3. Process, consultation and reasons for non-notification

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DECISION

8 October 2015

1. Summary

Substance Velum Prime

Application code APP202487

Application type To import or manufacture for release any hazardous substance under Section 28 of the Hazardous Substances and New Organisms Act 1996 (“the Act”)

Applicant Bayer New Zealand Limited

Purpose of the application To import Velum Prime, a nematicide containing 400 g/L fluopyram for the control of nematodes in carrots

Date application received 10 April 2015

Consideration date 8 October 2015

Further information was requested from the applicant during the evaluation and review of the application in accordance with section 58 of the Act and the consideration was postponed in accordance with section 59 of the Act

Considered by The Chief Executive¹ of the Environmental Protection Authority (“the EPA”)

Decision Approved with controls

Approval code HSR101067

Hazard classifications (refer to Table 1, Section 4)

6.9B (oral), 9.1C, 9.3C

1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with

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2. Background

2.1. Velum Prime is intended for use as a nematicide to control root knot nematode in carrots. It contains 400 g/L fluopyram in a soluble concentrate formulation.

2.2. The applicant intends to import Velum Prime into New Zealand fully formulated, packed and labelled in 1 L to 20 L High Density Poly Ethylene (HDPE) containers.

2.3. The product is intended to be applied at rates of up to 1250 mL/ha.

2.4. It is intended that the substance should be used completely i.e. until the container is emptied, to avoid a requirement for disposal.

2.5. Before disposing of the empty containers, users should triple rinse them and add the rinsate to the spray tank for application to crops requiring treatment. Empty containers can be recycled through AgRecovery (0800 247 326, www.agrecovery.co.nz) or crushed or punctured and sent to a landfill.

3. Process, consultation and reasons for non-notification

3.1. The application was lodged pursuant to section 28 of the Act.

3.2. I consider that, once outstanding information was provided by the applicant, the application contained sufficient information for an assessment of the substance to be undertaken.

3.3. WorkSafe New Zealand and the Ministry for Primary Industries (ACVM group) were advised of the application on 24 April 2015 and invited to comment. No comments were received.

3.4. In accordance with section 53(2) of the Act, the application was not publicly notified as it was

considered that there was unlikely to be significant public interest in it. This is because there are other approved products available on the market containing the same active ingredient that are intended for similar use as nematacides.

4. Hazardous properties

4.1. The staff determined the hazard classification of Velum Prime based on the information provided by the applicant and other available information as documented in Appendix B.

4.2. Information provided by the applicant included mammalian toxicity studies with Velum Prime (acute toxicity, skin and eye irritation, skin sensitisation), and a dermal absorption study. Ecotoxicological studies with Velum Prime were also provided (studies relating to the aquatic toxicity, acute toxicity to earthworms, and oral and contact acute toxicity to honeybees). Additional information relating to the environmental fate and behaviour, and ecotoxicity of fluopyram was used from a prior EPA risk assessment for application ERMA200863 (Luna Devotion, approval HSR100691). This information complemented new information obtained from the Review Report of the active ingredient fluopyram made by the EU Standing Committee on the Food Chain and Animal Health².

2 European Commission, Health and Consumers Directorate-General (2013). Review report for the active substance fluopyram.

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4.3. The classifications determined by the staff are different to those submitted by the applicant (Table 1).

The 6.9B classification is triggered by the active ingredient fluopyram and has been applied to Velum Prime. Differences in the 9.3 classification were due to differing interpretation of mixture rules.

4.4. I am satisfied with the hazard classifications identified by EPA staff as listed in Table 1 and accordingly confer them on this substance.

Table 1 Hazard classifications of Velum Prime as proposed by the applicant and the staff

Hazard Endpoint Applicant classification EPA classification

Target organ systemic toxicity (oral) - 6.9B

Aquatic ecotoxicity 9.1C 9.1C

Vertebrate ecotoxicity - 9.3C

5. Risk and benefit assessment

Assessment of risks to human health and the environment

5.1. There are already approved substances in New Zealand containing fluopyram, however, these substances are applied using a different use pattern and at a different application rate to that intended for Velum Prime.

5.2. A maximum application rate control was previously set for one of these approved substances, Luna Privilege (HSR100746). The maximum application rate set for that substance was 150 g fluopyram/ha, which is significantly lower than the application rate of 500 g fluopyram/ha proposed for Velum Prime.

5.3. Accordingly, the staff undertook a quantitative risk assessment of the proposed use pattern for Velum Prime to evaluate the potential for significant risk to human health and the environment when

fluopyram is applied at this higher application rate.

5.4. The quantitative risk assessment compared the anticipated levels of exposure to the substance against acceptable levels of exposure. These acceptable levels of exposure were determined from the staff’s analysis of the study data provided by the applicant for Velum Prime and other available

information. Summaries of these studies are included in Appendices C and D, and the detailed results of the exposure modelling are presented in Appendices E and F.

5.5. The identification and qualitative assessment of the risks to human health and the environment associated with Velum Prime are set out in Tables 2 and 3, respectively. More information is detailed in Appendices E, F, and G.

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Human health risk assessment

5.6. The results of the operator exposure modelling indicated that the predicted operator exposure during mixing, loading, and application of Velum Prime is below the Acceptable Operator Exposure Level (AOEL) even without the use of Personal Protective Equipment (PPE). While this result is

acknowledged I consider that it is appropriate to retain requirements for PPE since the use of PPE when handling agrichemicals is good practise.

5.7. The staff advised me that they considered their modelling of exposures to workers re-entering treated areas was likely to overestimate exposure. This is because the model used is based on an

assumption that workers will be in direct contact with treated foliage whereas Velum Prime is intended to be applied to soil prior to planting. Even though the potential for exposure may have been

overestimated, the predicted levels of exposure of re-entry workers are below the AOEL, and therefore considered acceptable.

5.8. Bystander exposures were also predicted to be substantially lower than the AOEL when modelled at the highest proposed application rate.

Environmental risk assessment

5.9. The quantitative environmental risk assessment concluded that risks for aquatic organisms, sediment- dwelling organisms, soil organisms, and non-target arthropods were below the level of concern.

5.10. Acute exposure risks for birds were found to be below the level of concern, but for chronic exposure high risks to birds were identified. The detailed results of the risk assessment are given in Appendix F.

5.11. The staff therefore advised me that the intended use pattern of the substance, prior to application of controls, could lead to non-negligible risks to the environment.

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Lifecycle Description Likelihood Magnitude Matrix Comment Level of risk Manufacture

and packaging

Target organ or system toxicity

Highly improbable

Moderate Negligible Manufacturing and packaging processes in New Zealand will be required to meet the HSNO requirements for equipment, PPE, emergency management and provision of information as well as WorkSafe New Zealand’s Health and Safety regulations. Compliance with these requirements make the likelihood of exposure that would lead to an adverse effect so highly improbable that the level of risk for these adverse effects is negligible.

Negligible

Importation, transport, storage, disposal

Target organ or system toxicity

Highly improbable

Moderate Negligible The target organ toxicity effect for fluopyram is for repeat dose oral toxicity, which is not expected to occur in these phases of the substance lifecycle.

Negligible

Use Target organ or system toxicity

A quantitative risk assessment was undertaken for the use phase of the lifecycle of Velum Prime. The key results are summarised in section 5 and detailed in Appendix E.

Negligible

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Lifecycle Description Likelihood Magnitude Matrix Comment Level of risk Manufacture,

importation, transport and storage

Death or adverse effects to aquatic or terrestrial organisms.

Highly improbable

Minor Negligible Provided the exercise of this approval is in adherence with the HSNO controls (and the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994 (as applicable)), the staff consider a spill to be highly improbable.

Negligible

Use (application)

Death or adverse effects to aquatic or terrestrial organisms.

A quantitative environmental risk assessment was undertaken for the use phase of the lifecycle of Velum Prime. The key results are summarised in section 5 and detailed in Appendix F.

Negligible

Disposal Death or adverse effects to aquatic or terrestrial organisms.

Highly improbable

Minor Negligible Users will in most cases utilise all of the substance by its normal use as a nematicide. All cases of disposal are required to be in accordance with the requirements of the Hazardous Substances (Disposal) Regulations 2001.

Negligible

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Relationship of Māori to the environment

5.12. The staff have advised me that Velum Prime triggers a number of hazardous properties giving rise to the potential for cultural risk e.g. those arising from target organ/systemic toxicity, aquatic ecotoxicity, and vertebrate ecotoxicity. Cultural risk includes the deterioration of the mauri of taonga flora and fauna species, the environment and the general health and well-being of individuals and the community.

5.13. In general, the introduction and use of hazardous substances has the potential to inhibit the ability of Māori to fulfil their role as kaitiaki. This is particularly in relation to the guardianship of waterways, given the ecotoxic nature of some substances to aquatic species, and potential risks to the mauri of human health under prolonged exposure to some substances.

5.14. The main concerns relating to this application for Māori are likely to be in relation to dangers to birds, as a result of the quantitative risk assessment showing the potential for non-negligible risks to birds from chronic exposure to Velum Prime. Māori traditional matauranga systems value New Zealand’s native birds as taonga. Māori attribute cultural and spiritual values to birds in addition to some birds being considered traditionally cherished cuisine. Therefore there is the potential for cultural risk arising from harm to birds.

5.15. The controlled use of Velum Prime is not expected to breach the principles of the Treaty of Waitangi.

Assessment of risks to society and the community and the market economy

5.16. The staff did not identify any risks associated with the approval of Velum Prime to society, communities or the market economy.

5.17. There are not expected to be any significant adverse impacts on the social environment with the controlled use of Velum Prime, apart from the health effects and environmental effects already discussed. Consequently, I consider that this aspect of potential risk need not be considered further.

New Zealand’s international obligations

5.18. The staff did not identify international obligations that may be impacted by the approval of Velum Prime.

Overall assessment of risks

5.19. Based on the results of the staff risk assessment I consider that, with compliance with the controls in place, the risks to human health associated with Velum Prime are mitigated and therefore negligible.

5.20. There are potential non-negligible risks to birds associated with chronic exposure to Velum Prime.

5.21. This potential non-negligible risk also gives rise to the potential for cultural risk to Māori as a result of the potential non-negligible risks to native birds.

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5.22. I consider that in order to mitigate these risks it is necessary to impose additional controls designed to reduce the risks to birds. The controls applied to Velum Prime are discussed in section 6 below.

5.23. The risks to the environment for other species, and the acute risks to birds, were determined to be below the level of concern in the quantitative risk assessment. I consider that these environmental risks associated with Velum Prime will be negligible.

Identification of benefits

5.24. According to the applicant, the approval of Velum Prime will provide the following benefits:

 higher crop yields from the control of nematodes in carrots

 the availability of another product for control of nematodes, providing another option for farmers

 Velum Prime has a lower hazard profile than other products containing fluopyram.

The effects of the substance being unavailable

5.25. The staff advised me that the likely effects of the substance being unavailable relate to less consumer choice resulting in less competitive pricing. This is because similar products for nematode control are available on the New Zealand market.

Overall assessment of benefits

5.26. I am satisfied that the availability of Velum Prime will provide beneficial economic effects for some businesses and individual farmers as well as flow-on effects to local communities and the New Zealand economy.

6. Controls

6.1. Based on the hazard classification determined for Velum Prime, a set of associated default controls specified by regulations under the Act has been identified as being applicable to Velum Prime. The default controls form the basis of the controls set out in Appendix A. Based on the risk assessment, it is considered that the following exposure limits are relevant and that the additions and variations to the default controls set out below should be applied to Velum Prime.

The setting of exposure limits

6.2. Tolerable Exposure Limits (TELs), Acceptable Daily Exposures (ADEs) and Potential Daily Exposures (PDEs) can be set to limit hazardous substances from entering the environment in quantities sufficient to present a risk to people. No TELs have been set for any component of Velum Prime at this time as the risk of adverse effects to human health have been estimated to be negligible, provided users demonstrate compliance with the controls as set out in Appendix A. However, the EPA is required to set ADE and PDE values for new active ingredients that may become present in food to allow the

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setting of Maximum Residue Level values (MRLs) by the Ministry for Primary Industries. The following ADE and PDE values were previously set for fluopyram:

ADE: 0.012 mg/kg bw/d PDEfood: 0.0084 mg/kg bw/d PDEdrinking water: 0.0024 mg/kg bw/d PDEother: 0.0012 mg/kg bw/d

6.3. Workplace exposure standards (WESs) can be set to limit exposure of people to toxic substances in places of work. The EPA typically adopts WES values listed in the WorkSafe New Zealand Workplace Exposure Standards document (effective from February 2013):

http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure- standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices- 2013.pdf

WorkSafe New Zealand has set WES values for Component E of Velum Prime. I consider these values to be applicable to Velum Prime.

6.4. Environmental Exposure Limits (EELs) can be set to limit hazardous substances from entering the environment in quantities sufficient to present a risk to it. No EELs are set for any component of Velum Prime at this time as the risk of adverse effects to the environment has been qualitatively assessed as negligible, provided users demonstrate compliance with the controls as set out in Appendix A. The default EEL values are deleted.

6.5. Restrictions on the application of hazardous substances within application areas can be set if an EEL value has been set for them. As no EEL values have been set for any component of Velum Prime, a maximum application rate is not able to be set under this regulation. However, the staff have advised me that the environmental exposure modelling indicates that there may be a risk where the substance is used outside the specific parameters used in the risk assessment. It is therefore considered

appropriate to set maximum application rates under section 77A.

Additional controls

6.6. Due to the proposed use pattern of Velum Prime, the staff determined that significant environmental exposure may potentially occur. It is therefore necessary to put restrictions on application of Velum Prime to mitigate the risk of death or adverse effects to aquatic and terrestrial organisms. Accordingly, it is considered that the application of controls addressing these risks will be more effective than the default controls in terms of their effects on the management, use and risks of the substance.

Consequently, the following additional controls are applied to Velum Prime to restrict the level of risk to the environment:

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 Velum Prime must not be applied into or onto water³

 Velum Prime shall be applied via ground-based methods only⁴

6.7. The quantitative risk assessment identified potential risks to birds from chronic exposure to Velum Prime. The staff have advised me that to mitigate this risk it is appropriate to apply controls prescribing approved handler requirements to Velum Prime. On the basis of this risk assessment, and because the approved handler requirements are not triggered by default by the hazard classification of Velum Prime, I consider that it is appropriate to apply the approved handler controls (control codes E7 and AH1) under section 77 of the Act. I note that the need to apply the approved handler control arises solely as a consequence of risks associated with the ecotoxicity of Velum Prime, specifically chronic risks to birds, and not the toxicity to human health. For this reason I consider that the requirements of this control can be modified to apply only when the substance is applied in a wide dispersive manner (e.g. when sprayed on large areas such as crops) or by a commercial contractor. The variation to the E7 control is shown in Appendix A.

6.8. As noted in 6.5 above, I consider it appropriate to set a maximum application rate and a minimum interval between applications as an additional control under section 77A. The following control is applied to Velum Prime:

The maximum application rate for this substance is set at 1.25 L of formulated substance/ha (equivalent to 500 g fluopyram/ha), with a maximum of one application to the same area in any 365 day period.

6.9. I consider that an important aspect to ensuring environmental risks are well managed is to ensure that users of the substance are aware of the restrictions on the maximum application rate and the

minimum interval between repeat applications. In order to ensure this information is conveyed to users an additional control is applied to Velum Prime requiring that this information be included on the label for the substance. The control specifying additional label information is described in Appendix A.

6.10. The staff have advised me that the default controls do not address the risks associated with storage or use of the substances within stationary container systems (e.g. tanks). These risks include the failure of primary containment resulting in a large spill of the substance into the environment. In addition, the default controls do not allow for dispensation where it is unnecessary for any pipework associated with the stationary container systems to have secondary containment. Accordingly, controls addressing these risks are considered more effective than the default controls in terms of their effect on the management, use and risks of the substance. The revised controls are shown in Appendix A.

3 Where ‘water‘ means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application.

4 Ground-based methods of applying pesticides include, but are not limited to, application by ground boom, airblast or knapsack, and do not include aerial application methods

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Variation and deletion of controls

6.11. The default controls include requirements for secondary containment of pooling substances. It is considered that the risks associated with the containment of substances which are not class 1 to 5 substances (i.e. do not ignite or explode) are different to those associated with class 1 to 5

substances. Consequently the secondary containment requirements can be reduced for Velum Prime.

It is considered that these reduced secondary containment measures are adequate to manage the risks of a spillage of Velum Prime. Therefore, the proposed variation is more cost-effective in terms of managing the risks of the substance. The revised controls are shown in Appendix A.

Review of controls for cost-effectiveness

6.12. I consider that the proposed controls, provided they are complied with, are the most cost-effective means of managing the identified potential risks associated with this application. The applicant was given an opportunity to comment on the proposed controls as set out in this decision. The applicant indicated that they had no concerns with the proposed controls.

Mitigation of risks

6.13. The staff have advised me that the controls applied to Velum Prime, including additional controls applying an approved handler requirement for wide dispersive use, prohibiting application into or onto water, and restriction to ground-based methods of application, will reduce the likelihood of chronic exposure of Velum Prime to birds so that the level of risk is negligible.

6.14. I consider that with controls in place, the risk to taonga bird species will be negligible. As a result, the potential cultural risk to Māori that could arise as a result of harm to bird species will be mitigated.

6.15. Based on the information provided, with the controls in place, I consider that the risks to Māori culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga will be mitigated so that significant impacts are not anticipated.

Environmental user charges

6.16. I consider that applying controls on Velum Prime is an effective means of managing risks associated with this substance. I consider that it is not necessary to apply environmental user charges to this substance as an alternative or additional means of achieving effective risk management.

7. Conclusion

7.1. Taking into account the staff assessment of the potential risks and benefits associated with Velum Prime, I consider that, with controls in place:

 the risks to human health and the environment arising from the hazardous properties and the use of Velum Prime are negligible

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 significant adverse impacts on the social or economic environment from the use of Velum Prime are not anticipated

 significant impacts on Māori culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga that will breach the principles of the Te Tiriti o Waitangi/Treaty of Waitangi are not anticipated

 benefits will be derived for New Zealand by allowing the use of Velum Prime

8. Decision

8.1. Pursuant to section 29 of the Act, I have considered this application to import a hazardous substance for release made under section 28 of the Act. In doing so, I have applied the relevant sections of the Act and clauses of the Hazardous Substances and New Organisms (Methodology) Order 1998 (“the Methodology”).

8.2. I am satisfied with the hazard classifications identified by the staff in Table 1 (Section 4) and accordingly confer them on Velum Prime.

8.3. I consider that, with controls in place, the risks to human health and to the environment are negligible, and there will be benefits associated with the release of Velum Prime. Therefore, I consider that the application may be approved in accordance with clause 26, with the controls proposed by the staff and documented in Appendix A.

8.4. The importation of the hazardous substance, Velum Prime, is thus approved with controls as listed in Appendix A. I am also satisfied that, as the manufacture of Velum Prime would not impose any additional risks over the importation of the substance, this approval should apply to both importation and manufacture of Velum Prime.

Dr Allan Freeth Date: 8 October 2015

Chief Executive, EPA

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Appendix A: Controls applying to Velum Prime

Notes: The controls for this substance apply for the indefinite duration of the approval of this substance.

Please refer to the Hazardous Substances Regulations⁵ for the requirements prescribed for each control and the modifications listed as set out in Section 6 of this document.

Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001

Code Regulation Description Variation

T1 Regs 11 – 27 Limiting exposure to toxic substances through the setting of TELs

No TEL values have been set for any component of Velum Prime at this time.

T2 Regs 29, 30 Controlling exposure in places of work through the setting of WESs.

A WES value has been set for Component E of Velum Prime as detailed in the Workplace Exposure Standards document:

http://www.business.govt.nz/worksafe/info rmation-guidance/all-guidance-

items/workplace-exposure-standards-and- biological-exposure-indices/workplace- exposure-standards-and-biological- indices-2013.pdf

T4 Reg 7 Requirements for equipment used to handle substances

T5 Reg 8 Requirements for protective clothing and equipment

E1 Regs 32 – 45 Limiting exposure to ecotoxic substances through the setting of EELs

No EEL values are set at this time and the default EELs are deleted

E2 Regs 46 – 48 Restrictions on the application of substances within application areas

Maximum application rates have been set under section 77A for this substance E6 Reg 7 Requirements for equipment used to

handle substances

E7 Reg 9 Approved handler/security requirements for certain ecotoxic substances

The following control is substituted for Reg 9(1) of the Hazardous Substances (Classes 6,8 and 9 Controls) Regulations 2001:

(1) This substance must be under the personal control of an approved handler when the substance is:

(a) applied in a wide dispersive⁶ manner; or

5 The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz

6 'wide dispersive' use refers to activities which deliver uncontrolled exposure - also refer to:

http://www.epa.govt.nz/Publications/ER-IS-33-2.pdf

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(b) used by a commercial contractor.

Hazardous Substances (Identification) Regulations 2001

I1 Regs 6, 7, 32 – 35, 36(1) – (7)

Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability I3 Reg 9 Priority identifiers for ecotoxic substances I9 Reg 18 Secondary identifiers for all hazardous

substances

I11 Reg 20 Secondary identifiers for ecotoxic substances

I16 Reg 25 Secondary identifiers for toxic substances

I17 Reg 26 Use of generic names

I18 Reg 27 Requirements for using concentration ranges

I19 Regs 29 – 31 Additional information requirements, including situations where substances are in multiple packaging

I21 Regs 37 – 39, 47 – 50

General documentation requirements

I23 Reg 41 Specific documentation requirements for ecotoxic substances

I28 Reg 46 Specific documentation requirements for toxic substances

I29 Regs 51, 52 Signage requirements

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Hazardous Substances (Packaging) Regulations 2001

P1 Regs 5, 6,

7(1), 8

General packaging requirements

P3 Reg 9 Criteria that allow substances to be packaged to a standard not meeting Packing Group I, II or III criteria

PG3 Schedule 3 Packaging requirements equivalent to UN Packing Group III

PS4 Schedule 4 Packaging requirements as specified in Schedule 4

Hazardous Substances (Disposal) Regulations 2001

D4 Reg 8 Disposal requirements for toxic and corrosive substances

D5 Reg 9 Disposal requirements for ecotoxic substances

D6 Reg 10 Disposal requirements for packages D7 Regs 11, 12 Information requirements for

manufacturers, importers and suppliers, and persons in charge

D8 Regs 13, 14 Documentation requirements for manufacturers, importers and suppliers, and persons in charge

Hazardous Substances (Emergency Management) Regulations 2001

EM1 Regs 6, 7, 9 – 11

Level 1 information requirements for suppliers and persons in charge EM7 Reg 8(f) Information requirements for ecotoxic

substances EM8 Regs 12 – 16,

18 – 20

Level 2 information requirements for suppliers and persons in charge EM11 Regs 25 – 34 Level 3 emergency management

requirements: duties of person in charge, emergency response plans

EM12 Regs 35 – 41 Level 3 emergency management requirements: secondary containment

The following subclauses are added after subclause (3) of regulation 36:

(4) For the purposes of this regulation,

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and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it—

(a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in

a secondary containment system.

(5) In this clause, pipework—

(a) means piping that—

(i) is connected to a stationary container; and

(ii) is used to transfer a hazardous substance into or out of the stationary container; and

(b) includes a process pipeline or a transfer line.

The following subclauses are added to the end of regulation 37:

(2) If pooling substances which do not have class 1 to 5 hazard

classifications are held in a place above ground in containers each of which has a capacity of 60 litres or less—

(a) if the place’s total pooling potential is less than 20,000 litres, the secondary

containment system must have a capacity of at least 25% of that total pooling potential:

(b) if the place’s total pooling potential is 20,000 litres or more, the secondary

containment system must have a capacity of the greater of—

(i) 5% of the total pooling potential; or

(ii) 5,000 litres.

(3) Pooling substances to which

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subclause (2) applies must be segregated where appropriate to ensure that leakage of one

substance may not adversely affect the container of another substance.

The following subclauses are added to the end of regulation 38:

(2) If pooling substances which do not have class 1 to 5 hazard

classifications are held in a place above ground in containers 1 or more of which have a capacity of more than 60 litres but none of which have a capacity of more than 450 litres—

(a) if the place’s total pooling potential is less than 20,000 litres, the secondary

containment system must have a capacity of either 25% of that total pooling potential or 110%

of the capacity of the largest container, whichever is the greater:

(b) if the place’s total pooling potential is 20,000 litres or more, the secondary

containment system must have a capacity of the greater of—

(i) 5% of the total pooling potential; or

(ii) 5,000 litres

(3) Pooling substances to which subclause (2) applies must be segregated where appropriate to ensure that the leakage of one substance may not adversely affect the container of another substance.

EM13 Reg 42 Level 3 emergency management requirements: signage

Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004

Tank Wagon

Regs 4 to 43 as applicable

Controls relating to tank wagons and transportable containers

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Hazardous Substances and New Organisms (Personnel Qualifications) Regulations 2001

AH1 4 - 6 Approved Handler requirements (including test certificate and qualification

requirements)

Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004

Sch 8 Schedule 8 This schedule prescribes the controls for stationary container systems. The requirements of this schedule are detailed in the consolidated version of the

Hazardous Substances (Dangerous Goods and Schedule Toxic Substances) Transfer Notice 2004, available from http://www.epa.govt.nz/Publications/Trans fer-Notice-35-2004.pdf

The following clause replaces Clause 1 of Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004:

(1) This Schedule applies to every stationary container system that contains, or is intended to contain the substance.

Additional controls

Code Section of the Act

Control

Water 77A This substance must not be applied into or onto water⁷.

App Method

77A This substance may only be applied via ground-based application methods⁸.

App Rate 77A The maximum application rate for this substance is set at 1.25 L of formulated

substance/ha (equivalent to 500 g fluopyram/ha), with a maximum of one application to the same area in any 365 day period.

Label 77A The following statements, or words to this effect, must appear on the label of any package containing this substance:

The maximum application rate for this substance is set at 1.25 L of formulated

substance/ha (equivalent to 500 g fluopyram/ha), with a maximum of one application to the same area in any 365 day period.

7 where ‘water‘ means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application.

8 Ground-based methods of applying pesticides include, but are not limited to, application by ground boom, airblast or knapsack, and do not include aerial application methods.

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Appendix B: Staff classification of Velum Prime

Formulation data were provided for some endpoints for Velum Prime. Classification for endpoints where data were not provided was estimated using information on the effects of the individual components and mixture rules.

The mixture rules used for classifying substances can be found in the User Guide to Thresholds and Classifications⁹.

The classifications of Velum Prime are shown in Table B1.

Data quality – overall evaluation

The EPA has adopted the Klimisch et al (1997)¹⁰ data reliability scoring system for evaluating data used in the hazard classification and risk assessment of chemicals.

The staff acknowledge that there are frequently data gaps in the hazard classification for chemicals which have been in use internationally for a long time. International programmes such as the OECD High Production Volume programme¹¹, REACH¹², and European Regulation 1107/2009/EC¹³ are progressively working towards filling these data gaps. As new information becomes available, staff will update the Hazardous Substances and New Organisms (HSNO) classifications for those substances.

Table B1 Applicant and Staff classifications of the mixture

Hazard Class/Subclass

Mixture classification Method of classification

Remarks Applicant’s

classification

Staff’s classification

Mixture data Read across Mixture rules14

Class 1 Explosiveness No No

Class 2, 3 & 4 Flammability No No Class 5 Oxidisers/Organic

Peroxides No No

Subclass 8.1 Metallic

corrosiveness No ND

Subclass 6.1 Acute toxicity (oral) No No

9http://www.epa.govt.nz/Publications/ER-UG-03-2.pdf

10 Klimisch, H-J., Andrear, M., & U. Tillmann, 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Reg. Toxicol. Pharmacol. 25, 1–5 (1997)

11 http://www.icca-chem.org/Home/ICCA-initiatives/High-production-volume-chemicals-initiative-HPV/

12 http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

13 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF

14 Use of mixture rules may not adequately take into account interactions between different components in some circumstances and must be considered of lower reliability than data on the mixture itself.

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classification

Subclass 6.1Acute toxicity

(dermal) No No

Subclass 6.1 Acute toxicity

(inhalation) No No

Subclass 6.1 Aspiration hazard No No

No components of concern &

kinematic viscosity

> 14 mm²/s Subclass 6.3/8.2 Skin

irritancy/corrosion No No

Subclass 6.4/8.3 Eye

irritancy/corrosion No No

Subclass 6.5A Respiratory

sensitisation No ND

Subclass 6.5B Contact

sensitisation No No

Subclass 6.6 Mutagenicity No ND

Subclass 6.7 Carcinogenicity No ND

Subclass 6.8 Reproductive/

developmental toxicity No ND

Subclass 6.8 Reproductive/

developmental toxicity (via lactation)

No ND

Subclass 6.9 Target organ

systemic toxicity No 6.9B (oral)

Fluopyram It is not clear why the applicant did not propose 6.9B.

This classification must be applied based on mixture rules.

Subclass 9.1 Aquatic ecotoxicity 9.1C 9.1C Fluopyram

Subclass 9.2 Soil ecotoxicity - No

Subclass 9.3 Terrestrial - 9.3C Fluopyram

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classification

vertebrate ecotoxicity Subclass 9.4 Terrestrial

invertebrate ecotoxicity - No

-: No information provided by the applicant

NA: Not Applicable --> For instance when testing is technically not possible: testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion or the radio-labelling of the substance required in certain studies may not be possible.

ND: No Data or poor quality data (according to Klimisch criteria¹⁵) --> There is a lack of data for one or more components.

No: Data are available for the formulation or for all components and classification is not triggered.

15 Klimisch, H-J., Andrear, M., & U. Tillmann, 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Reg. Toxicol. Pharmacol. 25, 1–5 (1997)

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Appendix C: Mammalian toxicity – Robust study summaries for the formulation

¹⁶

The technical name of the substance to be marketed as Velum Prime is Fluopyram SC 400 G. This name is used in the study summaries below.

Acute toxicity [6.1]

Acute Oral Toxicity [6.1 (oral)]

Type of study Acute oral toxicity in the rat

Flag Key Study

Test Substance FLUOPYRAM SC 400 G

Endpoint LD50, signs of toxicity

Value > 2000 mg/kg bw

Reference

Matting E 2013 FLUOPYRAM SC 400 (400 g/L) - Acute Oral Toxicity Study in Rats. CiToxLAB Hungary Ltd., H-8200 Veszprém, Szabadságpuszta, Hungary.

Study code: 13/277-001P; Activity ID: TXGMP191.

Klimisch Score 1

Amendments/Deviations None

GLP Yes

Test Guideline/s

OECD 423 (2001); EPA OPPTS 870.1100 (1998); EC 440/2008 Method B.1. Tris (2008)

Species Rat

Strain RccHan:(WIST)

No/Sex/Group 3 F

Dose Levels 2000 mg/kg bw

Exposure Type Oral gavage

Study Summary

Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw.

No mortality was observed in this group and a second group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group; therefore no further testing was required.

Treatment with FLUOPYRAM SC 400 G caused decreased activity (6/6), hunched back (6/6), incoordination (5/6), prostration/prone position (3/6), decreased general body tone (6/6) and piloerection (6/6). All animals were symptom free 3 days after the treatment.

Body weight and body weight gain of treated animals showed no indication of a

16 Standard terms and abbreviations are explained in Appendix I

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treatment-related effect.

No macroscopic observations were seen in animals after the termination of the study on Day 14.

Additional Comments

The clinical signs of toxicity are not considered to be of sufficient severity or duration to warrant a 6.1E classification.

Conclusion Test data for the substance do not trigger classification for acute oral toxicity (LD50: > 2000 mg/kg bw)

Acute Dermal Toxicity [6.1 (dermal)]

Type of study Acute dermal toxicity in the rat

Flag Key study

Endpoint LD50,signs of toxicity

Value > 2000 mg/kg bw

Reference

Matting E 2013 FLUOPYRAM SC 400 (400 g/L) - Acute Dermal Toxicity Study in Rats. CiToxLAB Hungary Ltd., H-8200 Veszprém, Szabadságpuszta, Hungary.

Study code: 13/277-002P; Activity ID: TXGMP189.

Klimisch Score 1

GLP Yes

Test Guideline/s OECD 402 (1987); EPA OPPTS 870.1200 (1998); EC 440/2008 (2008)

Species Rat

Strain RccHan:(WIST)

No/Sex/Group 5M & 5F

Dose Levels 2000 mg/kg bw

Exposure Type Application to shaved skin; semi-occlusive patch

Study Summary

A limit test was carried out at 2000 mg/kg bw in both sexes. The test item was administered by a single semi-occlusive dermal application for a 24 hour exposure period. At the end of the exposure period, residual test item was removed using body temperature water.

No mortality occurred during the course of the study. No local dermal signs or systemic clinical signs of toxicity were observed after treatment with the test item during the 14 days observation period.

There were no treatment-related effects on body weight or body weight gain and there was no evidence of any macroscopic observations on necropsy at the end of

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the study.

Additional Comments None Conclusion

Test data for the substance do not trigger classification for acute dermal toxicity (LD50: > 2000 mg/kg bw)

Acute Inhalation Toxicity [6.1 (inhalation)]

Type of study Acute inhalation toxicity in the rat

Flag Key study

Endpoint LC50, signs of toxicity

Value > 3.34 mg/L

Reference

Mátyás A 2014 FLUOPYRAM SC 400 (400 g/L) - Acute Inhalation Toxicity Study (Nose-only) in the Rat. CiToxLAB Hungary Ltd., H-8200 Veszprém,

Szabadságpuszta, Hungary. Amended Final Report No. 1. Study code: 13/277- 004P. Activity ID: TXGMP188

Klimisch Score 1

Amendments/Deviations None considered to affect the conclusions of the study

GLP Yes

Test Guideline/s OECD 403 (2009); EPA OPPTS 870.1300 (1998); EC 440/2008, Annex Part B, B.2 (2008)

Species Rat

Strain Wistar Crl:WI

No/Sex/Group 5M & 5F (1M & 1F used in sighting study)

Dose Levels

Sighting study: 3.77 mg/L; Mass Median Aerodynamic Diameter (MMAD) and Geometric Standard Deviation (GSD): 3.79 and 2.11 respectively

Main study: 3.34 mgL; MMAD and GSD: 3.70 and 2.15 respectively Exposure Type Nose only, 4 hour exposure

Study summary

Wistar Crl:WI rats were exposed to a test atmosphere of FLUOPYRAM SC 400 (400g/L) at a maximum feasible concentration for 4 hours using a nose-only exposure system. The test item was diluted to 50% w/w concentration with water and then administered as a liquid aerosol.

The study was performed in two steps. A sighting exposure was performed first, where a test atmosphere at a concentration of 3.77 mg/L was tested on single animals of both sexes (Group 0.1). No lethality was observed at this

concentration. Thereafter the main study was performed at a concentration of 3.34

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mg/L. Five male and five female rats were used in the main group (Group 1).

No mortality occurred in either the sighting study or the main study. Laboured respiration (slight to moderate) was observed on the day of exposure in all animals of the study. Slight ataxia and hunched back were also noted in a single female rat in Group 1 on Day 0.

Additionally, wet fur in all rats and red-brown staining or ruffled fur were recorded in several animals on Day 0-1. These observations were considered to be related to the restraint and exposure procedures and were considered not to be

toxicologically significant.

All rats were symptom-free from Day 2 in the sighting group and from Day 1 in the main group.

Slight bodyweight loss (up to 2.4 %) or retardation in bodyweight gain was recorded in all exposed animals with the exception of 3 females of Group 1. All animals showed body weight gains from Day 7 in Group 0.1 and from Day 3 in Group 1.

No external or internal finding was recorded at necropsy in Group 0.1 or Group 1.

Additional Comments None Conclusion

Test data for the substance do not trigger classification for acute inhalation toxicity (LC50: > 3.34 mg/L)

Skin Irritation [6.3/8.2]

Type of study Skin irritation in the rabbit

Flag Key study

Endpoint Skin irritation (Mean 24, 48 & 72 hours Draize scores) Value Not irritating (Erythema: 0.00; Oedema 0.00)

Reference

Matting E 2013 FLUOPYRAM SC 400 (400 g/L) - Acute Skin Irritation Study in Rabbits. CiToxLAB Hungary Ltd., H-8200 Veszprém, Szabadságpuszta, Hungary.

Study code: 13/277-006N; Activity ID: TXGMP186.

Klimisch Score 1

Amendments/Deviations None considered to have an impact on the conclusions of the study

GLP Yes

Test Guideline/s OECD 404 (2002); EPA OPPTS 870.2500 (1998); EC 440/2008, Annex Part B, B.4 (2008)

Species Rabbit

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Strain New Zealand White

No/Sex/Group 3M

Dose Levels 0.5 mL

Exposure Type Semi occlusive patch to clipped skin for 4 hours

Study Summary

At the observation time points, 1, 24, 48 and 72 hours after patch removal, there were no local signs on the skin of the treated animals. As no local signs were observed, the study was terminated after the 72-hour observation.

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.

Additional Comments None

Conclusion Test data for the substance do not trigger classification for skin irritation/corrosion.

Eye Irritation [6.4/8.3]

Type of study Eye irritation in the rabbit

Flag Key study

Endpoint Eye irritation (Mean 24, 48 & 72 hours Draize scores) Value

Not irritating (Corneal opacity: 0.00; Iritis: 0.00; Conjunctival redness: 2/9 = 0.22; Conjunctival oedema (chemosis): 1/9 = 0.11)

Reference

Matting E 2013 FLUOPYRAM SC 400 (400 g/L) - Acute Eye Irritation Study in Rabbits. CiToxLAB Hungary Ltd., H-8200 Veszprém, Szabadságpuszta, Hungary. Study code: 13/277-005N; Activity ID:

TXGMP187.

Klimisch Score 1

GLP Yes

Test Guideline/s

OECD 405 (2012); EPA OPPTS 870.2400 (1998); EC No 440/2008, B.5 (2008)

Species Rabbit

Strain New Zealand White

No/Sex/Group 3M

Dose Levels 0.1 mL

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Exposure Type Instillation in the conjunctival sac

Study Summary

Rabbits were administered systemic analgesia and topical anaesthesia as per the OECD Test Guideline. The test item was placed into the

conjunctival sac of the left eye of each animal. The untreated right eye served as control. A single volume of 0.1 mL of the test item was administered as a single dose. The treated eyes were rinsed at the one hour observation time point as irritation was observed.

The test item caused conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 48 hours. There were no corneal effects observed in the study.

No mortality was observed during the study and the body weight and body weight changes were considered to be normal with no indication of any treatment-related effect. There were no clinical signs of systemic toxicity observed that could be related to treatment.

Mean 24, 48 & 72 hour Draize scores:

Corneal opacity: 0.00 Iritis: 0.00

Conjunctival redness: 2/9 = 0.22

Conjunctival oedema (chemosis): 1/9 = 0.11 Additional Comments None

Conclusion

Test data for the substance do not trigger classification for eye irritation/corrosion

Contact Sensitisation [6.5]

Type of study Skin sensitisation in the mouse (Local Lymph Node Assay)

Flag Key study

Endpoint Sensitisation (stimulation index for lymph node proliferation)

Value Not sensitising (stimulation indices below the threshold for classification)

Reference

Hargitai J 2014 FLUOPYRAM SC 400 (400 g/L) – Local Lymph Node Assay in the Mouse. CiToxLAB Hungary Ltd., H-8200 Veszprém, Szabadságpuszta, Hungary.

Final Report Amendment No 1. Study code: 13/277-037E; Activity ID: TXGMP192.

Klimisch Score 1

Amendments/Deviations None considered to impact on the conclusions of the study

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GLP Yes

Test Guideline/s OECD 429 (2010); EPA OPPTS 870.2600 (2003); EC No 440/2008, B.42 (2008)

Species Mouse

Strain CBA/J Rj

No/Sex/Group Preliminary irritation/toxicity test: 2F Main study: 5F

Dose Levels

FLUOPYRAM SC 400 G: 100% (undiluted), 50 and 25% (w/v) in 1% Pluronic Negative control: 1% Pluronic

Positive control: 25% (w/v) α-Hexylcinnamaldehyde (HCA) in 1% Pluronic Exposure Type Topical application to the dorsal surface of each ear

Study Summary

Based on the results of the preliminary irritation/toxicity test, test substance concentrations of 100, 50 and 25% (w/v) were selected for the main study.

No mortality or signs of systemic toxicity were observed during the study. Test item precipitate/minimal amount of test item precipitate was observed on the ears of the animals in the 100% group on Days 1-6 and in the 50% group on Days 1-3.

No treatment related effects were observed on animal body weights in any test item treated groups.

The observed stimulation index values were 0.7, 0.5 and 0.6 at concentrations of 100, 50 and 25%, respectively.

The positive control (α-Hexylcinnamaldehyde 25% (w/v) dissolved in 1% Pluronic) was used to demonstrate the appropriate performance of the assay. A significant lymphoproliferative response (stimulation index value of 5.2) was noted for the positive control chemical and this result confirmed the validity of the assay.

In conclusion, under the conditions of the present assay FLUOPYRAM SC 400 G was shown to have no sensitisation potential (non-sensitiser) in the Local Lymph Node Assay.

Additional Comments

At the radio-label counting stage there was a higher degree of fluctuations than usual in the signals of some samples at the time of the measurement indicated in the Study Plan, most probably due to factors like quenching¹⁷. Visual turbidity was not seen in any of the samples. In order to be sure of adequate data, the whole set of samples (including the background vials and the samples of the negative and positives control groups) were re-measured several times (within seven days after the preparation) to get analysable data. Based on the half-life of the ³H isotope (over 12 years), this difference could not influence the activity of the samples in a measurable manner. In the report, the mean DPM values are shown,

17 Quenching refers to the loss of radioactive energy emission counts which may result from interference from a variety of components in a sample; e.g. due to chemicals that absorb radioactive energy before it is converted to light, or coloured compounds that absorb light in the range of the wavelength emitted by the scintillator.

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but all the data of the individual measurements are kept and archived in the raw data binder. This fact was considered not to adversely affect the results or integrity of the study.

Staff note that two animals in the positive control group showed lower than usual DPN values (radioactive disintegrations per minute [DPM] divided by the number of lymph nodes). However, it was considered that the overall results of the positive control group demonstrated the appropriate performance of the assay. The observed mean DPN values for the negative (vehicle) and positive controls were within the historical control range.

Conclusion

Test data for the substance do not trigger classification for contact sensitisation

General conclusion about acute toxicity classification

FLUOPYRAM SC 400 G is of low acute toxicity by the oral, dermal and inhalation routes and does not trigger classification. FLUOPYRAM SC 400 G is not irritating to the skin or eyes and is not a skin sensitiser and no classification is required for these endpoints.

Dermal absorption

The applicant provided an in vitro dermal absorption study for fluopyram in Velum Prime (referred to in the study report as Fluopyram SC 400). This study is summarised below.

Type of study In vitro dermal absorption

Flag Key Study

Test Substance [¹⁴C]-Fluopyram in the formulation Fluopyram SC 400

Reference

Muhamedi A 2014, FLUOPYRAM SC 400: [¹⁴C]-FLUOPYRAM: In vitro dermal absorption study using human skin. Bayer S.A.S., Bayer CropScience, 355, rue Dostoϊevski, BP 153, 06903 Sophia Antipolis Cedex, France. Study ID: SA 13086; Bayer ID: M-479218-01-1.

Klimisch Score 1

GLP Yes

Test Guideline/s OECD 428 (2004)

Test system

The test substance was applied to non-occluded split-thickness human and rat skin membranes mounted in flow-through diffusion cells in-vitro.

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Number of replicates 6 replicates per dose level

Dose Levels

Concentrated product (400 g fluopyram/L) and two representative dilutions:

0.125 g/L and 0.025 g/L

Exposure Duration 8 hours with sampling up to 24 h

Study Summary

Dermatomed skin membranes were maintained in flow-through cells at approximately 32°C. The integrity of the membranes was first tested by the Trans Epidermal Water Loss (TEWL) method. The three formulations were applied at a rate of 10 μL/cm² to non-occluded skin samples mounted in flow-through diffusion cells. Receptor fluid samples were collected at hourly intervals for the duration of the study (24 hours). The solubility of the fluopyram in the receptor fluid was demonstrated to be sufficient for the study.

Eight hours post-application, the remaining dose material was washed off the skin with freshly prepared 1% v/v Tween 80 in PBS (phosphate buffered saline) using natural sponge swabs. At the end of the study (24 hours post-application) the skin samples were swabbed again and were tape-stripped to remove residual surface dose and the stratum corneum.

The skin samples were removed from the diffusion cells and taken for analysis.

Good recovery data were obtained for the neat formulation and the spray dilutions, with mean total recoveries of radioactivity in the range of 94.59 % to 100.06 % of the applied dose.

Following application of [¹⁴C]-fluopyram at the three dose levels of 400, 0.125 and 0.025 g/L, a comparison of the results indicates that the majority of the applied radioactivity was not absorbed at all three dose levels.

Higher mean levels of absorption were observed for the two spray dilutions in comparison to the neat formulation. Potentially absorbed doses were 0.04% for the concentrate and 10.6% and 15.3% for the intermediate and low dose dilutions, respectively. The spray dilution data indicate that a five- fold decrease in the concentration led to a 1.5-fold increase in dermal absorption.

Consideration was given to whether all the tape stripped material (stratum corneum) could be excluded, rather than just the first two tape strips. For the high dose group, less than 75% of the total absorption occurred in the first half of the study. Therefore the tape stripped material could not be excluded and the radioactivity found in the skin, surrounding skin and

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stratum corneum could be considered as a potentially absorbable fraction for the high dose group. However for the intermediate dose and low dose groups >75% of the total absorption occurred within the first half of the study duration. Therefore the stratum corneum (tape strip) values may be excluded from the potentially absorbable fraction for these doses.

Therefore, the mean total amount of radioactivity considered to be potentially absorbable for the neat formulation was 0.04%. The mean total amount of radioactivity considered to be potentially absorbable following exclusion of the stratum corneum was 9.42% for the intermediate dose formulation and 13.98% for the low dose formulation.

Additional Comments

The staff note that two replicates were subsequently excluded from analysis for each of the dilutions. The reason for this exclusion is not fully clear from the study report (it is noted that they were excluded following analysis of the data). However a review of the individual data for the excluded samples clearly indicates that there were technical issues with these replicates.

The staff note there appears to be a typographical error in the certificate of analysis for the low dose sample: the ‘formulation’ row of the certificate states that it is FLU SC 400 diluted to a concentration of 0.125 g/L Fluopyram (the intermediate dose) but the heading at the top of the certificate refers to a concentration of 0.025 g/L and the ‘concentration’ row states that the concentration is 0.0258 g/L. Given that a dose response was observed, the staff do not consider that this affects the interpretation of the study.

Conclusion

Total potentially absorbable dose:

Concentrate: 0.04%

Intermediate dose spray dilution (0.125 g/L): 10.62%

Low dose spray dilution (0.025 g/L): 15.33%

Total potentially absorbable dose minus the stratum corneum:

Concentrate: N/A

Intermediate dose spray dilution (0.125 g/L): 9.42%

Low dose spray dilution (0.025 g/L): 13.98%

Conclusion on dermal absorption

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The data provided indicate that dermal absorption of fluopyram in the concentrated product Velum Prime is minimal, but increases when the product is diluted.

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Appendix D: Ecotoxicity - Robust study summaries for the formulation

In the following summaries Velum Prime is called Fluopyram SC 400 G. Some studies provided were conducted using Fluopyram SC 500 G (500 g a.i./L).

Aquatic toxicity

Fish Acute Toxicity (Freshwater Species) Type of study Limit test

Flag Key study

Test Substance Fluopyram SC 400 G

Species Oncorhynchus mykiss (Rainbow trout) Type of exposure Static for 96 hours

Endpoint LC50

Value > 284 mg/L (corresponding to > 100 mg a.i/L)

Reference

E. Bruns (2013) Fluopyram SC 400 G Acute toxicity to fish (Oncorhynchus mykiss) under static conditions (limit test). Bayer CropScience AG, Development - Environmental Safety – Ecotoxicology – Testing, Alfred-Nobel-Str. 50, 40789 Monheim, Germany. Study ID: E 280 4491 – 8. Report No EBGMP301

Klimisch Score 1

GLP Yes

Test Guideline/s US EPA OCSPP 850.1075

No/Group 15 per replicate (30 per test group)

Dose Levels 0 (control), 284 mg/L (equivalent to 100 mg a.i./L)

Analytical measurements

Yes from fresh medium on day 0 and at 48 h and from the old medium at 48 and 96 hours, by HPLC. All concentrations were analysed except 6.3 and 12.5 mg/L because they were below the NOEC.

Study Summary

Thirty fish (15 fish in each aquarium) were exposed in a limit test for 96 h under static test conditions to a nominal concentration of 284 (100) mg test item (a.i.) / L against a water control with further 30 fish.

The analytical determination of fluopyram (in water by HPLC - UV) revealed recoveries of 97 % to 98 % of nominal over the whole testing period of 96 hours at the limit test concentration of 284 (100) mg test item (a.i.) / L. As the toxicity has to be attributed to the tested formulation as a whole, all results are related to nominal test concentrations of the formulated product.

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Dissolved oxygen concentrations ranged from 79 % to 104 % oxygen saturation, the pH values ranged from 6.8 to 7.5 and the water temperature ranged from 10°C to 14°C in all aquaria over the whole testing period .

The 96h-LC50 is greater than 284 (100) mg test item (a.s.) / L .

All 30 fish at this test level showed the following symptoms after 96 hours:

- Fish remained for unusually long periods on the bottom of the aquarium;

- Showed labored respiration - Turned dark in coloration - Laid on their sides or backs Conclusion

The LC50 is higher than 284 mg/L (corresponding to > 100 mg a.i./L). No mortality observed at 284 mg/L.

Invertebrates Acute Toxicity (Freshwater Species)

Type of study Full test

Flag Key study

Species Daphnia magna

Type of exposure Static for 48 hours.

Endpoint EC50

Value 77.7 mg/L (62.7-96.2 mg/L)

Reference

T. Riebschläger (2013) Acute toxicity of fluopyram SC 400 G to the waterflea Daphnia magna in a static laboratory test system. Bayer CropScience AG BCS-D-EnSa-Testing, 40789 Monheim, Germany. Study ID: E 320 4459-7.

Report No EBGMP300.

Klimisch Score 1

GLP Yes

Test Guideline/s

OECD 202 (2004)

OPPTS Guideline 850.1010 (1996)

No/Group 6 replicates of 5 daphnids

Dose Levels 0, 11.5, 20.7, 37.3, 67.1 and 121mg form./L (nominal concentrations) Analytical measurements Yes from fresh medium on day 0 and at 48 h, by HPLC.

Study Summary

The acute toxicity of the test substance to Daphnia magna was determined in a 48-hr static test.

Measured concentrations were between 101% and 103% (mean: 101%) of the nominal concentrations. The corresponding concentrations of the aged test

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solutions at the end of the 48 hours exposure period ranged between 101% and 113% (mean: 106%) of nominal.

The pH values in the test medium and in the control was 7.8, the dissolved oxygen concentration was always higher than 60% oxygen saturation (it was 8.2 mg/L or above) and the temperature was in the range of 19.7-20 °C.

The EC50 was 77.7 mg form/L (CI: 62.7-96.2 mg form/L).

Comments

Due to the limited solubility of fluopyram in water, testing above a maximum concentration of 121 mg form./L was not applicable.

Conclusion The EC50 was 77.7 mg/L (corresponding to 27.4 mg a.i./L).

Algae Acute Toxicity (Freshwater Species)

Type of study Full test

Flag Key study

Species Pseudokirchneriella subcapitata Type of exposure Static, 72 hours

Endpoint ErC50

Value 22.9 (17.8-30.7) mg/L

Reference

E. Bruns (2013) Pseudokirchneriella subcapitata growth inhibition test with fluopyram SC 400 G. Bayer CropScience AG BCS-D-EnSa-Testing, 40789 Monheim, Germany. Study ID: E 323 4489-3. Report No EBGMP299.

Klimisch Score 1

GLP Yes

Test Guideline/s OECD 201 (2006)

No/Group 3 replicates for test concentrations and 6 for the control of 10⁴ cells/mL Dose Levels 0, 3.13, 6.25, 12.5, 25.0 and 50.0 mg form./L (nominal concentrations) Analytical measurements Yes, from fresh medium on day 0 and at 72 h, by HPLC.

Study Summary

The influence of the test substance on the growth of the green algal species Pseudokirchneriella subcapitata was determined in a 72-hr static test.

The pH values ranged from 7.7 to 8.1 in the controls and the incubation

temperature ranged from 21.4°C to 22.3°C (measured in an additional incubated glass vessel) over the whole period of testing at a continuous illumination of 5406 lux. The study met all validity criteria.