import or manufacture any hazardous substance for … · 2019. 4. 6. · • common name...

ENVIRONMENTAL RISK MANAGEMENT AUTHORITY

NGA KAIWHAKATUPATO WHAKARARU TAIAO

FORM HS1

Application for approval to

IMPORT OR MANUFACTURE ANY HAZARDOUS

SUBSTANCE FOR RELEASE

under section 28 of the Hazardous Substances and New Organisms Act 1996

Name of Substance(s): LUNA DEVOTION ®

Applicant: Bayer New Zealand Ltd.

Office use only

Application Code: Date received:___/ ___/ ___/ ERMA NZ Contact: __________________________________ Initial Fees Paid: $ Application Version No: _____________________________

ERMA New Zealand

2

.

LUNA DEVOTION

Schedule of Appendices

A [ CD ] Acute toxicity, ecotoxicity of formulated product.

( Contains CONFIDENTIAL files )

B [ DVD ] Fluopyram: Toxicology, Ecotoxicology, Environmental Fate, Physical and

Chemical properties.

( Contains CONFIDENTIAL files )

C [ CD ] Composition of Luna Devotion, SDS of product and excipients

( CONFIDENTIAL )

3

Section One - Applicant Details

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

Name: Bayer New Zealand Ltd.

Address: P.O. Box 2825 Shortland Street Auckland 1140, and P.O. Box 11332 Sockburn

CHRISTCHURCH 8443

Phone: [09] 443 3093 and [03] 341 0490

Fax: [09] 443 1194 and [03] 348 4016

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

Street Address: 3, Argus Place, Hillcrest, AUCKLAND 0627

1.3 Name of the contact person for the application:

Name: Max Moore, Technical & Regulatory Affairs Manager

Address: Bayer New Zealand Ltd

P.O. Box 11332,

Sockburn

CHRISTCHURCH 8443

Phone: [03] 341 0490

Fax: [03] 348 4016

Email: [email protected]

Registration consultant:

Richard Paxman

81 Pah Road

Cockle Bay

AUCKLAND

Tel. (09) 535 0120

e-mail: [email protected]

4

Section Two - Application Type and Related Approvals Required

2.1 Is the information in this application relevant to import, manufacture or both:

• Import only? Yes

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

[ Unlikely ever to be economically justified ]

2.2 If the information in the application relates to manufacture in New Zealand, provide

information on the proposed manufacturing process and any alternatives

Not applicable

2.3 If you have reasons for not providing detailed information in this application, explain

what they are and provide some justification.

2.4 If this substance(s) needs an approval under any other legislation, has an

application for this approval been made ?

( Optional) ( See comments under “Section 2.4 of Form” in the User Guide.

Name of Approval Application made

Agricultural Compounds and Veterinary Medicines Act 1997 Yes

Food Act 1981 Yes [ via ACVMG]

Medicines Act 1981 No N/A

Chemical Weapons (Prohibition) Act 1996 No N/A

Radiation Protection Act 1965 No N/A

Biosecurity Act 1993 No N/A

Resource Management Act 1991 No N/A

Other (please specify No N/A

5

Section Three - Information on the Substance(s)

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

LUNA DEVOTION is a fungicide containing : 250g/litre fluopyram +250g/litre triadimenol

in the form of a soluble concentrate

.1. fluopyram

• Chemical Name (CA) N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-

(trifluoromethyl)benzamide

• Chemical Name (IUPAC) N-{2-[3-chloro-5-(trifluoromethyl)-2-pyridyl]ethyl}

-α,α,α-trifluoro-o-toluamide

• Common Name fluopyram

• Synonyms AE C656948

• Trade Names LUNA DEVOTION

• CAS Registry Number 658066-35-4

• Molecular Formula C16H11ClF6N2 O

• Molecular weight:

• Minimum purity: 960 g/kg

• Structural Formula

6

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

LUNA DEVOTION is a fungicide containing : 250g/litre fluopyram +250g/litre triadimenol

in the form of a soluble concentrate

2. triadimenol

• Chemical Name (CA) β-(4-chlorophenoxy)-α-(1,1-dimethylethyl)-

1 H -1,2,4-triazole-1-ethanol

• Chemical Name (IUPAC) (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-

dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

• Common Name triadimenol

• Synonyms

• Trade Names Cereous

• CAS Registry Number 55219-65-3

• Molecular Formula C14H18ClN3O2

• Molecular weight: 295.8 g/mol

• Minimum purity: 970 g/kg

• Structural Formula

Data for triadimenol is archived under Cereous:

ERMA Approval Code: HSR000459

Registered pursuant to the ACVM Act 1997: No P003506

The formulation of LUNA DEVOTION is CONFIDENTIAL. Details of the formulation, and of the

formulants will be found in Appendix C

7

3.2 Provide information on the chemical and physical properties of the substance

i.e. the formulated product

Physical and Chemical properties of Luna Devotion [ formulated product ]

Appearance: Beige coloured liquid

Odour: Weak, Characteristic odour

pH: 6.0 – 8.0 ( 100% @ 23 ° C. )

Boiling point: > 100 °C.

Solubility: Forms a suspension

Density: approx. 1.16 g/cm³ at 20 °C

Flash Point: > 100 °C.

Auto-ignition temp. > 500 °C.

Corrosive: Not considered to be corrosive

Oxidising: Not considered to be an oxidiser

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

Physical and Chemical properties of Luna Devotion:

Impact on Hazard Classification:

1 Explosive Not triggered [ see Sec. 3.2 ]

3 Flammable Not triggered [ see Sec. 3.2 ]

5 Oxidising Not triggered [ see Sec. 3.2 ]

8.1 Metallic corrosive Not triggered [ see Sec. 3.2 ]

8

Toxicity

Acute toxicity: Luna Devotion [ product as sold ]

Study/Parameter Species (sex) Results

Reference

Appendix XX ( CD )

Acute oral toxicity Rat ( f ) LD50 cut off = 2000 mg/kg bw M-355575-01

Acute dermal toxicity Rat ( m/f ) LD50 > 2000 mg/kg bw M-355580-01

Acute inhalation Rat ( m/f ) LC50 > 1.769 mg/m3 M-356110-01

Acute skin irritation Rabbit Not irritant M-355203-01

Acute eye irritation Rabbit Not irritant M-355206-01

Skin sensitization test LLNA in mice Not sensitising M-353485-01

Impact on Hazard classification

6.1 Acute toxicity Triggered: see above 6.1 E

6.3 Skin irritation Not triggered: see above

6.4 Eye irritation Not triggered: see above

6.5 Sensitisation Not triggered: see above

8.2 Skin corrosive Not triggered: see above

8.3 Eye corrosive Not triggered: see above

9

Toxicity of the active ingredients

1. Fluopyram

Table~acute tox. studies; fluopyram

Type of study

(Doc. N°)

Species Results OECD Classification

(proposed)

EPA

Classification

(proposed)

Oral route

M-259398-01

Rat No mortalities observed

at 2000 mg/kg

Cat. 5 / Unclassified

(LD50 cut off > 5000

mg/kg)

Category III

(LD50 > 2000 mg/kg)

Dermal route

M-259275-01

Rat LD50 > 2000 mg/kg. Cat. 5 / Unclassified

Category III

Inhalation

M-283420-01

Rat Rat LC50 at 4 hours >

5112 mg/m3

Cat. 5 / Unclassified

Category IV

Skin irritation

M-263302-01

Rabbit Non-irritating Cat. 5 / Unclassified

Category IV

Eye irritation

M-263277-01

Rabbit Non-irritating Cat. 5 / Unclassified

Category III

Skin

sensitisation

M-281845-01

Mouse Non-sensitising Cat. 5 / Unclassified

Unclassified not applicable

No assessment of hazard impact has been made on the basis of these data since they are subsumed within

those for the formulated product.

10

Chronic Toxicity:

A Summary of the Toxicological and Toxicokinetic Studies on the Active Substance

( Fluopyram: AE C656948) will be found in the file: FLU TC T2 TOX summaries.pdf

See Appendix B

Summary of short-term toxicity of fluopyram

Type of study [ doc. ref. ]

concentrations if feed or

NOEL / NOAEL LOAEL

doses ppm mg/kg/d ppm mg/kg/d

28 day rat study,

KIIA 5.3.1/01

( M-085510-01 )

0,50,400,3200 ppm

400

(M/F)

31.0/36.1

(M/F)

3200

(M/F)

254/263

(M/F)

28 mouse study,

KIIA 5.3.1/02

( M-084486-01 )

0, 150, 1000, 5000 ppm

150

(M/F)

24.7/31.1

(M/F)

1000

(M/F)

162/197

(M/F)

28 dog study,

KIIA 5.3.1/03

( M-242097-01 )

0, 30, 150, 750 mg/kg/day

n.a. 150

(M/F)

n.a. 750

(M/F)

90 day rat study,

KIIA 5.3.2/01

( M-250946-01 )

0,50,200,1000, 3200 ppm

200

(M/F)

12.5/14.6

(M/F)

1000

(M/F)

60.5/70.1

(M/F)

90 day mouse study,

KIIA 5.3.2/02

( M-251136-01 )

0,30,150,1000 ppm

150

(M/F)

26.6/32.0

(M/F)

1000

(M/F)

188/216

(M/F)

90 day dog study,

KIIA 5.3.3/01

( M-276047-01 )

0, 800, 5000, 20000/10000

ppm

800

(M/F)

28.5/32.9

(M/F)

5000

(M/F)

171/184

(M/F)

1 year dog study,

KIIA 5.3.4/01

( M-294279-01 )

0, 100, 400, , 2000 ppm

400

(M/F)

13.2/14.4

(M/F)

2000

(M/F)

67.6/66.1

(M/F)

Percutaneous 28-day rat

study, KIIA 5.3.7/01

(M-293833-01)

0, 100, 300, 1000 mg/kg/day

n.a. 300

(M/F)

n.a. 1000

(M/F)

Impact on hazard classification: In our opinion the short term toxicity of fluopyram, from the above data

justifies a hazard classification of 6.1 C.

11

Summary of long-term toxicity/ carcinogenicity of fluopyram

Type of Study, doses NOAEL

mg/kg/day

LOAEL

md/kg/day

Rat – 104 week Chronic Toxicity/ Oncogenicity

(M-298339-01 )

30, 150, & 750/375 ( males) 1500 females ppm

1.20/1.68

(M/F)

6.0/8.6

(M/F)

Mouse – 78 week Chronic Toxicity/ Oncogenicity

(M-295688-01 )

30, 150, & 750 ppm

4.2/5.3

(M/F)

20.9/26.8

(M/F)

Genotoxicity potential was evaluated in a series of tests including in vitro and in vivo tests. There was

no indication of gene mutation either in the presence or absence of metabolic activation in both the

bacterial reverse mutation and mammalian gene mutation tests. The in vitro chromosome aberration

test and the in vivo mouse micronucleus test were also both negative. These studies demonstrated that

fluopyram has no genotoxic potential.

Summary of reproductive toxicity of fluopyram

Type of Study,

doses

NO(A)EL

( mg/kg/d )

LOAEL

( mg/kg/d )

Adverse effects at LOAEL

target organs

Reproductive toxicity studies

Two generation rat

KII 5.6.1/02

( M-299334-01)

0, 40, 220, 1200 ppm

14.5/17.2

(M/F)

82.8/96.0

(M/F)

parents Clinical pathology changes,

increased liver weight,

protein droplet nephropathy

(M) and centrilobar

hypertrophy

82.8/93.1

(M/F)

>93.1

(M/F)

reproduction None

17.0

(M/F)

97.9

(M/F)

offspring Decreased body weight and

bodyweight gain with

secondary decreases in

spleen and thymus weights

and secondary slight delay

in preputial separation

Developmental toxicity studies

Developmental

toxicity - rat

KII 5.6.10/01

( M-299438-01)

0, 30, 150, 450

30 150 dams Reduced bodyweight gains

and food consumption,

increased liver weight, and

diffuse centrilobular

hypertrophy in females

mg/kg/day 150

(M/F)

450

(M/F)

foetus Decreased foetal

bodyweight (5%), increased

incidence of two minor

variations at both the

visceral and skeletal

evaluation

Developmental

toxicity - rabbit

KII 5.6.11/01

( M-279773-01)

25 75 dams Reduced bodyweight gain

and food consumption

0, 10, 25, 75

mg/kg/day

25

(M/F)

75

(M/F)

foetus Decreased foetal body

weight (-11%)

12

There were no treatment-related maternal, litter or foetal findings at the mid dose of 25 mg/kg/day or

the low dose of 10 mg/kg/day.

A dose level of 25 mg/kg/day AE C656948 was considered to be a No Observed Effect Level (NOEL)

both in the dam and in terms of foetal development in the New Zealand White rabbit.

In our opinion fluopyram is not classified as a reproductive toxicant.

Neurotoxicity

Based on neurotoxicology endpoints, a NOAEL of 2500 ppm was established for males and females

(specifically, 164.2 and 197.1 mg/kg for male and female rats, respectively).

1. triadimenol




from which we conclude the hazard classification: 6.1D, 6.9B

In summary we consider the Toxicological Classification of Luna Devotion is

6.1 C, 6.9 B

Ecotoxicity

Ecotoxicity: Luna Devotion [ product as sold ]

Acute toxicity of fluopyram + triadimenol SC 500 (250+250) G to fish (Oncorhynchus mykiss) under

static conditions

The test conditions met all validity criteria, given by the mentioned guidelines. Based on nominal

concentrations the following results were determined:

LC 50 (96 h)

54.1 mg / L test item

(C.I.95%: 43.3 – 67.7 mg / L)

100 % mortality 100 mg / L test item

NOLEC

no-observed-lethal-effect-concentration


NOEC

highest concentration without sub-lethal effects


13

Acute toxicity of fluopyram + triadimenol SC 250+250 G to the waterflea Daphnia magna in a static

laboratory test system

No immobilities or other effects on behaviour occurred in untreated control within 48 hours of exposure.

Based on nominal concentrations of fluopyram + triadimenol SC 250+250 G, the following EC50 for

immobilisation after 48 hours of static exposure were calculated:

Statistical Results of Probit Analysis Conducted for Determination of EC50 values:

Probit analysis for data obtained after

EC 50

mg form./L

(nominally)

lower 95% cl

mg form./L

(nominally)

upper 95% cl

mg form./L

(nominally)

24 hours 160 64 399

48 hours 67 27 163

Lemna gibba G3: Growth inhibition test with Fluopyram + Triadimenol SC 500 G (250+250)

under static conditions

Results are based on nominal concentrations of the test item.

End point

(0-7 day)

Effect on frond no.

[mg formulation/L]

Effect on total frond area of plants

[mg formulation/L]

ErC50

(CL 95%)

10.1

(8.57 - 12.2)

3.90

(3.29 - 4.64)

LOErC 2.50 0.63

NOErC 1.25 0.31

The LOErC and NOErC determinations are based on statistical data analysis.

Conclusions:

The most sensitive response variable was total frond area of plants resulting in (0-7-day)-ErC50 of 3.90 mg

formulation/L and a lowest (0-7-day)-NOErC of 0.31 mg formulation/L.

Fluopyram + triadimenol SC 500 (250 + 250) G: acute toxicity to earthworms (Eisenia fetida) tested

in artificial soil with 5 % peat

Observations: No morphological and behavioural effects were observed.

Conclusions:

Test item Fluopyram + triadimenol SC 500

(250 + 250) G

mg test item/kg dry weight soil

Test object Eisenia fetida

Exposure 14 d

LC50 (mg test item/kg dry weight soil) 728

95 % confidence limits n.d.

NOEC (no-observed-effect-concentration)

(mg test item/kg dry weight soil)

< 100

LOEC(lowest-observed-effect-concentration)

(mg test item/kg dry weight soil)

100

n.d.: not determined due to mathematical reasons

14

In this study the LC50 (14 d) was 728 mg test item/kg dry weight soil. The Lowest Observed Effect

Concentration (LOEC) of Fluopyram + triadimenol SC 500 (250 + 250) G to earthworms (Eisenia fetida)

was determined to be 100 mg test item/kg dry weight soil. The No Observed Effect Concentration (NOEC)

was determined to be lower than 100 mg test item/kg dry weight soil.

Toxicity to the predatory mite Typhlodromus pyri (Acari, Phytoseiidae) using a laboratory test

Fluopyram + Triadimenol SC 250 + 250 G

Conclusions:

In this laboratory test the effects of Fluopyram + Triadimenol SC 250 + 250 G residues on the survival of

the predatory mite Typhlodromus pyri were determined at the rates of 138, 245, 436, 776 and 1380 mL

product/ha applied to glass cover slides.

In all rates tested no or only slight corrected mortality (<6.0%) was observed. No statistically significant

effect on reproduction occurred. The reduction in reproductive success relative to the control at the 138,

245, 436, 776 and 1380 mL product/ha rates of Fluopyram + Triadimenol SC 250 + 250 G was 19.9, 23.8,

0.9, -18.4 and 3.6%, respectively.

The LR50 was estimated to be > 1380 mL product/ha.

Fluopyram + Triadimenol SC 250 + 250 G: Toxicity to the parasitoid wasp Aphidius rhopalosiphi

using a laboratory test

In this laboratory test the effects of Fluopyram + Triadimenol SC 250 + 250 G residues on the survival of

Aphidius rhopalosiphi were determined at 180, 320, 569, 1012 and 1800 mL product/ha, applied to glass

plates.

In all rates tested no or only slight corrected mortality (<3.5%) was observed.

No statistically significant effect on reproduction occurred. The reduction in reproductive success relative

to the control at the 1800 and 1012 mL product/ha rate of Fluopyram + Triadimenol SC 250 + 250 G was

27.3% and 11%, respectively. With the rates of 569 and 320 mL product/ha 21.8% and 5% were detected.

At the lowest rate of 180 mL product/ha a reduction in reproductive success of 9.1% was found.

The LR50 was estimated to be >1800 mL product/ha.

From a consideration of these reports we propose a chronic toxicity hazard classification as under

9.1 Aquatic triggered 9.1C

9.2 Soil Not triggered

9.3 Terrestrial vertebrate triggered 9.3 C

9.4 Terrestrial invertebrate Not triggered

Impact of excipients on hazard classification

A review of the Safety Data Sheets of the excipients [ See Appendix C ] indicates that the excipients

contribute no hazards other than those accommodated in the data for the acute toxicity of the formulated

product, or the toxicological / ecotoxicological hazards of the active ingredients.

Summary of proposed overall classification:

6.1 C , 6.9 B , 9.1C, 9.3 C

15

3.4 Identification of the default Controls on the substance(s).

Substance HSNO

Classification

HSNO Default Controls

fluopyram + triadimenol

a soluble concentrate containing

250g/litre fluopyram +250g/litre

triadimenol

This includes the following

trade name product:

Luna Devotion

6.1 C

6.9 B

9.1C

9.3 C

Toxic

T1, T2, T3, T4, T5, T6, T7, T8

Ecotoxic

El, E2, E6, E8,

Identification

I1, I3, I8, I9, I11, I16, I17, I18, I19, I20, I21,I23,

I28, I29, I30

Packaging and Packaging Group

P1, P3, P13, PS4, PG3

Disposal

D4, D5, D6, D7, D8,

Emergency Management

EM1, EM6, EM7, EM8, EM11, EM12, EM13

TR1, AH1

3.5 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, Formulation:

Luna Devotion is manufactured and formulated in Germany, and will be imported into New Zealand as the

formulated product, packed for retail sale.

Manufacture, Formulation in New Zealand:

It is not expected to be either manufactured [ active ingredients ] nor formulated in New Zealand: neither

is justified on the grounds of economics.

Packaging:

Luna Devotion will be packed in 5 litre HDPE containers, to UN specification.

The quantity imported per year is not expected to exceed 10,000 litres, it may be assumed this will be

imported into Auckland in May/ June each year.

16

Transport:

Luna Devotion has the following Dangerous Goods classification for Road /Sea Transport:

IMDG

UN-Number 3082

Class 9

Packaging group III

Marine pollutant

Description of the goods

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (FLUOPYRAM SOLUTION)

Storage:

Bulk Storage: Luna Devotion will be stored primarily in the dedicated chemical warehouses of Bayer

New Zealand Ltd., situated at Cryers Road, E. Tamaki, Auckland and Treffers Road, Wigram,

Christchurch. These stores have procedures in place for managing a wide range of chemical products.

The staff are trained in and familiar with the protocols for the separation of products according to their

characteristics, for safe handling and storage, and the measures to adopt in case of any emergency.

The product will be stored in original packaging, palletised, in 500 litre lots.

17

Distributors: During the course of sale and distribution the product will be transported to the premises of

agricultural distributors each of which has dedicated pesticide storage facilities, and whose staff have been

trained in the procedures for managing and storing such products, and in dealing with emergencies that

might arise. The maximum quantity of Luna Devotion stored in such a distributor’s store is not expected to

exceed 500 litres.

End users: The use of Luna Devotion is restricted by its label claims to growers of onions. These are all

expected to be familiar with safe practices regarding the storage and handling of pesticides: Luna Devotion

will not present them with any hazards with which they are not already familiar. We would not expect on-

farm storage to exceed 50 litres.

Use: Luna Devotion is recommended for application to onion crops for the control of white rot in onions.

The label recommendation is to apply two applications each of 1 litre of product per hectare, at an interval

of four weeks: the first application being made at 100 – 150 white rot degree days ( OWRDD ).

Disposal:

The preferred option for disposal, and considered the primary route, is for its use as per the label

instructions. Because of the value of the product, and its chemical stability, any unused material can be

held over to the following season without incurring any special problems.

If disposal as above is not possible, due to product contamination, or for other reasons, Luna Devotion may

be disposed of in an approved landfill.

Empty containers will be accommodated in the Agrecovery scheme for the retrieval of empty pesticide

containers.

4.1 Identify all of the potential risks, costs and benefits of the substance(s)

18

4.1 Identification of risks, costs, benefits.

Review of potential environmental effects

Environmental constants

Triadimenol




parameter Values

Vapour pressure 1.35 mPa at 20 °C

Henry constant 2.2 e-6 Pa*m3/mole

water solubility 95 mg/l

Octanol/ water partition coefficient log P : 3.18 at 25 °C

Half-life in water >480 days at pH from 3 to 10

Fluopyram

Parameter Values

Molecular Weight 396.72 g/mol

Molecular Formula C16 H11 Cl F6 N2 O

Water solubility (at 20°C) pH 4 → 15 mg/L

pH 7 → 16 mg/L

pH 9 → 15 mg/L

Vapour pressure/volatility 20°C → 1.2 x 10-6

Pa

25°C → 3.1 x 10-6

Pa

50°C → 2.9 x 10-4

Pa

Henry’s Law Constant 20°C→ 2.98 x 10-5

Pa m3 mol

-1

UV absorption < 292 nm

pKa (at 23°C) 0.5

Pow/log Pow pH 6.5 → 2060 / 3.3

Relative Density 1.53

Melting Point 118°C

Stability of compound at room temperature Stable, no decomposition

19

Review of environmental effects

Water contamination/

degradation:

Soil contamination /

degradation:

Behaviour in air

Effects on ecosystems:

Effects on aquatic organisms:

Effects on vertebrates:

Effects on native flora:

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

These data for triadimenol are archived under Cereous:


A summary of these data, for fluopyram will be found in file

KII A 11.01. This file, together with the full reports of

environmental fate studies, toxicity and ecotoxicity, will be

found in Appendix B

Ecotoxicity data for the formulated product will be found in

Appendix A

4.1 Identification of risks, costs, benefits.

Review of potential environmental effects

Please note, in some of these reports fluopyram is referred to by it’s code number: AE C656948

Air contamination:

The active ingredients in Luna Devotion are not volatile: it is expected to have no adverse effect on air

quality. The vapour pressure of AE C656948 [fluopyram] (1.2 x 10-6

Pa at 20 °C, section 1, point IIA

2.3.1) and the calculated Henry’s constant (2.98 x 10-5

Pa m3 mol

-1 in water at pH 7 and 20°C, section 1,

point IIA 2.3.2) indicate that AE C656948 is non-volatile and therefore will not reach the atmosphere by

volatilisation.

Water contamination:

Contamination of water is unlikely in normal practice. Label cautions are included

Hydrolysis

AE C656948 is hydrolytically stable under acidic, neutral and alkaline conditions. Accordingly no

hydrolysis half-life could be calculated.

Aqueous photolysis

Under sterile conditions in aqueous buffer solution (pH 7) AE C656948 is steadily degraded by photolytic

processes. The experimental half-lives (SFO) were 21.0 (phenyl label) and 25.0 days (pyridyl label).

Soil contamination:

Contamination of soil other than application as per label, is unlikely in normal practice. In the event of a

product spill any environmental damage would be restricted.

Fluopyram is expected to be stable in typical soil conditions: “An amount of about 50% of the total applied

AE C656948 disappeared within 21.3 to 347 days after treatment. The dissipation of AE C656948 then

proceeded more slowly until the end of the study to residue levels of 3.2% to 26.5% of the total applied

amount after 2 years. “

Effects on ecosystems:

No detrimental effects are expected. While fluopyram is stable in the environment it has low toxicity to

aquatic organisms and terrestrial vertebrates.

20

Effects on aquatic organisms:

The threshold for aquatic plants is triggered [ 9.1C]. No harmful effects are expected from normal use of

the product.

Effects on vertebrates:

The threshold for terrestrial vertebrates is triggered [ 9.3C]. No harmful effects are expected from normal

use of the product.

Effects on native flora:

Triadimenol : triadimenol is present in Falcon, a fungicide applied to established crops of wheat and

barley. The highest nominal product application rate of 0.6 L [ of the ] product / ha. showed no significant

adverse effect (i.e. greater than 50%) on representative non-target crops in the vegetative vigour test.

Fluopyram: following a foliar application of AE C656948 SC 500A G applied at 503 mL AE C656948 SC

500A G /ha (equivalent to 250 g a.i. fluopyram per ha) to ten species no adverse effects on survival, visual

phytotoxicity, growth, plant biomass (shoot dry weight) and shoot length were obtained 21 days after

application which exceeded the 25% trigger values for further testing.

There are no reasons which would cause any person to apply the product other than according to the label

directions, there is therefore negligible risk to native flora.

Effects on native fauna:

The threshold for terrestrial vertebrates is triggered [ 9.3C]. No harmful effects are expected from normal

use of the product.

Effects on soil organisms, bees, non-target organisms:

The formulated product ( Luna Devotion ) was tested against a range of representative species. The reports

of these tests will be found in Appendix A . In summary the results are:

Aphidius rhopalosiphi: The LR50 was estimated to be >1800 mL product/ha.

Typhlodromus pyri : The LR50 was estimated to be > 1380 mL product/ha.

Apis mellifica : the toxicity of Luna Devotion was tested in both acute contact and oral toxicity test on

honey bees. The LD50 ( 24h + 48h) was greater than 200 g product/ bee in the contact toxicity test. The

LD50 ( 24h + 48h) of the test item was determined to be 96.9 and 94.1 g product/ bee in the oral toxicity

test, respectively.

Eisenia fetida : In this study the LC50 (14 d) was 728 mg test item/kg dry weight soil. The Lowest

Observed Effect Concentration (LOEC) of fluopyram + triadimenol SC 500 (250 + 250) G to earthworms

(Eisenia fetida) was determined to be 100 mg test item/kg dry weight soil. The No Observed Effect

Concentration (NOEC) was determined to be lower than 100 mg test item/kg dry weight soil.

Soil organisms – carbon transformation: No effect from up to 6 litres of product / ha. after 28 days.

Soil organisms – nitrogen transformation: No effect from up to 6 litres of product / ha. after 28 days.

Effects on Economic Social and Cultural Wellbeing of Communities

Document N includes a section “ Impact on human and animal health “ including ADI, ARfD, AOEL /

MOE and drinking water limit calculations, for fluopyram. This will be found in Appendix B

Regarding triadimenol, the following statement is taken from the Falcon application ( since Falcon

contains triadimenol ): Exposure of workers, operators bystanders. “Since the risk assessment carried out

indicated that the health-based limit values (AOEL) for spiroxamine, tebuconazole and triadimenol will not

be exceeded under practical conditions of use, a study providing the measurement of operator exposure

under field conditions was not necessary and therefore was not carried out.”

Adverse effects on public health:

No adverse effects are anticipated.

Exposure of workers, operators, bystanders. No risk is discernible for operators or bystanders.

Accidental oral ingestion:

21

This is not anticipated under normal use practices.

Inhalation exposure

Because of its physical nature ( soluble concentrate ) and the low vapour pressure of the active ingredients,

no inhalatory risk is to be expected for this product.

Effects on Economic Social and Cultural Wellbeing of Communities

Adverse effects on public health:

No adverse effects are anticipated.

23 Table 4.1 Summary of risk identification of Luna Devotion

Source of

potentially

significant

risk

Adverse

effect/

impact

Likelihood Distribution of

effects

[ geographic ]

Distribution

of effects

[demographi

c]

Distribution

of effects

[temporal]

Reversible/

irreversible

Voluntary/

involuntary

Magnitude Level of

residual risk

Transport

Human

health

Very

unlikely

Localised

Not expected

Short term

Reversible

Involuntary

Minimal

Insignificant

accident

over

Aquatic

environment

Very

unlikely

Localised

Short term

Reversible

Involuntary

Minor

Insignificant

land Terrestrial

Environment

Very

unlikely

Localised

Short term

Reversible

Involuntary

Minimal

Insignificant

Damage to

Human

health

Very

unlikely

Localised

Not expected

Short term

Reversible

Involuntary

Minimal

Insignificant

packaging

during

Aquatic

environment

Very

unlikely

Localised

Short term

Reversible

Involuntary

Minimal

Insignificant

storage Terrestrial

Environment

Very

unlikely

Localised

Short term

Reversible

Involuntary

Minimal

Insignificant

Spillage of

Human

health

Unlikely

Localised

Not expected

Short term

Reversible

Involuntary

Minimal

Insignificant

substance

during

Aquatic

environment

Unlikely

Localised

Short term

Reversible

Involuntary

Minimal

Insignificant

dispensing

and use

Terrestrial

Environment

Unlikely

Localised

Short term

Reversible

Involuntary

Minimal

Insignificant

Incorrect

Human

health

Unlikely

Localised

Not expected

Short term

Reversible

Involuntary

Minimal

Insignificant

disposal of

surplus

Aquatic

environment

Unlikely

Localised

Short term

Reversible

Involuntary

Minor

Insignificant

substance Terrestrial

Environment

Unlikely

Localised

Short term

Reversible

Involuntary

Minimal

Insignificant

24

Costs

Since Luna Devotion is intended to directly replace currently used foliar fungicides on onions,

with no adverse variation in risk relative to the existing products it can be regarded as cost neutral.

Identification of Benefits

Contains two active ingredients to help combat resistance management.

Saves tank mixing separate fungicides.

Both components in the formulation act systemically,

The inclusion of a new fungicidal group ( fluopyram ) increases the growers’ options in the matter of

managing resistance.

Luna Devotion is not expected to have any adverse effects on non-target plants when used as directed.

4.3 Provide an assessment of any particular risks, costs and benefits

which arise from the relationship of Maori and their culture and

traditions with their taonga, or which are, for other reasons, of

particular relevance to Maori.

In our judgement the importation and use of Luna Devotion will not adversely affect the natural resources

of the flora, fauna, waterways, land and culture of the indigenous Maori.

4.4 Provide an assessment of any risks, costs or benefits to New

Zea1and’s international obligations.

Luna Devotion is registered in Europe and elsewhere.

Residues in products exported to other countries will be accommodated by MRL’s established in those

countries and/or by the Codex Alimentarius. In any case the use rate and use timing of Luna Devotion will

ensure there are no residues in treated produce above the default MRL. Our international obligations are

satisfied.

25

4.5 Provide information on the proposed management of

the substance.

Luna Devotion is an agricultural fungicide which will be handled, stored, transported and used by persons

familiar with similar materials. Handled with care and according to the label we consider it represents a

low risk, both to humans and to the environment. It is our opinion that the warnings and precautions set out

on the label, are adequate to eliminate or mitigate the slight hazard posed by the product.

The overall management of the substance in respect of transport, storage, application and container disposal

will be in compliance with the Code of Practice for the Management of Agrichemicals. [ NZS 8409:2004 ]

Documentation to facilitate this will include the ready availability of the container label, Product Safety

Card and Material Safety Data sheet.

Transport / Storage

Luna Devotion has the following Dangerous Goods classification for Road /Sea Transport:

IMDG

UN-Number 3082

Class 9

Packaging group III

Marine pollutant

Description of the goods

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (FLUOPYRAM SOLUTION)

Luna Devotion conforms to the requirements of Schedule 4 of the Hazardous Substances. (Packaging)

Regulations 2001. We are advised by Bayer AG that the packaging for Luna Devotion is required to meet

a “drop-test” of 1.8 metres. Warehouse staff of proprietors and resellers are required to observe Codes of

Practice [ ISO 9002 or Growsafe ] while storing Luna Devotion, growers are also Growsafe accredited.

[ As per NZS 8409:2004 ]

Dispensing and use

The concentrated product is added to the spray tank and diluted with water, as per the label, prior to

application. Label statements warn: Toxic to aquatic organisms. Do not mix or load near any body of

water: avoid spray drift over, or spillage into open water. Avoid contamination of any water supply with

chemical or empty container.

Disposal of surplus substance

Advice regarding disposal is included on the label: “Disposal: Dispose of this product only by using

according to the label or at an approved landfill. Avoid contamination of any water supply with product or

empty container. Container Disposal: Triple rinse container and add residue to mixture. Take to an

Agrecovery collection site.

The value of the product is such as to discourage careless disposal.

26

4.6 Provide an overall evaluation of the combined impact of all of the risks,

costs and benefits set out in sections 4.2, 4.3 and 4.4.

4.6 Quantification Analysis of risks

Risk At risk Probability

of

occurrence

Degree of

effect

Risk score =

probability x

degree §

Level of

risk without

controls

Level of

risk with

controls

1 Oral

exposure

End user 1 1 1 negligible negligible

Storeman 1 1 1 negligible negligible

2 Dermal / eye

exposure



3 Inhalation

exposure



4 Food residues Consumer 1 1 1 negligible negligible

Water

contamination

Fish

invertebrates

Aquatic

plants

1

1

1

1

2

2

1

2

2

negligible

low

low

negligible

negligible

negligible

5 Soil

contamination

Soil micro

flora, fauna

1 1 1 negligible negligible

6 Non-target

species

Plants,

animals

1 1 1 negligible negligible

§ Scale: 1 = Negligible risk. 10 = Monitoring/ intervention required.

27

5.1 ERMA New Zealand 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.

Luna Devotion is registered in the USA, Europe, South America and elsewhere.

It is also being submitted to the ACVMG for registration under the ACVM Act.

Section 6.1 Glossary

Section 7.1 Name of the substance for the public register

Luna ® Devotion

Section 7.2 Purpose of the Application, for the public register

To import Luna Devotion as an agricultural fungicide for the control of white rot on onions.

7.3 Use Category

Main Category 3

Industry Category 1

Function/ Use 38

28

Section 7.4 Executive Summary

This is an application to import Luna Devotion into NZ for use as an agricultural fungicide. The product

will be formulated and packed overseas and contains : 250g/litre fluopyram +250g/litre triadimenol in the

form of a soluble concentrate.

Luna Devotion is recommended for application to onions for the control of White Rot applied as a foliar

spray. The label recommendation is to apply 1 litre of product , making two applications at monthly

intervals starting at 100-150 onion white rot degree days.

For purposes of resistance management it is recommended that Luna Devotion, or another DMI fungicide

should be applied no more than twice per crop, at recommended label rates.

Our estimation of the hazard classification of Luna Devotion is as follows:

6.1 C , 6.9 B , 9.1C, 9.3 C

With normal care during handling and application, and the observance of label directions we believe the

risks to users, consumers, bystanders and the environment are negligible.

In our judgement the importation and use of Luna Devotion will not adversely affect the natural resources

of the flora, fauna, waterways, land and culture of the indigenous Maori.

Following importation Luna Devotion will be handled, stored and transported by trained personnel,

experienced in the safe management of hazardous substances. The overall management of the substance in

respect of transport, storage, application and container disposal will be in compliance with the Code of

Practice for the Management of Agrichemicals. [ NZS 8409:2004 ] Documentation to facilitate this will

include the ready availability of the container label, Product Safety Card and Material Safety Data sheet.

In summary, the benefits of Luna Devotion are:

Contains two active ingredients to help combat resistance management.

Saves tank mixing separate fungicides.

Both components in the formulation act systemically,

The inclusion of a new fungicidal group ( fluopyram ) increases the growers’ options in the matter of

managing resistance.

Luna Devotion is not expected to have any adverse effects on non-target plants when used as directed.

29

CHECKLIST Mandatory sections filled out Yes Appendices enclosed Yes / NA Fees enclosed Yes Application signed and dated Yes

Signed Date

Max Moore, Technical & Regulatory Affairs Manager

import or manufacture any hazardous substance for … · 2019. 4. 6. · • common name...

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