1. INTRODUCTION AND SUMMARY

1.1 This submission on the Agricultural Compounds and Veterinary Medicines (ACVM) Amendment Bill and the Hazardous Substances and New Organisms (HSNO) Amendment Bill is made by The New Zealand Initiative (the Initiative), a Wellington-based think tank supported primarily by major New Zealand businesses. In combination, our members employ more than 150,000 people.

1.2 The Initiative undertakes research that contributes to the development of sound public policies in New Zealand, advocating for a competitive, open, and dynamic economy and a free, prosperous, fair, and cohesive society.

1.3 The Initiative’s members span the breadth of the New Zealand economy. The views expressed in this submission are those of the author rather than the Initiative’s members.

1.4 We strongly support the Bills' intent. New Zealand's farmers, growers and veterinarians wait too long for products already assessed and approved by trusted overseas regulators. The Government has correctly identified greater reliance on trusted overseas regulators as the central lever for reducing those delays. We also acknowledge that the Bills make real improvements beyond reliance, including moving rigid statutory timeframes into regulations, strengthening the independent data-assessor framework, and improving
public notification of applications. Our recommendations build on that direction.

1.5 Cabinet suggested a stronger reliance model than the Bills implement. Cabinet material described amendments requiring the Director-General under the ACVM Act to use appropriate, available product assessments by recognised international regulators for the same, or substantially the same, product and use. It also described HSNO changes intended to allow the EPA to rely on international modelling, data and assessments unless specific New Zealand circumstances warrant detailed assessment.1

1.6 The operative ACVM provision instead requires only that the Director-General have regard to overseas assessments. A duty to have regard to something is not a duty to use it, rely on it, or give it decisive weight. It can be discharged by reading an overseas assessment, noting it, and then conducting much the same domestic assessment as before. On its current wording, the Bill gives officials an information-gathering tool but gives applicants no entitlement to rely on a favourable recognised overseas approval.2

1.7 The HSNO reforms need the same discipline. The EPA already recognises international regulators for some hazardous-substance assessment purposes. If ACVM is strengthened but HSNO remains an open-ended discretionary assessment, the main bottleneck will remain.3

1.8 We therefore recommend that the Bills be amended so that a recognised overseas approval creates a rebuttable presumption of New Zealand approval. Officials should be able to displace the presumption only by giving written reasons identifying a specific New Zealand risk, or a specific export-market-access risk, and explaining why that risk cannot be managed through conditions or controls.

1.9 In summary, we recommend that the Committee:

a. replace the have regard to formulation in new paragraph (aa) inserted into section 20 of the ACVM Act with a presumption of registration or approval on terms no more restrictive than the recognised overseas authorisation, subject to a reasoneddeparture
test;

b. extend the same presumption to the HSNO rapid-assessment, temporary hazardous-substance approval, recognition and controls provisions, including sections 28A, 29A to 29AC, 76E and 77, because HSNO approval is the gateway to ACVM registration for many novel products;

c. insert statutory wording, or equivalent provisions, that specify when the regulator must rely on recognised overseas assessments and how any departure must be justified;

d. prescribe a tiered list of comparable overseas regulators and require a public register of every decision in which a recognised overseas approval was discounted, restricted or refused;

e. make public notification risk-triggered, not pathway-triggered, so that reliance-based applications are notified only where the regulator first records a plausible New Zealand-specific risk not already addressed abroad;

f. treat divergent overseas standards, including maximum residue limits and exportmarket requirements, as conditions-of-authorisation questions rather than as rounds for full domestic reassessment;

g. require annual reporting of queue time, regulator assessment time, applicant stop-clock time, and total elapsed time for ACVM and HSNO applications, including separate reporting for reliance-based applications;

h. make refusals and material restrictions time-limited and reviewable against overseas experience, while allowing exception grounds to be narrowed by secondary instrument but expanded only by primary legislation;

i. place the substance of the HSNO levy, including its purpose, cost-recovery limits, memorandum account, performance reporting and review cycle, on the face of the Act; and

j. pair the presumption with a remedy for non-decision, calibrated to the statutory context: registration or approval with conditions for ACVM products where the Director-General misses a statutory deadline without issuing a compliant reasoned departure notice; deemed temporary hazardous-substance approval after a short negative-clearance screen for HSNO hazardous substances authorised by at least two Tier 1 regulators; and, for new organisms and environmental-release cases, a prompt confined decision on the incremental New Zealand-specific ecological or biosecurity risk rather than deemed release.

1 Cabinet Economic Policy Committee, 21 May 2025, Minute of Decision ECO-25-MIN-0075. ACVM
recommendations, number 25. Included at page 104 of https://www.regulation.govt.nz/assets/Publication-Documents/Information-Release-ECO-25-SUB-0075-Agricultural-and-Horticultural-Products-Regulatory-Review-Omnibus-Bill.pdf. Review Recommendation 7 was “that the EPA and NZFS maximise their use of assessments by international regulators for assessing the risks of a product while still considering aspects unique to New Zealand.”
See Appendix 2 of https://www.regulation.govt.nz/assets/Publication-Documents/Cabinet-paper-ECO-25-SUB-0006-Agricultural-and-Horticultural-Products-Regulatory-Review-Progressing-Recommendations.pdf

2 Clause 20 of the ACVM Amendment Bill inserts new paragraph (aa) into section 20 of the ACVM Act, adding assessments by recognised overseas regulators held by the Director-General to the matters to which the Director-General must have regard when evaluating risks and benefits under section 21. Clause 21 inserts new section 20A, allowing the Director-General to declare recognised overseas regulators for the purposes of section 20(aa).

3 See EPA release, 16 August 2023, “EPA confirms overseas regulators for assessment information”.
https://www.epa.govt.nz/news-and-alerts/latest-news/epa-confirms-overseas-regulators-for-assessmentinformation/. EPA authority to recognise overseas bodies as international regulators is currently set at 76E of the Hazardous Substances and New Organisms Act 1996.