form hs3: import or manufacture any hazardous substance in … · 2019. 4. 6. · form hs3: import...

Send by post to: Environmental Protection Authority, PO Box 131, 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.

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:

Elanco Animal Health

Name of Substance: This application refers to 2 substances which are very similar and therefore included in the same application.

BK0130 / BK0131

APPLICANT CHECKLIST

Mandatory sections filled out Appendices enclosed

Initial fees Enclosed Signed and dated

Electronic copy of application e-mailed to EPA

Please note that Elanco holds a $50 credit with EPA. A payment to EPA has been made for $525 with the

reference BK0130.

Office Use Only

Application Code:

Date received:

EPA Contact:

Initial Fees Paid: $

Application Version No:

2

Application Form Import or Manufacture any Hazardous Substance in Containment

November 2011 EPA0100

Important

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.

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.

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.

Commercially sensitive information must be collated in a separate Appendix.

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

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

3



Section One – Applicant Details

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

Name: Elanco Animal Health

Address: PO Box 259 354, Botany, Auckland 2163

Phone: 09 523 9324

Fax: 09 271 6881

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

Address: Level 1, 123 Ormiston Road, Botany Junction, Auckland 2016

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

appropriate authority.

Name: Laura Young

Position: Research and Regulatory Manager

Address: As above

Phone: 09 523 9324

Fax: 09 271 6881

Email: [email protected]

4



Section Two – Application Type and Related Approvals Required

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

hazardous substance in containment.

If you are making the application for some other reason, you will need a different form.

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 it is not 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, relabeling, 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 substances are proposed Veterinary medicines which will be manufactured in 2 concentrations and then used

in research studies, to determine the appropriate dose for further clinical field studies.

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

5



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 formulations are an aqueous suspension containing 2 active ingredients. The manufacturing process is a

simple mixing of the excipients and active ingredients to create a homogenised mixture that meets the product

specifications.

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):

Yes No

Yes No

Yes No

6



Section Three – Information on the Substance(s)

Note all information that is commercially sensitive must be attached as an Appendix. The application form should

be cross-referenced to the Appendix but should be able to be read as a stand-alone document which will be

publicly available.

If approval is being sought for more than one hazardous substance, this section must be completed separately for

each hazardous substance.

BK0130:

(spinosad 2.5%, abamectin 3.2%)

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

This section should include all information necessary to unequivocally identify the substance(s) and may include:

Chemical Name (Chemical Abstracts Preferred Index name or IUPAC name)

Common Name

Synonyms

Trade Names

CAS Registry Number

Molecular Formula

Structural Formula

Impurities

For mixtures, in addition to the above information being provided on the actual mixture, information is also required

on the composition of the mixture ie the chemical name, CAS number, function (eg active ingredient, emulsifier,

surfactant, filler) and percentages of ALL components of the mixture (including non-hazardous components and

impurities) should be provided. This information may be best expressed in tabular form. If the composition is

variable, please ensure to state the limits.

If there are commercial reasons for not providing full information in the main part of the form, alternative

approaches must be discussed with and agreed by the EPA. These must include the provision of a unique identifier

of some kind.

The substance is an aqueous suspension (mixture) containing spinosad (2.5%) and abamectin (3.2%).

Mixture formulation details are provided in Appendix 1 (Confidential).

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

Provide as much information as possible on the chemical and physical properties of the substance(s) [at 20°C and

1 atmosphere unless otherwise stated] eg

Appearance (colour, odour, physical state or form)

7



pH

Density

Vapour pressure

Boiling/melting point

Solubility in water

Water/octanol partitioning co-efficient

For mixtures, information is required on the chemical and physical properties of the mixture itself. However, if this

information is not available, you should provide information on the chemical and physical properties of EACH

hazardous component of the mixture.

The mixture is a smooth white to light brown suspension free from lumps. The pH of the mixture is 7.5 –

8.5. Details of the mixture properties are not yet available. An MSDS for hazardous components which are

not listed on the EPA HSNO chemical classification and information database are provided in Appendix 1.

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

Information should be provided on the hazardous properties of the substance(s) known to the applicant. You

should consider each of the six hazardous properties below and provide information on those hazardous

properties. This information is needed in order to assess risks and determine whether or not and how the

substance can be adequately contained.

explosiveness

flammability

oxidising properties

corrosiveness

toxicity

ecotoxicity

If your substance is a mixture and you cannot provide direct information on its hazardous properties, you can apply

mixture rules to the hazardous components of the mixture. If you do this, then you will need to provide information

on the hazardous properties of each hazardous component of the mixture, and show your workings.

8



Component hazardous properties:

Co

mp

on

en

t

Qu

an

tity

% w

/v

Co

mm

en

t

Skin

co

rro

siv

ity

Eye c

orr

osiv

ity

Acu

te o

ral

tox

icit

y

Acu

te

de

rmal

tox

icit

y

Sen

sit

isati

on

Mu

tag

en

icit

y

Carc

ino

ge

nic

ity

Rep

rod

uc

tive

tox

icit

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Ta

rge

t o

rgan

tox

in

Aq

ua

tic t

ox

in

So

il t

oxin

Vert

eb

rate

to

xin

Inv

ert

eb

rate

tox

in

A 10.0 Not haz

B 1.0 Not haz

C 0.2 Not haz

D 0.2 6.3A 8.3A 6.1D 6.5B 9.1B 9.3C

E 0.2 6.4A 6.8B

F 1.0 6.4A 6.1E

G 4.5 6.3B 6.4A 6.1E

H 2.5 6.1E 6.9B 9.1A 9.4A

I 3.2 6.1B 6.8B 6.9A 9.1A 9.2A 9.3A 9.4A

J QS Not haz

Component H – Spinosad

Component I - Abamectin

9



Explosiveness:

As there are no chemical groups typically associated with explosive properties present in the substance, BK0130 is

not considered explosive.

Flammability:

Experience in production and handling shows that none of the raw materials in BK0130 ignite spontaneously with

air at room temperature after prolonged periods of time or react with water to emit flammable gases at room

temperature. BK0130 is not flammable.

Oxidising properties:

None of the components of BK0130 are oxidising agents or organic peroxides. Therfore BK0130 is does not have

any oxidising properties.

Corrosiveness:

Metal corrosivity:

Proxel GXL contains sodium hydroxide which is a metal corrosive. Proxel GXL is present within BK0130 at less

than 1% w/v, and sodium hydroxide is present within GXL at less than 1%w/w, so is therefore present within

BK0130 at a very small quantity.

BK0130 is a stable formulation containing spinosad, abamectin and known pharmaceutical and food grade

excipients. It is not metal corrosive.

Skin corrosivity:

Two components in BK0130 contain ingredients which are classified as skin irritants. However these components

makes up less than 5% of the substance BK0130. Following the additivity rules for mixtures, because the

concentration of skin corrosives and irritants is less than 5%, BK0130 is not a skin corrosive or a skin irritant.

The pH of BK0130 is 7.5 – 8.5 and therefore BK0130 is not considered a skin corrosive.

Eye corrosivity:

One component in BK0130 is classified as eye corrosive. This component makes up less than 1% of the substance

BK0130.

Three components in BK0130 are classified as eye irritants. These components make up less than 10% of the

substance BK0130.

Following the additivity rules for mixtures, the combination of these eye corrosive and irritants falls below the

threshold and BK0130 is therefore not classified as an eye corrosive or eye irritant.

The pH of BK0130 is 7.5 – 8.5 and therefore BK0130 is not considered an eye corrosive.

10



Sensitisation

Component D in BK0130 is a mixture which contains a contact sensitiser. This component is present in

Component D at 10-29%. Component D is present in BK0130 at 0.2%, so the sensitising component is present in

BK0130 at <0.07%. Therefore BK0130 is not considered to be a contact sensitiser.

Acute toxicity:

Oral toxicity:

Applying the mixture additivity rules, there are 5 components with oral toxicity, which sum to give an LD50 for the

mixture of 270mg/kg, classifying the substance BK0130 with 6.1C (oral).

Dermal toxicity:

There are no components in BK0130 with dermal toxicity, therefore BK0130 is not a dermal acute toxin.

Mutagenicity:

None of the components of BK0130 are classified as mutagens, therefore BK0130 is not classified as a mutagen.

Carcinogenicity:

None of the components of BK0130 are classified as carcinogens, therefore BK0130 is not classified as a

carcinogen.

Reproductive and developmental effects:

BK0130 contains 2 components which have 6.8B classifications. Abamectin is present in the formulation at above

the 0.1% threshold, and therefore BK0130 is classified as a reproductive toxin, 6.8B.

Target organ toxicity:

Both spinosad and abamectin are classified as target organ toxicants. Both spinosad and abamectin are present in

BK0130 at >1% but <10% of the substance, and therefore both provide a classification of BK0130 as 6.9B.

Aquatic ecotoxity:

Abamectin is a highly toxic aquatic ecotoxin component. Due to the multiplier applied to the concentration of

abamectin in the formulation, BK0130 is classified as 9.1A.

Soil ecotoxicity:

11



Abamectin is a highly toxic soil ecotoxin component. Due to the multiplier applied to the concentration of abamectin

in the formulation, BK0130 is classified as 9.2A.

Terrestrial vertebrate toxicity:

Abamectin is a toxic vertebrate toxin component. It does not attract a multiplier in the mixture additivity rules, and

therefore BK0130 is classified as 9.3B.

Terrestrial invertebrate toxicity:

Spinosad and abamectin are both terrestrial invertebrate toxins. Both attract a multiplier in the calculation of the

mixture classification. This results in BK0130 being classied as 9.4A.

Conclusion for BK0130:

Hazardous Property Threshold Classification

category

Explosiveness Not triggered -

Flammability Not triggered -

Oxidising Not triggered -

Corrosiveness Not triggered -

Toxic

Acute toxicity Oral Triggered 6.1C

Dermal Not triggered -

Inhalant Not triggered -

Skin irritancy Not triggered -

Eye irritancy Not triggered -

Sensitisation Not triggered -

Mutagenicity Not triggered -

Carcinogenicity Not triggered -

Reproductive/ Developmental toxicity

Triggered 6.8B

Target Organ Triggered 6.9B

Ecotoxic

Aquatic Triggered 9.1A

Soil Triggered 9.2A

Terrestrial Vertebrate Triggered 9.3B

Terrestrial Invertebrate Triggered 9.4 A

12



Section Three – Information on the Substance(s)

Note all information that is commercially sensitive must be attached as an Appendix. The application form should

be cross-referenced to the Appendix but should be able to be read as a stand-alone document which will be

publicly available.

If approval is being sought for more than one hazardous substance, this section must be completed separately for

each hazardous substance.

BK0131:

(spinosad 2.5%, abamectin 0.6%)

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

This section should include all information necessary to unequivocally identify the substance(s) and may include:

Chemical Name (Chemical Abstracts Preferred Index name or IUPAC name)

Common Name

Synonyms

Trade Names

CAS Registry Number

Molecular Formula

Structural Formula

Impurities

For mixtures, in addition to the above information being provided on the actual mixture, information is also required

on the composition of the mixture ie the chemical name, CAS number, function (eg active ingredient, emulsifier,

surfactant, filler) and percentages of ALL components of the mixture (including non-hazardous components and

impurities) should be provided. This information may be best expressed in tabular form. If the composition is

variable, please ensure to state the limits.

If there are commercial reasons for not providing full information in the main part of the form, alternative

approaches must be discussed with and agreed by the EPA. These must include the provision of a unique identifier

of some kind.

The substance is an aqueous suspension (mixture) containing spinosad (2.5%) and abamectin (0.6%).

Mixture formulation details are provided in Appendix 1 (Confidential).

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

Provide as much information as possible on the chemical and physical properties of the substance(s) [at 20°C and

1 atmosphere unless otherwise stated] eg

Appearance (colour, odour, physical state or form)

pH

13



Density

Vapour pressure

Boiling/melting point

Solubility in water

Water/octanol partitioning co-efficient

For mixtures, information is required on the chemical and physical properties of the mixture itself. However, if this

information is not available, you should provide information on the chemical and physical properties of EACH

hazardous component of the mixture.

The mixture is a smooth white to light brown suspension free from lumps. The pH of the mixture is 7.5 –

8.5. Details of the mixture properties are not yet available. An MSDS for hazardous components which are

not listed on the EPA HSNO chemical classification and information database are provided in Appendix 1.

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

Information should be provided on the hazardous properties of the substance(s) known to the applicant. You

should consider each of the six hazardous properties below and provide information on those hazardous

properties. This information is needed in order to assess risks and determine whether or not and how the

substance can be adequately contained.

explosiveness

flammability

oxidising properties

corrosiveness

toxicity

ecotoxicity

If your substance is a mixture and you cannot provide direct information on its hazardous properties, you can apply

mixture rules to the hazardous components of the mixture. If you do this, then you will need to provide information

on the hazardous properties of each hazardous component of the mixture, and show your workings.

Component hazardous properties:

14



Co

mp

on

en

t

Qu

an

tity

% w

/v

Co

mm

en

t

Skin

co

rro

siv

ity

Eye c

orr

osiv

ity

Acu

te o

ral

tox

icit

y

Acu

te

de

rmal

tox

icit

y

Sen

sit

isati

on

Mu

tag

en

icit

y

Carc

ino

ge

nic

ity

Rep

rod

uc

tive

tox

icit

y

Ta

rge

t o

rgan

tox

in

Aq

ua

tic t

ox

in

So

il t

oxin

Vert

eb

rate

to

xin

Inv

ert

eb

rate

tox

in

A 10.0 Not haz

B 1.0 Not haz

C 0.2 Not haz

D 0.2 6.3A 8.3A 6.1D 6.5B 9.1B 9.3C

E 0.2 6.4A 6.8B

F 1.0 6.4A 6.1E

G 4.5 6.3B 6.4A 6.1E

H 2.5 6.1E 6.9B 9.1A 9.4A

I 0.6 6.1B 6.8B 6.9A 9.1A 9.2A 9.3A 9.4A

J QS Not haz

Component H – Spinosad

Component I - Abamectin

Explosiveness:

15



As there are no chemical groups typically associated with explosive properties present in the substance, BK0131 is

not considered explosive.

Flammability:

Experience in production and handling shows that none of the raw materials in BK0131 ignite spontaneously with

air at room temperature after prolonged periods of time or react with water to emit flammable gases at room

temperature. BK0131 is not flammable.

Oxidising properties:

None of the components of BK0131 are oxidising agents or organic peroxides. Therfore BK0131 is does not have

any oxidising properties.

Corrosiveness:

Metal corrosivity:

Proxel GXL contains sodium hydroxide which is a metal corrosive. Proxel GXL is present within BK0131 at less

than 1% w/v, and sodium hydroxide is present within GXL at less than 1%w/w, so is therefore present within

BK0131 at a very small quantity.

BK0131 is a stable formulation containing spinosad, abamectin and known pharmaceutical and food grade

excipients. It is not metal corrosive.

Skin corrosivity:

Two components in BK0131 contain ingredients which are classified as skin irritants. However these components

makes up less than 5% of the substance BK0131. Following the additivity rules for mixtures, because the

concentration of skin corrosives and irritants is less than 5%, BK0131 is not a skin corrosive or a skin irritant.

The pH of BK0131 is 7.5 – 8.5 and therefore BK0131 is not considered a skin corrosive.

Eye corrosivity:

One component in BK0131 is classified as eye corrosive. This component makes up less than 1% of the substance

BK0131.

Three components in BK0131 are classified as eye irritants. These components make up less than 10% of the

substance BK0131.

Following the additivity rules for mixtures, the combination of these eye corrosive and irritants falls below the

threshold and BK0131 is therefore not classified as an eye corrosive or eye irritant.

The pH of BK0131 is 7.5 – 8.5 and therefore BK0131 is not considered an eye corrosive.

Sensitisation

16



Component D in BK0131 is a mixture which contains a contact sensitiser. This component is present in

Component D at 10-29%. Component D is present in BK0131 at 0.2%, so the sensitising component is present in

BK0130 at <0.07%. Therefore BK0131 is not considered to be a contact sensitiser.

Acute toxicity:

Oral toxicity:

Applying the mixture additivity rules, there are 5 components with oral toxicity, which sum to give an LD50 for the

mixture of 1404mg/kg, classifying the substance BK0131 with 6.1D (oral).

Dermal toxicity:

There are no components in BK0131 with dermal toxicity, therefore BK0131 is not a dermal acute toxin.

Mutagenicity:

None of the components of BK0131 are classified as mutagens, therefore BK0131 is not classified as a mutagen.

Carcinogenicity:

None of the components of BK0131 are classified as carcinogens, therefore BK0131 is not classified as a

carcinogen.

Reproductive and developmental effects:

BK0131 contains 2 components which have 6.8B classifications. Abamectin is present in the formulation at above

the 0.1% threshold, and therefore BK0131 is classified as a reproductive toxin, 6.8B.

Target organ toxicity:

Both spinosad and abamectin are classified as target organ toxicants. Spinosad is present in BK0131 at >1% but

<10% of the substance, and therefore provides a classification of BK0131 as 6.9B.

Aquatic ecotoxity:

Abamectin is a highly toxic aquatic ecotoxin component. Due to the multiplier applied to the concentration of

abamectin in the formulation, BK0131 is classified as 9.1A.

Soil ecotoxicity:

17



Abamectin is a highly toxic soil ecotoxin component. Due to the multiplier applied to the concentration of abamectin

in the formulation, BK0131 is classified as 9.2A.

Terrestrial vertebrate toxicity:

Abamectin is a toxic vertebrate toxin component. It does not attract a multiplier in the mixture additivity rules, and

therefore BK0131 is classified as 9.3B.

Terrestrial invertebrate toxicity:

Spinosad and abamectin are both terrestrial invertebrate toxins. Both attract a multiplier in the calculation of the

mixture classification. This results in BK0131 being classied as 9.4A.

Conclusion for BK0131:

Hazardous Property Threshold Classification

category

Explosiveness Not triggered -

Flammability Not triggered -

Oxidising Not triggered -

Corrosiveness Not triggered -

Toxic

Acute toxicity Oral Triggered 6.1D

Dermal Not triggered -

Inhalant Not triggered -

Skin irritancy Not triggered -

Eye irritancy Not triggered -

Sensitisation Not triggered -

Mutagenicity Not triggered -

Carcinogenicity Not triggered -

Reproductive/ Developmental toxicity

Triggered 6.8B

Target Organ Triggered 6.9B

Ecotoxic

Aquatic Triggered 9.1A

Soil Triggered 9.2A

Terrestrial Vertebrate Triggered 9.3B

Terrestrial Invertebrate Triggered 9.4 A

18



Information from this point onward relates to both BK0130 and BK0131:

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.

The information provided needs to reflect the containment character of the application. It will be used in the

development of exposure scenarios and the assessment of risks and hence the specification of the containment

conditions.

The substances will be manufactured at a site in New Zealand. The substances will be transported to a research

facility where they will be stored in a locked facility. Upon initiation of the study/ies, the substances will be diluted

and then administered to sheep as an ectoparasiticide dipwash, as part of research studies consisting of dose

determination for the target species, and clinical field studies. Other supporting research studies may also be

required. Product administration uses current application equipment already used in the marketplace for similar

products.

The substances will be fully controlled by the research facility and any unused substance will be returned to the

registrant and/or the manufacturing facility for disposal, by a commercial chemical disposal company.

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

This information is used in the development of exposure scenarios and the assessment of risks.

A maximum of 20L of each of the substances will be manufactured to be used in the research studies.

19



Section Four: – Information on the Proposed Containment System

4.1 Provide information on the proposed containment system.

It is essential that good information is provided on the containment system because the adequacy of containment

in conjunction with the hazardous properties of the substance will have a major impact on whether or not approval

is given.

You will need to provide a description of the containment proposed AND information on how you intend to address

the following issues (proposed controls):

methods for preventing the escape of the contained hazardous substance and preventing the contamination of

the facility.

methods for excluding unwanted organisms from the facility or to control organisms within the facility

methods for excluding unauthorised people from the facility

methods for preventing unintended release of the substance by experimenters

methods for controlling the effects of any accidental release of the substance

inspection and monitoring requirements of the containment facility

A management plan may be attached as an appendix. This plan should specify the procedures for implementing

the above methods for containing the substance(s), and provide details of the qualifications of the person

responsible for implementing those controls.

The substance is similar to other substances currently in use in New Zealand for ectoparasiticide control in sheep.

The substance will be used similar to these existing products in terms of the preparation (dilution) and

administration of the product to sheep.

The product will be transported by a registered courier company and fully traceable. An inventory of product use

will be maintained as part of the study protocols to ensure that all of the substance is accounted for.

The study site is a permanent study site that routinely conducts research on experimental substances with animals.

The business which owns the study site is approved by the Ministry of Primary Industry as a Research, Teaching,

Testing Organisation with an Operating Plan to conduct research studies on unregistered products. The personnel

employed in this business to undertake such studies are suitably qualified Veterinarians and Biologists.

The site is a secure facility than ensures that treated animals remain on the site, and unauthorised persons cannot

access the site.

An MSDS for the substance will be provided to the study site.

The research studies will be fully monitored by the sponsoring company, and will be compliant with GCP standards.

20



Section Five – Identification and Assessment of Risks

In completing this section, it is important that you take account of the proposed containment system you described in Section 4. We are particularly interested in knowing about risks that may still remain with the containment system in place. You will need to consider the effects on the environment and public health including any social effects. You should also take account of the quantity of material involved and the number of different locations that may be involved.

Complete this section as far as you can.

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

Include information on potentially significant possible risks of the substance and whether or not these risks are

likely to be significant. It is important to think about the source of the risk ie the way in which the risk is created (the

exposure pathway), and then the consequences of exposure. Risks should be considered in relationship to:

the sustainability of native and valued introduced flora and fauna

the intrinsic value of ecosystems

public health (including occupational exposure)

the relationship of Maori and their culture and traditions with their ancestral lands, water, sites, waahi tapu,

valued flora and fauna and other taonga

the economic and related benefits to be derived from the use of the hazardous substance

New Zealand’s international obligations.

Environmental Effects

Risk: Water Contamination BK0130 / BK0131 may have an adverse affect on fish and phytoplankton. Risk: Soil Contamination BK0130 / BK0131 is ecotoxic and may have an adverse affect on terrestrial invertebrates. Risk: Ecosystem Contamination BK0130 / BK0131 is ecotoxic and could contaminate ecosystems following accidental spillage. Risk: Effects on Native Flora and Fauna BK0130 / BK0131 is not phytotoxic and poses no risk to native flora. BK0130 / BK0131 is ecotoxic and may have an adverse effect on native fish, and aquatic and terrestrial invertebrates and vertebrates following accidental spillage. Risk: Effects on Beneficial Terrestrial Invertebrates BK0130 / BK0131 is highly toxic to bees.

21



2. Human Health

Risk: Oral exposure Adverse effects could potentially arise from the ingestion of BK0130 / BK0131.

Risk: Reproductive / Developmental toxicity Adverse effects could potentially arise from exposure to BK0130 / BK0131.

3. Effects on the relationship of Maori and their culture and traditions with their ancestral lands, water,

sites, wahi tapu, valued flora and fauna, and other taonga Effects to Maori, as a consequence of this relationship, have not been assessed by the applicant.

4. Effects on New Zealand’s international obligations.

Risks to New Zealand’s international obligations with regard to food residues, are to be assessed by the ACVM Group during product registration. A withholding period will be set as part of the ACVM appraisal. Other risks, costs and benefits related to New Zealand’s international obligations are not assessed by the applicant.

22



Identification of Risks

Brief name of risk

Source of risk Elements at risk Method used to identify risk

Is full assessment of risk required?

Human exposure

Oral exposure Workers clearing up accidental spillage. Workers administering BK0130 / BK0131 to sheep.

What if scenarios Common sense Assessment

Yes

Reproductive / developmental toxicity

Yes

Waterway contamination

Accidental spillage

Ecosystem What if scenarios Common sense Assessment

Yes

Soil contamination

Accidental spillage Ecosystem What if scenarios Common sense Assessment

Yes

Bees Contact with bees *

Ecosystem What if scenarios Common sense Assessment

No, contact is not likely

Terrestrial vertebrates

Accidental spillage Ecosystem What if scenarios Common sense Assessment

Yes

* Spinosad and abamectin are highly toxic to honey bees. However, as a formulation designed to be applied

using direct application to sheep (ie not dispersed into the air as a spray), toxicity to foraging bees is considered negligible.

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

An explicit risk assessment only needs to be provided for those risks which might be significant. The assessment

should consider whether the identified risks can be adequately managed by the proposed containment system and

the substance(s) itself adequately contained.

The assessment should include the nature, probability of occurrence and magnitude of each adverse effect. The

uncertainty bounds of the information contained in the assessment should also be discussed.

(Optional)

Human Exposure Risk: Oral exposure / Reproductive/Developmental Toxicity Human exposure to the substances is only likely during normal handling and application if protective equipment is not used as specified, or if oral ingestion occurs. The other possible exposure opportunity is through an accidental spill. At clean-up sites following accidental spillage, direct contact/exposure should not occur (trained workers; appropriate documented procedures; protective clothing etc.). Volumes of material spilled would be small due to the small volumes to be used in the studies.

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Workers involved in transportation and loading of this product would not be exposed as appropriate containers are used to contain the substances, and product will be transported using courier companies with Dangerous Goods Qualifications.

Likelihood of risk: POSSIBLE Magnitude: LOW

Costs Any health costs would be borne by workers trained and equipped to deal with such incidents. The hazards would not impact the wider community. Benefits - Human heath

Studies into the viability of spinosad and abamectin for the treatment of ectoparasites in sheep has the potential to benefit the health of New Zealanders.

Prevention of flystrike, and treatment of lice infested or flystruck sheep supports the sheep farming industries. New

Zealand earns significant funds from trade in meat and wool products. Trade improves the prosperity of New Zealanders, improving public health generally. The benefits to human health also relate to the potential of spinosad and abamectin to reduce the use of the more toxic currently marketed substances such as organophosphates. Environmental Exposure Risk - Ecotoxicity following accidental spillage BK0130/BK0131are manufactured and filled into final containers ready for distribution to the study site. Environmental exposure is possible following accidental spillage of product in transit to the study site. Unbroken containers could be collected up for reuse or approved disposal. Volumes of material spilt would be small. Spillage at the study site could occur. BK0130/BK0131 will not be used near waterways. Spillage onto soil around the yard/treatment area would not cause undue toxicity as spinosad and abamectin are rapidly degraded in sunlight. Spinosad is not very toxic to earthworms and does not leach into water tables. Abamectin is toxic to earthworms, however volumes spilt are likely to be small and inconsequential, and the substance will be used in areas of low earthworm activity and relevance (sheep yards). The risk to terrestrial vertebrates is low due to the small volumes, and significant vertebrates are unlikely to be present in the treatment area.

Likelihood of risk: UNLIKELY Magnitude: LOW

Costs Costs of cleaning up an accident spillage would be borne by the applicant. Financial costs of disposal would be borne by the applicant. Benefits Spinosad is safer than many currently available products for lice control in sheep. Many of these products contain insecticides that are inherently more toxic than spinosad. Of the available options for louse control, spinosad appears one of the safest, for the environment, humans and animals.

Spinosad presents a favourable environmental profile. It does not leach, bioaccumulate, volatilize, or persist in the environment. Spinosad will degrade photochemically when exposed to light. No long term health problems are noted in mammals and a low potential for acute toxicity exists. Although spinosad is moderately toxic to fish, this represents a reduced risk to fish when compared with many synthetic insecticides in use.

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Spinosad poses less risk than most other insecticides to mammals, birds, fish and beneficial insects. While spinosad may pose some hazard to the environment, it provides a ‘softer option’ to other marketed louse treatments. The combination of spinosad and abamectin in the substances provides a novel alternative to ectaparasite control in New Zealand. Resistance of parasites to current active ingredients is increasing, and the provision of new formulations will enable better control of ectoparasites in the future. Other Benefits Economic

Flystrike prevention, and flystrike and louse treatment can improve the profitability of sheep farms. This can enhance the economic well being of the wider community and future generations.

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Section Six – International Considerations

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)

These substances have not been considered in combination by any regulatory authority in New Zealand or in any

other country to the applicant’s knowledge.

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Section Seven – 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 not already included.

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Section Eight – Summary of Public Information

The information provided in this section may be used in the Authority’s public register of substances required under

Section 20 of the HSNO Act.

This summary information will be used to provide information for those people and agencies (eg Ministry for the

Environment, Department of Conservation, Regional Councils, etc), who will be notified of the application, and for

potential submitters who request information. This information will also be used to prepare the public notice of the

application.

For these reasons, applicants should ensure that this summary information does not contain any commercially

sensitive material.

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

Please use a maximum of 80 characters.

BK0130/BK0131

8.2 Purpose of the application for the public register:

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

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

This substance is to be used in product development field trials as an ectoparasitide for use in sheep.

BK0130 and BK0131 are aqueous solutions containing spinosad and abamectin, and the substances trigger HSNO

thresholds for acute oral toxicity, reproductive/developmental toxicity, target organ toxicity and ecotoxicity.

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).

Main category: There are four main categories. 3 – non-dispersive

Industry category: There are 16 industry categories. 1 – agricultural industry

Function/Use category: There are 55 function/use categories. 41 – pharmaceuticals, subcategory

veterinary medicines

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(Optional)

8.4 Executive Summary:

In this section, the applicant should provide a summary of information contained in this application, including:

the identification of the substance, its hazardous properties, intended uses, and disposal

an assessment of the adverse effects of the substance

information on the proposed containment

Identification of the substance BK0130 and BK0131 are insecticides for the prevention and treatment of lice and flystrike in sheep. Hazardous properties BK0130 and BK0131 are potentially acutely orally toxic, target organ toxins and reproductive/developmental toxins. BK0130 and BK0131 are toxic to aquatic and soil organisms, terrestrial vertebrates and are highly toxic to bees. The substances pose less risk than some other insecticides to mammals, birds, fish and beneficial insects. While there is some hazard to the environment, this product provides a ‘softer option’ to other currently marketed ectoparasiticides. Intended uses Field studies are proposed to investigate the efficacy, safety and residue profile of the formulations. This information gathered will be used in an application to the ACVM Group for product registration. Assessment of the adverse effects of the substance Oral exposure to the substances is unlikely if protective equipment is used during use of the substances. The risk of oral toxicity, target organ toxicity, or reproductive/developmental toxicity is therefore low. Due to the proposed method of use (not near waterways, and in sheep yards) and the small quantities required, risks to the environment are judged to be unlikely and the magnitude of the risk low. Risks to bees are very low as no exposure path is present for contact to occur. Significant terrestrial vertebrates are unlikely to be present in sheep yards and therefore low risk. The risk of spillage and its effects are low due to the small volumes to be used and the containers and transport employed to reduce the risk of spillage. Information on the containment and disposal A total of 20L of each substance is proposed to be manufactured for use in these studies. This product would be transported in the finished containers by commercial courier, to the secure study site. One container would be opened at a time, and all product use would be documented and accounted for. The studies will be performed in sheep yards away from waterways, by suitably trained personnel employed by the commercial research business. Unused formulation will be disposed of by appropriate methods. Treated animals will be held at the study site for the duration of the withholding period, as assigned by the ACVM Group.

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14 January 2013

Signature Date

form hs3: import or manufacture any hazardous substance in … · 2019. 4. 6. · form hs3: import...

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