The Ministry for the Environment is calling for submissions on changes to the laboratory use and importation of genetically engineered (GE) organisms. The consultation document proposes changes to how the HSNO Act regulates laboratory research of all new organisms including genetically engineered using new biotechnologies*.

The aim is to streamline the approval and assessment process for biomedical therapies and medicines and ensure the regulations are more up to date and future proof. The Ministry for the Environment document proposing loosening regulatory oversight for GE laboratory microbes, viruses and bacteria poses a threat to people's health and the environment.

These proposals weaken monitoring of lab work and open up new risks from changes in technology and biomedical applications.

"This consultation document relaxes the conditions for oversight of genetically engineered and new organisms," said Claire Bleakley, president of GE-free NZ.

"Trust in organisations that carry out dangerous experiments can only be maintained if there is regulatory oversight to ensure the security of the laboratories."

Laboratory security has been an issue before and relaxing regulation will add to existing vulnerabilities and failures in monitoring.

There have been reports of laboratory workers catching meningococcal disease [2] and typhoid [3] from samples they are examining. The scientist at the Environmental, Science and Research Institute (ESR) nearly died after she contracted meningococcal disease in her laboratory. Reports have found that clinical microbiologists were 65 times more likely to contract meningococcal disease from their laboratory work. [4].

There is evidence of risks from gain of function experiment using the corona virus SARS, which has been linked to virus escapes in 2004 [5] and is now the possible origin for the SARS Cov-2 pandemic. [6],[7]

New Zealand people have participated in three trials of genetically engineered medicines of which one was withdrawn, one never took place and one is still being trialled.[8]

Monitoring of secure labs and experimental sites appears to have been lax in the last few years in New Zealand. Inspection monitoring has found continual serious non compliances but there has been no further inspection to confirm that these have been addressed.

“There must be regulatory oversight and annual reports to identify concerns, breaches or failures,” said Claire Bleakley.

“The community must be protected if GE lab research or gene therapy drugs are being trialled and there is risk of transmission. Clinical trials with people undergoing experimental gene therapy must not be allowed to walk around the community without any quarantine controls."

Regulatory inspection and monitoring must be ensured for all laboratories who work with Genetically Engineered microbes, gain of function and gene edited organisms.

Submissions close on the 25 August 2023 at 11.59pm.

* New Biotechnologies are genetically engineered organisms that use gene editing technologies that include CRISPR, TALENS, dsRNA, Zinc Finger nucleases and many other technologies to delete or insert altering their functional traits.

References:

[1] https://consult.environment.govt.nz/comms/gmo-regulations/
[2] https://www.nzherald.co.nz/nz/scientist-loses-limbs-to-meningococcal-disease/WOXLTD3UUVTDBSIO63OTWLSALU/
[3] https://www.stuff.co.nz/national/health/132679822/two-lab-workers-in-three-months-hospitalised-with-rare-typhoid-infections-caught-at-work
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1234112/
[5] https://www.dni.gov/files/ODNI/documents/assessments/Report-on-Potential-Links-Between-the-Wuhan-Institute-of-Virology-and-the-Origins-of-COVID-19-20230623.pdf
[6]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC416634/
[7] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10234839/
[8] https://www.genengnews.com/news/pexa-vec-nexavar-combination-fails-phase-iii-trial-in-liver-cancer/

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