Applying to Release Weed Biocontrol Agents
The Environmental Protection Authority (EPA) regulates the importation, development and release of new organisms in New Zealand under the Hazardous Substances and New Organisms (HSNO) Act 1996. It has been widely acknowledged that the EPA process works well, providing a robust, coherent, fair and logical framework for making decisions about the release of weed biocontrol agents. It is the envy of many practitioners overseas battling more difficult regulatory environments. In the last 5 years the EPA has assessed and approved 13 biocontrol agents for New Zealand, including nine insects and two pathogens targeting eight weeds. Recently a paper has been published giving an overview of how the EPA regulatory process works, and the associated costs, which we summarise in relation to weed biocontrol below.
In terms of the process, applicants must submit a dossier of information that provides the evidence for why they consider a proposal to release a new organism meets the regulatory requirements. The information needs to inform the EPA about the risks, costs and benefits of the prospective biocontrol agent to allow for comparative evaluation. “The EPA has pioneered world-leading qualitative risk assessments to ensure environmental, economic, societal, public health, and cultural perspectives are addressed in a decision-making framework,” said lead author of the paper, Clark Ehlers. The benefits and risks are considered in light of the status quo and future pest management strategies. The likelihood and magnitude of each benefit or risk is evaluated on a ranking scale, and the EPA will decline an application where the adverse effects are considered to outweigh the benefits. “Furthermore, the EPA must determine whether the prospective biocontrol agent can meet a set of minimum standards in the HSNO Act, e.g. whether a new organism is likely to cause significant displacement of native species within its natural habitat or is likely to cause significant deterioration of natural habitats,” explained Clark.
There can be a long lead time to prepare and submit an application. The effort required to collate all the supporting information means significant costs for the applicant and EPA staff, who provide advice and support throughout. As well as drafting the application, applicants bear the costs of consulting with independent technical experts and reviewers, and with Māori (an obligation under the Treaty of Waitangi and written into New Zealand law). Following formal receipt of an application, strict statutory timeframes apply. A decision to release a new biocontrol agent must be made public within 100 business days of receiving an application. Within this time, the EPA publicly notifies the application, which involves inviting comments from the public; performs a scientific and cultural assessment of the application; and holds a public hearing and consideration meeting, at which time an independent committee makes a decision to approve or decline the application. Applicants must cover their costs associated with responding to any comments received following the public notification process, and for preparation for and attendance at a public hearing. The EPA sets its application fees in line with the understanding that research and development of new biocontrol agents may take many years and success is not always guaranteed. They recently reassessed their fees, and concluded that for some applications there is a high public benefit that needs to be taken into consideration (e.g. weed biocontrol agents), and for others there may be significant commercial benefits (e.g. developing IP protected new endophyte strains for pest control in crops).
With this public good in mind, the EPA currently charges $23,000 to process and assess a weed biocontrol agent application, which is not based on full cost recovery. The EPA charge comprises about 41% of the total regulatory costs per agent ($55,550). “When the EPA was first formed, I expressed concerns that the new regulatory costs would impose a significant burden for weed biocontrol programmes, even causing some to fail or be abandoned, but I am been pleased to be proven wrong,” said Simon Fowler, a co-author on the paper. Overall, these regulatory costs are only 15% of the total research and development costs required to obtain EPA approval for release of an agent where New Zealand is taking a pioneering role ($364,550), or 39% of the total costs to New Zealand ($138,300) where other countries have already invested substantially.
Furthermore, the full regulatory, research and development costs are also low when compared to the benefits that could eventually accrue from approved biocontrol agents. Ironically, with weed biocontrol releases, end-users can benefit from reduced pest control costs even if they did not invest in any of the costs upfront. Such programmes are unlikely to be seen as a good investment by the private sector. Hence, the costs for new biocontrol agents tend to be borne by government agencies in New Zealand.
As well as the benefits arising from better managing weeds through biocontrol, the work undertaken to inform EPA applications provides supplementary benefits, such as contributing to the field of invasion biology. In addition, surveys of the invertebrate fauna and pathogens contribute to our understanding of the ecology of weeds, as well as our knowledge of the food webs and ecosystem services associated with plants in their native ranges and when they have become invasive species in non-native environments.
For further details see:
Ehlers GAC, Caradus JR, Fowler SV (2020). The regulatory process and costs to seek approval for the development and release of new biological control agents in New Zealand. BioControl 65(1): 1–12. https://doi.org/10.1007/s10526-019-09975-9