By Dr Sarmad Frogh Arshad, Advocate High Court
When Pakistan’s National Biosafety Committee formally recognized gene editing in its May 2026 reforms, it made a specific and consequential choice. Under the revised rules, a gene-edited crop that carries no foreign gene, or one where an inserted gene has since segregated out, can be certified as non-GMO by an institutional biosafety committee, with the National Biosafety Committee issuing the final certificate either way. In plain terms, Pakistan decided that what makes a crop count as a GMO is whether foreign DNA is actually present in the finished plant, not the laboratory technique used to get there.
That sounds like a narrow technical distinction. It is actually one side of an argument that has split the world’s biggest biotech regulators for most of the past decade, and the side Pakistan just chose is the one a United States federal court struck down eighteen months ago.
Two very different answers to the same question
The European Union settled this question in 2018, and it settled it the other way. In Case C-528/16, Confédération paysanne and Others, the Court of Justice of the European Union ruled that organisms produced through directed mutagenesis, the category that covers most modern gene-editing techniques, are genetically modified organisms under Directive 2001/18/EC, regardless of whether any foreign DNA ends up in the final plant. The court’s reasoning turned on process, not product: an old exemption in the directive covered only mutagenesis techniques with a long, conventionally accepted safety record, and newer, more targeted techniques did not qualify just because their effects resembled something conventional breeding might eventually produce. Scientists were blunt about the practical consequence. A commentary in Nature Biotechnology at the time argued the ruling left newer breeding methods stuck in an unclear legal position, since it put a single-base-pair edit in the same category as inserting an entire foreign gene.
The United States tried the opposite approach, and for a while it worked. In May 2020, the US Department of Agriculture’s Animal and Plant Health Inspection Service finalized what it called the SECURE rule, which exempted certain categories of gene-edited plants from pre-market regulation specifically because their modifications, such as targeted single base-pair substitutions or edits achievable without inserting foreign DNA, could plausibly have arisen through conventional breeding anyway. It is the same underlying logic Pakistan has now adopted: look at what the plant actually contains, not how it got there.
Then, on 2 December 2024, a federal judge vacated it. In National Family Farm Coalition v. Vilsack, the US District Court for the Northern District of California granted summary judgment against APHIS, finding it arbitrary and capricious for the agency to have built its conventional-breeding exemptions into the final rule without properly accounting for its separate statutory authority to regulate noxious weeds. The ruling was procedural rather than a rejection of product-based regulation as a concept. The court did not say gene-edited plants without foreign DNA are inherently dangerous. It said APHIS had not adequately explained, on the administrative record, why an entire category of statutory risk it was supposed to consider had been left out of the new framework. As of this year, USDA has reverted to its older, pre-2020 process-based rules while it works on a replacement, expected sometime in 2026, that is meant to survive the same kind of challenge.
Why the procedural failure matters more than the substantive one
This is the detail worth Islamabad and Lahore paying close attention to, because it is not really a story about whether product-based gene-editing exemptions are good policy. Both the EU and the pre-vacatur US framework are defensible regulatory choices, and serious scientists and regulators disagree about which gets the balance right. The US case is a story about what happens when an agency adopts a defensible policy without building an administrative record solid enough to survive a court testing it against the full range of the agency’s own statutory obligations.
Pakistan’s biosafety framework rests on essentially the same kind of foundation the US rule did: a set of rules issued under primary legislation, in Pakistan’s case the Pakistan Environmental Protection Act 1997, by an administrative body exercising delegated authority. If a future legal challenge to the National Biosafety Committee’s gene-editing certification criteria argued that the criteria did not adequately account for every risk category the Committee is statutorily responsible for assessing, whether ecological, agricultural, or otherwise, that would be structurally the same argument that succeeded against APHIS. The lesson from Washington is not that Pakistan chose the wrong substantive rule. It is that the rule’s supporting record needs to be built to withstand exactly this kind of test now, while the framework is still new, rather than patched together after a challenge has already been filed.
A workable middle path is already visible
There is a practical way to take the best of both approaches without importing either one’s weakness. The EU’s process-based rule is precautionary to the point of blocking useful innovation, which is precisely what drew criticism from its own scientific community. The pre-vacatur US rule was closer to what most biotechnologists would consider proportionate, but it fell because the administrative groundwork was incomplete, not because the underlying idea was unsound.
For Pakistan, that suggests two concrete steps. First, the National Biosafety Committee’s technical justification for its foreign-gene test should explicitly address the fuller range of risks its enabling legislation gives it authority over, not only whether a given plant meets the GMO definition, so the reasoning behind the rule stands up regardless of which specific ground a future challenge might use. Second, given that this exact criterion is now under long-term contest in both Brussels and Washington, Pakistan’s regulators would be well served by treating the American litigation as a live case study rather than a settled precedent, and revisiting the domestic rule’s supporting record if the US arrives at a materially different final position once its replacement rule is published.
Gene editing is likely to matter more for Pakistani agriculture than for most of the jurisdictions currently fighting over how to regulate it, given the country’s stakes in cotton, sugarcane, and increasingly climate-resilient cereal breeding. Getting the substance of the rule right was the hard part, and Pakistan’s regulators appear to have made a reasonable choice on that front. Making sure the rule can survive the kind of test that just took down its American counterpart is the part that still needs finishing.
The writer holds a PhD in Biotechnology and previously served as Biosafety Officer at Muhammad Nawaz Shareef University of Agriculture, Multan. He is an Advocate of the Lahore High Court and a registered master trainer with the Pakistan Biological Safety Association.
