Lack of Capability at MPI to Manage GE-derived Plants: Risk of Unintended Consequences

There is risk of regulatory failure after the Environmental Protection Agency (EPA) decision to devolve responsibility for genetically engineered “Null segregants” to the Ministry of Primary Industries (MPI).

MPI does not have the resources or adequate technological testing facilities or equipment to be able to run the complex GE evaluation on a null segregant.

The EPA recognises that Null segregants are progeny of genetic engineering or gene editing (GE) that adopt the trait but do not maintain basic detection of the genetic engineering event. They are considered GMOs until MPI has evaluated them. [1]

“It is not good enough for the EPA to off-load their responsibility for GE evaluation,” said Claire Bleakley, GE-free NZ president.

“MPI lacks the capacity to do what is being asked. Without adequate safety studies, technological expertise and 'omics' testing facilities, the EPA’s decision to devolve responsibility to MPI risks integrity of the regulatory system and the safety of the economy and environment.”

There are important lessons from previous failures in regulation that are being ignored in the EPA’s decision. 

The introduction of HT Swede (HT-S57) was directly linked to the deaths of hundreds of cows from metabolic and liver disease in Southland. [2] [3] The development of the CleanCrop swedes was to make them tolerant to spraying with chlorsulfuron (Telar). These were developed by Tony Connor and Mary Christie who ran the failed genetically engineered brassica trials. It has been posited that the HT Swede were possible null segregants. [4]

Another example of unintended consequences occurred overseas; with calves whose embryos were gene edited to make them hornless. The animals inherited the trait and the company, Recombinetics, submitted data to show that the trait had been inherited. This was heavily promoted as “precision technology and as fast as doing it in your backyard”. However, Dr Norris et al , from the Centre for Veterinary Medicine at the Food and Drug Agency (FDA) ran a sequencing programme and discovered the calves had inherited foreign DNA from bacterial plasmids conferring antibiotic resistance as well as unintended integration errors that were not looked at by the company.

Norris et al (2020) went on to recommend improved screening methods to detect plasmid integration; the alignment of sequencing data that includes the reference genome and plasmid sequences; PCR methods to detect increased copies of the template and unintended integration through digital droplet PCR southern blot and long reading sequences like Nanopore and PacBio screening methods. This will provide more precise measure of the prevalence’s of the template plasmid and integration events. [5]

“New improved screening technologies are not being applied as they should be. MPI are being set up to fail because they lack the advanced detection technology tools.” said Claire Bleakley.

"Recombinetics believed their testing was adequate and did not look for off target effects or foreign DNA. Taking industry assurances without rigorous oversight and up to date testing will allow potentially dangerous genetically engineered organisms to be released.”

Genetically Engineered products are not the solution to sustainable economic security. The Government should be supporting resilient farming systems and promoting high performance plants and animals available today in New Zealand.

References:

[1] OIA to GE Free NZ from EPA CEO, Dr Freeth. https://www.gefree.org.nz/assets/Uploads/Letter-to-Claire-Bleakley-re-null-segegants-25-March-2024.pdf
[2] Swede questions still unanswered Farmers Weekly December 4, 2014. https://www.farmersweekly.co.nz/news/swede-questions-still-unanswered/
[3] https://www.dairynz.co.nz/media/jj1g15j3/swede-associated-toxicity-in-dairy-cattle-during-winter-2014.pdf
[4] CleancropTM Brassica System: The development of herbicide resistant brassica crops for New Zealand farming systems https://www.grassland.org.nz/publications/nzgrassland_publication_2265.pdf
[5] Norris, A.L., Lee, S.S., Greenlees, K.J. et al. Template plasmid integration in germline genome-edited cattle. Nat Biotechnol 38, 503 (2020). https://doi.org/10.1038/s41587-020-0467-6