Process for consideration of group standards



HRE08001

Hazardous Substances Consideration Committee

1 TOPIC: Consideration of Application for the Modified Reassessment of “Ethaneperoxoic Acid, < 5% Acetic Acid and Hydrogen Peroxide”

Introduction

1 Jaegar Australia Pty Ltd is seeking the modified reassessment of the substance identified as “ethaneperoxoic acid, < 5% acetic acid and hydrogen peroxide”. The substance was approved under the Hazardous Substances and New Organisms Act 1996 (“the Act”) via the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (as amended) and has the HSNO Approval Number of HSR001479.

2 Clause 6 of the Transfer Notice states that:

“No person may use a hazardous substance described in Schedules 1 and 2 to this notice as a pesticide or a veterinary medicine.”

4 The proposed modification relates to the removal of this restriction on the use of the substance as a pesticide.

5 The applicant intends that the substance will be used as a fungicide to control Botrytis on grapevines.

Legislative Criteria for the Application

1 Unless otherwise stated, references to section numbers in this report refer to sections of the Act and clauses to clauses of the Hazardous Substances and New Organisms (Methodology) Order 1998 (“the Methodology”).

2 In its decision dated 20 May 2008 (Application Number: RES08001), the Authority determined that the proposed use of the substance as a pesticide is a significant change of use and therefore constitutes grounds for its reassessment (section 62(2)(c)). Consequently, the applicant is able to make an application for the modified reassessment of the substance.

3 The application was lodged on 15 August 2008 in accordance with section 63A on the basis that─

1 a reassessment of the hazardous substance under section 63 is not appropriate because the reassessment will involve only a specific aspect of the approval (i.e. the restriction on the substances use as a pesticide); and

2 the amendment is not a minor or technical amendment to which section 67A applies (i.e. a change is use is not considered a minor or technical amendment).

4 The Authority may approve or decline an application for reassessment under this section, as it considers appropriate, after taking into account (see section 63A(6)):

all the effects associated with the reassessment; and

the best international practices and standards for the safe management of hazardous substances.

7 When making their decision, the Authority must follow the decision path outlined in Appendix 1.

Notification and Consultation

1 The Minister for the Environment was advised of the application[1] and given the opportunity to “call-in” the application[2]. This action was not initiated.

2 The Department of Labour (Workplace Group), the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary Medicines (ACVM) Group) and the Department of Conservation were identified as having a specific interest in the application and were provided with a copy of the application (excluding the confidential information but with the opportunity to access this if necessary).

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

1. No comments or submissions were received.

3 Other Government departments, Crown agencies and other interested parties, as listed in Appendix 5, were provided with a copy of the application summary and given the opportunity to comment or to make a submission.

12.

1. No comments or submissions were received.

4 The application was publicly notified on the ERMA New Zealand website on 29 August 2008 and subsequently advertised in The Dominion Post, the New Zealand Herald, the Christchurch Press and the Otago Daily Times[3].

2. No submissions were received.

AGENCY EVALUATION

1 To enable the Agency to consider all the effects associated with the proposed reassessment, the Agency has undertaken an assessment of the risks, costs and benefits associated with the proposed modification to the approval of the substance.

Risk Assessment

1 A “cost” is defined in Regulation 2 of the Methodology as “the value of a particular adverse effect expressed in monetary or non-monetary terms”. Thus, these have been assessed in an integrated fashion together with the risks of the adverse effects in the following assessment.

2 As the proposed modification relates to a change in use of the substance, the Agency has confined its risk assessment to the use phase of the substance’s lifecycle.

3 In accordance with sections 5 and 6 and clauses 9 and 12, the Agency has assessed the potentially non-negligible risks of the change in use of this substance in terms of risks to the environment, to human health and safety, to the relationship of Māori to the environment, to society and the community, to the market economy, and to New Zealand’s international obligations.

Assessment of the risks to the environment

5 The Agency has classified “ethaneperoxoic acid, < 5% acetic acid and hydrogen peroxide” as being very toxic to the aquatic environment (9.1A) and harmful to terrestrial vertebrates (9.3C). Thus, a range of organisms in the environment may be adversely affected if exposed to the substance.

6 In addition to its ecotoxic properties, the substance has been classified by the Agency as being combustible (3.1D – low hazard). The Agency considers that there is potential for damage to the environment to occur if the substance were to be ignited at any stage of its lifecycle. However, the Agency considers that adherence to the HSNO controls on flammable substances will ensure that the level of risk to the environment associated with its flammable properties is negligible.

7 The Agency has undertaken quantitative modelling of the risks to the environment, during the proposed use of the substance as a pesticide, using the GENEEC2 model. This quantitative assessment of the risks to the aquatic environment shows that the use of the substance presents an acute risk to the aquatic environment that can be mitigated through restricted use (see Appendix 2). An estimation of the risk to the terrestrial environment was unable to be made due to a lack of available toxicity data.

8 The Agency notes the results of the quantitative modelling and considers that application of the following controls will reduce the level of risk to the environment to negligible:

• the approved handler controls (triggered by the 9.1A classification). The Agency considers that requiring people using the substance as a pesticide to be approved handlers, will minimise the risks associated with exposure to the aquatic and terrestrial environments;

• prohibiting the application of the substance into or onto water;

• restricting the method of application of the substance to ground-based methods only; and

• setting a maximum application rate, application frequency and minimum application interval.

Assessment of the risks to human health and safety

10 The Agency has classified “ethaneperoxoic acid, < 5% acetic acid and hydrogen peroxide” as being an acute oral and inhalation toxicant (6.1D), a skin corrosive (8.2B) and eye corrosive (8.3A) and a target organ toxicant (6.9A).

11 The substance is also classified as presenting a low flammability hazard (3.1D) and thus has the potential to cause minimal to major adverse health effects (ranging from smoke inhalation to burns, for example). However, the Agency considers that adherence to the HSNO controls on flammable substances will ensure that the level of risk to human health associated with its flammable properties is negligible.

12 The Agency did not carry out an assessment of risks to operator health using an exposure model, because of the corrosive nature of the substance. In the case of ethaneperoxoic acid, ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download