Regulatory & legal
A regulatory question is almost always a measurement question: what, and how well, you are able to show the inspector.
The cluster collects pages where the legal frame is the envelope and the content is a measurement. A living crop-protection agent cannot be assessed with the data package built for chemistry — FIFRA and EU 1107/2009 registration had to invent their own science. Demonstrating that something no one has ever eaten is safe is cohort and threshold design. A fermentation-derived chemical may inherit the registration data of its petrochemical twin — the substance-identity question under REACH. A pathogen can be listed; a sequence cannot. Border quarantine cannot prove a consignment clean — only that no procedure was violated.
Start with biopesticide registration: the living-product-versus-chemical-package mismatch is shown there on the most constructive example.
Articles 10
| Export control and dual-use compliance Why a pathogen can be put on a control list but a sequence cannot — and what screening actually tests. |
| Bioeconomy trade disputes at the WTO When a country restricts a bio-product, the question a WTO panel asks is evidentiary: is there a risk assessment, and does the measure rationally follow from it? |
| Conflict environmental forensics Attributing damage to a place, a material and an event — and why the measurement is usually easier than the admissibility. |
| Ecological risks of synthetic biology Why most engineered constructs disappear from a wild population by themselves, and why the containment numbers that look reassuring are laboratory numbers. |
| Patent lifecycle management in biotechnology A biotech patent's real life is set by two things a renewal calendar cannot manage: how much of a claimed genus the disclosure can actually hold, and how much term regulatory review leaves. |
| Measuring a bio-based or biodegradable claim What the words on the label are actually measured against — and the gap between the test conditions and the world. |
| Biopesticide registration (FIFRA, EU 1107/2009) Why a living control agent cannot be assessed with the data package built for a synthetic molecule. |
| FSMA and HACCP certification for bio-based food Why a food safety plan is a measurement problem, and what happens when an ingredient has no thermal history. |
| Novel food safety substantiation How you demonstrate that something no one has eaten before is safe to eat in quantity. |
| Port biological quarantine Border inspection cannot prove a consignment is clean — it can only bound how dirty it might be. |