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Send by post to: Environmental Protection Authority, Private Bag 63002, Wellington 6140 OR email to: HSApplications@epa.govt.nz

Application for a Modified Reassessment

under section 63A of the Hazardous Substances and New Organisms Act 1996

MODIFIED REASSESSMENT

Name of substance(s):

PredaSTOP for stoats containing 410g/kg PAPP (Para-aminopropiophenone)

Applicant:

Connovation Ltd

Date:

30/10/2014

APPLICANT CHECKLIST

Mandatory sections filled out Appendices enclosed Fees enclosed Signed and dated

OFFICE USE ONLY

Application code Date received

EPA contact Initial fees paid $

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1. Applicant details

1.1. Name and postal address in New Zealand of the organisation making the application

Name: Connovation Ltd

Address: 36B Sir William Ave, East Tamaki, Auckland Phone: 09 273 4333

Fax: 09 273 4334

Email: lee@connovation.co.nz

1.2. The applicant’s location address in New Zealand (if different from above)

Name:

Address:

Phone:

Fax:

Email:

1.3. Name of the contact person for the application

Name: Lee Shapiro Position: Research Manager Phone: 0272734342 Fax: 09 2734334

Email: lee@connovation.co.nz

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2. Type of application

2.1. The approvals being reassessed

HSR100494 and HSR100496

2.2. Specific aspect of the approval being reassessed

The requirement for end users to notify any landowner within 3km of a stoat control operation with PredaSTOP

2.3. Grounds for the reassessment

The Decision Making Committee for application APP202060 (“the Committee”) determined that grounds for the modified reassessment of approvals for PredaSTOP exist. The Committee considered that the applicant’s proposal is not minor or technical in effect and that the reasons for the proposed modifications met the criteria set out under the Act and constituted grounds for a reassessment.

In reaching its decisionthe Committee decided:

1) The legislative basis to undertake a modified reassessment is that significant new information relating to the effects of the substances exists.

2) Information showing a significant change of use, or a significant change in the quantity manufactured, imported, or developed has become available.

The Committee had no concerns from a Māori perspective regarding the applicant’s wish to determine whether there are grounds for the modified reassessment of PredaSTOP.

2.4. Consultation

Extensive dialogue with the Department of Conservation (DOC), Regional Councils and pest control contractors has highlighted that the current notifications for PredaSTOP for stoats has effectively made this product unusable.

A considerable amount of funding was provided by DOC for the research and development of PredaSTOP for the control of stoats. Once PredaSTOP was approved for use, a large number of practitioners from DOC, Regional Councils, community groups and private contractors paid to update their Controlled Substance Licences to include PAPP due to the potential for this tool to really boost the ability to control stoats and amplify native species protection. The overwhelming feedback from these practitioners has indicated that by using a stoat specific bait

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station to deliver PredaSTOP to stoats, and removing the 3km notification requirement, would result in widespread uptake and use of this effective tool.

The development of PredaSTOP for stoats, as well as the ongoing research into the extension of its use in a resettable stoat toxin delivery device called the Spitfire, has had extensive input from our Maori advisory group – Nga Matapopore. Connovation Ltd are the key commercial partner in an MBIE funded program run through Lincoln University. As part of the MBIE funded hui on October 9th and 10th 2014 with the Nga Matapopore group, there was a discussion about the impediments to the use of PAPP for ground control. It was discussed how, when we had registered PAPP for ground control in 2011, we thought we had delivered a major new tool for protection of kiwi however conditions imposed by ACVM (MPI) and EPA made PAPP unusable in practise and to date it has not been used in New Zealand. During closing remarks by Nga Matapopore we were encouraged to persevere and overcome these impediments to the use of PAPP for stoat control to enable the use of this much needed tool.

3. Information on the substances

3.1. The unequivocal identification of the substance

Para aminopropiophenone (PAPP)

Synonyms : 1, 4 para-aminopropiophenone 1-propanone, 1-4 aminophenyl 4-aminopropiophenone CAS No: 70-69-9

Formula : C

9

H

11

NO Molecular weight: 149.19

3.2. Information on the chemical, physical and hazardous properties of the substance

Structure: There is a central aromatic ring with an amino group opposite (in the

para position) a propyl-phenone chain. This creates a combination of

both polar and non-polar sections of the molecule.

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Appearance: Light yellow crystalline powder

Melting point: 140°C (100%); 137 – 142°C (98% min.) Boiling point: 482  C

Solubility in water: 352 mg/L @ 37

0

C Log n-octanol/water partition coefficient: 1.43- 1.25

pka: 3.19

Vapour Pressure: 8.05 * 10

-4

torr @ 25.0 °C

pH: 5.15 (as saturated solution, 0.353 g/L) Appearance: Green smooth paste with grainy texture Odour: Nil

Specific gravity: 1.06 – 1.08

pH: Not applicable

3.3. Identification of the controls on the substances

The original EPA decision document on PredaSTOP is attached as Appendix 1 and contains the controls.

3.4. The proposal to modify the approval of the substances

To remove the current control, when using PredaSTOP for stoats, that requires users to notify landowners within 3km of a control operation using this product. To add the control that, when using PredaSTOP for stoats, users must lay baits in a stoat specific bait station.

3.5. Commercial sensitivity

The applicant does not consider that there are any significant issues regarding commercial sensitivity associated with the proposed modifications because the proposal relates to the use pattern of PredaSTOP and its active ingredient PAPP and not to the chemistry and manufacturing information in the original approval that may have commercial sensitivities. The relevant use pattern information is already in the public domain.

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4. Risks, costs and benefits

4.1. Identification of all the effects associated with the reassessment proposal (section 63A(6)(a))

Removal of the notification requirement will enable PredaSTOP for stoats to be used. It is a valuable tool for stoat control that has been rendered useless partly due to the requirement for end users to notify any landowner within 3km of a stoat control operation with PredaSTOP, in many cases this will mean the notification of thousands of households and is not practical or possible. Some currently used stoat traps restrict access to non-target species although there is no requirement to notify neighbouring properties of trapping even if using traps that allow access to cats and may accidentally kill domestic cats. The effect of removing the notification requirement when using PredaSTOP baits for stoats will inhibit access of cats to these baits through a stoat specific bait station and enable the targeted control of stoats with little risk to domestic cats.

4.2. Assessment of the risks associated with the reassessment proposal

The requirement for users to notify landowners within 3km of a control operation using PredaSTOP for stoats was based on the potential risk to domestic cats. The requirement to use a stoat specific bait station that cats cannot access means that this risk becomes negligible and therefore a 3km notification requirement would be unjustified.

The EPA have already evaluated the risks and costs of PAPP paste A and PAPP ready to use bait and determined that they “pose negligible risks to human health and to the environment”.

4.3. Assessment of the costs associated with the reassessment proposal

By using a stoat specific bait station, for the application of PredaSTOP for stoats, end users will be required to purchase/build these stations and will not be able to use existing bait stations that allow access to cats also. This may add cost to these end users for using PredaSTOP for stoats.

4.4. Assessment of the benefits associated with the reassessment proposal

At least 94% of Brown and Great Spotted kiwi chicks (Apteryx mantelli and Apteryx haastii) fail to reach adulthood and predators, chiefly stoats, cause approx. half of these loses (Mclennan et al 1996). Current stoat control relies on labour intensive trapping and secondary poisoning of stoats that scavenge rats that have been killed with 1080 baits. PredaSTOP for stoats is currently the only registered toxin for stoat control in New Zealand and to date it has not been used partly due to the notification requirement. Removing the notification when using PredaSTOP for stoats will allow many practitioners who are already licenced for this product to immediately start wide spread and effective stoat control. The use of a stoat specific bait station will allow the targeted delivery of PredaSTOP and reduce the risk to non-target species.

McLennan, J.A; Potter, M.A.; Robertson, H.A.; Wake, G.C.; Colbourne, R.M.; Dew, L.; Joyce, L.; McCann, A.J.;

Miles, J.; Miller, P.J.; Reid, J. 1996: Role of predation in the decline of kiwi, Apteryx spp., in New Zealand. New Zealand Journal of Ecology 20: 27–35.

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4.5. Assessment of any particular risks, costs and benefits which arise from the relationship of Māori and their culture and traditions with their taonga, or which are, for other reasons, of particular relevance to Māori

When PredaSTOP for stoats was originally assessed by the EPA they determined that with controls in place “it is unlikely that PAPP Paste A or PAPP Ready-to-use Bait could have a significant impact on Māori culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga”. The change to the controls referred to, namely the additional control of use being restricted to a stoat specific bait station and the removal of the notification requirement will enable a significant benefit to taonga species protection- namely kiwi.

The development of PredaSTOP for stoats, as well as the ongoing research into the extension of its use in a resettable toxin delivery device called the Spitfire, has had extensive input from our Maori advisory group – Nga Matapopore. Connovation Ltd are the key commercial partner in an MBIE funded program run through Lincoln University. As part of the MBIE funded hui on October 9th and 10th 2014 with the Nga Matapopore group, there was a discussion about the impediments to the use of PAPP for ground control. It was discussed how, when we had registered PAPP for ground control in 2011, we thought we had delivered a major new tool for protection of kiwi however conditions imposed by ACVM (MPI) and EPA made PAPP unusable in practise and to date it has not been used in New Zealand. During closing remarks by Nga Matapopore we were encouraged to persevere and overcome these impediments to the use of PAPP for stoat control to enable the use of this much needed tool.

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5. International considerations

5.1. The best international practices and standards for the safe management of the substance (section 63A(6)(b))

PAPP is not currently registered for use on stoats in any other country as stoats are very much a New Zealand problem due to our unique fauna and lack of terrestrial mammals apart from bats. Internationally, the restrictions on the use of vertebrate toxic agents (VTA) are tightening with best practice aiming towards more targeted delivery of VTAs. Imposing the control of using a stoat specific bait station will only bring the controls on PredaSTOP further in line with international best practice.

5.2. International obligations and treaties

New Zealand has international obligations regarding welfare and also residues in meat. The VTA products containing PAPP have benefits for both, and assists in our obligations with regards to international biodiversity.

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6. Hazardous substance knowledge

6.1. A glossary of scientific and technical terms used in the application

6.2. Other information considered relevant to this application not already included

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7. Summary of public information

7.1. Name of the substance for the public register

PredaSTOP for stoats containing 410g/kg PAPP (Para-aminopropiophenone)

7.2. Purpose of the application for the public register

To make it a condition that when using PredaSTOP baits for stoats that they must be laid in a stoat specific bait station and to remove the current control that requires users to notify landowners within 3km of a control operation using this product.

7.3. Executive summary

The vertebrate toxic agent PAPP was registered in New Zealand in 2011 for the control of stoats under the trade name PredaSTOP for stoats. This product has yet to be used in part due to the requirement for end users to notify any landowner within 3km of a stoat control operation with PredaSTOP for stoats, in many cases this will mean the notification of thousands of households and is not practical or possible. This restriction was due to the concern of accidental poisoning of domestic cats. The design of a new stoat specific bait station will enable users to target stoats with PredaSTOP baits and exclude access of domestic cats to these baits. The use of this bait station changes the use of the substance by specifically excluding cats and the risk to cats is significantly reduced and therefore we are applying for the notification requirement to be removed.

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8. Applicant’s signature

30/10/2014

Signed Date

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