Application for a Modified Reassessment · 4.4. Assessment of the benefits associated with the reassessment proposal Permitting the use of a higher application rate will potentially

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

OR email to: [email protected]

Application for a Modified Reassessment under section 63A of the Hazardous Substances and New Organisms Act 1996

APPLICATION FORM MODIFIED REASSESSMENT

www.epa.govt.nz

Name of substance(s):

Firebird

Applicant:

Bayer New Zealand Limited

Date:

3 November 2014

APPLICANT CHECKLIST

Mandatory sections filled out

Appendices enclosed

Fees enclosed

Signed and dated

OFFICE USE ONLY

Application code Date received

EPA contact Initial fees paid $

Application version no.

mailto:[email protected]

2

Application form: Application for a Modified Reassessment

April 2013 EPA0143

1. Applicant details

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

Name: Bayer New Zealand Limited

Address: PO Box 2825, Shortland Street, Auckland 1140

Phone: +64 9 441 8516

Fax: +64 9 441 8645

Email: [email protected]

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

Name: Bayer New Zealand Limited

Address: 3 Argus Place, Hillcrest, Auckland 0627

Phone: +64 9 441 8516

Fax: +64 9 441 8645


1.3. Name of the contact person for the application

Name: Chris Young

Position: Regulatory Affairs Officer

Phone: +64 9 441 8516

Fax: +64 9 441 8645


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2. Type of application

2.1. The approvals being reassessed

Firebird (HSR100012)

2.2. Specific aspect of the approval being reassessed

The current approval for Firebird includes the following additional controls:

- The maximum application rate for Firebird shall be 300 mL/ha, once per season;

- The method of application of Firebird shall be limited to ground-based application only.

We would like to increase the maximum application rate for Firebird to allow for the use of higher application rates

in certain situations, for instance during high weed pressure. Our intentions are to apply for an application rate of

500 mL/ha to be added to the product label; however, we propose that the EPA goes a step further and considers

an application rate of 700 mL/ha.

Thus, we would like to propose a change to (one of) the additional controls for Firebird:



It may be noted that the grounds for reassessment were determined based on an increase to the maximum rate of

application for Firebird from 300 mL/ha to 500 mL/ha. While the 500 mL/ha use rate that was specified in our

‘grounds for reassessment’ application is the maximum use rate that we are intending to add to the product label,

we feel that it would be prudent to get the reassessment performed on an even higher rate. We believe that the

grounds for reassessment should still exist; the assessment of the higher maximum application rate should help to

ensure the safe use and management of the substance as well as leaving some room for flexibility in case there is

a need to further increase the use rate on the label in the future.

2.3. Grounds for the reassessment

Allowing for an increase in the maximum application rate for Firebird would represent a significant change in the

use of the substance. We would like to change the maximum application rate for Firebird so that it is 700 mL/ha to

allow for the use of application rates higher than those currently covered by the HSNO approval. In order to do

this, the additional controls that are related to the Firebird HSNO approval will need to be altered.

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April 2013 EPA0143

2.4. Consultation

Consultation was undertaken with Māori to address the impact of increasing the maximum application rate of

Firebird. Bayer New Zealand elected to meet with representatives from Ngāi Tahu on 17 April 2014, with Matthew

Allen and Manu Graham from the EPA also present. The idea behind the consultation was to provide Ngāi Tahu

with an opportunity to raise and discuss any concerns they may have, so that the concerns may be addressed in

the submission to the EPA.

The concerns raised during the consultation process were centred mainly on the potential for product leaching or

being washed into water bodies. Following the consultation with Ngāi Tahu to discuss Firebird, the concerns raised

by Ngāi Tahu and the responses from Bayer New Zealand are summarised in the table in Section 4.5.

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April 2013 EPA0143

3. Information on the substances

3.1. The unequivocal identification of the substance

Trade name: Firebird

Formulation type: Suspension concentrate

Active ingredients: 400 g/L flufenacet + 200 g/L diflufenican

Use situations: A selective herbicide to be used pre-emergence of weeds and pre- or post-emergence of the crop

for the control of certain broad-leaved and grass weeds in autumn- and winter-sown wheat and barley.

Current HSNO approval number: HSR100012

Year of original HSNO approval for Firebird: 2009

Original ERMA New Zealand Evaluation and Review Report for Firebird, Application Number HSR08057:

http://www.epa.govt.nz/search-

databases/HSNO%20Application%20Register%20Documents/HSR08057_HSR08057%20ER%20vFINAL%20%28

2009.05.11%20%29.pdf

Original ERMA New Zealand Authority Decision for Firebird, Application Number HSR08057:

http://www.epa.govt.nz/search-

databases/HSNO%20Application%20Register%20Documents/HSR08057_2009.06.17%20HSR08057%20Decision

%20FINAL.pdf

ACVM registration number: P008095

Year of first ACVM registration: 2010

The formulation for Firebird is confidential. Please refer to the confidential appendices for the unequivocal

identification of the substance.

3.2. Information on the chemical, physical and hazardous properties of the substance

Appearance: Beige white suspension

Odour: Weak, characteristic

Density: ~1.24

http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/HSR08057_HSR08057%20ER%20vFINAL%20%282009.05.11%20%29.pdf



http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/HSR08057_2009.06.17%20HSR08057%20Decision%20FINAL.pdf



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April 2013 EPA0143

pH: ~5.5

Flash point: No flash point up to 105 °C

Auto ignition temperature: 445 °C

Not explosive

Hazard classifications:

6.1D Acute toxicant

6.5B Contact sensitiser

6.9B Target organ systemic toxicant

9.1A Aquatic ecotoxicant

9.2A Soil ecotoxicant

9.3C Terrestrial vertebrate toxicant

3.3. Identification of the controls on the substances

T1, T2, T4, T5, T7, E1, E2, E5, E6, E7, I1, I3, I8, I9, I11, I16, I17, I18, I19, I20, I21, I23, I28, I29, I30, P1, P3, P13,

P15, PS4, PG3, D4, D5, D6, D7, D8, EM1, EM6, EM7, EM8, EM11, EM13, AH1

Controls relating to tank wagons and transportable containers and stationary container systems

Additional controls:

77A The substance must not be applied onto or into water

77A A maximum application rate is set for this substance – The maximum application rate for Firebird shall

be 300 mL/ha, once per season

77A A restriction has been placed on the application method for this substance – The method of

application of the substance shall be limited to ground based application only

3.4. The proposal to modify the approval of the substances

It is proposed that the maximum application rate is modified to 700 mL/ha.

3.5. Commercial sensitivity

The formulation is confidential to the applicant.

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April 2013 EPA0143

4. Risks, costs and benefits

4.1. Identification of all the effects associated with the reassessment proposal (section 63A(6)(a))

Increasing the maximum use rate from 300 mL/ha to 700 mL/ha means that a greater amount of product can

potentially be applied to crops. Permitting the use of a higher application rate will potentially aid in the control of

weeds, which could lead to improved crop health and higher crop yields. It could also lead to a slightly higher

exposure of the environment to the substance; however, there should be sufficient controls in place to minimise

any potential risk to people or the environment.

4.2. Assessment of the risks associated with the reassessment proposal

There are not expected to be many changes to the risks that are present under the current approval for the

product. The main potential sources of risk remain the same – an incident (e.g. spillage) during manufacture or

import, packing, transport or storage could result in spillage and subsequent exposure of people or the environment

to the substance. During use, the application of the product or an incident during use could result in exposure or

users or bystanders or the environment, while the disposal of the product or packaging could potentially result in

the exposure of people or the environment to the substance.

A higher use rate could potentially increase the exposure of the environment to the substance. However, the main

risks of adverse effects on the environment would be as a result of an accident, not from the general use of the

product. Furthermore, the risks associated with the product are addressed by the controls on the use of the

product and the directions and warnings on the label.

Overall, when used in accordance with the label recommendations, the product is not likely to present an

unacceptably high risk to people or the environment whether the maximum application rate is 300 mL/ha or up to

700 mL/ha.

4.3. Assessment of the costs associated with the reassessment proposal

Increasing the maximum use rate from 300 mL/ha to 700 mL/ha is not anticipated to lead to any extra costs

associated with the use of the product. Although the higher use rate could increase the exposure of the

environment to the substance, the remaining controls that are currently in place should restrict the level of risk to

the environment.

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4.4. Assessment of the benefits associated with the reassessment proposal

Permitting the use of a higher application rate will potentially aid in the control of weeds, which could lead to

improved crop health and higher crop yields.

4.5. Assessment of any particular risks, costs and benefits which arise from the relationship of Māori and

their culture and traditions with their taonga, or which are, for other reasons, of particular relevance to

Māori

Consultation was undertaken with Māori to address the impact of increasing the maximum application rate of

Firebird. Firebird is used predominantly in the South Island. Bayer New Zealand elected to meet with

representatives from Ngāi Tahu on 17 April 2014, with Matthew Allen and Manu Graham from the EPA also

present. The purpose of the consultation was to gather their views on the proposed use of Firebird so that these

may be taken into account in Bayer’s application to the EPA.

The concerns raised during the consultation process were centred mainly on the potential for product leaching or

being washed into water bodies. The specific concerns raised by Ngāi Tahu with regards to the proposed use of

Firebird are summarised in the table in the following table, alongside the response to each issue from Bayer New

Zealand.

Table 7.3: Issues raised by Ngāi Tahu regarding the proposed change to the maximum use

rate of Firebird

Issue Bayer’s Response

1. Spray drift during application of Firebird could result in harmful effects on plants other than the intended targets. Will buffer zones be recommended to mitigate the risk?

No specific buffer zones are currently prescribed on the Firebird label, although the issue of buffer zones may be considered by the EPA as part of their assessment of the application. The product is generally used in the autumn at a time when there is not much risk to sensitive crops, as most crops have been harvested by then. The current Firebird label includes a warning to the user to apply the product carefully and avoid spray drift.

Guidance to mitigate the risk of spray drift when applying agricultural chemicals is widely available. The code of practice NZS 9409:2004 (HSNOCOP 3) Management of Agrichemicals is a code that is available from Standards New Zealand which provides guidance to ensure that agrichemicals are used in a safe, responsive and effective manner, whilst minimising any adverse effects on the environment or human and animal health. It contains sections on the management and use of agrichemicals and includes information about provisions to restrict and control spray drift hazard associated with the use of pesticides.

The control of spray drift is the responsibility of the person applying the product. It is in his/her best interests to minimise spray drift, as spray drift not only has the potential to have adverse effects on nearby crops and the local environment, but it is also a waste of product and means that less product is reaching the intended target. In any case, it is

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April 2013 EPA0143

standard practice to take measures to limit spray drift – through the selection, maintenance and calibration of spray equipment, the consideration of the height of the release of the spray and the judgement about the weather conditions at the time of the spray (e.g. wind speed, wind direction). Therefore, the risk of human and environmental exposure due to spray drift is minimal.

The current controls for Firebird include a requirement for the substance to be under the control of an approved handler when the substance is applied in a wide dispersive manner or used by a commercial contractor. Reference to this Approved Handler requirement is included on the product label. This means that if Firebird is applied in a wide dispersive manner or by a commercial contractor, the applicator will have some knowledge of the HSNO legislation and will be competent in the safe handling of hazardous substances.

2. Firebird could leach or be washed off into water bodies where Maori gather food. This could affect flora and fauna important to Maori:

a. Watercress, flax and other plants – what is the effect of Firebird on these plants?

b. Whitebait, fresh water crayfish (koura) and eels (tuna) – what effects will Firebird have on these organisms?

The Firebird formulation is classified as being highly toxic in the aquatic environment (9.1A), highly toxic in the terrestrial environment (9.2A) and harmful to terrestrial vertebrates (9.3C). When assessed at a use rate of 300 mL/ha, Firebird was determined to present a low acute risk to fish and crustacean, low chronic risk to algae, and a high acute risk to algae.

A range of organisms in the environment may be adversely affected over a prolonged period of exposed to Firebird. However, the product is applied a maximum of once per year, and the level of risk is restricted through the additional controls that have been set for the current EPA approval for Firebird, including:

10.5.1 “Firebird shall not be applied onto or into water.”

10.5.3 “The method of application shall be limited to ground-based application only.”

Also, retaining the approved handler controls will minimise the risks associated with exposure to the aquatic environment.

We would like the EPA to assess the level of risk to the environment, including the species of flora and fauna important to Maori, in order to determine if the current controls are acceptable given the risk to the environment arising from an increased maximum application rate.

3. Are toxicity and ecotoxicity tests conducted overseas in mallard duck, rainbow trout and other species relevant for New Zealand organisms such as whitebait, fresh water crayfish and eels? Could we conduct once-off tests of chemicals on local species to show that tests in overseas species can be extrapolated to New Zealand species?

The question of whether the species currently used in overseas toxicology and ecotoxicology tests can be extrapolated to New Zealand species is a matter for the EPA to determine. The EPA is responsible for setting the data required in support of applications for approval of hazardous substances. The current data requirements for chemical pesticides are set out in the following documents:

“EPA data requirements for chemical pesticides”, http://www.epa.govt.nz/Publications/Data_requirements_pesticides_EPA_FINAL_May2014.pdf; and

“Thresholds and Classifications under the Hazardous Substances and New Organisms Act 1996”, http://www.epa.govt.nz/Publications/ER-UG-03-2.pdf.

These documents require data generated in accordance with the OECD Guidelines for the Testing of Chemicals, see http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-

http://www.epa.govt.nz/Publications/Data_requirements_pesticides_EPA_FINAL_May2014.pdf

http://www.epa.govt.nz/Publications/Data_requirements_pesticides_EPA_FINAL_May2014.pdf

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

http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals_chem_guide_pkg-en


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chemicals_chem_guide_pkg-en. The choice of species to be used in these tests is dependent on many factors including availability of disease-free organisms of known parentage, ease of maintenance, convenience for testing, background scientific literature as well as historical control data which will be critical for the interpretation of experimental findings. The organisms stipulated in the guidelines are accepted in OECD countries as surrogates for all other organisms, given that tests cannot be performed on every single species in an ecosystem. In other words, it is acceptable to extrapolate findings in these species to other organisms for purposes of classification and risk assessment.

Therefore, in our view it is unnecessary to repeat toxicology and ecotoxicology tests on New Zealand flora and fauna. The data generated in surrogate species is sufficient for classifying the product and assessing its potential risks to the New Zealand environment. Additional testing will drastically increase the costs of bring innovative new products to New Zealand and will also cause unnecessary animal suffering. It will also set New Zealand at odds with other OECD member countries and may be cited as a barrier to trade.

4. There seems to be an inconsistency between the label statement “very toxic to aquatic organisms with long-lasting effects” and the conclusions regarding potential environmental risks of Firebird

This label text is hazard-driven, i.e. it is determined by the 9.1A classification of the product. However, a high hazard does not necessarily lead to a high risk because risk is a function of hazard and exposure. Our conclusion about the environmental risks of Firebird takes into account the exposure scenarios, not just the hazard classification.

5. Concern regarding potential for skin/eye irritation in people collecting flax following drift from application of sensitising products like Firebird

The control of spray drift is the responsibility of the person applying the product. It is in his/her best interests to minimise spray drift, as spray drift not only has the potential to have adverse effects on nearby crops and the local environment, but it is also a waste of product and means that less product is reaching the intended target. The current controls for Firebird include a requirement for the substance to be under the control of an approved handler when the substance is applied in a wide dispersive manner or used by a commercial contractor.

Although Firebird triggers HSNO classification 6.5B, when Firebird is applied in an appropriate and responsible manner, the amount of spray drift reaching flax should be minimal, and thus the likelihood for skin irritation in people collecting flax is very low.

6. There is a disparity between the

2009 Evaluation and Review

report for Firebird and the

consultation document supplied

in relation to persistence and

bioaccumulation potential of

the actives in the environment.

Flufenacet is considered to be

persistent in the aquatic and

terrestrial environments, while

diflufenican is considered to be

bioaccumulative. The

consultation document

Based on the data considered for the 2009 Evaluation and Review report for Firebird, flufenacet is considered to be not rapidly degradable in soil, primarily due to the degradability of the major metabolite FOE 5043-sulfonic acid, DT50 range 189-270 days. However, the Agency’s conclusion was that although this flufenacet metabolite appeared in mean concentrations exceeding 0.1 μg/L (the designated EU cut-off), it had been demonstrated that the FOE sulfonic acid has no toxicological or ecotoxicological relevance.

While the EPA will assess the risks to the environment from the proposed increase in maximum use rate, we believe that the potential benefits of a higher maximum use rate for Firebird outweigh the costs.


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concludes that the use of

Firebird at the proposed higher

rate will not pose unacceptable

risks to the environment.

7. The 2009 Evaluation and Review

report states in item 8.25 “…the

Agency notes that should

inappropriate use, or accident,

result in the contamination of

waterways or the environment

generally, that users notify the

appropriate authorities

including the relevant iwi

authorities in that region. This

action should include advising

them of the contamination and

the measures taken to contain

and remediate.” There is no

mention of this requirement on

the current or proposed label

for Firebird.

The current label for Firebird includes the statement, “If contamination of drains, streams, watercourses, etc. is unavoidable, warn the local water authority”. It is proposed that this statement is extended to, “If contamination of drains, streams, watercourses, etc. is unavoidable, warn the local water authority and any relevant iwi authorities in the region”.

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5. International considerations

5.1. The best international practices and standards for the safe management of the substance (section

63A(6)(b))

N/A

5.2. International obligations and treaties

The proposed increase in maximum use rate of the product should not pose any risks to New Zealand’s

international obligations.

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April 2013 EPA0143

6. Hazardous substance knowledge

6.1. A glossary of scientific and technical terms used in the application

N/A

6.2. Other information considered relevant to this application not already included

N/A

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April 2013 EPA0143

7. Summary of public information

7.1. Name of the substance for the public register

Firebird

7.2. Purpose of the application for the public register

To apply for the modified reassessment of the herbicide Firebird, containing 400 g/L flufenacet plus 200 g/L

diflufenican as a suspension concentrate, for its use as a higher maximum application rate (up to 700 mL/ha) on

weeds.

7.3. Executive summary

Firebird is a herbicide registered under the ACVM Act 1997 (P8095) and approved under the HSNO Act 1996

(HSR100012).

The HSNO classifications for Firebird are 6.1D, 6.5B, 6.9B, 9.1A, 9.2A, and 9.3C.

The current approval for Firebird includes the following additional controls:



We would like to increase the maximum application rate for Firebird to allow for the use of higher application rates

in certain situations, for instance during high weed pressure. Our intentions are to apply for an application rate of

500 mL/ha to be added to the product label; however, we propose that the EPA goes a step further and considers

an application rate of 700 mL/ha.

Thus, we would like to propose a change to (one of) the additional controls for Firebird:



Permitting the use of a higher application rate will potentially aid in the control of weeds, which could lead to

improved crop health and higher crop yields.

There are not expected to be many changes to the risks that are present under the current approval for the

product. The main potential sources of risk remain the same. These are primarily related to the risk of exposure of

people or the environment to the substance as a result of an accident or inappropriate use of the product, not from

the general use of the product. The substance itself has not changed, and the directions for use, other than the

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April 2013 EPA0143

maximum application rate, are not expected to change. Although a higher use rate could lead to a slightly higher

exposure of the environment to the substance, there should be sufficient controls in place to minimise any potential

risk to people or the environment. Overall, when used in accordance with the label recommendations, the product

is not likely to present an unacceptably high risk to people or the environment whether the maximum application

rate is 300 mL/ha, 500 mL/ha or 700 mL/ha.