Application form_pesticides_new …€¦ · Web viewUse this form to apply for the import or manufacture of pesticides to be released in New Zealand under section 28 of the Hazardous

Import or manufacture a pesticideApplication formAugust 2020

Name of substance:

Date:

Please use the accompanying document Import or manufacture a pesticide: Guide to completing the application form.

Hazardous Substances and New Organisms Act 1996 (HSNO Act)

Use this form to apply for the import or manufacture of pesticides to be released in New Zealand under section 28 of the Hazardous Substances and New Organisms Act 1996 (HSNO Act).

Use a different form to make an application for:

another type of substance (such as a veterinary medicine or industrial chemical)

another type of application (such as emergency, special emergency or containment).

All forms are available on our website.

Health and Safety at Work Act 2015 (HSWA)

WorkSafe New Zealand (WorkSafe) may be consulted regarding the management of risks to human health from the use of hazardous substances, as WorkSafe is the regulator for the purposes of the Health and Safety at Work Act 2015 (HSWA). Under section 30(1)(a) of HSWA, the Person Conducting a Business or Undertaking (PCBU) must eliminate risks to health and safety so far as reasonably practicable. If this is not reasonably practicable, the PCBU must minimise the risks so far as is reasonably practicable. Risks are to be minimised following the hierarchy of controls set out in regulation 6 of the Health and Safety at Work (General Risk and Workplace Management) Regulations 2016. Here is a link to WorkSafe’s website regarding hazardous substances risks in a workplace and the hierarchy of controls: WorkSafe - Risk management.

Release of information

The Environmental Protection Authority (EPA) will use the information you provide in this form to consider your application. This form will be made publicly available on the EPA database, however we will redact personal information and any commercially sensitive information. Please contact us if you would like to discuss this.

Information you provide in this application form is subject to potential disclosure under the Official Information Act 1982 (OIA). Commercially sensitive information must be marked as such, and may be withheld in the event of an OIA request, if permitted by the OIA. Further information on the OIA is available at www.ombudsman.parliament.nz/.

Privacy

You have the right to access and correct any personal information the EPA holds under the Privacy Act 1993.

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http://www.ombudsman.parliament.nz/

https://worksafe.govt.nz/topic-and-industry/hazardous-substances/managing/risk-management/

Import or manufacture a pesticideApplication Form

August 2020 |

Information provided as part of this application is collected by the EPA for the purpose of administering the issue and management of applications. This includes informing the public of applications. We may also contact you for feedback on the application process using a third party provider.

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Send your application to the EPA Hazardous Substances Applications team:

preferably by email to: [email protected]

or by post to: Environmental Protection Authority, Private Bag 63002, Wellington 6140

You will be invoiced once the application is received (lodgement fee). You will receive a second invoice once the application pathway is determined.

See our website for information about fees and charges

For advice on preparing your application, please contact one of our applications advisors:

by email: [email protected]

Freephone (within New Zealand): 0800 2255 372 (0800 CALL EPA)

mailto:[email protected]

https://www.epa.govt.nz/applications-and-permits/fees-and-charges/

mailto:[email protected]


August 2020 | EPA0316

Section 1. Applicant details

1.

1.1. Name and contact details of applicant

Name:

New Zealand Business Number (NZBN):(if applicable)

Contact name:

Job title:

Postal address:

Phone:

Email:

1.2. Contact person details

All correspondence will be sent to the contact person identified here.

Company name:

New Zealand Business Number:(NZBN): (if applicable)

Contact name:

Job title:

Postal address:

Phone:

Email:

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August 2020 |

1.3. Invoice contact

Only fill in if the contact person is different from 1.2 – invoice will be sent to the contact person identified here.

Company name:

New Zealand Business Number:(NZBN): (if applicable)

Contact name:

Job title:

Postal address:

Phone:

Email:

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Section 2. General information

2.

2.1. Range of uses (tick one)

Domestic ☐ Professional ☐

2.2. Biopesticides (tick one)

Biopesticide ☐ Not a biopesticide ☐

2.3. Executive summary

2.4. History of EPA applications

If not applicable, please write N/A.

SOS reference number:

S26 application number (APPXXXXXX):

Containment approval number (HSCXXXXXX):

Application for release approval number (APPXXXXXX):

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August 2020 |

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Section 3. ScenarioThe numbers in italics refer to Annex I and II of the guide to completing an application form

3.

3.1. New substance containing at least one new active ingredient to New Zealand

o First approval worldwide (1) ☐ (complete all sections of the form).

o Active ingredient(s) already approved elsewhere (1) ☐ (complete all sections of the form).

If you tick any box above, go to section 4. If no, go to section 3.2.

3.2. New substance containing only active ingredient(s) already approved in New Zealand

New conditions (2): o new uses ☐

o new application method ☐

o higher application rates ☐

(Complete all sections except s8)

New formulation (3): o new mixture of active ingredients ☐

o new concentration of active ingredient(s) ☐

(Complete all sections except s8)

New version of an existing substance from the same company (4): o composition change ☐

o new data leading to a change of classification ☐Name of the existing substance:

Approval number of the existing substance:

(Complete all sections except s7 and s8)

Generic substance (5)o generic ☐

Name of reference substance (already approved substance):

Approval number of reference substance (already approved substance):

(Complete all sections except s7 and s8)

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August 2020 |

Section 4. Identity of the active ingredient(s)

4.

4.1. Active ingredient number one

Active ingredient (Common name):

Chemical name (IUPAC):

Molecular formula:

Structural formula:

Manufacturer development codes:

CIPAC No:

CAS No:

Function:

☐Herbicide ☐Fungicide ☐Insecticide

☐ Other, eg plant growth regulators (specify):

Pending approval(s) in other jurisdictions:

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August 2020 |

4.2. Active ingredient number two



Molecular formula:

Structural formula:


CIPAC No:

CAS No:

Function:



Pending approval(s):

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4.3. Active ingredient number three



Molecular formula:

Structural formula:


CIPAC No:

CAS No:

Function:




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August 2020 |

4.4. Active ingredient number four



Molecular formula:

Structural formula:


CIPAC No:

CAS No:

Function:


☐ Other, eg, plant growth regulators (specify):


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Section 5. Substance description

5.

5.1. Formulation

Formulated substance name:

Formulation type (CropLife International code): |_|_|

Manufacturer development code(s):

Density:

5.2. Active ingredient(s) and content

Active ingredient(s) Concentration Units (g/L or g/kg)

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a) Active ingredient name Pure ai concentration

Unitsb) If applicable, name of the active ingredient expressed in its acid, salt, ester

formPure ai concentration

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3




4



form…Pure ai concentration

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August 2020 |

5.3. Regulatory status of the formulated substance

JurisdictionRegulatory status

Comment*Never approved Pending Approved Restricted Not

renewed

Australia ☐ ☐ ☐ ☐ ☐Canada ☐ ☐ ☐ ☐ ☐Europe ☐ ☐ ☐ ☐ ☐Japan ☐ ☐ ☐ ☐ ☐USA ☐ ☐ ☐ ☐ ☐Other jurisdictions

(specify in

comments)

☐ ☐ ☐ ☐ ☐

*For instance, specify here under which regulation(s) or directive(s).

Section 6. Life cycle of the substance

6.

6.1. Transport

Will your formulated substance be transported by road, rail, air and/or sea within New Zealand?

Road ☐Sea ☐Rail ☐ Air ☐

Please provide any additional information relating to transport of your formulated substance

UN Number

UN Transport Hazard Classes

UN Packing Group Number

Marine Pollutant? (IMDG code)

6.2. Packaging

Type of packaging and nature of packaging material:

Pack sizes:

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Type of closure (consider opening size, type of cap, child resistant packaging):

Mixing/loading: ready-to-use ☐ mixing/loading ☐Please provide any additional information relating to the packaging of your formulated substance:

6.3. Storage

Provide details of how the substance will be stored, and the facilities (including warehouse storage) it will be stored in:

6.4. Disposal

Disposal of damaged packaging, contaminated absorbents and other materials:

Detailed instructions for safe disposal of the formulated substance and its packaging:

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Section 7. Intended uses of the formulated substance

7.1. GAP Table for plant protection products

Crop and/or situation (a)

F G or I (b)

Pest or group of pests

controlled (c)

Application Application rate per treatment PHI (days)

(l)

Remarks

Method kind (f-h)

Growth stage and season

(j)

Numbermin max

(k)

Interval between

applications (min)

Kg ai/hLmin max

Water L/ha min

max

Kg ai/hamin max

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(a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (eg fumigation of a structure)

(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) eg biting and suckling insects, soil borne insects, foliar fungi, weeds(f) All abbreviations used must be explained(g) Method, eg high volume spraying, low volume spraying, spreading, dusting, drench(h) Kind, eg overall, broadcast, aerial spraying, row, individual plant, between the plants - type of

equipment used must be described

(i) g/kg or g/l(j) Growth stage at first and at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, season at time of application(k) The minimum and maximum number of applications possible under practical conditions of use

must be provided(l) PHI - – minimum pre-harvest interval

Additional comments

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7.2. GAP Table for pesticides not used as plant protection products

User (a)

Area of Use (b)

Pest or group of pests controlled

(c)

Application Application rate per treatment

(f)

Remarks (g)

Method (d)

Number min max (e)

Interval between applications – days

(minimum)

(a) Professional/non-professional(b) Domestic/commercial/industrial(c) e.g. biting and suckling insects, soil borne insects, foliar fungi, weeds(d) Method, eg aerosol, automatic dispenser, hose-on, knapsack etc

(e) The minimum and maximum number of applications possible under practical conditions of use must be provided

(f) g/kg and g/l or others

Additional comments

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Section 8. HSNO hazard classification of the active ingredient(s) Only complete this section for new active ingredients [scenario (1)].

8.1. Active ingredient number one

Hazard Class/Subclass Classification Justification

Examples 6.1D LD50 = 1250 mg/kg (rat)

Physical/Chemical properties

Class 1

Explosiveness

Class 2, 3 & 4

Flammability

Class 5

Oxidisers/Organic Peroxides

Subclass 8.1

Metallic corrosiveness

Toxic properties

Subclass 6.1 Acute toxicity

Oral

Dermal

Inhalation

Aspiration hazard

Subclass 6.3/8.2

Skin irritancy/corrosion

Subclass 6.4/8.3

Eye irritancy/corrosion

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Subclass 6.5A

Respiratory sensitisation

Subclass 6.5B

Contact sensitisation

Subclass 6.6

Mutagenicity

Subclass 6.7

Carcinogenicity

Subclass 6.8

Reproductive or developmental toxicity

Subclass 6.8

Reproductive or developmental toxicity (via lactation)

Subclass 6.9

Target organ systemic toxicity

Oral

Dermal

Inhalation

Ecotoxic properties

Subclass 9.1

Aquatic ecotoxicity

Subclass 9.2

Soil ecotoxicity

Subclass 9.3

Terrestrial vertebrate ecotoxicity

Subclass 9.4

Terrestrial invertebrate ecotoxicity

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8.2. Active ingredient number two




Class 1

Explosiveness

Class 2, 3 & 4

Flammability

Class 5


Subclass 8.1


Toxic properties


Oral

Dermal

inhalation

Aspiration hazard

Subclass 6.3/8.2


Subclass 6.4/8.3


Subclass 6.5A


Subclass 6.5B

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Subclass 6.6

Mutagenicity

Subclass 6.7

Carcinogenicity

Subclass 6.8


Subclass 6.8


Subclass 6.9


Oral

Dermal

inhalation

Ecotoxic properties

Subclass 9.1

Aquatic ecotoxicity

Subclass 9.2

Soil ecotoxicity

Subclass 9.3


Subclass 9.4


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8.3. Active ingredient number three




Class 1

Explosiveness

Class 2, 3 & 4

Flammability

Class 5


Subclass 8.1


Toxic properties


Oral

Dermal

Inhalation

Aspiration hazard

Subclass 6.3/8.2


Subclass 6.4/8.3


Subclass 6.5A


Subclass 6.5B

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Subclass 6.6

Mutagenicity

Subclass 6.7

Carcinogenicity

Subclass 6.8


Subclass 6.8


Subclass 6.9


Oral

Dermal

Inhalation

Ecotoxic properties

Subclass 9.1

Aquatic ecotoxicity

Subclass 9.2

Soil ecotoxicity

Subclass 9.3


Subclass 9.4


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8.4. Active ingredient number four




Class 1

Explosiveness

Class 2, 3 & 4

Flammability

Class 5


Subclass 8.1


Toxic properties


Oral

Dermal

inhalation

Aspiration hazard

Subclass 6.3/8.2


Subclass 6.4/8.3


Subclass 6.5A


Subclass 6.5B

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Subclass 6.6

Mutagenicity

Subclass 6.7

Carcinogenicity

Subclass 6.8


Subclass 6.8


Subclass 6.9


Oral

Dermal

inhalation

Ecotoxic properties

Subclass 9.1

Aquatic ecotoxicity

Subclass 9.2

Soil ecotoxicity

Subclass 9.3


Subclass 9.4


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Section 9. HSNO hazard classification of the formulated substance


Examples3.1C

6.1D

Flashpoint = 46 deg C (closed cup)

Calculated LD50 = 1250 mg/kg (mixture rules)


Class 1

Explosiveness

Class 2, 3 & 4

Flammability

Class 5


Subclass 8.1


Toxic properties


Oral

Dermal

Inhalation

Aspiration hazard

Subclass 6.3/8.2


Subclass 6.4/8.3


Subclass 6.5A


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Subclass 6.5B


Subclass 6.6

Mutagenicity

Subclass 6.7

Carcinogenicity

Subclass 6.8


Subclass 6.8


Subclass 6.9


Oral

Dermal

Inhalation

Ecotoxic properties

Subclass 9.1

Aquatic ecotoxicity

Subclass 9.2

Soil ecotoxicity

Subclass 9.3


Subclass 9.4


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Section 10. Statutory considerations

10.1. Effects on the environment

Risks linked to the use, disposal and accidental spillage phases.

Other considerations:

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10.2. Effects on public health

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10.3. Effects on the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, wāhi tapu, valued flora and fauna, and other taonga

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10.4. New Zealand’s international obligations

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Signature of applicant or person authorised to sign on behalf of applicant

☐ I am making this application, or am authorised to make this application on behalf of the applicant.

☐ I have completed this application to the best of my ability and, as far as I am aware, the information I have provided in this application form is correct.

Click here to enter date

Signature Date

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Appendix 1. Statutory Declaration for rapid assessment under section 28A of the Act

I Enter name, of Enter address, Enter occupation, being the applicant or authorised agent on behalf of the applicant, solemnly and sincerely declare that the information contained in this application for Enter substance name is true and correct. I make this solemn declaration conscientiously believing the same to be true and by virtue of the Oaths and Declarations Act 1957.

Signature

Declared at Enter location on this Enter day of Enter month, 20 Enter year

Witness signature

Barrister or Solicitor of the High Court of New Zealand[or Justice of the Peace, Notary Public, or other person authorised to take a statutory declaration]

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Documents

Application form_pesticides_new …€¦ · Web viewUse this form to apply for the import or manufacture of pesticides to be released in New Zealand under section 28 of the Hazardous