change the infectious assessment. The preservative is sometimes the reason a shipment is regulated at all.
- 08
What is keeping it cold
Dry ice is a dangerous good in its own right, UN1845, and liquid nitrogen carries its own regime. Neither of them is cargo, and both are declarable.
- 09
What customs will be told
The commodity code follows from everything above, and then the basis for the value you declare. Both are recorded the same way a classification is.
The free classifier walks the first two of these, plus the modification question where it changes the answer. That is the head of the problem and the part people get wrong most often. The rest, and everything on the record above, is the product.
Customs value, in detail
A customs value for material nobody ever sold.
Material that was never bought or sold still needs a value on the customs paperwork, and “no commercial value” is not one. Nor is a nominal figure chosen to fill the box. Both are what the valuation rules call arbitrary or fictitious values, and both are barred.
There is no market price database for research material, and there should not be one. Customs law already prescribes the method, which is a far stronger position than a price feed. The WTO Valuation Agreement sets six methods in mandatory sequence. For material that was never sold, methods 1 to 4 genuinely fail, and standard computed value fails too because there is no producer profit to add. What remains is Method 6 applied as a modified computed value: a per-material-type cost build-up from your own accounting, with no profit component, because the goods are not for sale.
No profit component
Where the goods are not for sale. CBP said so directly in HQ H125103, and it is duty-reducing, so it is worth getting right.
Per material type, not a blanket average
CBP rejected an averaged declaration value spread across all of an importer’s R&D materials for being insufficiently specific. The build-up has to be tailored.
Reviewed annually
The cadence CBP blessed in the GSK ruling. A cost-component set carries an effective date and a review-due date, and warns when it goes stale.
Nominal and nil values are barred
Method 6 expressly prohibits arbitrary or fictitious values, which is what declaring a dollar or writing "no commercial value" amounts to.
CBP HQ H125103 (Merck) · CBP HQ H011276 (GSK) · WTO Agreement on Implementation of Article VII of GATT 1994
So the engine does not need a price database and must not build one. It asks which basis applies, helps assemble the build-up from components you already hold, and records the basis with its evidence. A value becomes a decision with a basis and a date, exactly like a classification.
Deployment
It runs where your samples are, not where our servers are.
On your infrastructure
No egress, by construction
- A self-hosted container in your own network, with no external calls in the determination path.
- Sample provenance, patient-adjacent history and programme identifiers never leave your perimeter.
- Rule set updates arrive as signed, dated bundles you install on your own schedule, not as a live feed.
- The same posture as the rest of the platform, including the local model used for drafting, which runs on your hardware.
Inside your product
For couriers, LIMS and biobank software
- A published API and a question set delivered as a versioned schema, so you render the elicitation in your own interface.
- The determination record comes back whole, with basis, rule, cited answers and rule set version, ready to store against your own objects.
- No Pharmalogiks branding has to appear anywhere in your product.
- Framed as capacity and auditability. Your in-house expertise is what you sell; this is what lets it reach more shipments without diluting it.
How it is bought
Two things, bought separately, because they are two things.
The software and the rulebook have different lifetimes, and pretending otherwise is how an organisation ends up running a stale rule set it believes is current.
The engine
- What it is
- Software. Asks the questions, applies the rules, writes the record.
- How it is bought
- Once. Installed, integrated, and it rarely churns.
- Why it renews
- It does not need to. That is deliberate.
The rule sets
- What it is
- The regulatory content. Versioned, dated, maintained.
- How it is bought
- Annually, per jurisdiction group.
- Why it renews
- The DGR is reissued every year and sanctions lists move constantly. A stale rulebook gives confident wrong answers, which is worse than none.
There is precedent for the split. Verisk paid $65.2m for SAP’s regulatory content business while SAP carried on selling the software around it. The content is its own product, and it is the half that has to keep being right.
Questions
The ones we get asked.
No, and that is rather the point. The questions are about the material in front of you: what is in the tube, where it came from, what has been done to it, how much of it there is, what is keeping it cold. Determine holds the regulatory knowledge and you hold the facts about the sample. Where you genuinely do not know something, say so, and it escalates rather than guessing, because that is what the regulations direct.
Try it on a real sample.
The classifier is free and takes about a minute. It asks the same kind of questions, shows the clause behind every step, and tells you what your answers ruled out, which is the half everybody skips.