A reassessment is where the risks, costs and benefits associated with an approved substance (or a substance in transition) are reconsidered. Sections 62, 63 and 63A of the HSNO Act provide for hazardous substances to be reassessed. As a result of that reconsideration the Authority of ERMA New Zealand may decide to change the conditions placed on the approval, or in extreme cases withdraw the approval altogether.
The reassessment process has two steps:
- The Authority must agree that there are "grounds" for a reassessment. If so, then
- Any person can make an application for the reassessment which is processed in the same way as a normal application.
The costs of preparing applications for grounds for reassessment and for reassessment are generally borne by the person making the application.
- Making Applications (quick guide) [pdf - 595 kb]
- Grounds for Reassessment of a Hazardous Substance (application form HS-8) [pdf - 298 kb]
- Fees and Charges Schedule
Reassessment FAQs
What is a reassessment?
A reassessment is a fresh look at the risks, costs and benefits of a substance approved under the HSNO Act. Following receipt of new information, anyone may make a case for the Environmental Risk Management Authority (ERMA New Zealand) to look again at any associated risks. A reassessment may be either a full reassessment of the approval, or a more limited review of a specific aspect of the approval (ie a modified reassessment under section 63A). If conditions placed on an approval are insufficient to manage the risks, ERMA New Zealand may recommend they be modified. In the case of full (as opposed to modified) reassessments, ERMA New Zealand may recommend withdrawal of an approval, meaning the import, manufacture and use of a substance is effectively banned in this country.
Can I continue to use a substance while it is being reassessed?
Yes. Provided you continue to use the substance in the correct way and follow controls set by the Authority. If a reassessment results in changes to the controls, these new controls will be recorded in the decision document.
What is the reassessment process?
Two steps apply to reassessments:
- Grounds for reassessment must be established. An application to establish whether there are grounds for reassessment is prepared and lodged with ERMA New Zealand. If the Authoritys decision-making committee is satisfied that good reasons exist to re-evaluate risks, costs and benefits of the original approval, the reassessment may proceed. Reasons must be framed in terms of significant new information becoming available regarding the effects of the substance, existence of alternative substances, or a significant change in use or quantity of the substance.
- A full application for reassessment must be prepared . Once grounds are established, an application for either a "full" or a "modified" reassessment is prepared. ERMA New Zealand checks applications for completeness and the applications are then notified for public submission. Applications and submissions are reviewed, and a report prepared for the decision-making committee. Public hearings may be held if requested by submitters. The decision of the Authority is publicly notified within 30 working days after the hearing.
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Who may submit a proposal for reassessment?
Anyone can make a case for reassessment. If the Chief Executive makes the case, the reassessment is referred to as a Chief Executive Initiated Reassessment (CE Reassessment).
Who pays?
ERMA New Zealand pays for chief executive initiated reassessments - this includes deciding whether there are grounds for a reassessment and then carrying out the reassessment if grounds exist.
In all other cases, the person requesting the application pays. However, the Authority may agree to waive part of these charges if it is considered there is public interest in carrying out the reassessment. Applicants should discuss this possibility with ERMA New Zealand before deciding on whether to make an application.
How do people get involved in the reassessment?
Read the application and make a submission if you have any concerns. If you make a submission and wish to be heard, then you can attend a hearing and talk face to face with the Authority members.
Can people see the application?
An application can be viewed at our office in Wellington or on our website. We'll send out summary information on request.
How can I be sure the process has integrity?
The application, reports and decision are all open to public scrutiny and we encourage people to become involved and provide submissions. At times information may be withheld to protect commercial interest.
The Authority is appointed by the Minister for the Environment rather than ERMA New Zealand to ensure independence.
How do I find out more information about the process and/or the application?
See our publications pages or call (04) 916 2426 for information to be posted to you.
How do people make a submission?
There is a standard format which helps us process your submissions and ensures you provide us with the information we need. We can send the form to you or you can download it from our website.
We also have a facility on our website where you can make a submission directly online by going to the application which is open to submission
However, any format will be accepted, provided that the minimum requirements in the Act are met. Submissions should usually be in writing. They must include reasons for the submission and whether you wish to be heard. In addition you should note the decision you seek, your contact details in case we need to clarify any of your points raised or invite you to a hearing.
What is a pre-hearing?
Once a submission has been received, ERMA New Zealand may decide to convene an informal meeting involving both the applicant and all submitters, to identify and discuss relevant scientific, technical and other matters.
Pre-hearings must not compromise the formal decision-making role of the Authority.
At any stage, either the applicant or submitter may withdraw a request to be heard at the formal hearing, in which case the Authority will make its decision based on the documents supplied.
What is a hearing?
A cornerstone of the HSNO Act is the public's right to be heard. New Zealander's ability to able to have their say and talk directly to the Authority brings with it the responsibility to ensure the information presented is relevant and of good quality.
If a hearing is requested, it must begin within 30 working days of the closing date for submissions, or when the application was received, whichever is later. The Authority can lengthen or reduce this timeframe if everyone agrees, or if it is satisfied that the parties (applicant, submitters and any other body with a statutory role in the process) will not be unduly prejudiced.
The Authority has to give at least ten days notice to all parties of the date, time and place of the hearing. The timeframe can also be lengthened if the Authority decides more information is needed.
ERMA New Zealand will decide where the hearing will take place. Generally, this will be held in our Wellington offices, but this will depend on where the majority of submitters and the applicant reside.
An ERMA New Zealand report (Evaluation and Review Report) will be presented to the hearing committee (unless it is a Chief Executive-initiated reassessment). This report may include a review by external consultants or an advisory committee.
Parties will receive this report in advance of the hearing. Applicants and submitters are expected to pre-circulate the information they intend to present at the hearing, together with a list of those likely to attend.
This information should be given to the Authority and the other parties at least four days before the start of the hearing.
Submitters can be represented at the hearing or they may call witnesses, but are not obliged to do either. There is no cross-examination at hearings, but all witnesses may be questioned by the hearing committee, and with the leave of the chairperson, by other parties.
How do Chief Executive Initiated Reassessments differ from externally-initiated reassessments?
CE Reassessments are selected from the CE Reassessments list. Applications for grounds for externally-initiated reassessments can be made for any substance.
Externally-initiated reassessment applications are treated in the same way as applications for approval of new substances. With CE Reassessments, the application and the evaluation report are combined.
What is the Chief Executive Initiated Reassessment list?
ERMA New Zealand develops a list of substances for which new information suggests a need for another look at the substance. This is the CE Reassessment list. ERMA New Zealand prioritises this list to decide which substances will be subject to this.
How does the Chief Executive decide which substances should be placed on the Chief Executive Initiated Reassessment list?
There are several steps in this process:
- ERMA New Zealand collects new information during the course of its work. This may be brought to ERMA New Zealand's attention by the public, overseas regulatory agencies, by applicants or through ERMA New Zealand's own searching of published information.
- ERMA New Zealand staff screen this information to determine candidates for reassessment. The result of this is the CE Reassessments list.
- ERMA New Zealand consults on the list.
- The list is prioritised taking account of submissions and resources available for the reassessment programme.
- The Authority makes a decision on prioritisation and how many CE Reassessments should be performed.
How many Chief Executive Initiated reassessments will be performed?
The intention is to initiate (publicly notify for submissions) at least four each financial year. In the year to 30 June 2009, the substances to be publicly notified for submissions are:
- Azinphos methyl and formulations
- Methyl parathion and formulations
- Dichlorvos and formulations
- Trichlorfon and formulations
- Methylarsinic acid and formulations
with decisions being notified in respect of at least two of these substances by 30 June 2009.
How can I get involved?
Anyone can make formal submissions at three stages in the CE Reassessments process:
- In response to consultation on the list
- Asking to be consulted on applications for grounds for reassessment
- Responding to consultation on specific reassessment applications. By making a submission at this stage, anyone (including other agencies and organisations) has the legal right to be heard by the Authority's decision-making committee.
Alternatively, members of the public can submit applications for grounds to perform a reassessment.
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Who will decide which substances should be reassessed under the CE Reassessment programme?
A committee of the Environmental Risk Management Authority.
Who and what is the Authority?
The Authority is an independent body of eight members, set up under the HSNO Act to make decisions on hazardous substance and new organism applications. Members are appointed by the Minister for the Environment, who must ensure the membership includes a balanced mix of knowledge and experience in matters likely to come before the Authority.
Who appoints the decision-making committee? How are the members appointed?
The Authority sets up a decision-making committee from its members.
What role does the Ministry for the Environment play in the reassessment process?
The Ministry for the Environment administers the HSNO Act, but does not influence Authority decisions.
What influence does the Minister for the Environment have?
The Minister appoints Authority members, has no role in decisions on applications, unless the Minister 'calls in' an application.
What is the function of Ngā Kaihautū Tikanga Taiao?
Ngā Kaihautū Tikanga Taiao is a Māori advisory committee appointed by the Authority. It provides advice and assistance to the Authority on matters relating to policy, process and applications from a Māori perspective.