GM Cattle Development application approved
Tuesday 1 October 2002
GM Cattle Development application approved with controls
A special committee established by the Environmental Risk Management Authority has approved, with controls and in modified form, an application from AgResearch Ltd to develop transgenic cattle that can express functional therapeutic foreign proteins in their milk and to develop transgenic cattle to study gene function and genetic performance.
The application was generic in nature because it was for work on cattle (Bos Taurus) cells and animals modified with genes selected from a widely specified range. The application provided for the donor genes to be sourced from humans, mice, cattle, sheep and goats. Other genes need to be inserted to indicate whether or not the genetic modification is working and to indicate whether or not the genetic modification sought has actually been achieved. The work proposed was also categorised as a development but had both indoor and outdoor components and covered the whole range of work from the creation of embryos to the growing up of the genetically modified cattle. These characteristics of the application raised legal questions about whether the application could be considered as a development, as opposed to a field trial, and whether such a generic application could be validly considered under the HSNO Act. The Committee decided that the application could be accepted for consideration on both counts.
Although accepting the application as valid, the Committee decided that the extent of the range of possible genetically modified organisms encompassed by the application introduced too great a level of uncertainty to enable risks, costs and benefits to be confidently assessed and weighed. Consequently, the organism description was narrowed down and additional controls imposed, to reduce uncertainty to a level considered to be satisfactory for decision-making. In particular the revised organism description excludes the use of most viral sequences to minimise the chance of developing new viral diseases, and prohibits the introduction of sequences that are known to enable viruses to enter mammal cells. The introduction of sequences from other pathogens into cattle is prohibited, to minimise risks associated with development of diseases. There are also controls on the nature of the genetic material to be used, to minimise risks that might arise from horizontal gene transfer (HGT). All sequences to be introduced into the cattle have to be well characterised and that information then reported to ERMA New Zealand, prior to those sequences being used, so that uncertainty over the source and nature of the genetic modifications is reduced. Finally, the permitted duration of the trial has been reduced to 7 ½ years, the minimum necessary to carry out the work, and a control imposed requiring annual reports on the progress of the trial.
The application was the first to be considered since the passing of the HSNO (GMO) Amendment Act 2002, therefore relevant criteria in that Act had to be applied for the first time. In particular the Committee considered whether there were alternative methods for achieving the research objectives which had fewer risks than the method in the application. The conclusion reached was that there were no other practicable methods for meeting all of the research objectives, and that any differences in risks were not significant. There was accordingly no case for declining the application on these grounds.
In looking at risks potentially posed by the application, the Committee especially considered risks to animal welfare, the development of new diseases, the potential for the transfer of existing diseases to the cattle, risks arising from HGT, and Maori spiritual concerns. These risks are all related to the nature of the genetic modifications. There were considered to be negligible risks to public health and the environment associated with the possible escape of genetically modified animals from containment.
In relation to Maori spiritual risks, the Committee acknowledged the concerns expressed by Ngati Wairere in particular and took steps to recognise those concerns in the setting of controls, and by requiring on-going dialogue between Ngati Wairere and AgResearch on these and other issues, through the two monitoring groups already established. The Committee felt that these measures, in conjunction with other appropriate cultural steps, would enable significant spiritual harm to be avoided.
The amended organism description and the controls on the approval were considered to reduce risks in aggregate to a low level, taking account of the uncertainty associated with them.
The Committee's view was that the principal benefit of the research was the scientific information to be gained including the acquisition of new skills.
The applicant and others made reference to the specific downstream economic and health benefits to be gained from the products that might result from the commercial use or release of the genetically modified cattle. These products might especially include biopharmaceuticals. The Committee did not consider these downstream benefits to be relevant to this application.
Because the risks were considered to be low rather than negligible, a final decision had to be made by weighing benefits against costs and risks. The Committee decided that the largely scientific benefits outweighed all of the risks, including biological and physical risks as well as spiritual and cultural concerns and after taking account of the impact of controls applied. The application, modified as indicated, should therefore be approved.
The genetic modifications covered by this approval all meet the requirements of the HSNO (Low Risk Genetic Modification) Regulations 1998.
The Committee imposed a wide range of controls on the approval, to ensure that any risks would be managed down to a low level. Some of the key controls are as follows:
- The indoor and outdoor containment facilities
are to be managed in accordance with MAF and ERMA New
Zealand approved containment standards.
- The cattle are to be managed in accordance with the Animal Welfare Act 1999; and animal welfare and ethics guidelines administered by MAF and the Ruakura Animal Ethics Committee.
- The husbandry of the animals is to be overseen by an experienced veterinarian who shall have the power to determine a humane endpoint for any part of the trial or the overall endpoint of the trial.
- The outdoor containment facility is to be enclosed by a double perimeter fence, with an inner fence electronically monitored and alarmed, stock proof and capable of preventing entry and escape of cattle.
- All cattle no longer required for breeding shall be disposed of by burial in unlined offal pits on the site. The applicant is required to consult with Ngati Wairere with respect to developing additional culturally appropriate mechanisms and protocols relating to disposal.
- All milk, skim milk, and cream shall be destroyed on site, by either an effluent treatment digester, incineration, or by spraying on to pasture following treatment to destroy any cells present.
- No part or product of genetically modified cows, surrogate mothers or recipient cows or non-transgenic calves shall enter the food chain.
- All conventional cattle within the facility are to be double tagged; all genetically modified cattle shall be individually identified by an ear tag and also implanted with a subcutaneous electronic microchip for individual electronic identification.
- Breeding shall be limited to the minimum necessary to complete development. No breeding of animals is allowed, except where necessary to ensure that 'true to type' animals have been produced and to investigate stability of inheritance. Prior to any breeding of transgenic cattle, the Chief Executive of ERMA New Zealand shall be advised of the intention to breed and the reasons for the breeding.
- The applicant is required to facilitate the continued operation of the existing monitoring groups with Ngati Wairere, to enable Ngati Wairere representatives to monitor the implementation and progress of the development, and to develop culturally appropriate mechanisms and protocols, as required. AgResearch is required to advise the Chief Executive of ERMA New Zealand if either of these groups are disbanded or cease to operate satisfactorily.
- The approval is for a period of seven and a half years from the date of the signed decision.
- Further information, including the full details on the controls, the full text of the Decision and the application documents can be found on the ERMA New Zealand website from our Register or on request.
A media conference will be held at ERMA New Zealand, Level 1, BP House, 20 Customhouse Quay, Wellington, to start from 2.15pm (set up time will be from 1pm) on Tuesday 1 October.