Approvals Operations Group
Regulation and Assurance
Ministry for Primary Industries
Pastoral House, 25 The Terrace
PO Box 2526, Wellington, New Zealand 6140
Tel: 04 894 2550, fax: 04 894 2566
Email: approvals@mpi.govt.nz
Operating Plan Template for Agricultural Compounds Used
under the Regulatory Exemption for Research, Testing and
Teaching/Training Purposes
ACVM 26 (July 2015)

This form can be used by those intending to use agricultural compounds for research, testing and teaching/training purposes as per the
exemption provision in the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011.
One of the conditions of this exemption is that the user must hold an MPI-approved operating plan.

For additional information on this regulatory exemption please read the document Operating Plan for Agricultural Compounds Used
under the Regulatory Exemption for Research, Testing and Teaching/Training Purposes: ACVM Guideline.

If you are unsure whether you are required to have an approved operating plan, contact the ACVM Group by email.

Please ensure the application fee accompanies the completed operating plan template. Refer to section 13 for payment options.

Send the operating plan electronically to approvals@mpi.govt.nz. Electronic signature is acceptable.

If there are any changes to the details provided in this form after it has been submitted, you must promptly inform the Ministry for Primary
Industries of the changes in writing.

Refer to the Privacy Act 1993 and Official Information Act 1982 notices at the end of this form regarding collection of information by the
Ministry for Primary Industries.
1.
Operating Plan Title
Title
Approval Number
(if assigned)
2.
Operating Plan Owner
Organisation
Name
3.
Organisation Address and Contact Details
Street/Physical (location of actual premises)
Postal, including post code (for communication)
Tel
Mobile
Contact
Name
Email
(for queries regarding this application)
By entering an email address you consent to being sent
information and notifications electronically, if required.
4.
Scope of the Operating Plan
The scope should cover the details listed in the box below.
Note: If a future activity falls outside the scope, a new or amended operating plan will be required.
Type
Agricultural Chemical
Veterinary Medicine
Vertebrate Toxic Agent
Class
(See Product Types in the
Guidelines for Product Data Sheets
for Registration of Agricultural
Chemicals, Veterinary Medicines or
Vertebrate Toxic Agents).
Novel active ingredients
Registered active ingredients with new risk profiles
Registered active ingredients with known risk profiles
Nature of activities
Product type:
Research
Testing
Training/Teaching
Animal species or use situation
Any special risk areas to be
considered
(such as antibiotic use, use of
treated produce for human or
animal consumption)
AC-AFT-138-3.3
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July 2015
5.
List of Substances or Compounds
List full formulations of all substances or compounds to be used here (or attach if more room needed) and/or
process for notification to the ACVM Group. Copies of EPA notifications are acceptable.
Any additional compounds or substances which fall within the scope of this operating plan must be notified to
the ACVM Group before use (see Appendix 2).
AC-AFT-138-3.3
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July 2015
6.
Individual Study Plan Requirements
Provide the template that you will use to create the individual study plans. Refer to Appendix 1 for examples of
items that should be included. For common processes the plans may reference the organisation’s standard
operating procedures.
Please note that each plan must be available for audit if required.
7.
Study Plan Approval Process
Provide details as to how your organisation will assess and approve each study plan and how it ensures that
unapproved activities will not occur. Alternatively, attach a copy of the standard operating procedure your
organisation may have that provides the above details. Refer to the guidance document for more information.
AC-AFT-138-3.3
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July 2015
8.
Organisational Strategy for Management of Special Risks
Provide the overall management strategy for each of the special risk areas detailed in section 4 (Scope)
specific to this operating plan. The overall management strategy will inform individual study plans and should
include the due diligence process which will be carried out by the organisation to mitigate risk in each case. A
flow diagram could be included if appropriate.
9.
Internal Verification
Provide details of the organisation’s internal verification procedure, to ensure that the Operating Plan is:
(1) appropriate in each case; and
(2) being complied with.
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July 2015
10. Redirection of Imported Compounds/Substances
Substances/compounds will be released to the organisation which owns the Operating Plan (or their
representative, who holds a copy of the letter of approval). If substance/compounds are to be released to other
sites under control of the Operating Plan, list the company names and addresses here.
11. Statement of Intended Conformity
The organisation must comply with the following:
I confirm that:

All substances or compounds will be notified to MPI before use, either as part of the operating plan
application or as a subsequent notification.

The organisation assures MPI that it will conduct internal audits of the operating plan and associated
procedures as described in Section 9, and will take appropriate actions in order to ensure compliance.

The organisation assures its co-operation with MPI for any compliance monitoring undertaken by MPI
to confirm that the organisation is complying with the approved operating plan.

An amended operating plan for MPI approval under section 28 of the ACVM Act 1997 will be submitted
before the organisation implements any variation to the scope or procedures approved in this operating
plan.

No research, testing, training or teaching activities using substances prohibited under Regulation 4 of
the ACVM (E & PS) Regulations 2011 will be conducted under this operating plan.

All materials imported under the conditions of the Operating Plan will only be used in accordance with
the conditions of the plan.
Name
Tel
Job title
Fax
Signature
Email
Date
12 Applicant Statement
I confirm that:

I am authorised to make this application as a person with legal authority to act on behalf of the Company in
section A1; and

the information supplied in and with this application is truthful and accurate to the best of my knowledge.
Tel
Name
Email
Signature
Date
AC-AFT-138-3.3
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July 2015
12.
MPI Service Charge
ON PAYMENT THIS BECOMES A TAX INVOICE
GST No: 64-558-838
APPLICATION FEE: $178.25 (incl GST) initial payment. Any additional time required (over one hour) will be billed at the rate of $178.25
(incl GST)/hour.
PAYMENT OPTIONS:
Payments comprising multiple fees must be supported by a remittance advice. Please attach your advice to this application or send it
separately to: MPI Approvals, PO Box 2625, Wellington 6140.
MPI does not accept cash. Payment must be made using one of the following methods. Please mark your choice with an X and fill in the
appropriate section.
APPROVED CREDITOR
DIRECT CREDIT:
1.
Pay into Bank Account no. 03 0049 0001709 002
2.
In the ‘Reference’ details, put the code: RTTOP
3.
Enter the date of deposit and the payee name on this form below:
Date of Deposit
Payee Name
CHEQUE:
1.
Make the cheque payable to Ministry of Primary Industries.
2.
Attach the cheque to this application.
CREDIT CARD:
1.
Choose the type of card you wish to use (delete one):
2.
Fill in the card details below:
VISA
MasterCard
Card No:
Name on Card
Expiry Date
Signature
Collection of Information
Collection of Personal Information
Pursuant to Principle 3 of the Privacy Act 1993, we advise that:

This information is being collected for the purpose of approving an operating plan under section 28 of the ACVM Act 1997; and

The recipient of this information, which is the agency that will collect and hold the information, is the Ministry for Primary
Industries, PO Box 2526, Wellington 6140; and

The information collected will be held on file by MPI; and

The collection of information is authorised under section 10 of the ACVM Act; and

The supply of this information is voluntary; and

Failure to provide the requested information is likely to result in MPI being unable to approve an operating plan under section 28
of the ACVM Act; and

Under Principles 6 and 7 of the Privacy Act 1993, you have the right of access to, and correction of, any personal information
that you have provided.
Collection of Official Information
All information provided to the Ministry for Primary Industries is official information and may be subject to a request made under
the Official Information Act 1982.
If a request is made under that Act for information you have provided in this application, the Ministry for Primary Industries will
consider any such request, taking into account its obligations under the Official Information Act 1982 and any other applicable
legislation.
AC-AFT-138-3.3
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July 2015
Appendix 1
Individual Study Plans
Each research, testing, teaching or training activity must have an individual study plan which must include details
of use and state how risk areas will be defined and managed. These plans should contain the types of information
given in the box below.
Each plan must be available for audit if required.
For common processes the plans may reference the organisation’s standard operating procedures.

Study plan title and/or number

Operating plan reference number

Objective(s)

Substance or compound formulation name and ingredients (in sufficient detail to support risk management
decisions appropriate for the activity)

Anticipated start date of the use

Anticipated duration of the use

Amount of substance or compound to be used

Justification for the amount of the substance/compound (based on details of use)

Details of animal species, plant species used (host and target species if appropriate)

Details of use (size/crop area/animal number, application or dose methods, rates, numbers and timings)

Location information




Location of sites, laboratories etc
Reasons for selecting the locations
How access to the locations are restricted and how visitors will be authorised
Measures to be implemented to ensure that all sites and locations are free from residues that might compromise
further use

How any residues in plant or animal material will be managed (such as destruction of produce from treated
animals/plants, provisional registration or approval in special circumstances)

Personnel



Security of substance or compound







People/positions who are authorised to handle and use these compounds
People/positions who are at the sites where substance/compound will be stored
Processes for transport/supply/dispensing to specified persons/tracking/disposal
Directions for preparation, application, calibration of substance and cleaning of equipment
Directions for disposal of excess stock of the substance or compound
Processes to prevent diversion/misuse of the substance or compound
Statutory clearances or approvals





Study director(s)
Names of other personnel involved and their responsibilities
Details of the HSNO approval for the use of the substance or compound
Details of the biosecurity clearance if the substance or compound contains any imported ingredient originating from
an organism (such as plant, animal, fungus etc)
Details of Animal Ethics Committee approval for trials involving animals
Details of approval from the Ministry of Health if the trial involves prescription or restricted medicines as defined in the
Medicines Act 1981
Emergency response plan detailing how emergencies that may result in breaches to the risk areas managed
under the ACVM Act will be handled.
AC-AFT-138-3.3
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July 2015
Appendix 2
Template for notification of a new substance or compound not previously
notified
(To be sent on the organisation’s letterhead by the person named as the contact on the approved operating plan)
Date
Approvals Operations Group
Regulation and Assurance Branch
Ministry for Primary Industries
PO Box 2526
Wellington 6140
(approvals@mpi.govt.nz)
Notification of Use of Agricultural Compounds on Animals or Plants
[Operating Plan Title and Number]
As required by the operating plan cited above, we advise MPI of our intention to conduct a research, testing,
training or teaching activity that will involve the administration/application of the following substance/compound not
currently included in the scope of the approved operating plan. This compound has not been subsequently notified
to MPI.
Name of the Substance/Compound: [Name]
Formulation:
Ingredient
CAS Number
Amount (g/L or g/kg)
I confirm that the research, testing, training or teaching activity will be conducted according to the approved
operating plan referred to above.
Signature
(Contact person named in the operating plan)
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