Published on 07/12/2022
The first challenge is that the process involves three government regulators, with different processing times, resources and responsibilities.
They are:
1. The Agricultural Chemical and Veterinary Medicines Group (ACVM) of the Ministry for Primary Industries operating under the ACVM Act1.
2. The Environmental Protection Authority (EPA) operating under the HSNO Act2.
3. WorkSafe NZ operating under the Health and Safety at Work Act3.
To bring new chemistry into NZ, companies must first import small quantities to carry out field trials in containment to generate data about its efficacy and safety to our environment. This needs approval from the ACVM and the EPA.
The ACVM process is relatively straightforward - requiring the company to hold an operational plan which covers all products a company may wish to trial for up to five years. Companies must simply notify ACVM of the formulation of each trial product.
Companies wishing to import crop protection products must also apply to the EPA for approval to import substances (i.e. formulations) into containment for trials.
Specific approvals must be issued for each product and formulation, which can take up to six months. This approval does not cover any other products.
If formulations need to be tweaked during trials, a new application may be required.
Over the past four years, this has, at times, caused companies to miss critical trial timing windows.
The variability in controls set, including between approvals issued to the same registrants, has also led to significant compliance costs and barriers for some companies.
Animal and Plant Health NZ (and Agcarm before it) has been working with the EPA to reinstate a system that would enable containment trials to be conducted with a standard set of controls without needing new approvals each time a product is to be tested.
By contrast, many veterinary medicines do not require containment approval for trials because most are approved by way of group standards.
If the proposed product fits within the limits of these prescribed standards, no signoff from the EPA is required for importation/manufacture.
The Health and Safety at Work Act and Regulations4 must be followed for trials. Any laboratory work must conform to Part 18 of these regulations.
Once data is generated and compiled, an application for registration to the ACVM must be made with data to meet the following requirements:
• Residues
• Efficacy/crop safety
• Animal welfare
• Chemistry and manufacturing.
Chemistry data must meet specific NZ requirements. The cost to generate this data can amount to more than $200,000.
The registrant must also make an application to the EPA for hazardous substance approval, by providing the following data:
• Physical and chemical properties
• Toxic and eco toxic properties
• Hazard classifications
• Environmental fate
• Human health
• Assessment of possible risks to Māori culture by the product
• Life cycle of the substance.
The approximate cost of generating this data varies between $150 to more than $600,000 and is similar to what is presented to overseas jurisdictions.
Differences in risk assessment methodology mean additional studies may be required by the EPA.
The application fee is $30,000, including $5,000 for a public hearing, required in 90 percent of cases where public submissions are requested to be heard by the EPA.
With many veterinary medicines, three group standards cover the majority of existing and future approvals 5, 6, 7.
The Limited Pack Size, Finished Dose group standard allows for medicines, with either new or existing active ingredients, to be imported and used if the finished pack size is less than 500g or 500ml, and the product meets certain hazard classification limits.
Group standards for non-dispersive, closed system, and non-dispersive open system application allow for larger pack sizes and broader use patterns but only for existing (in NZ) active ingredients.
If a company wishes to introduce a new active ingredient that falls outside of the group standard or does not meet the hazard classifications restrictions, it must apply to the EPA and go through the same process as a crop protection product.
WorkSafe NZ enforces the Health and Safety at Work (Hazardous Substances) Regulations and Health and Safety at Work Act.
Both these prescribe general obligations on companies and end-users of crop protection and veterinary medicine products, determined by the hazard classifications of each product. Under the regulations, WorkSafe can also prescribe product-specific requirements by way of a Safe Work Instrument (ss227-229 of the Act).
This is a relatively new legislative tool yet to be used for these products but is likely to be used to establish workplace controls for use.
If WorkSafe proposes issuing a Safe Work Instrument, the EPA may delay finalising an application until WorkSafe has developed and consulted on it before approving it.
There are no legislative timeframes, but Safe Work Instruments have taken three months to a year - from development to ministerial signoff.
1www.legislation.govt.nz/act/public/1997/0087/latest/DLM414577.html
2www.legislation.govt.nz/act/public/1996/0030/latest/DLM381222.html
3www.legislation.govt.nz/act/public/2015/0070/latest/DLM5976660.html
4www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309401.html#DLM7311303
5www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/Old-Group-Standards/7139b07cfa/Previous-Veterinary-Medicines-Limited-Pack-Size-Finished-Dose-Group-Standard-HSR100757.pdf
6www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/Old-Group-Standards/4833405b0a/Previous-Veterinary-Medicines-Non-dispersive-Closed-System-Application-Group-Standard-HSR100758.pdf
7www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/Old-Group-Standards/e9b0689f5c/Previous-Veterinary-Medicines-Non-dispersive-Open-System-Application-Group-Standard-HSR100759.pdf