National Biotechnology Authority (Contained Use, Confined Field Trial and General Release of Genetically Modified Organisms) Regulations, 2026

Anyone undertaking contained use, confined field trials or general release of genetically modified organisms must obtain National Biotechnology Authority approval. Applications must include a risk assessment; contained use and confined field trials must take place in registered facilities with institutional biosafety committees.

Contained-use and confined-field-trial permits last three years, while general-release permits last ten years. The scheduled fees are US$2,000 for a confined field trial and US$5,000 for general release, or their ZWG equivalents. The contained-use fee refers to the separate biotechnology facility registration regulations. Amendments cost US$300 and replacement permits US$50, or ZWG equivalents. Inspection charges and travel costs are additional.

Contained-use and trial operators need contingency plans before starting. General-release permit holders must maintain a risk management plan, seek written approval for required revisions, and monitor activities and report to the Authority. Facility subletting requires Authority approval.

General-release applications must be publicised in the Gazette, newspapers and on the Authority website, with 28 days for written public comments. Decisions must be recorded on the Biosafety Clearing House and published in the Gazette.

Unauthorised activities or use of unregistered trial or contained-use facilities can attract a level-12 fine, up to five years in prison, or both. For unapproved contained use or release, the text also directs destruction of the organism and product and confiscation of the facility. No separate commencement date is stated.