application form: hs3 import or manufacture any hazardous ......either wooden doc 200 boxes (without...

To submit an application, please send by post to: Environmental Protection Authority, Private Bag 63002,

Wellington 6140

OR email to: [email protected]

Payment must accompany application: see our fees and charges schedule for details. Please allow 10 working days for

processing.

Application Form: HS3 Import or Manufacture any Hazardous Substance in Containment under section 31 of the Hazardous Substances and New Organisms Act 1996

www.epa.govt.nz

APPLICATION FORM CONTAINMENT

Applicant:

Department of Conservation

Name of substance:

Encapsulated PAPP mustelid bait

APPLICANT CHECKLIST

Mandatory sections filled out Appendices enclosed

Initial fees enclosed Signed and dated

Electronic copy of application emailed to EPA

Office use only

Application code:

Date received:

EPA contact:

Initial fees paid: $

Application version no.:

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Application Form: Import or Manufacture any Hazardous Substance in Containment

April 2013 EPA0100

Important

1. You can talk to an applications advisor at the EPA, who can help you scope and prepare your application.

We need all relevant information early on in the application process. Quality information up front will speed

up the process.

2. This application form may be used to seek approvals for more than one hazardous substance where the

substances are related – for example, a concentrated compound (active ingredient) and its related

formulations, or a range of substances for similar purposes to be tested in a field trial.

3. Any extra material that does not fit in the application form must be clearly labelled, cross-referenced, and

included in an appendix to the application form.

4. Commercially sensitive information must be collated in a separate appendix.

5. Unless otherwise indicated, all sections of this form must be completed for the application to be

progressed.

6. You can get more information at any time by contacting us. One of our staff members will be able to help

you.

Environmental Protection Authority

Private Bag 63002

Wellington

New Zealand

Telephone: 64 4 916 2426

Facsimile: 64 4 914 0433

Email: [email protected]

http://www.epa.govt.nz

mailto:[email protected]://www.epa.govt.nz/

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April 2013 EPA0100

Section 1 – Applicant details

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

Name: Department of Conservation

Address:

Phone:

Fax:

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

Address:

1.3 Name of the contact person for the application:

This person should have sufficient knowledge to respond to queries and either have the authority to make

decisions that relate to processing the application on behalf of the applicant, or have the ability to go to the

appropriate authority.

Name:

Position:

Address:

Phone:

Fax:

Email:

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April 2013 EPA0100

Section 2 – Application type and related approvals required

This form is only for an application to import a hazardous substance into containment, or manufacture a hazardous

substance in containment.

2.1 Is this application to manufacture or import a hazardous substance in containment for any of the

following purposes?

Containment applications can only be made for a limited range of purposes. In particular, the substance must not

be intended for commercial manufacture or sale.

Small amounts of any hazardous substance for use as an analytical standard, where approval to

import or manufacture that substance has been declined? Yes No

Research on any hazardous substance to acquire information for use in assessing that substance

for a HSNO approval? Yes No

Research and development on any hazardous substance? Yes No

Use in an emergency? Yes No

Formulating, relabelling, repackaging, or storing any hazardous substance for export to a destination

outside New Zealand? Yes No

Other purposes? Yes No

2.2 If you answered ‘yes’ to one of the purposes listed above, please provide some supporting detail. If

you answered ‘yes’ to ‘other purpose’, describe the purpose and explain why this purpose is

appropriate to a containment application.

The purpose of this application is to allow for field trials of a potential vertebrate toxic bait containing PAPP (4-

aminopropiophenone) as the active ingredient on stoats. The efficacy data will be used to register this formulation

for use on stoats in New Zealand. The baits will be trialled at two field trial sites by researchers with a Controlled

Substances Licence. Dr Murphy, the applicant, has previously undertaken containment trials on stoats with PAPP

formulations (HSC100058:CONN77; HSC100149; HSC100174) and ferrets (HSC100058: CONN06 & CONN54) in

secure captive facilities and in the field.

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April 2013 EPA0100

2.3 Is the information in this application relevant to import, manufacture or both?

Import the substance(s) only? Yes No

Manufacture the substance(s) only? Yes No

Import and manufacture the substance(s)? Yes No

If import only, indicate whether or not manufacture is likely in New Zealand: Yes No

The active (PAPP) is imported into New Zealand by Connovation Ltd and manufactured by Connovation Ltd into an

encapsulated formulation

2.4 If the information in the application relates to manufacture of the substance(s) in New Zealand,

provide information on the proposed manufacturing process and any alternatives.

The bait formulation identified as ‘Encapsulated PAPP mustelid bait’, will be manufactured by Connovation Ltd

(Confidential recipe will be forwarded on request). Baits will be stored securely & frozen until dispatch and

subsequent use.

2.5 If this substance(s) needs an approval under any other legislation, has an application for this

approval been made?

(Optional)

Name of approval Application made

Agricultural Compounds and Veterinary Medicines Act 1997 Yes No NA

Food Act 1981 Yes No NA

Medicines Act 1981 Yes No NA

Chemical Weapons (Prohibition) Act 1996 Yes No NA

Radiation Protection Act 1965 Yes No NA

Biosecurity Act 1993 Yes No NA

Resource Management Act 1991 Yes No NA

Other (please specify):

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April 2013 EPA0100

Yes No

Section 3 – Information on the substance(s)

3.1 State the unequivocal identification of the substance(s).

Recipe for ‘Encapsulated PAPP stoat bait’ will be forwarded by Connovation Ltd. on request

Active Ingredient Chemical Name (CAS or IUPAC name): 4-aminopropiophenone Common Name: Para-aminopropiophenone Synonyms: 1,4 para-aminopropiophenone, 1-propanone, 1-4 aminophenyl, 4-aminopropiophenone Trade Names : PAPP CAS Registry Number: 70-69-9 Molecular Formula: C9H11NO Structural Formula:

Purity: >98%

3.2 Provide information on the chemical and physical properties of the substance(s).

Physical properties of PAPP. Characteristic Value

Molecular Weight 149.19

Molecular Formula C9H11NO

Colour Yellow

Physical State Crystals

pka 3.19

Solubility in Water Soluble. Solubility may increase significantly at lower pH. 352 mg/L at 37°C

Log n-octanol/water partition coefficient

1.43- 1.25

Melting Point 140 C

Boiling Point 482 C ( Chem Abs: 305 C)

Vapour Pressure at STP 8.05 * 10-4 Torr @Temp: 25.0 °C

Related Compounds The hydrochloride - (C9H11NOHCl);

The sulfate - (C9H11NOH2SO4)

Synthesis React propionyl chloride on aniline in carbon disulphide in the presence of aluminum chloride.

(Chemical Abstracts, 2003; Baskin and Fricke 1992; Meyland and Howard 1995; Newsome et al 1987; Karabunarliev et al 1996; Yalkowsky and Dannenfelser 1992)

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April 2013 EPA0100

High purity PAPP Melting point 140°C is available as a light yellow crystal. PAPP is prepared by the action of propionyl chloride on aniline in carbon bisulfide in the presence of aluminium chloride.

3.3 Provide information on the hazardous properties of the substance(s).

PAPP has 6.1B (oral) and 6.9A, 9.1D and 9.3A HSNO classifications.

It is intended to insert 120 mg PAPP active that has been encapsulated into c.1 mm diameter granules, into 18 g

meat baits which would result in 0.67% PAPP active/bait.

3.4 Provide information on what will happen to the substance throughout its whole life, from its

introduction into New Zealand, its uses, through to disposal.

Manufacture The encapsulated PAPP bait is to be manufactured at the Connovation Limited premises located at 36B Sir William Ave East Tamaki. This is a secure facility and the bait products will be made and stored in the secure laboratory within the facility, under the control of a person with an appropriate Approved Handler certificate for substances that are highly toxic and used as Vertebrate Toxic Agents. The baits will be packaged in secure labelled containers that include product information and a Material Safety Data Sheet (MSDS) will be available.

Transportation The transportation of the PAPP baits off-site to the analytical laboratory or study supervisor, and then to the study site will be in secure tamper resistant labelled containers within a Dangerous Goods Management box in accordance with all Land Transport Rules (NZS 5433:2012).

Analytical studies Analyses of the PAPP baits will be undertaken at the Toxicology Laboratory, Landcare Research, Lincoln. Stoat field trials An animal ethics application to undertake the field trials has been approved by the Department of Conservation Animal Ethics Committee. An application for provisional registration will also be made to the ACVM Group. Two field trials will be undertaken. Field sites will be about 1000-ha in size and stoats will be monitored using tracking tunnels and trail cameras. We aim to target a sample size of up to 20 stoats per field trial. A maximum of 100 bait stations will be used at each field site. The bait stations will be of a type approved by the compulsory performance standard in the DOC Perfomance Standard Pesticide Use #123 – PredaSTOP paste for stoats – either wooden DOC 200 boxes (without traps), or tracking tunnels as used by Dilks et al. 2011. They will either be on an approximate 400-m by 400-m grid or follow DOC best practice for stoat control using traps - no further than 800-m apart and placed up to 200-m apart on lines. One encapsulated PAPP bait will be placed in each bait station. Baits will be checked at least weekly and replaced if missing. It is intended to leave baits in the bait stations for four weeks to test efficacy & longevity.

Dilks P., Shapiro L., Greene T., Kavermann M.J., Eason C.T., Murphy E.C. 2011. Field evaluation of para-aminopropiophenone (PAPP) for controlling stoats (Mustela erminea) in New Zealand. NZ J Zoology 38:1–8.

Disposal All unused bait, packaging or other contaminated material will be disposed as hazardous waste by a commercial waste management company. Any dead stoats or non-target animals found in the operational area will be collected and sent for residue testing.

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April 2013 EPA0100

3.5 Provide information on the quantity of the substance proposed to be imported or manufactured.

Up to 500 baits will be required for each trial, adding up to a maximum of 18 kg of the PAPP baits for both trials – containing 120 g of PAPP active in total.

Section 4 – Information on the proposed containment system

4.1 Provide information on the proposed containment system.

OPERATION CONTAINMENT MEASURES

Bait Manufacture The active ingredient, PAPP, will be stored in a locked poisons

store at Connovation Ltd.

Manufacture of the PAPP baits will be in a secure laboratory

within an enclosed building with security coded entry at

Connovation Ltd.

The PAPP baits will be packaged into labelled sealed containers

and frozen until use in a secure laboratory

The PAPP baits will be held at Connovation until required for

analysis and for transport to the study site.

At the research facility, boots and gloves are to be worn to

prevent skin contact. Those persons involved in the trial will be

familiar with the trial outline, and the Safety Data Sheet will be

available

Transportation Transportation to the analytical laboratory will be by Dangerous

Goods Courier with the sealed containers and packages to be

labelled in accordance with Land Transport regulations.

PAPP analysis Analyses of the PAPP baits will be undertaken at the Toxicology

Laboratory, Landcare Research, Lincoln.

Stoat field trials Baits will be presented in a tunnel style bait station to stoats.

Baits will be checked at least weekly for consumption and

replaced if taken.

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April 2013 EPA0100

Disposal All unused bait, packaging or other contaminated material will

be disposed as hazardous waste by a commercial waste

management company.

Any dead stoats found will be collected and analysed for

residues by Landcare Research, Lincoln.

Section 5 – Identification and assessment of risks

5.1 Identify all of the risks of the substance(s).

Environment

PAPP baits will be stored in a secure laboratory until required for the field study. There is a very low risk of spillage, or for off-site contamination

Transport is to be in sealed tamper resistant labelled containers. The PAPP baits will be under the control of an Approved Handler when manufactured and when to be used.

The baits will be delivered in a tunnel to exclude non-target species, following the DOC compulsory standard - Performance Standard 123: PredaSTOP for stoats.

All unused PAPP bait will be removed from the study site and disposed as hazardous waste by a commercial waste management company.

Adverse effects could potentially arise from accidental spillage of the bait and contact with non-target vertebrates. In the event of any spillage, the paste would be mopped up or scraped up into a sealable labelled container for disposal.

It is considered that any potential risks to the environment and non-target species from this trial are very limited.

Occupational Exposure & Poisoning risk Appropriate personal protective equipment will be worn during manufacture of the PAPP baits as required for the Connovation Standard Operating Procedures and Health and Safety System. Gloves, dust mask and lab coat will be worn at all times during manufacture to avoid skin contact with raw materials or the final products. A Safety Data Sheet will be available.

Those persons involved in the trial will have a trial outline, copy of the Containment Controls, and Safety Data Sheet at hand.

5.2 Provide an assessment of the potential risks identified in Section 5.1.

No significant risks have been identified.

Section 6 – International considerations

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April 2013 EPA0100

6.1 The EPA is interested in whether this substance (or any of its components) has been considered by

any other regulatory authority in New Zealand, or by any other country. If you are aware of this,

please provide details of the results of such consideration.

(Optional)

Manufacture of PAPP baits does not contravene any of New Zealand’s international obligations. Animal welfare

obligations are met through an Animal Ethics Approval for the study and compliance with any conditions.

PAPP development in NZ is part of an international programme involving the Department of Conservation and

Connovation Ltd in NZ and Animal Control Technologies (Australia) Pty Ltd. The aim is to provide more humane

safer pest control on an international scale.

Products containing PAPP have been approved for use by the EPA for stoats and feral cats in 2011 under the

product name PredaSTOP, and the APVMA (Australia) in 2016 under the product names DOGABAIT and

FOXECUTE.

Section 7 – Miscellaneous

7.1 Provide a glossary of scientific and technical terms used in the application.

7.2 Provide here any other information you consider relevant to this application that is not already

included.

A encapsulated PAPP bait is being developed by DOC and Connovation Ltd to protect native endangered species that are attacked by stoats and ferrets. PAPP in the form of PredaSTOP paste is registered for stoat control, however the PredaSTOP paste is not palatable to ferrets. Having a bait that controls both stoats and ferrets would be a valuable additional pest control tool. This research hopes to lead to encapsulated PAPP being registered in a ready-made bait for use in bait stations. If the bait is effective, future trials will investigate its use for aerial delivery. PAPP was originally researched in Europe and the USA as treatment for cyanide and radiation poisoning. PAPP has been developed specifically for the control of stoats and feral cats because of the special sensitivity displayed by these species (Eason et al. 2014). Its toxicity is mediated by the induction of methaemoglobinaemia (the ferric state of haemoglobin). Normally, methaemoglobin levels in the blood are below 1%. Levels of methaemoglobin in the blood above 70% are usually fatal, creating a lethal deficit of oxygen in cardiac muscle and the brain. In stoats and feral cats, death after a lethal dose usually occurs within 2 hours after eating bait, with clinical signs first appearing in 10 to 20 minutes for stoats and at around 35 minutes for cats. Animals become lethargic and sleepy before they die, hence PAPP is relatively humane. A simple antidote exists, namely methylene blue. Further, birds display a lack of toxicity to PAPP when compared to other vertebrate pesticides. Eason, C.T, Miller, A. MacMorran, D.B., Murphy, E.C. 2014. Toxicology and ecotoxicology of para-

aminopropiophenone (PAPP) – a new predator control tool for stoats and feral cats in New Zealand. New Zealand Journal of Ecology 38(2): 177–188.

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April 2013 EPA0100

Section 8 – Summary of public information

8.1 Name of the substance(s) for the public register:

Please use a maximum of 80 characters.

Encapsulated PAPP mustelid bait

8.2 Purpose of the application for the public register:

This should include an abstract (in a maximum of 255 characters) giving information on the intended use of the

substance and why an application is needed, based on its hazardous properties.

To manufacture into containment minced meat baits containing encapsulated PAPP granules, as a Vertebrate

Toxic Agent, to undertake field trials on stoats.

8.3 Use categories of the substance(s):

The EPA has adopted the system of use categories developed by the European Union, which identify various

functional uses of substances. This information is pertinent to the assessment of exposure scenarios and the

determination of risk, and is also useful for building up a profile of the substance. There are three sets of use

categories. Within each of these, applicants should state which use categories are relevant to all intended uses of

the substance(s).

1. Main category: There are four main categories.

2. Industry category: There are 16 industry categories.

3. Function/Use category: There are 55 function/use categories.

(Optional)

Main Category : Non dispersive

Industry category: 0 Other

Function/Use category: Pesticide, non agricultural [Pest Control]

8.4 Executive summary:

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April 2013 EPA0100

Stoats are one of the biggest threats to New Zealand’s native birds. They are fierce hunters, often killing prey larger than themselves. They are excellent climbers and strong swimmers, and are found in most habitat types. Landscape control of stoats is needed to protect a wide range of threatened species, including kiwi and kea. Para-aminopropiophenone (PAPP) is being developed as a humane toxin in New Zealand to protect native endangered species that are attacked by predators. The toxic effects of PAPP are related to the reduction of oxygen supply to the brain. Stoats become lethargic, sleepy and unconscious prior to death. PAPP in raw minced meat baits was registered for stoat control in 2011, however the baits are messy to make and deteriorate quickly. A ready-made sausage meat bait containing encapsulated PAPP has been developed that would be suitable for use in bait stations. Field trials are planned to test the efficacy of this bait on stoats. The active will be manufactured by Connovation Ltd at their Auckland site. The hazardous classifications for the meat baits containing encapsulated PAPP arise from the active PAPP. All other ingredients are non-hazardous. Samples will be required to be assessed at an external laboratory. The encapsulated PAPP will be under the control of an Approved Handler unless otherwise locked up. Those persons involved in the studies are experienced in handling VTA products. Personal protection equipment will be worn; Safety Data Sheets will be available as will documentation for the controls for use of the products. All unused encapsulated PAPP bait and packaging, and any dead stoats, will be disposed of by a commercial waste management company. It is considered that any potential risks to the environment and non-target species from this trial are very limited.

Signature Date

15 November 2018

application form: hs3 import or manufacture any hazardous ......either wooden doc 200 boxes (without...

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