decision - epa · 12/18/2015 · confidential appendix c). the studies confirmed that roundup gel...

DECISION

www.epa.govt.nz

18 December 2015

1. Summary

Substance Name Roundup Gel Max Weedkiller

Application code APP202696

Application type To import or manufacture for release any hazardous

substance under Section 28 of the Hazardous Substances

and New Organisms Act 1996 (“the Act”)

Application sub-type Section 28A(2)(b) – least degree of hazard – based on the

proposed substance being formulated so that it has one or

more hazardous properties and each hazardous property

has the least degree of hazard for that property

Applicant Monsanto Australia Limited

Purpose of the application To import for release Roundup Gel Max Weedkiller, a

herbicide containing 72 g/L glyphosate (as 88 g/L glyphosate

potassium salt) as a gel for use as a herbicide by home

gardeners

Date application received 30 November 2015

Consideration date 15 December 2015

Considered by The Chief Executive1 of the Environmental Protection

Authority (“the EPA”)

Decision Approved with controls

Approval code HSR101087

Hazard classifications

(refer to Table 1) 9.1D

1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.

2

Decision on application for approval to import or manufacture Roundup Gel Max Weedkiller for release (APP202696)

December 2015

2. Background

2.1. Roundup Gel Max Weedkiller is a herbicide containing the active ingredient 72 g/L glyphosate

(as 88 g/L glyphosate potassium salt). It is a ready-to-use gel applicator intended for home use.

2.2. The full composition of Roundup Gel Max Weedkiller is detailed in Confidential Appendix B.

2.3. The applicant intends to import Roundup Gel Max Weedkiller into New Zealand.

3. Process and consultation

3.1. The application was lodged pursuant to section 28A of the Act and contained sufficient

information for an assessment of the substance to be undertaken.

3.2. The consideration phase of the application was delayed in accordance with section 59 of the

Act to allow more time to evaluate and review the information provided to support the

classification of the substance.

3.3. WorkSafe New Zealand, the Ministry of Health and the Department of Conservation were

advised of the application on 1 December 2015. No comments were received.

4. Hazardous properties

4.1. The hazard profile of Roundup Gel Max Weedkiller was initially determined using mixture rules

and other available information, and was subsequently revised based on information provided

by the applicant.

4.2. The applicant provided several studies applicable to the formulated substance (detailed in

Confidential Appendix C). The studies confirmed that Roundup Gel Max Weedkiller does not

meet the hazard classification thresholds for acute toxicity, skin and irritation/corrosivity, skin

sensitisation, aquatic ecotoxicity or terrestrial vertebrate toxicity. These results have been taken

into consideration when classifying the substance.

4.3. A class 8.1 metal corrosive classification was indicated on the basis of mixture rules and the

amount of potassium hydroxide in the substance. However the final pH of the substance

(around 8) indicates that the concentration of potassium hydroxide that remains after reaction

with the acid groups in the polymer is low. I therefore consider that the substance is not

corrosive to metal.

4.4. A class 9.1D classification is applied on the basis of the biocidal properties of the substance.

The assignment of a 9.1D classification is in accordance with the Hazardous Substances

(Classification) Regulations 2001.

4.5. The hazard classifications for Roundup Gel Max Weedkiller are set out in Table 1.

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December 2015

Table 1: Hazard classifications of Roundup Gel Max Weedkiller

Hazard Endpoint HSNO

Classification

based on mixture

rules

HSNO

Classification

determined by

applicant

Final HSNO

Classification

determined by

the EPA

Skin irritancy 6.3A - -

Metallic corrosive 8.1A - -

Eye corrosivity 8.3A - -

Aquatic ecotoxicity 9.1C 9.1D (biocide) 9.1D (biocide)

Terrestrial vertebrate

ecotoxicity

9.3C - -

5. Meeting the criteria for rapid assessment under section 28A(2)(b) of the Act

5.1. Based on the classification of the substance, I consider that the criteria for rapid assessment

under section 28A(2)(b) have been met and that Roundup Gel Max Weedkiller has a

formulation with each hazardous property having the least degree of hazard for that property.

5.2. The full composition of Roundup Gel Max Weedkiller is detailed in Confidential Appendix B of

this decision.

5.3. I consider that there are no other matters which would prevent this application for Roundup Gel

Max Weedkiller from being approved under section 28A of the Act.

6. Risk assessment

Assessment of risks to human health and the environment

6.1. Based on the hazard classification for Roundup Gel Max Weedkiller, a set of default controls

are prescribed by regulations under the Act. These default controls form the basis of the

controls set out in Appendix A and have been taken into account in the risk assessment.

6.2. I have considered the potential of Roundup Gel Max Weedkiller to cause adverse effects to

human health and the environment (including non-target organisms) during all stages of the

substance’s lifecycle.

Assessment of risks to human health

6.3. I note that Roundup Gel Max Weedkiller does not meet any of the classification thresholds for

human toxicity (class 6) and does not have eye or skin corrosive properties.

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December 2015

6.4. With controls in place, such as hazard identification through labelling, signage and adequate

packaging, I am satisfied that the likelihood of unintended exposure to Roundup Gel Max

Weedkiller to be highly improbable, giving an overall qualitative assessment of the risk of toxic

effects on human health as negligible.

Assessment of risks to the environment

6.5. I note that Roundup Gel Max Weedkiller does not trigger any ecotoxicity classifications other

than as a biocide (9.1D) and consider the risk of adverse effects to the environment during

manufacturing, importation, transport, storage, use and disposal of Roundup Gel Max

Weedkiller as being negligible.

Relationship of Māori to the Environment

6.6. I have assessed the potential for Roundup Gel Max Weedkiller to adversely affect the

relationship of Māori to the environment in accordance with sections 5(b), 6(d) and 8 of the Act.

6.7. In general, the introduction and use of hazardous substances has the potential to inhibit the

ability of Māori to fulfil their role as kaitiaki.

6.8. I note that Roundup Gel Max Weedkiller has biocidal properties which give rise to the potential

for cultural risk. Cultural risk includes any negative impacts to taonga flora and fauna species,

the environment, and the general health and well-being of individuals and the community.

6.9. I am satisfied that based on the information provided, including the use pattern and the controls

that will apply to Roundup Gel Plus Weedkiller, the risks to Māori culture or traditional

relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other

taonga will not be significant.

6.10. If Roundup Gel Max Weedkiller is applied in the proposed manner I consider that it will not

breach the principles of the Treaty of Waitangi.

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

6.11. There are not expected to be any significant adverse impacts on the social environment,

communities or the economy with the controlled use of Roundup Gel Max Weedkiller, as similar

products are already approved for home use.

New Zealand’s international obligations

6.12. I am not aware of any international obligations that will affect the approval of Roundup Gel Max

Weedkiller.

Overall assessment of risks

6.13. I consider that with controls in place (detailed in Appendix A), the risks of unintended biocidal

effects associated with Roundup Gel Max Weedkiller will be negligible.

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December 2015

7. Controls

7.1. Based on the hazard classification, a set of default controls have been prescribed by regulation

under the Act as being applicable to Roundup Gel Max Weedkiller. The default controls form the

basis of the controls set out in Appendix A.

7.2. The effectiveness of the default controls for Roundup Gel Max Weedkiller in managing the

identified risks associated with the substance was reviewed by EPA staff. Based on the risk

assessment, the following modifications and additions to the default controls are recommended

for Roundup Gel Max Weedkiller:

Table 2: Setting exposure limits

Control Comment

E1 This control relates to the setting of environmental exposure limits (EELs) to control

hazardous substances entering the environment in quantities sufficient to present a

risk to the environment. EELs have not been proposed for any component of Roundup

Gel Max Weedkiller at this time as the level of risk to the environment is negligible.

The default EEL values have been deleted.

E2 The default controls require the EPA to set a maximum application rate for class 9

substances that are to be applied to an area of land (or air or water) and for which an

EEL has been set. As no EEL has been proposed, control E2, relating to the setting of

a maximum application rate, is deleted.

Table 3: Variation and deletion of controls

Control Comment

EM12 This control includes requirements for secondary containment of pooling substances. It

is considered that the risks associated with the containment of substances which are

not class 1 to 5 substances (i.e. do not ignite or explode) are different to those

associated with class 1 to 5 substances. Consequently the secondary containment

requirements can be reduced (as specified in Appendix A). It is considered that these

reduced secondary containment measures are adequate to manage the risks of a spill

of Roundup Gel Max Weedkiller as it does not ignite or explode. Therefore, the

proposed variation is more cost-effective in terms of managing the risks of the

substance. The revised control is shown in Appendix A.

Table 4: Additional controls added to Roundup Gel Max Weedkiller:

Control Comment

Max impure I note that the technical active ingredient in Roundup Gel Max Weedkiller, glyphosate

acid, is associated with the toxicologically significant impurities formaldehyde and N-

nitroso-N-phosphonomethylglycine. When present in high enough concentrations such

impurities may cause adverse effects to people and/or the environment. Imposing a

restriction on the concentration of such impurities in the active ingredient used to

manufacture Roundup Gel Max Weedkiller will prevent them from being present in

concentrations sufficient to cause adverse effects to people or the environment.

Accordingly, I consider that the application of an additional control to address this

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December 2015

concern will be more effective than the specified (default) controls in terms of its effect

on the management, use and risks of the substance. I have set the controls accordingly.

Schedule 8 I note that the default controls do not set requirements for the design and management

of stationary container systems (e.g. tanks), such requirements are required to maintain

the integrity of the stationary container system and prevent a spill into the environment.

The controls relating to stationary containment, as set out in Schedule 8 of the

Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer

Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page

767), as amended, shall apply to this substance, notwithstanding clause 1 of that

schedule.

7.3. The modifications to the default controls for Roundup Gel Max Weedkiller, as described above,

have been incorporated into the list of controls for the substance provided in Appendix A.

8. Decision

8.1. Pursuant to section 28A of the Act, I have considered this application to import or manufacture a

hazardous substance for release.

8.2. Having considered the composition, hazardous properties and use of Roundup Gel Max

Weedkiller, I am satisfied that it meets the criteria for rapid assessment under section 28A(2)(b)

in that it has one or more hazardous properties and each hazardous property has the least

degree of hazard for that property.

8.3. I am satisfied with the hazard classifications identified by the EPA in Table 1 and confer them

on Roundup Gel Max Weedkiller.

8.4. I consider that by applying the HSNO default controls to Roundup Gel Max Weedkiller, together

with the additions and variations proposed in section 7, that any risks associated with the

substance will be mitigated.

8.5. In this consideration, I have also applied the following clauses of the Hazardous Substances

and New Organisms (Methodology) Order 1998:

clause 9 – equivalent of sections 5, 6 and 8 of the Act;

clause 12 – risk assessment;

clause 21 – the decision accords with the requirements of the Act and regulations;

clause 24 – the use of recognised risk identification, assessment, evaluation and

management techniques;

clause 25 – the evaluation of risks; and

clause 35 – the costs and benefits of varying the default controls.

8.6. The application to import or manufacture the hazardous substance Roundup Gel Max

Weedkiller, for use as a herbicide, is thus approved with controls as detailed in Appendix A.

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December 2015

Dr Allan Freeth Date: 18th December 2015

Chief Executive, EPA

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December 2015

Appendix A: Controls applying to Roundup Gel Max Weedkiller

Please refer to the Hazardous Substances Regulations2 for the requirements prescribed for each

control and the modifications listed as set out in Section 7 of this document.

Table A1: Controls for Roundup Gel Max Weedkiller– codes, regulations and variations

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

Code Regulation Description Variation

E1 Regs 32 – 45 Limiting exposure to ecotoxic

substances through the setting of

EELs

No EELs are set for this

substance at this time and

the default EEL values are

deleted.

E6 Reg 7 Requirements for equipment used

to handle substances

Hazardous Substances (Identification) Regulations 2001


I1 Regs 6, 7, 32 –

35, 36(1) – (7)

Identification requirements, duties of

persons in charge, accessibility,

comprehensibility, clarity and

durability

I9 Reg 18 Secondary identifiers for all

hazardous substances

I11 Reg 20 Secondary identifiers for ecotoxic

substances

I19 Regs 29 – 31 Additional information requirements,

including situations where

substances are in multiple

packaging

I21 Regs 37 – 39,

47 – 50

General documentation

requirements

I29 Regs 51, 52 Signage requirements

Hazardous Substances (Packaging) Regulations 2001


P1 Regs 5, 6, 7(1),

8

General packaging requirements

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

http://www.legislation.co.nz/

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December 2015


P3 Reg 9 Criteria that allow substances to be

packaged to a standard not meeting

Packing Group I, II or III criteria

PS4 Schedule 4 Packaging requirements as

specified in Schedule 4

Hazardous Substances (Disposal) Regulations 2001


D5 Reg 9 Disposal requirements for ecotoxic

substances

D6 Reg 10 Disposal requirements for packages

D7 Regs 11, 12 Information requirements for

manufacturers, importers and

suppliers, and persons in charge

D8 Regs 13, 14 Documentation requirements for

manufacturers, importers and

suppliers, and persons in charge

Hazardous Substances (Emergency Management) Regulations 2001


EM1 Regs 6, 7, 9 –

11

Level 1 information requirements for

suppliers and persons in charge

EM7 Reg 8(f) Information requirements for

ecotoxic substances

EM8 Regs 12 – 16,

18 – 20

Level 2 information requirements for

suppliers and persons in charge

EM11 Regs 25 – 34 Level 3 emergency management

requirements: duties of person in

charge, emergency response plans

EM12 Regs 35 – 41 Level 3 emergency management

requirements: secondary

containment

The following subclauses are

added after subclause (3) of

regulation 36:

(4) For the purposes of this

regulation, and regulations

37 to 40, where this

substance is contained in

pipework that is installed

and operated so as to

manage any loss of

containment in the

pipework it—

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December 2015


(a) is not to be taken

into account in

determining whether

a place is required to

have a secondary

containment system;

and

(b) is not required to be

located in a

secondary

containment system.

(5) In this clause, pipework—

(a) means piping that—

(i) is connected to a

stationary

container; and

(ii) is used to

transfer a

hazardous

substance into or

out of the

stationary

container; and

(b) includes a process

pipeline or a transfer

line.


added at the end of regulation

37:

(2) If pooling substances

which do not have class 1

to 5 hazard classifications

are held in a place above

ground in containers each

of which has a capacity of

60 litres or less—

(a) if the place’s total

pooling potential is

less than 20,000

litres, the secondary

containment system

must have a capacity

of at least 25% of

that total pooling

potential:

(b) if the place’s total


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December 2015


20,000 litres or

more, the secondary

containment system


of the greater of—

(i) 5% of the total

pooling potential;

or

(ii) 5,000 litres.

(3) Pooling substances to

which subclause (2)

applies must be

segregated where

appropriate to ensure that

leakage of one substance

may not adversely affect

the container of another

substance.


added at the end of regulation

38:

(2) If pooling substances

which do not have class 1

to 5 hazard classifications

are held in a place above

ground in containers 1 or

more of which have a

capacity of more than 60

litres but none of which

have a capacity of more

than 450 litres—

(a) if the place’s total


less than 20,000

litres, the secondary

containment system


of either 25% of that

total pooling

potential or 110% of

the capacity of the

largest container,

whichever is the

greater:

(b) if the place’s total


20,000 litres or

more, the secondary

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December 2015


containment system


of the greater of—

(i) 5% of the total

pooling potential;

or

(ii) 5,000 litres

(3) Pooling substances to

which subclause (2)

applies must be

segregated where

appropriate to ensure that

the leakage of one

substance may not

adversely affect the

container of another

substance.

EM13 Reg 42 Level 3 emergency management

requirements: signage

Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004

Code Regulation Description

Tank

Wagon

Regs 4 to 43 as

applicable

Controls relating to tank wagons

and transportable containers.

Additional controls

Code Regulation Description

Max impure Section 77A The following limits are set for toxicologically relevant impurities in the

active ingredient (glyphosate acid) used to manufacture this substance:

- Formaldehyde, (CAS# 50-00-0): 1.3 g/kg maximum

- N-nitroso-N-phosphonomethylglycine (CAS# 56516-72-4): 1.0

mg/kg maximum

Stationary

Container

Systems

Schedule 8 This schedule prescribes the controls for stationary container systems.

The requirements of this schedule are detailed in the consolidated

version of the Hazardous Substances (Dangerous Goods and Schedule

Toxic Substances) Transfer Notice 2004, available from

http://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdf

The following clause replaces Clause 1 of Schedule 8 of the Hazardous

Substances (Dangerous Goods and Scheduled Toxic Substances)

Transfer Notice 2004:

This Schedule applies to every stationary container system that contains,

or is intended to contain the substance.

http://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdf

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