Application for the Reassessment of a Group of Hazardous ......2012/01/22 · Copper pyrithione 14915-37-8 *Copper as: copper (I) oxide 1317-39-1 copper thiocyanate 1111-67-7 Dichlofluanid

www.epa.govt.nz

Application for the Reassessment of a Group of Hazardous Substances under Section 63 of the Hazardous Substances and New Organisms Act 1996

January 2013

APP201051 – Antifouling Paints

Applicant - Chief Executive, Environmental Protection Authority

2

Application for reassessment of antifouling paints (APP201051)

January 2013

Applicant‘s details

Name: Rob Forlong, Chief Executive

Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140

Phone: 04 474 2426

Fax: 04 914 0433

Email: [email protected]

Applicant‘s contact person

Name: Ilana Burton

Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140

Phone: 04 474 2426

Fax: 04 914 0433

Email: [email protected]

Signature of Applicant

Rob Forlong Date

Chief Executive

Environmental Protection Authority

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January 2013

Executive Summary

This document is the Chief Executive of the Environmental Protection Authority (EPA)‘s request to the EPA

to reassess a group of antifouling paints (―the Application‖).

EPA staff have prepared the Application, providing advice and recommendations to an independent

decision-making committee appointed in accordance with the Hazardous Substances and New Organisms

Act 1996 (HSNO) to reassess the substances.

Antifouling paints (AFPs) are slow-release, surface-acting pesticides applied to prevent the build up of

microorganisms, plants and algae (biofouling) on submerged surfaces such as the hulls of vessels, nets and

wharves.

An independent decision-making committee, acting under delegation from the EPA, has determined there

are grounds under HSNO to conduct a group reassessment of AFPs. These formulations each contain one

or more of the active ingredients listed in Table 1.

Table 1 Active ingredients of the AFPs included in the reassessment

Active ingredient CAS Number

3(2H)-Isothiazolone, 4,5-dichloro-2-octyl-

(DCOIT)

64359-81-5

Chlorothalonil 1897-45-6

Copper pyrithione 14915-37-8

*Copper as: copper (I) oxide 1317-39-1

copper thiocyanate 1111-67-7

Dichlofluanid 1085-98-9

Diuron 330-54-1

Irgarol 1051 28159-98-0

Mancozeb 8018-01-7

Octhilinone 26530-20-1

Thiram 137-26-8

Tolyfluanid 731-27-1

Ziram 137-30-4

Zinc pyrithione 13463-41-7

Zineb 12122-67-7

*Copper, in the form of either copper (I) oxide or copper thiocyanate, is used in all of the AFP formulations in this

reassessment. In this Application the word copper refers to either copper (I) oxide or copper thiocyanate.

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January 2013

Grounds to reassess the AFP formulations were determined1 on the basis that significant new information

has become available relating to the effects of the substances. The decision on grounds also took into

account the particular concerns that Māori have about AFPs.

An assessment of the adverse and positive effects (risks and benefits), and proposals for approval outcomes

are detailed in the Assessment Section of this Application.

EPA staff will review the information contained in the Application in light of any submissions received, and

provide advice to the decision-making committee prior to any hearings held for this reassessment.

Antifouling paints provide a range of important benefits for the marine industry and boat users. They also

provide biosecurity benefits by controlling of biofouling organisms. When making its decision on this

Application the decision-making committee will consider both the risks and benefits associated with these

substances, and take into account international trends in their use. Based on the currently available

information the Chief Executive of the EPA, through this Application, requests:

Continuation of approvals for substances where the benefits outweigh the risks;

Introduction of appropriate controls to manage risks posed by specific substances; and

Revocation of approvals for substances where the risks outweigh the benefits and cannot be managed

through the application of controls.

Table 2, below, contains a summary of EPA staff‘s recommendations on behalf of the applicant. These

recommendations may not reflect the final recommendations made to the decision-making committee once

submissions on the Application have been considered.

EPA staff recommendations will largely align the New Zealand regulatory status of AFPs with overseas

jurisdictions, such as phase out of AFPs containing chlorothalonil, diuron and thiram.

Table 2: Recommendations for AFP substances included in the Application

Active ingredient contained

in AFP formulations

Recommendations

Chlorothalonil Revoke AFP approvals after 6 month phase-out period

Copper Retain AFP approvals with additional controls

Copper pyrithione Retain AFP approvals with additional controls

Dichlofluanid Retain AFP approvals with additional controls

Diuron Revoke AFP approvals after 4 year phase-out period

Apply additional controls during phase-out

Irgarol 1051 Revoke AFP approvals after 6 month phase-out period

1 http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/ERMA200111_Decision.pdf

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January 2013

Active ingredient contained

in AFP formulations

Recommendations

Mancozeb Revoke AFP approvals after 6 month phase-out period

(on basis of chlorothalonil risks – mancozeb AFPs all have chlorothalonil as

a co-biocide)

Octhilinone Revoke AFP approvals after 4 year phase-out period


DCOIT Revoke AFP approvals after 4 year phase-out period


Thiram Revoke AFP approvals after 10 year phase-out period


Tolyfluanid Retain AFP approvals with additional controls

Ziram Revoke AFP approvals after 4 year phase-out period


Zinc pyrithione Retain AFP approvals with additional controls

Zineb Retain AFP approvals with additional controls

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January 2013

Overview of the reassessment process

Grounds Application – Gounds approved 23/9/11

Grounds must be established in order for an application for a reassessment

to be lodged. An application for grounds is lodged with the EPA and is heard

by an independent decision making committee established under HSNO.

Reassessment Application

Once grounds have been established, an application for a

reassessment is lodged and notified for public consultation.

This document is the reassessment application

Evaluation and Review Report

After receipt of submissions on the Application, EPA Staff prepare an

evaluation and review report taking into account information that has been

submitted. This will be considered by the decision-making committee.

Decision

After a public hearing and consideration of the application, the

decision-making committee will issue its final decision.

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January 2013

Table of Contents

Executive Summary ............................................................................................................................... 3

Overview of the reassessment process .............................................................................................. 6

1. Background .................................................................................................................................. 9

1.1 Hazardous Substances and New Organisms Act 1996 ...................................................... 9

1.2 History of the group reassessment approach ................................................................... 10

1.3 The engagement process ................................................................................................. 11

2. Establishing grounds for reassessment ................................................................................. 13

3. Adverse effects of AFPs ........................................................................................................... 14

3.1 Human health effects ........................................................................................................ 14

3.2 Environmental effects ........................................................................................................ 14

4. Benefits of AFPs ........................................................................................................................ 15

5. Methods of disposal ................................................................................................................. 15

EPA Staff Assessment ........................................................................................................................ 16

6. Introduction ................................................................................................................................ 17

Part 1: Overview ................................................................................................................................... 18

7. Overview of assessment processes and methodology ........................................................ 19

7.1 Data gathering ................................................................................................................... 19

7.2 Risk assessment ............................................................................................................... 19

7.3 Benefits assessment ......................................................................................................... 19

7.4 Evaluation .......................................................................................................................... 20

7.5 Controls ............................................................................................................................. 20

7.6 Peer review ....................................................................................................................... 21

7.7 Dealing with uncertainty .................................................................................................... 21

Part 2: Technical evaluation and methodology ................................................................................ 22

8. Risk assessment: Human health and environment ............................................................... 23

8.1 Human health – Risk characterisation .............................................................................. 23

8.2 Approach taken for human health risk assessment .......................................................... 24

8.3 Environmental effects – Risk characterisation .................................................................. 26

8.4 Approach taken for environmental risk assessment ......................................................... 27

9. Benefits Assessment ................................................................................................................ 30

9.1 Generic benefits of AFPs .................................................................................................. 30

9.2 Specific benefits ................................................................................................................ 32

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January 2013

9.3 Economic risks, costs and benefits ................................................................................... 34

9.4 Cost effectiveness of controls ........................................................................................... 38

10. Social and cultural considerations .......................................................................................... 40

10.1 Adverse effects on society and communities .................................................................... 40

10.2 Benefits to society and communities ................................................................................. 40

10.3 Relationship of Māori to the environment ......................................................................... 41

10.4 International obligations .................................................................................................... 43

11. Proposed controls .................................................................................................................... 44

Part 3: Recommendations .................................................................................................................. 46

12. Recommendations and Rationale ............................................................................................ 47

Appendix A: Formulations of antifouling paints (AFP) approved under HSNO ............................ 52

Appendix B: Overseas regulation of AFP active ingredients ......................................................... 63

Appendix C: Human health risk assessment methodology ............................................................ 72

Appendix D: Environmental risk assessment methodology ........................................................... 92

Appendix E: Description of additional controls for the mitigation of risk arising from the use of

antifouling paint formulated substances. ....................................................................................... 141

Appendix F: Regulatory action proposals and additional controls for antifouling formulated

substances used for biofouling control .......................................................................................... 149

Reference list ..................................................................................................................................... 151

Glossary of terms .............................................................................................................................. 156

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January 2013

1. Background

Under the Hazardous Substances and New Organisms Act 1996 (HSNO) the Chief Executive of the EPA

can request previously approved substances be reassessed.

This document is an Application2 to reassess a group of hazardous substances under HSNO. The applicant

is the Chief Executive of the EPA. The substances to be reassessed are approved antifouling paints (AFP).

AFPs are slow release, surface-acting pesticides applied to prevent biofouling on submerged surfaces such

as the hulls of vessels, nets and wharves. AFPs come in liquid form. Most of the substances have physical

hazards and all are toxic and ecotoxic. Almost all the substances being reassessed are skin sensitisers

and/or eye irritants or corrosives. The formulations covered by this reassessment along with their approval

numbers and hazard classifications are listed in Appendix A.

The scope of this Application is restricted to a review of AFPs. The risk assessment methodology we have

employed requires that emphasis be placed on the active ingredients, as they are the major contributors to

the hazard profile of these substances. The effects of other components contained in AFPs (e.g. solvents)

are not being reassessed. AFP substances that have been applied to vessels overseas and subsequently

brought to New Zealand on the vessel are also not included in the scope of this application.

Throughout this document, AFPs have been divided into groups according to the active ingredients they

contain. For risk assessment purposes, the AFP formulations which contain the same active ingredients are

much more similar to one another than they are to any formulation containing a different active ingredient. As

such, they have been grouped together and assessed in these groups. To clarify, although the active

ingredients are often mentioned, this reassessment is only concerned with the formulations of AFPs

containing them.

1.1 Hazardous Substances and New Organisms Act 1996

The EPA is responsible for regulating hazardous substances and new organisms under HSNO which sets

out the framework for the management of hazardous substances throughout their lifecycle.

When carrying out a reassessment of hazardous substances, the EPA follows the statutory requirements set

out in HSNO. A reassessment is an assessment of a substance that is already approved under HSNO.

The decision on a reassessment is made by an independent decision-making committee of the EPA.

Members of the HSNO Committee are appointed by the EPA board, and the decision-making committee is a

sub-committee of the full HSNO Committee. The full HSNO Committee consists of eight people appointed by

the Minister for the Environment following a process of nomination. HSNO Committee members have a

variety of backgrounds and expertise in a range of fields such as science, law and tikanga Māori, and are

appointed for a fixed term of 3 years.

2 In order to distinguish between the two uses of the word ―application‖ (i.e. when referring to the application document and references to the application of paints), the application document will be identified as ―the Application‖.

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January 2013

In the case of a Chief Executive initiated reassessment, EPA staff assist the Chief Executive in making a

request for reassessment. The public may then provide further information to the decision-making committee

through written submissions. EPA staff will consider any new information contained in those submissions

and provide advice to the decision-making committee in the form of an Evaluation and Review report. The

decision-making committee will consider the information contained in the Application, submissions, the

Evaluation and Review report, and any further information obtained at the hearing, in coming to its decision.

When making a decision, the decision-making committee is required to consider the controls that can be

imposed on the substance, the positive and adverse effects of the substance, and the likely effects on the

environment, economy and communities if the substance is unavailable. The decision-making committee will

also consider the purpose of the HSNO Act when reaching their decision.

HSNO requires the assessment of adverse and positive effects. The adverse effects of the substances in

this Application have been considered in relation to their toxicity to human health and the environment, and

are referred to as risks. Positive impacts related to the availability of a substance for users and the New

Zealand economy have been referred to as benefits. The process followed by EPA staff is explained in detail

in the Assessment section of this document.

1.2 History of the group reassessment approach

This application covers 53 formulations approved for use as AFPs under HSNO. Each of the formulations

contains at least one of the active ingredients listed in Table 1. The formulations are detailed in Appendix A.

The 53 AFP formulations received their current approvals in one of two ways. Prior to 2004 approvals for

formulations were granted under the Pesticides Act 1979. In 2004 twenty three approved AFP formulations

were transferred to the HSNO Act framework. At the time of transfer no risk assessment of the potential

adverse effects from the use of these substances was undertaken. Applications for approval of the remaining

30 formulations were assessed under Part 5, section 28 of HSNO. These substances were assessed using

qualitative risk assessment techniques.

Individual AFPs have different chemical, toxicological and ecotoxicological profiles. This can result in

different levels of risk associated with their use, although each of the substances are used for broadly similar

purposes and outcomes.

EPA staff have undertaken the reassessment of these AFPs as a group, rather than individually, for the

following reasons:

Dealing with substances which have similar effects in a single group reassessment will ensure that any

risks that may arise from the substitution of one AFP substance for another are properly understood and

managed;

Substance-by-substance reassessments of AFPs may lead to a gradual decrease in available products.

Reassessing these substances as a group will result in greater certainty for industry and government

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January 2013

agencies about the products available to them in future. Certainty about future availability should help to

direct research and development efforts for alternative long-term solutions to control biofouling;

An integrated approach will ensure consistent and effective controls to manage risks are put in place

across the group of substances;

By reducing the number of reassessments being undertaken, the approach enables a more efficient use

of industry and EPA resources; and

Reassessing the group of AFPs will allow the EPA to meet the needs of industry and ensure that there

are tools available for aiding biosecurity, while protecting the health and safety of people and the

environment.

EPA staff have engaged with stakeholders including users and manufacturers of AFPs, government

agencies, non-governmental organisations and Māori. Feedback during the consultation process has been

supportive of a group reassessment approach.

1.3 The engagement process

The engagement process for this Application began in 2011 after an application and decison to approve the

grounds for this reassessment were made. An overview of engagement activities undertaken to date are

captured in Table 3 below.

Table 3 AFP stakeholder engagement

Date Activity

September 2011 Grounds for reassessment established and decision3 publicly notified

October 2011 Fact sheet about the reassessment process sent to stakeholders and available on

EPA website

December 2011 Questionnaire to obtain technical and use information sent to manufacturers or

distributors of active ingredients used in antifouling paints

February 2012 Project update with proposed timelines sent to stakeholders and available on EPA

website

June 2012 Call for Information4 and Preliminary Risk Assessment5 sent to stakeholders and

available on EPA website for comment and additional information gathering

June 2012 – January 2013

Contact with stakeholders including phone calls, field trips, presentations and

meetings with manufacturers, suppliers, industry representatives, regional

councils, government departments,non-govermental organisations, users, Māori

3 http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/ERMA200111_Decision.pdf 4 http://www.epa.govt.nz/Publications/Antifouling%20paints%20reassessment%20%20Call%20for%20Information.pdf 5 http://www.epa.govt.nz/Publications/Antifouling%20paints%20reassessment%20Preliminary%20Risk%20Assessment.pdf

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January 2013

and the public

January 2013 Application for reassessment of antifouling paints notified (APP201051)

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January 2013

2. Establishing grounds for reassessment

An application for a reassessment cannot be lodged if the applicant has not first established that grounds

exist for a reassessment. To establish grounds, an application for grounds is lodged with the EPA. It is heard

by an independent decision-making committee.

On 23 September 2011 the decision-making committee decided that under the Hazardous Substances and

New Organisms Act 1996, there were grounds to reassess AFPs. The two main reasons constituting

grounds are that there is significant new information now available relating to the effects of the substances,

and that Māori have concerns about the effects of AFPs.

Significant new information

Since granting approvals for the AFPs, the amount of information regarding the effects of AFPs and actions

taken by international regulators (such as banning or restricting the use of certain antifouling active

ingredients also used in New Zealand) has increased.

The new information available is from international regulatory bodies including the Advisory Committee on

Pesticides (ACP, UK), the Australian Pesticides and Veterinary Medicines Authority (APVMA ), the European

Union (EU) and individual EU member states, and the United States Environmental Protection Agency (US

EPA). A summary of information available on the regulatory status of AFPs in overseas jurisdictions is set

out in Appendix B.

The decision-making committee determined that there is significant new information from overseas

regulatory authorities relating to the effects of AFPs and that in light of this new information, reassessment of

the substances is warranted.

Other factors

The decision-making committee noted Māori are becoming increasingly aware of hazardous substances and

the risks they may pose. Māori have a particular interest in ensuring the Mauri of waterways is not damaged

and in ensuring food sources are protected. As AFPs can leach into waterways, the safe use of these

substances is particularly relevant to Māori.

EPA staff engage specifically with Māori to take into account the relationship of Māori, their culture and

traditions, with their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga.

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January 2013

3. Adverse effects of AFPs

3.1 Human health effects

Although no epidemiological data are currently available for users of AFPs, adverse effects on human health

may include acute oral, dermal and inhalation toxicity, skin and eye irritation and corrosion6, skin

sensitisation, carcinogenicity, reproductive and developmental toxicity and specific target organ toxicity (e.g.

liver, kidney, effects on the nervous system, etc.). These effects are expected not only from the biocidal

active ingredient in AFPs but may derive from other components of the paint mixtures. The main stages of

the AFP lifecycle where significant exposure could occur are cited below.

Application

The risks of adverse effects to human health are most likely to occur during application of AFPs. The

applicators and bystanders are most likely to be exposed during application. Skin contact and inhalation are

considered the main routes of exposure. It is noted that risks to bystanders during application may arise only

as a result of a lack of compliance with appropriate controls to manage exposure associated with one

particular application type, namely high-pressure spraying.

Removal

Health risks arising from exposure to active ingredients during the removal stage of AFPs are related to the

method of removal e.g. dry or wet, manual or assisted, sanding and sandblasting. Exposure due to removal

of AFPs is generally expected to be negligible although undetermined amounts of active ingredient in the

residual paint may pose risks to bystanders due to a potential lack of containment and wind dispersion. Dry

blasting removal, which is potentially more dispersive than wet blasting techniques, is therefore expected to

pose greater risks to bystanders unless appropriate controls designed to prevent particle drift are in place.

3.2 Environmental effects

Antifouling paints, by their very nature are toxic to aquatic organisms, resulting in a very real potential for

harmful effects on non-target organisms. Risks to the environment occur at three distinct stages of the AFP

lifecycle. These are:

During application when air and waterborne paint particles can enter the aquatic environment;

During the service life of the AFP they are designed to release biocides into the aquatic environment by

leaching and abrasive activity; and

During maintenance and hull preparation when biocidal residues are removed along with the paint, and

can be easily transmitted into the aquatic environment.

Biocidal leaching into the environment occurs throughout the service life of the paint. The service life is the

period of time that an AFP is present on a submerged surface in a marine or freshwater environment. This

6 Only one AFP approval is classified as an eye corrosive.

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January 2013

route of exposure presents a far greater risk to the environment than application, maintenance or removal,

because larger quantities of biocides enter the environment through leaching (Gadd et al., 2011). Leaching is

of particular concern in marinas where large numbers of vessels are moored for long periods of time.

Application, maintenance and removal of AFPs occur out of the water, and should be carried out in a manner

which minimises the amount of AFPs entering the environment.

4. Benefits of AFPs

Antifouling paints provide benefits to the environment, economy and communities. The benefits below are

collectively provided by all biocides used in AFPs in New Zealand.

Benefits to biosecurity

Antifouling paints help to prevent the introduction and transfer of indigenous and non-indigenous species into

and around New Zealand waters. As part of the Ministry of Primary Industries (MPI) Biosecurity New

Zealand‘s Marine Biosecurity Programme (MAF, 2011b), vessel operators are encouraged to use antifouling

paints before entering New Zealand waters or travelling between regions.

Benefits to vessel performance

Antifouling paints help to reduce frictional drag as vessels travel through water and this leads to greater fuel

efficiency, a reduction in costs to operators, and a minimisation of greenhouse gas emissions.

Benefits to vessel integrity

Antifouling paints help to reduce the growth of biofouling on vessel hulls, preventing damage to the hulls and

reducing costs for operators.

5. Methods of disposal

Antifouling paints should be used according to the label instructions. If any unused products require disposal

they must be disposed of in accordance with the Hazardous Substances (Disposal) Regulations 20017.

Disposal of used AFPs after they have been removed from the hulls of boats at the end of the service life of

the paint also requires appropriate action to be taken to ensure that adverse effects resulting from

environmental exposure does not occur, and should be carried out in accordance with the Hazardous

Substances (Disposal) Regulations 2001.

7 http://www.legislation.govt.nz

http://www.legislation.govt.nz/regulation/public/2001/0119/latest/DLM41657.html?search=ta_regulation_H_rc%40rinf%40rnif_an%40bn%40rn_25_a&p=1http://www.legislation.govt.nz/

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EPA Staff Assessment

This section contains the EPA staff’s assessment of the risks and benefits associated with AFPs, proposed

controls to manage the risks, and recommendations to the decision-making committee regarding regulatory

outcomes for the reassessment of AFPs.

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January 2013

6. Introduction

The Chief Executive of the EPA has requested a reassessment of a group of antifouling paints used to

prevent the build up of microorganisms, plants and algae (biofouling) on submerged surfaces (the

Application). This assessment has been undertaken by EPA staff in response to the Chief Executive‘s

application, and contains the EPA staff evaluation of the active ingredients and formulations within the

Application. It includes a technical analysis of the adverse and positive effects (risks and benefits) associated

with AFPs and provides draft recommendations on the Application for notification to the general public.

These may or may not be the final recommendations that EPA staff make to the decision making committee

in the final Evaluation and Review report which will be prepared following receipt of all submissions.

It is important to note that the recommendations of EPA staff may or may not be supported by the

decision-making committee for this Application. The decision-making committee can choose to

accept, reject or modify the recommendations. For this reason we encourage you to address both

the process, and the recommendations themselves, when making submissions.

The Assessment Section is divided into three parts:

1. An overview of the assessment processes and methodology;

2. Details of the technical evaluation and methodology used by EPA staff; and

3. The Recommendations of EPA staff.

Reading the assessment

Shaded boxes have been used throughout the Assessment Section to indicate where there are questions

or assumptions which submitters may wish to address. The boxes are numbered for ease of reference.

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January 2013

Part 1: Overview

This section provides an overview of assessment processes and methodology undertaken by EPA staff

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January 2013

7. Overview of assessment processes and methodology

7.1 Data gathering

International research, processes and data analysis models were used to inform the EPA staff assessment.

In order to assess the local effects of AFPs, real world data on the way the substances are used in New

Zealand was sought. Initial risk assessments based on international research and data analysis models,

along with a list of possible controls, were sent to stakeholders. They were asked to supply data to refine the

risk assessment, comment on the practicality of the controls, and supply benefits information for the

substances they use. Written stakeholder engagement and data gathering included:

1. A questionnaire to antifouling paint manaufacturers;

2. A Call for Information to users, suppliers and manufacturers;

3. An information sheet for boat owners; and

4. Review of literature, including regulatory action taken by overseas authorities.

Stakeholder feedback from questionnaires, hui, site visits and conversations was used to help determine the

level of risks and benefits associated with use of the individual AFPs.

7.2 Risk assessment

HSNO requires the assessment of adverse and positive effects. The adverse effects of substances have

been considered in relation to their toxicity to human health and the environment, and are referred to as

risks. A risk is a combination of the magnitude of an effect and the likelihood of that effect occurring. The

risks of adverse effects on human health and the environment have been assessed by comparing predicted

or measured exposures to the substances for applicators, bystanders and the environment, with maximum

levels of exposure that are not expected to result in harmful effects. The data relating to the toxicological and

ecotoxicological effects are based on animal or human studies. Where possible, the toxicity and ecotoxicity

data specific to the substances evaluated are those used by other international regulators. In some instances

the EPA has not been able to source key information about the toxicity of these substances. In these

instances the EPA has used reasonable worst case scenarios or default values, or has not calculated the

risks. A full explanation of the EPA‘s approach to assessing the risks is explained in Section 8 of this report.

7.3 Benefits assessment

The assessment of the benefits of AFPs was informed by stakeholder feedback, and an economic analysis

which focused on the potential costs and benefits associated with future unavailability of four of the highest

risk substances. The analysis considered both the general benefits of using AFPs, and any specific benefits

provided by individual products. By reducing biofouling, all AFPs provide generic benefits for biosecurity, fuel

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January 2013

efficiency and vessel integrity. Individual product choice is influenced by factors such as longevity, efficacy,

cost, or compatibility with hull materials. The full approach to assessing the benefits is explained in Section 9

of this report.

7.4 Evaluation

Staff recommendations have been made using the methodology below:

If risks are negligible then the approval should be retained;

If additional controls make the risks negligible, then the approval should be retained with those additional

controls;

If the risks are non-negligible even with extra controls a risk/benefit analysis is conducted and;

a. If the benefits are greater than the risks the approval is recommended to be retained;

b. If the risks are greater than the benefits the approval is recommended to be revoked either with or

without a phase-out period.

These recommendations also take into account the purpose of HSNO, and the effect of the removal of

substances on the capacity of people and communities to provide for their own economic, social, and cultural

well-being now and in the future. The recommendations also account for the relationship of Māori and their

culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other

taonga.

7.5 Controls

When hazardous substances are approved, controls are placed on their use, so that the risks of the

substances can be safely managed. The controls assigned to hazardous substances vary according to

the hazard classification of the substance and the type of hazard it presents. EPA staff review hazard

classifications for substance that have been reassessed and provide advice to the decision-making

committee. Any changes to the hazard classifications of AFPs may result in changes to the prescribed

controls for those products. The controls refer to relevant HSNO regulations that relate to the

management of hazardous substances, such as AFPs, including requirements for the following:

Hazard-specific controls (e.g. for HSNO class 1-5 substances, and HSNO class 6, 8 and 9 substances);

Identification (e.g.labelling and information);

Packaging;

Emergency management; and

Disposal.

EPA staff have also compiled a controls toolbox to help reduce the risks of AFPs. These controls are

additional to those controls that currently apply to AFPs, and have been consulted on with stakeholders to

test their practicality.

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January 2013

7.6 Peer review

The recommendations made by the EPA are dependent on the quality of the data they are based on. For this

reason there has been a process of peer review involving parties external to the EPA.

The data used in the risk modeling were reviewed by Dr Lynne Clapham (human health) and Dr Robin Toy

(environment).

Economic cost/benefit information was researched and analysed by staff at Covec Limited.

Controls have been reviewed in consultation with members of the New Zealand AFP industry, applicators,

marina operators and members of the boating community.

7.7 Dealing with uncertainty

The risk-benefit assessment process deals with potential effects. In most circumstances there will be a

degree of uncertainty around expected risks, costs and benefits. We have sought to reduce these

uncertainties through research, modeling, stakeholder engagement and peer review.

Uncertainties persist where multiple sources have represented the risks, costs or benefits differently from

each other. Some examples where uncertainty remains are the anticipated level of financial loss to users if

specific AFPs are no longer available, the availability or efficacy of alternatives, and the rate and frequency

of application.

EPA staff have indicated in their assessment where there are evident uncertainties for each of the

substances.

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January 2013

Part 2: Technical evaluation and methodology

This section describes the technical processes followed by EPA staff.

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8. Risk assessment: Human health and environment

8.1 Human health – Risk characterisation

Paints used for antifouling purposes are mixtures of substances, one or more of which have biocidal

properties (the biocide). The paints are applied to the hulls of ships and other submerged surfaces to deter

the attachment of organisms, or to slow their growth. During application, users of AFPs, whether professional

or non-professional, are exposed to the AFPs.

The exposure assessment focuses on the application phase of the lifecycle of AFPs. This is considered to

pose the highest risk from the hazardous substance. The following assumptions have been factored into the

assessment of the risks to human health undertaken by EPA staff:

Use of personal protective equipment (PPE) and respiratory protective equipment (RPE) is considered to

be a key tool in managing applicator exposure to AFPs. Professional users are considered to have

access to higher levels of PPE and RPE than non-professionals, and it is considered unlikely that non-

professional users will use anything more than minimal PPE.

Professional users are also expected to have a greater level of expertise in the application of AFPs, and

are likely to have received training, resulting in lower exposure levels. The level of expertise of non-

professional users is assumed to be significantly lower than for professionals, and it is assumed that they

have not been trained.

Professional applicators are assumed to carry out frequent AFP applications including brush and roller,

and high pressure spray applications. Non-professionals are only likely to apply AFPs infrequently, using

brushes and rollers.

The hazardous properties of biocides in AFPs range from toxic effects that are elicited after a short exposure

(such as acute toxicity, skin and eye irritation and corrosivity, and skin sensitisation8) to long term exposure

effects (such as systemic target organ toxicity, reproductive/developmental toxicity or carcinogenicity). The

HSNO controls triggered by the hazard classifications are expected to manage the risks associated with

short term exposures to AFPs. The focus of this risk assessment is to adequately protect individuals that

may be susceptible to adverse effects after longer term exposure. The proposed additional controls in this

application are primarily intended to manage the risks posed by longer term exposure, although they may

also manage some of the risks posed by short term exposure.

For risk characterisation purposes it is necessary to calculate internal (systemic) body burdens from dermal

and inhalation exposures, which is based on the selection and use of a variety of physiological default values

(body weight, breathing rate, etc.) for specific situations. After determinating the systemic exposure,

occupational risks are estimated by comparing predicted exposure with the AOEL (Acceptable Operator

Exposure Level). The AOEL is the maximum daily dose considered to be without adverse health effects. It is

based on the most appropriate NOAEL (No Observable Adverse Effect Level) from relevant sub-chronic or

chronic toxicity studies conducted with experimental animals, and is calculated by dividing the NOAEL by

8 None of the biocides in the reassessment are classified as respiratory sensitisers but in most cases data is not available for this sub-classification as it is usually assigned based on human exposure studies.

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January 2013

one or more uncertainty factors, selected on the basis of the extent and quality of the available data, the

species for which data are available and the nature of the effects observed.

Risk quotients (RQs) are a comparison of the predicted exposure and AOELs that will not cause adverse

effects to human health. All RQs have been normalised such that values greater than 1 are considered to be

of concern, as adverse effects may be observed following such exposures.

Further details on the selection of the toxicity endpoints, exposure and general assumptions can be found in

Appendix C: Human health risk assessment methodology.

8.2 Approach taken for human health risk assessment

The table below shows a summary of the human health risk assessment, displaying the RQs for applicators

of AFPs with their respective minimum levels of PPE, and RPE where applicable. Detailed results of

systemic exposure and risk quotients against different levels of protective equipment are set out in Appendix

C: Human health risk assessment methodology. Risks for human health are considered above the level of

concern (LOC) when RQs are greater than1, even with the maximum levels of PPE, and RPEif applicable,

factored in the modelling. Different levels of RPE have been included in the assessment, and these are

indicated by the names used (such as RPE 4, RPE 40), and are described in Appendix C.

Table 4: AFP risk quotients for human health

Active Ingredient

Brush and

Rolling

(Non-

Professional)

Brush and

Rolling

(Professional)

Mixing and

Loading

(Professional)

High-Pressure

Spraying

(Professional)

Irgarol 3% 0.25 0.02 0.35 0.64

Zineb and

Mancozeb 6.92% 0.66 0.04 0.81 0.40

Tolyfluanid 5% 0.74 0.02 0.45 0.44

Chlorothalonil 7.9% 0.84 0.05 0.38 0.56

Dichlofluanid 4.2% 1.33 0.03 0.28 0.24

Dichlofluanid 2.92% 0.92 0.02 0.19 0.17

Pyrithione (copper

and zinc) 3% 1.56 0.12 0.81 0.56

Copper 52.4% 2.50 0.24 0.87 0.65

Copper 38.1% 1.82 0.18 0.64 0.85

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January 2013

As a result of the risk assessment, the risks of AFPs containing copper at concentrations of 38.1% and

above, dichlofluanid at concentrations of 4.2% and above, and all formulations containing, octhilinone,

thiram, zinc and copper pyrithione, are considered to present risks to non-professional users that cannot be

completely mitigated. Additionally, staff consider that the human health risks associated with AFPs

containing diuron at 4.23% and above, and ziram, cannot be completely mitigated and above the LOC for

one or more scenarios for professional use.

For AFPs with diuron at 4.23% and above, risks above the LOC are observed for non-professionals and for

the mixing and loading phase. Due to a high risk to professional operators during mixing and loading EPA

staff consider that this risk justifies the revocation of all professional tasks involving these substances

including high pressure spraying. A more obvious case is seen at 7% diuron, where high pressure spraying

operators are also exposed to unacceptable levels of the biocide. According to personal communications

with marina operators across New Zealand, high pressure spraying is the predominant application method

Copper 16.8% 0.80 0.08 0.52 0.87

Octhilinone 1.4% 4.96 0.09 0.85 0.50

Thiram 3% 4.58 0.10 0.82 0.55

DCOIT 2.13% 0.39 0.01 0.14 0.19

DCOIT 2.13%

Globic 0.81 0.02 0.2 0.21

Diuron 7% 15.83 0.43 2.45 1.08

Diuron 4.23% 9.56 0.26 1.48 0.77

Diuron 2% 4.52 0.12 0.95 0.81

Ziram 5% 63.26 1.18 9.43 3.61

Numbers in red are RQs above the LOC

= No PPE (Non-Professional)

= Gloves only (Non-Professional)

= PPE but no RPE (Professional)

= PPE and RPE 4*

= PPE and RPE 10*

= PPE and RPE 20*

= PPE and RPE 40*

* Level of RPE is described in Appendix C. In simple terms, the level of protection

offered by the RPE increases from RPE 4 to RPE 40.

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January 2013

by professionals, and therefore a significant risk identified for either one of the high-pressure spraying

phases represents a significant risk for the majority of the professional use of the AFP.

Ziram is the only biocide that yields levels of risk that are above the LOC for all possible scenarios modelled.

Based on the available data, its risk profile is the highest of the biocides that are part of this reassessment

and the risks cannot be adequately mitigated. EPA staff acknowledge that currently available toxicological

data on ziram played an important role in the outcome of its risk assessment. New data on dermal

absorption of ziram could potentially refine the risk assessment for AFPs containing this biocide.

8.1 Can you supply the EPA with current dermal absorption data for ziram?

Risks for non-professional users of irgarol, zineb and mancozeb AFPs are below the LOC without the

contribution of any protective equipment.

Results of the risk assessment focus on long term exposure to the biocide by users of AFPs, even under

potentially sporadic events such as for non-professional scenarios. However, the staff acknowledge that the

hazard classification of AFPs may differ from that of the biocidal component due to dilution and/or the

presence of other hazardous components in the mixture. Local effects based on the classification of

formulated products (such as acute oral and inhalation toxicity, eye and skin irritation and corrosion and skin

sensitization) may occur as a result of unprotected exposure to AFPs. Additionally, some AFPs are

flammable, which presents additional risks to be managed. Most HSNO class 6 (toxic) and class 8

(corrosive) substances trigger requirements for the use of PPE when handling such a substance, to protect

against exposure. The PPE control is considered sufficient to protect users from effects not covered by the

quantitative risk assessment undertaken, particularly in the case of the non-professional users. Additional

risks arising from the flammable nature of some AFPs are considered by the EPA staff to be adequately

managed through the existing controls that are in place.

8.2 Do you know of any anecdotal or other evidence of harm to human health caused by AFPs in acute or

long term cases?

8.3 Environmental effects – Risk characterisation

Some of the most popular antifouling biocides have been proven to damage non-target organisms, in

particular phytoplankton and corals (EC, 2006). These concerns have lead overseas regulators to restrict

use of some antifouling biocides (see Appendix B). These risks were investigated for New Zealand in a

report prepared for the Ministry for the Environment (Stewart, 2003; Stewart, 2006). The author found that

some biocides have accumulated in New Zealand marinas, which emphasised the need for a closer look at

the risk profile of AFPs in New Zealand marinas.

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January 2013

For risk assessment purposes it is necessary to calculate the environmental burden of leaching AFPs.

Environmental risks are estimated by comparison of the PEC (Predicted Environmental Concentration) with

the PNEC (Predicted No Effect Concentration). The PNEC is the maximum concentration at which an AFP is

considered to be without adverse environmental effects. It is based on the most appropriate NOEC (No

Observed Effect Concentration) from relevant sub-chronic or chronic ecotoxicity studies conducted with

experimental animals and plants, divided by one or more uncertainty factors. These uncertainty factors are

selected according to the extent and quality of the available data, the range of species for which data are

available, and the nature of the effects observed (in accordance with the TGD).

Risk quotients (RQs) compare PECs and PNECs that will not cause adverse effects to the environment. All

RQs have been normalised such that values greater than 1 are considered to be of concern, as adverse

effects may be observed at these concentrations.

8.4 Approach taken for environmental risk assessment

The table below shows a summary of the environmental risk assessment, displaying the RQs for the four

exposure scenarios modelled. Criteria for selection of these environments and detailed results are set out in

Appendix D: Environmental risk assessment methodology. Risks for the environment are considered to be of

concern when RQs are > 1.

Table5: Risk quotients for all active ingredients in four different exposure scenarios on the basis of ―Average‖ PECs

Active

ingredient

Half Moon Bay

marina

Lyttelton

Harbour Kinloch marina OECD marina

Chlorothalonil 100 23 30 24

Copper 3.3 0.6 7.5 0.33

DCOIT 10 2.8 6 3.9

Dichlofluanid 0.71 0.29 0.17 0.99

Diuron 15 3.1 4.7 2.9

Irgarol* 240 49 150 46

Mancozeb* 2 0.6 4.9 1

Octhilinone 8.6 1.8 2.8 1.6

Pyrithione (Copper) 2.3 0.59 2.4 0.93

Pyrithione (Zinc) 4.1 1.1 4.4 1.7

Thiram 2.7 0.65 7.6 0.74

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January 2013

Tolyfluanid* 4.5 1.7 1.1 5.1

Zineb 0.27 0.12 0.063 0.46

Ziram 0.97 0.31 2.2 0.74

* The leaching rate used to estimate PECs for these active ingredients was based on the highest for biocides

(excluding copper), as no specific data were available to EPA staff to allow us to calculate the leaching rate. All

other values are based on average PECs derived using average leaching rates.

This environmental risk assessment only includes risks to aquatic organisms (excluding sediment dwelling

organisms) that are exposed to biocides as a result of leaching from vessel hulls or other submerged

surfaces which have AFPs applied to them i.e. during the service lifecycle stage. Risks resulting from boat

maintenance activities, such as application and removal, have not been assessed, as they pose significantly

lower risks to the environment than leaching during the service life. These risks are expected to be further

mitigated by any controls put in place based on the assessment of service life risk. Risks associated with

exposure of other environmental compartments (e.g. terrestrial organisms and invertebrates) are considered

to be adequately managed through prescribed controls for packaging, transport and labelling, and have not

been addressed further.

Full details of the environmental risk assessment can be found in Appendix D: Environmental risk

assessment methodology.

In some instances the EPA has not been able to source key information about the physical characteristics of

these substances, which is required for leaching rate calculations. In these instances the EPA has used

reasonable worst case scenarios as an appropriate substitute.

8.3 Can you provide data on application factors to improve the leaching rate calculations for substances

where the worst case scenario has been used (Irgarol, mancozeb, tolyfluanid)

In calls for information on the effects of AFPs made during the preparation of this Application, the EPA

requested exposure and mesocosm data that could be used in its risk assessment. Several submitters have

provided data for specific substances, and these have been incorporated into the risk assessment. Full

details are contained in Appendix D: Environmental risk assessment methodology .

EPA staff assess the risks, taking into consideration possible control measures. However, EPA staff believe

that there are no controls capable of reducing the risks of AFPs to the aquatic environment during the

service life, other than to revoke the approvals of the most harmful substances, making them unavailable on

the New Zealand market.

According to our risk assessment, only two biocides used in antifouling paints, dichlofluanid and zineb, pose

environmental risks below the LOC.

All of the other active ingredients pose risks to the environment that are of concern. The active ingredients

appear in Table 6 in the order of their environmental risk, based on the worst-case RQ.

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January 2013

Table 6: Worst case scenarios for environmental RQs

Active ingredient Worst-case RQ

Irgarol 240

Chlorothalonil 100

Diuron 15

DCOIT 10

Octhilinone 8.6

Thiram 7.6

Copper 7.5

Mancozeb 4.9

Tolyfluanid 4.5

Pyrithione (Zinc) 4.4

Pyrithione (Copper) 2.4

Ziram 2.2

Dichlofluanid 0.71

Zineb 0.27

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January 2013

9. Benefits Assessment

The EPA recognises that AFPs are hazardous substances which can pose risks to human health and the

environment. However, these substances are being used because of the ongoing benefits they provide, and

where benefits outweigh risks, approvals may be retained. In this benefits assessment EPA staff have

identified a number of generic benefits common to all AFPs. Where possible, specific benefits s are also

identified.

In order to support this assessment, the EPA commissioned Covec Ltd (Covec) to undertake an analysis of

the potential costs and benefits associated with the phase-out of specific biocides (with a focus on diuron,

chlorothalonil, irgarol and ziram). Covec‘s analysis also considers the potential costs and benefits of

proposed controls. Covec‘s report is available on the EPA website along with other supporting documents for

this application9.

The Covec analysis was commissioned in accordance with statutory requirements and the decision

principles for impacts on the market economy as detailed in the Technical Guideline Assessment of

Economic Risks, Costs and Benefits: Consideration of impacts on the market economy.10 Indicators used

include the potential for changes in price and performance in different sectors of the antifouling market, and

the potential to substitute or reformulate products. The distribution of effects over different groups of users

were considered.

Stakeholder feedback was also provided to the EPA including that received on the following issues:

Specific benefits received by users from individual active ingredients;

Commercial and efficacy benefits identified by manufacturers; and

Impact on manufacturers‘ business if chlorothalonil, diuron, Irgarol and ziram were no longer available for

use in antifouling paints.

Additional information to support this benefits assessment is sourced from relevant literature and policy

documents.

9.1 Generic benefits of AFPs

A number of generic benefits provided by AFPs have been identified through literature review and

stakeholder feedback. EPA staff consider the benefits described below are provided by all biocides used in

antifouling paints.

9 http://www.epa.govt.nz/search-databases/Pages/applications-details.aspx?appID=APP201051# 10 http://www.epa.govt.nz/Publications/ER-TG-05-Assessing%20risks,%20costs%20and%20benefits.pdf

http://www.epa.govt.nz/search-databases/Pages/applications-details.aspx?appID=APP201051http://www.epa.govt.nz/Publications/ER-TG-05-Assessing%20risks,%20costs%20and%20benefits.pdf

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January 2013

Biosecurity

Antifouling paints help prevent the introduction of non-indigenous species and the transfer of indigenous and

non-indigenous species into and around New Zealand waters.

In their Risk analysis of vessel biofouling, the former Ministry for Agriculture and Fisheries (MAF, now

Ministry for Primary Industries or MPI) identified species within twelve of twenty broad taxonomic groups as

posing non-negligible risks. These groups are ―macro-fouling organisms with the potential to significantly

modify ecosystem structure and function, or the potential to impact upon economic activities such as

aquaculture‖. MAF‘s assessment of the impacts was:

While it is difficult to forecast the exact nature of impacts, it is known that introduced marine species

can significantly alter local environments leading to impacts on ecosystem services. Economic,

environmental, social and cultural values at risk from these impacts include aquaculture, fisheries,

taonga species, iconic habitats and recreational uses of the environment, respectively (MAF, 2011a).

As part of their Marine Biosecurity Programme, MPI aims to prevent the introduction of such invasive species

by encouraging vessel operators to use antifouling paints before entering New Zealand waters or travelling

between regions (MPI 2011), amongst other measures.

The New Zealand Coastal Policy Statement 2010 (NZCPS) also aims to control harmful aquatic organisms.

Policy 12 of the NZCPS is to ―Provide in regional policy statements and in plans, as far as practicable, for the

control of activities in or near the coastal marine area that could have adverse effects on the coastal

environment by causing harmful aquatic organisms to be released or otherwise spread‖ (DOC, 2010).

Regional councils are required to give effect to the NZCPS in their statements and plans. More stringent

requirements exist for the Kermadec and Subantarctic Islands, where visitors are required to provide the

Department of Conservation with evidence of their antifouling system, and operators may be subject to a hull

inspection (DoC, 2012).

Internationally, the risks of transfer of aquatic species, and the use of antifouling systems as a mitigation, is

also recognised by the International Maritime Organisation (IMO) and other international bodies. The IMO

have published guidelines to minimise the transfer of invasive species. MPI is currently consulting on Draft

Antifouling and In-Water Cleaning Guidelines in line with the IMO Guidelines (amongst other considerations)

(MPI 2011).

Antifouling paints which are applied overseas to many commercial vessels visiting New Zealand waters are

not within the scope of this benefits assessment. However, this Application does cover a number of

beneficial effects including reducing or controlling the risk of the introduction of harmful aquatic organisms

from vessels painted domestically re-entering New Zealand waters, or the spread of such organisms through

regional transport.

It is not possible to quantify the value of protecting New Zealand‘s marine environment from the introduction

and spread of pest species. However EPA staff consider that the use of AFPs as a tool in preventing the

introduction of such species offers significant benefits to the environment, society and communities, and to

the market economy. Effects of significance to Maori are discussed in Section 10.3.

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Vessel performance and integrity

Antifouling paints may provide cost and efficiency benefits to vessel operators. Biofouling can attach to hull

surfaces, causing roughening, and creating increased frictional resistance. As Covec has noted, this slows

vessels down for any given level of power output.

The use of AFPs to control biofouling in order to improve a vessel‘s performance presents benefits in terms

of reducing fuel costs, with consequent improvements in energy efficiency. An economic analysis of hull-

fouling on US naval vessels found significant cost savings due to the use of antifouling paint; conversely,

increased fouling was found to increase fuel consumption (Schultz, M.P., Bendick J.A., Holm E.R., Hertel

W.M., 2011). Feedback from stakeholders also indicates that significant fuel savings can be achieved

through the use of AFPs.

Improvements to energy efficiency and a reduction in air emissions may also occur as a result of reducing

fuel consumption. The IMO acknowledge that improving a ship‘s hydrodynamic performance (through

reduction of biofouling) is beneficial in this regard; and recognise this concept in the document entitled

Guidelines for the Development of a Ship Energy Efficiency Management Plan (SEEMP).

In addition, preventing biofouling can protect the integrity of the hull, which may be damaged through the

growth of fouling organisms, and this has cost implications for owners.

Use of paints for other marine-based activities

In addition to use on vessels, antifouling paints are used in aquaculture and other commercial activities

which require the protection of underwater surfaces from biofouling. Feedback from one stakeholder

engaged in aquaculture is that AFPs provide for a delay in ―biogrowth on cages‖. This allows gaps between

rope weave to prevent fish suffocation, and also makes the net harder which helps prevent predation strikes.

9.2 Specific benefits

While AFPs clearly offer generic benefits against biofouling, little information on the specific benefits of

individual substances is available. However, the Covec report and stakeholder feedback to the EPA identify

some properties which influence product selection, and this information is provided below.

Longevity

Covec has indicated that commercial boat operators cite durability as a more important factor than price

when selecting paints, and stakeholder feedback received by the EPA backs this up. One fishing company

commented that:

―Our expectation is a durable product that remains effective over the full life time expectancy of the

applied product. [We expect] between three to five years of effectiveness between paint applications

depending on the thickness of application and the ocean geographies where vessels are working‖

An engineering firm noted that the main criteria for product selection is customer satisfaction: longer effect

against dollar spent.

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January 2013

Vessel specific

The composition of the hull is an important factor influencing product choice, as the copper-base of the AFP

must be compatible with the hull material. All AFP formulations contain copper (either copper (I) oxide or

copper thiocyanate). Feedback to the EPA indicates that vessels with aluminium hulls are incompatible with

copper (I) oxide, and require the copper thiocyanate base.

Factors such as vessel speed and activity undertaken are also considered during product selection. These

factors may influence whether a hard (contact leaching) product or a soft (ablative, eroding, or self-polishing)

paint is selected. The different types of AFPs are elaborated on in the Covec report (pp. 2-3), and can be

summarised as:

Eroding AFPs: partially water-soluble allowing a layer of fresh biocide to be continuously exposed;

Polishing and ablative: have a more controlled antifouling action than the eroding types. These may not

always be suitable for high speed craft, as the action may reduce the thickness of the film too quickly; and

Hard or ‗contact leaching‘: those which dry to a hard, porous surface. Biocides leach out on contact with

water. Resists abrasion and rubbing, beneficial for fast powerboats and vessels moored in mud berths or

areas of fast tidal water movement. Also suitable for fishing boats where nets are in contact with the hull.

Stakeholder feedback suggested that different AFP products may be selected for different depths or water

temperatures.

Effectiveness

Few comments were received by the EPA regarding product efficacy. However, one fishing company

commented that stronger antifouling treatments are needed:

―A safe (non-toxic) product that doesn’t work on the accumulation of flora and fauna is of no use. In

our experience anti-fouling chemicals over time have become less effective while bio-marine pests

have evolved and are becoming resistant to chemical treatments. Put simply, in order to keep New

Zealand waters clean we may need access to stronger not weaker antifoul treatments.‖

Cost

There is a range of prices for AFPs available on the market, and Covec has commented on this. Retail prices

indicate that the cheapest paint products currently available are the Diuron-based Awlcraft (also known as

Coppercoat), copper-based Warpaint, and thiram-based Altex No.5. However, these price differences are

based on a snapshot of prices which change over time e.g. in 2011 a different product from the current one

was the cheapest available (Covec 2012, pp. 9-10). Should the paint user wish to minimise costs, prices

would be expected to influence paint selection.

Covec noted commercial operators offering painting services will allow a choice of alternative paint options,

with no impact on price.

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January 2013

Specific benefits associated with copper

Copper is used as the principal biocidal component in all AFPs. This means there would be no AFPs

available if copper was not approved for use in these products. This represents a significant specific benefit

for copper , as the use of copper is necessary for the provision of all of the generic benefits of AFPs.

Therefore, copper is considered to provide high benefits in all AFP formulations.

9.1 Submitters are encouraged to provide further benefits information for substances that provide them

with specific benefits.

9.3 Economic risks, costs and benefits

Where a substance poses non-negligible risks, the EPA must take into account the extent to which the risks

and any costs associated with that substance may be outweighed by benefits. The EPA must consider all

effects of the substance during its lifecycle, and the likely effects of the substance being unavailable.

According to Covec, the AFP market is:

―split between the large vessel market, for which a relatively small number of ships use a large

amount of paint, and the pleasure boat market, in which a large number of boats use a relatively small

amount of paint. We divide this into three separate categories:

Painting of pleasure craft by boat owners (DIYers);

Painting of pleasure craft by commercial painters; and

Painting of large commercial ships, including fishing boats by commercial painters.‖

The cost implications in each of these categories are analysed in the Covec report.

The implications of revocation are summarised here.

Impacts of revocation - cost

Covec analysed the potential cost implications of revoking four substances, chlorothalonil, irgarol, ziram and

diuron. For both small boats and large vessels, it was estimated costs would increase 5-10% in the short

term and be negligible in the long term, should approvals for these AFPs be revoked. However, these costs

are based on paint prices alone, and for those using commercial services, this may translate to a smaller

increase in the total cost of an antifouling treatment. Covec note ―the increase in commercial painting price

as a result of shifting to paints that are not banned, could be 0.2-0.9% in the costs of an antifouling treatment

on average (assuming 17% of current use is of banned products)‖. This takes into account the paint costs as

a proportion of total costs for pleasure craft and commercial ship owners using such a service.

On the basis of the substances analysed, Covec notes consumers may substitute products, concluding that:

―The bans on paints will have little total impact on costs. There appear to be substitutes available in all

markets, allowing consumers to switch products. The impacts will fall mainly on the producers and

importers of the products proposed to be banned; this is particularly Awlcraft currently. However,

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January 2013

phasing in the ban over time would enable new formulations to be developed allowing firms to

maintain market share.‖

In addition to chlorothalonil, irgarol, ziram and diuron EPA staff identified three further substances,

octhilinone, thiram and DCOIT, with high human health and environmental risks. Recommendations to

revoke approvals containing all of these substances are made in Section 12, following the weighing up of

their risks and benefits.

Two of these substances, Diuron and thiram, are contained in two of the cheapest and most widely used

AFPs, therefore, the impacts of their possible phase-out are examined in more detail below.

Diuron

Covec‘s findings show that the diuron-based product Awlcraft is currently the cheapest product available on

the market. Diuron was also the only substance proposed for phase-out in the Call for Information for which

stakeholders provided feedback. Stakeholder comments focussed on the impacts of revocation.

Feedback from users (commercial operators) was provided as follows:

―Any changes to, or restrictions on paint selection, should be phased in over time so that industry

working with science has an opportunity to develop alternative products. Withdrawing products before

adequate substitutes are available would put our vessel fleet in a dire situation where we could have

no options other than to withdraw from some fishing grounds.... a lead in of at least five years is

necessary to transition between phasing out one product and developing a viable alternative.‖

―As an international trading vessel we have very tight time line and time frames for maintenance

throughout the year and this time is booked 2 to 3 years ahead of time so that we can plan around

what needs to be done in the time window, any change to paint type and way to apply the paint could

slow this time down and prevent the vessel from departing on time...‖

Feedback from manufacturers focused on the time required to develop products and bring them to market,

and any losses to business:

―If restrictions are placed without a phase in period, our product range will be limited for the coastal

commercial vessel Marine market...Time will be required to... determine replacement products that

comply with the New Zealand regulations and obtain registration (6-12 months, provided that the

product fits into an existing HSNO group standard).‖

―In the longer term suitable products would be able to be formulated tested and proven to be fit for

purpose... a loss of a percentage of business may adversely affect the company in what is at present

difficult times.. changing products and formulations leads to costs involved in manufacturing different

products plus new labels, data sheets, manuals and point of sale literature. The cost can be very

high in relation to the relatively small NZ market.‖

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January 2013

Covec‘s analysis indicates that there may be negative cost implications for users should a short phase-out

time be mandated, but the availability of current alternatives and the potential for new formulation

development should ensure that some product will replace Awlcraft in the medium term at a similar price.

The short term increase in costs could be alleviated through an appropriate phase-out period. However, if

other lower priced products also become unavailable there will be a point at which the benefits of retaining

the remaining products outweigh their risks.

As a number of appropriate, cost effective substances with lower risk quotients are likely to remain available,

the benefits of retaining diuron are considered to be short term and minor.

Thiram

Thiram-based paint Altex No. 5 is a popular choice among users in New Zealand, and is currently the third

cheapest product available. Analysis of the specific cost implications was not within the scope of the Covec

report and therefore the cost implications of revocation of this biocide have not been quantified. However,

based on the feedback from stakeholders and the Covec analysis, EPA staff anticipate a potentially

significant effect on costs to paint users if thiram is revoked without an adequate phase-out period. This

would be particularly true if diuron, which is the co-biocide in the cheapest product on the market, was also

phased out. Loss of diuron on its own would have little effect in the medium term, however Covec

established loss of thiram would see a significant jump in price to the next cheapest product (p.9). Added to

this, feedback to the EPA indicates that thiram based AFPs have a significantly larger market share than

paints containing other biocides (excluding copper). This means, the loss of this lower priced, popular

biocide would affect a large number of users. The effects may be expected to occur particularly in the retail

market where a ―cost minimiser‖ chooses the cheapest product available on the market. If the approval for

diuron is revoked then the benefit of retaining thiram is likely to extend into the medium term and be

considered moderate.

Impacts of revocations - product availability

Based on the four paints proposed for revocation in the ―Call for Information‖ (ziram, irgarol, chlorothalonil

and diuron), Covec have concluded that users may face short term cost increases which will become

negligible over the longer term. EPA staff consider this conclusion would not be significantly altered for

additional revocations proposed as a result of the risk assessment, provided that sufficient time is allowed to

develop and phase-in new formulations.

The effect of revoking further paints has been evaluated, with a view to considering whether an effective

range of lower risk products would remain available on the market.

Table 7 summarises Covec‘s cumulative analysis of the impact of banning certain AFPs. It includes a

breakdown of the paints in terms of aluminium compatibility and type, and by commercial and retail markets.

Active ingredients are ordered according to the level of risk they present. Each line indicates the maximum

RQ and number of AFPs (by product) remaining on the market if that active ingredient was no longer

available. No change indicates that the substance is not currently in use in AFPs, in New Zealand.

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The final line shows that there would be no products available if the use of copper was banned, as it is a

component in all AFPs. The maximum RQ for copper is 7.5, and for the purpose of this cumulative analysis,

this RQ has been applied to all AFPs with active ingredients that have RQs lower than 7.5. The maximum

RQ for the active ingredient listed is included in brackets.

Table 7: Cumulative impacts of AFP bans

Ingredient

banned

Max

RQ

Paints

Avail.

Paints Available Alumin. compatible Paint Types*

Retail Comm. Retail Comm. A SP R H

Nothing banned 240 34 13 21 4 3 4 19 3 3

Irgarol 102 34 13 21 4 3 4 19 3 3

Chlorothalonil 63 34 13 21 4 3 4 19 3 3

Ziram 16 33 13 20 4 3 3 19 3 3

Diuron 10.1 25 9 16 4 2 3 14 2 2

DCOIT 8.7 22 9 13 4 1 3 12 2 2

Octhilinone 7.6 20 8 12 4 1 1 12 2 2

Thiram 7.5 17 7 10 4 1 1 9 2 2

Mancozeb 7.5 (4.9) 17 7 10 4 1 1 9 2 2

Tolyfluanid 7.5 (4.5) 17 7 10 4 1 1 9 2 2

Zinc Pyrithione 7.5 (4.4) 13 4 9 2 1 1 6 1 2

Copper Pyrithione 7.5 (2.5) 9 4 5 2 1 1 3 1 2

Dichlofluanid 7.5 (1.3) 7 2 5 1 1 1 3 1 0

Zineb 7.5 (0.8) 4 2 2 1 0 1 2 1 0

Copper 0 0 0 0 0 0 0 0 0 0

* A = Ablative, SP = Self-Polishing, R = Resin, H = Hard

Source: EPA (including industry questionnaires); Material Safety Data Sheets; advertised information from paint

manufacturers.

Covec noted that if all paints as hazardous as Sea Nine (DCOIT) were banned, only one commercial paint

would be available for use on aluminium vessels. Similarly, if Octhilinone was also banned, a single product

would have a monopoly amongst ablative paints, as three alternatives would be removed.

EPA staff have considered the potential effect of this. Available information indicates that:

Aluminium compatibility depends on the copper base, rather than the co-biocide, so re-formulation could

be possible; and

Should the number of ablative paints be reduced, information provided by manufacturers indicates that a

range of co-biocides could be used to replace those currently on the market. Alternative paints may be

developed if a sufficient phase-out period is provided.

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January 2013

EPA staff note that a detailed cost benefit analysis has not been performed for substances other than diuron,

ziram, irgarol and chlorothalonil. While the cost implications of phasing out three further substances (DCOIT,

thriam and octhilinone) is unquantified, it is anticipated that appropriate phase-out periods will mitigate

potential economic impacts.

The generic benefits assessment, Covec analysis, and judgements concerning the availability of substitutes,

along with the risk assessment, have been the basis for the recommendations made in Section 12.

9.2 Please comment on the recommendation to phase-out of DCOIT, thiram and octhilinone, including

potential implications for cost and availability.

9.4 Cost effectiveness of controls

EPA staff engaged Covec to analyse the cost effectiveness of the controls proposed in the ―Call for

Information‖. The details of Covec‘s analysis can be found in their report, a summary of their findings is

provided below.

Table 8: Cost impacts of proposed controls

Category Small boats Large boats Total

Paint bans

Some increase in costs: 5-10% in

short run for those using banned

paints; negligible in long run

Some increase in costs: 5-10% in

short run for those using banned

paints; negligible in long run

Less than $0.2 million

per annum

Enclosed work

areas

Can be managed through brush

and roller painting.

Fence screening likely to be

acceptable

Potentially high costs if full

encapsulation is required

Costs depend on

whether complete

enclosure is required.

High costs for large

boats

Collection and

disposal of waste

Filtration systems equivalent to

$120-170/marina berth Mostly in place

$1-1.5 million for

filtration systems

Sealed hard

stand

80-85% of marinas already have

sealed hard stands Not applicable

$1.7-2.6 million up-

front or $260-390,000

per annum.

Approved

handler

Some impact – cost for DVD or on-

line training (less than $100 per

person