ENVIRONMENTAL RISK MANAGEMENT...particular reference to benefits in comparison to existing fumigants...

ERMA New Zealand Decision: Application HSR07095 of 66

ENVIRONMENTAL RISK MANAGEMENT

AUTHORITY DECISION 21 June 2010

Application Code HSR07095

Application Type To import or manufacture for release any hazardous substance

under Section 28 of the Hazardous Substances and New

Organisms Act 1996 (―the Act‖)

Applicant Elliott Technologies Limited

Date Application Received 27 June 2008

Submission Period 4 July 2008 – 15 August 2008

Consideration Date 5 November 2009

Considered by A Committee of the Authority (‗the Committee‖)

Purpose of the Application To import or manufacture Ripper soil fumigant, to be used as

a pre-plant soil fumigant in strawberries and other high value

crops.

1 Purpose of the application

1.1 The purpose of the application is to import or manufacture Ripper soil fumigant,

to be used as a pre-plant soil fumigant in strawberries and other high value

crops.

1.2 The Ripper range of soil fumigant substances consists of three formulations,

containing the active ingredients iodomethane and chloropicrin in different

proportions. The formulations proposed in the application are:

33% iodomethane/67% chloropicrin (Ripper 330);

50% iodomethane/50% chloropicrin (Ripper 500); and

98% iodomethane/2% chloropicrin (Ripper 980).

2 Summary of decision

2.1 The import or manufacture Ripper for release is approved with controls.

2.2 In making this decision the Authority has applied the relevant sections of the

Act and clauses of the Methodology as detailed in the decision path attached to

this decision as Appendix 1.

2.3 The Committee considers that the three Ripper formulations proposed by the

applicant may be described as two substances; a range of compositions which

captures the Ripper 330 and Ripper 500 formulations (i.e. 30 – 55%

iodomethane and 45% - 70% chloropicrin) and a separate approval for Ripper

980. A substance from the Ripper range (30 – 55% iodomethane and 45% - 70%


chloropicrin) shall be referred to as ―the substance‖, and Ripper 980 will be

used to identify the manufacturing concentrate containing 98% iodomethane and

2% chloropicrin.

2.4 These substances have been given the following unique identifiers for the

ERMA New Zealand Hazardous Substances Register:

Ripper range (30 – 55% iodomethane and 45% - 70% chloropicrin)

Ripper 980

2.5 Ripper has been classified as follows:

Hazardous Property Ripper

range

Ripper 980

Acute Toxicity (Oral) 6.1B 6.1C

Acute Toxicity (Dermal) 6.1B 6.1D

Acute Toxicity (Inhalation) 6.1A 6.1C

Skin Irritancy / Corrosivity 8.2C 6.3A

Eye Corrosivity 8.3A 8.3A

Inhalation Sensitisation 6.5A 6.5A

Contact sensitisation 6.5B 6.5B

Carcinogenicity 6.7B 6.7B

Reproductive/developmental toxicity 6.8B 6.8B

Target Organ Toxicity 6.9A 6.9A

Aquatic Ecotoxicity 9.1A 9.1A

Soil Ecotoxicity 9.2A 9.2A

Ecotoxicity to terrestrial vertebrates 9.3A 9.3B

Ecotoxicity to terrestrial invertebrates - Lack of data

2.6 The Committee notes the following regarding the classification of Ripper

substances:

2.6.1 The Committee considers that, as an approval for a range covering both

Ripper 330 and Ripper 500 substances, it is appropriate to apply the

higher degree of hazard (i.e. 6.1B from Ripper 330, rather than 6.1C

from Ripper 500) to the range. Essentially this means that the Ripper

500 formulation is over-classified for acute oral toxicity. The

Committee considers that this is acceptable on the grounds that it will

have no impact on the already stringent controls that will apply to the

substance given the 6.1A inhalation hazard.

2.6.2 During the review of the data relating to Ripper, the Agency noted that

the US EPA skin classification for chloropicrin (Category I), is

equivalent to a skin corrosivity classification (8.2C). This

classification applied to Ripper 330 and Ripper 500 (but not to Ripper

980).


2.6.3 The Agency also noted that the classification assigned to chloropicrin

upon transfer included a respiratory sensitisation (6.5A) classification,

but not contact sensitisation (6.5B) classification. The Agency

considers that the contact sensitisation (6.5B) classification should be

applied to all the Ripper formulations, on the basis that a respiratory

sensitiser should also be classified as a skin sensitiser.

3 Application process

3.1 The application was formally received on 27 June 2008 and was publicly

notified on 4 July 2008 with submissions closing on 15 August 2008. Two

comments here received in favour of approval of the substance and Ripper 980,

from ―Perrys Berrys Limited‖ and the Strawberry Growers New Zealand Inc.

3.2 The Agency prepared an Evaluation and Review Report (―the E&R Report‖) to

aid the Committee in its decision making process. The E&R Report consists of

the Agency‘s review of the application and available data regarding the Ripper

substances and/or their constituent components. In the E&R Report, the Agency

proposed a suite of controls considered suitable to manage the risks associated

with the release of the Ripper substances and assessed the potential risks and

benefits the substances may pose to the environment, human health, Māori,

society and community and to the market economy.

3.3 Due to delays in completing the E&R Report, the Authority postponed the

consideration until 5 November 2009.

3.4 The Department of Labour (Workplace Group), the New Zealand Food Safety

Authority (Agricultural Compounds and Veterinary Medicines (ACVM)

Group), the Ministry of Health and the Department of Conservation and the

applicant were given the opportunity to comment on the E&R Report and the

controls proposed therein. The information available to the Committee

comprised:

the application; and

the E&R Report including a confidential appendix.

3.5 Three reports were commissioned to assist in the assessment of this application:

A report by Bruce Graham, reviewing the US EPA assessment of

Methyl Iodide for Registration as a soil fumigant;

A report by Air and Environmental Sciences Limited assessing the risks

to bystanders as a result of a leakage or spillage at a site when Ripper

substances are manufactured, stored or transported;

A report by Air and Environmental Sciences Limited on a New

Zealand-based quantitative assessment of bystander exposures

associated with the use of Ripper substances (air dispersion modelling).

3.6 The following members of the Authority considered the application: Ms Helen

Atkins (chair), Dr Max Suckling and Dr Deborah Read.

3.7 The information available to the Committee comprised:

the application;


the E&R Report including a confidential appendix; and

a copy of the manufacturer‘s training manual.

3.8 Consideration of the application commenced with a meeting held in Wellington

on 5 November 2009, between the Committee and the Agency. The Committee

considered that, on the basis of the information presented, release of the Ripper

substances would present non-negligible risks to human health during use in

commercial strawberry growing operations. The Committee considered that the

proposed suite of controls would be appropriate to prevent human or

environmental exposure. However, the Committee was unable to determine

whether the benefits associated with the substance and Ripper 980 outweighed

the risks. As a result, the Committee decided that it required additional

information from the applicant and relevant industry representatives in order to

assist in its deliberations.

3.9 The formal information request that was sent to the applicant by the Committee

(Appendix 2) focused on two key aspects:

additional information on benefits that may arise from release of the

substance;

additional information on alternatives options to the substance.

3.10 Responses to the information request were received from the applicant and other

industry members as follows:

The applicant, Elliott Technologies, provided a letter containing details

of benefits arising from the availability of Ripper substances, a

discussion of alternative products currently available in New Zealand,

and also additional information relating to the proposed New Zealand

use rates; the applicant also provided a copy of a report produced by

HortNZ, titled Sustainable Strawberry Soil Management without Methyl

Bromide;

Strawberry Growers New Zealand (Incorporated) provided a response to

the information request, detailing information on the benefits of Ripper

substances for weed control by comparison to the performance of

existing alternatives;

Perrys Berrys Limited responded to the information request by

providing details of their experiences of use of alternative products, and

measures taken to minimise fumigant usage.

3.11 The Committee decided that, in addition to the information provided as a result

of the information request, a hearing should be held to provide an opportunity

for the applicant and industry to answer questions from the Committee and

facilitate discussion of relevant points to assist the Committee in making its

decision. The hearing was held in Wellington on 3 February 2010. Further

information was provided at the hearing regarding the use of the substance, with

particular reference to benefits in comparison to existing fumigants and their

use. The Committee notes the following points from the hearing:

3.11.1 The Committee heard from Brian Smith, the Technical Manager of

Elliot Technologies. Mr Smith noted that the applicant was generally

happy with the controls in the Evaluation and Review Report and that


the use of the substance be restricted to strawberries. Mr Smith noted

that, due to the cost of doing trial work, there has been little work done

on other uses of the substance in New Zealand to date.

3.11.2 Mike Allan from Arysta (World wide) the manufacturer and patent

holder of the substance and Ripper 980, presented a comprehensive

report to the Committee on what the substance is, what it is used for in

other countries, whereabouts it is registered and its current registration

status. The Committee were greatly assisted by Mr Allan‘s

presentation and his answers to various questions, and notes the

following matters that were of particular benefit to the Committee‘s

decision making:

Mr Allan noted that the substance is a replacement for methyl

bromide and is currently part of a five year review as part of the

methyl bromide replacement programme. The particular benefits

of the substance are that it is a broad spectrum fumigant that acts

in the same manner as methyl bromide. In addition, the substance

breaks down within 1-5 days under ultra violet light, it is not

ozone depleting, it leaves no residue, it is not a volatile organic

compound (VOC), it allows for lower application rates than the

alternatives, and it can be applied using conventional equipment

(i.e. new equipment is not needed). In short, the Committee heard

that the substance is the only fumigant capable of maintaining

New Zealand s competitive position in strawberry and fruit

production.

In terms of the alternatives to the substance, Mr Allan presented

the Committee with a very useful summary, reproduced in the

following table, demonstrating the comparisons of the available

fumigants:


Arysta‟s comparisons of available fumigants

Product Fumigant quality

Co

ntr

ol

of

wee

d s

eed

s

Co

ntr

ol

of

soil

pa

tho

gen

s

Co

ntr

ol

of

nem

ato

des

Mu

lti-

yea

r

con

trol

Yie

ld

sta

bil

ity

Ben

efic

ial

pla

nti

ng

inte

rva

ls

Va

riet

y o

f

ap

pli

cati

on

met

ho

ds

Ripper

(the substance)

Methyl

bromide/chloropicrin

Telone C35

Chloropicrin

Key: Effective Partially

effective

Not

effective

The applicant‘s position in relation to the alternatives is that none

of them present all the qualities needed to effectively replace

methyl bromide.

Mr Allan acknowledged that the substance is an acutely toxic

product. He noted in this regard that the substance has a

stewardship regime that has won various awards which he

provided the Committee with information about. In summary, the

product is not sold to anyone without the proper training being in

place prior to sale.

3.11.3 Mr Ian Crook of Arysta Australasia also presented to the Committee on

the status and use profile of Ripper in Australia, and stressed the

inadequacies of the alternatives and the importance of the substance as

a true replacement for methyl bromide with the benefit of not being

ozone depleting.

3.11.4 Other benefits were identified during discussions that had not been

previously identified. In particular, the Committee notes the claimed

operational benefits arising from the substance when compared to

Telone C35. When Telone C35 is used, fields require rotary hoeing

every few weeks, with multiple fumigation applications. In addition,

due to the longer dissipation time, fields must be left for 8 weeks post-

fumigation in order to ensure that fumigant levels have decreased

sufficiently to allow for safe planting (i.e. a lack of phytotoxicity) of

seedlings.

3.11.5 Mrs Francie Perry of Perry‘s Berrys Limited (commercial strawberry

growers) provided extensive information on the benefits to the


strawberry industry of being able to use the substance when the stocks

of methyl bromide run out this year. Mrs Perry indicated that use of the

currently available fumigants, now that stocks of methyl bromide have

been completely exhausted, can reduce yields by up to 30% in a wet

season, and that during harvest up to 1000 staff are employed. Mrs

Perry stated that ―in a wet season, without Methyl Bromide (or Ripper),

a high risk business becomes commercial suicide‖. The Committee

thanks Mrs Perry for her input as this was extremely helpful and

important to the Committee‘s deliberations.

3.11.6 The Committee had the opportunity to discuss all the issues with a

number of people that the applicant had brought to the hearing but who

were not formally presenting.

3.11.7 The Committee was presented with detailed information on the

registration status of the substance elsewhere in the world by Mr Smith

and the Arysta team. Iodomethane is registered for use in the United

States and Japan.

3.11.8 The Committee heard from Mr Ian Horner from the New Zealand

Institute of Plant and Food Research that the timing of when the

substance (and methyl bromide) can be used is a critical factor in its

efficacy. Mr Horner stated the following:

methyl bromide is applied in August (as will the substance be);

these products breakdown quickly (once the covers are removed)

and planting can occur within a week of treatment occurring;

the substance has a significant timing advantage over (for

example) Telone, which is applied in October and takes eight

weeks to break down, and planting does not take place until

November or December.

3.11.9 The Committee also heard from Mr Ken Glassey of MAF Biosecurity

NZ. Mr Glassey noted that MAF Biosecurity NZ is interested in

alternatives/replacements for methyl bromide. The Committee has

subsequently been informed that MAF Biosecurity has a request for

proposal out for response in relation to the use of methyl iodide in

efficacy trials as a log fumigant.

3.11.10 Some presenters were concerned that the Committee was going to

impose a control that restricted the use of the substance to soil

fumigation for commercial strawberry growing operations only. The

Committee comments on this further in this decision in paragraph 4.16.

Suffice to say here that the Committee is not satisfied that sufficient

information on the benefits of other uses of the substance was

presented such that the Committee could conclude that the benefits of

those uses outweigh any risks associated with those uses. The

Committee notes that the applicant accepted the restriction on the use

of the substance proposed and recommended in the E&R report.


3.11.11 The Committee acknowledges the commitment to assisting their

decision making made by the attendees, and thanks all parties for their

contributions.

3.12 The controls detailed in the following paragraphs contain a number of

modifications and alterations identified after publication of the E&R report. In

addition, the Committee has modified the form of some of the controls that

should apply to the substance and Ripper 980.

4 Consideration

Default controls

4.1 In the E&R Report, the Agency assigned default controls for the substance and

Ripper 980 based on the hazardous properties, as set out in the HSNO

Regulations. The default controls were used as a reference for evaluation of the

application in the E&R Report. The default controls are listed in Appendix 4 of

the E&R Report and have not been reproduced here.

Identification of the potentially non-negligible risks, costs and benefits

of the substance

4.2 In its evaluation of the substance and Ripper 980, the Agency identified

potentially significant, and therefore non-negligible, risks, costs and benefits

associated with the the substance and Ripper 980.

Potentially non-negligible risks

4.3 The Agency considers that the potentially non-negligible risks associated with

the substance and Ripper 980 relate to the substance‘s properties as identified in

paragraph 2.5 above. These risks arise during all phases of its lifecycle.

Potentially non-negligible costs

4.4 The costs and risks were assessed together in an integrated fashion in the

Agency‘s assessment.

Potentially non-negligible benefits

4.5 The Committee notes that the E&R report details that the only use pattern that

has demonstrated any level of benefit for the release of the substance is for soil

fumigation used in commercial strawberry growing. The Committee considers

that any decision made should be on the basis that use of the substance is

restricted to use in commercial strawberry growing.

Assessment of the potentially non-negligible risks and costs of the

substance

4.6 Taking into account the Agency‘s assessment of the potentially non-negligible

risks and costs associated with the substance and Ripper 980 in New Zealand,

the Committee considers that:


the risks to human health and safety arising from the effects associated

with manufacture, packing, import, transport, storage and disposal of

the substance and Ripper 980 are low;

the risks to human health and safety of operators arising from the effects

associated with use of the substance and Ripper 980 are low, with

default controls in place;

the risks to human health and safety of bystanders arising from the

effects associated with use of the substance are medium, with default

controls in place. The Committee considers that the introduction of

additional controls (such as buffer zones around treatment areas) will

manage these risks and that, with additional measures in place, the risks

are negligible to low;

the risks to the environment arising from the effects associated with the

substance and Ripper 980 are negligible to low;

significant adverse impacts on the social or economic environment with

the controlled use of the substance and Ripper 980 are not anticipated;

it is unlikely that the substance and Ripper 980 could have a significant

impact on Māori culture or traditional relationships with ancestral lands,

water, sites, wāhi tapu, valued flora and fauna or other taonga, provided

that the substance and Ripper 980 are handled, stored, transported, used,

and disposed of, in accordance with the explicitly stated default and

additional controls proposed, and any other controls required by other

legislation.;

there is no evidence to suggest that the controlled use of the substance

and Ripper 980 will breach the principles of the Treaty of Waitangi.

4.7 The Committee notes that the controls imposed on alternative products are much

less stringent than those imposed on the substance and Ripper 980, but considers

that the alternative substances were approved under a different approval

mechanism and should be identified as candidates for reassessment to determine

whether such controls are appropriate for existing approved substances.

4.8 The Committee, in principle, agrees to the nature of the default controls,

variations to default controls and additional controls proposed in the E&R

report. However, the Committee highlights its concern that, with particular

reference to the controls associated with buffer zones, a number of the proposals

were repetitive, and not easy to interpret. As such, the Committee has redrafted

a number of controls in simpler terms.

4.9 Since the E&R report has completed, the Californian Department of Pesticide

Registration (CDPR) has finalised its Risk Characterization document for

iodomethane, and has published its proposed decisions (though these are not yet

finalised). The Agency has considered the assessment by the CDPR (Appendix

3). The Committee has considered the Agency‘s assessment of the CDPR, and

the notes the following points relating to the CDPR assessment:

4.9.1 The findings of the CDPR human health and ecological assessments do

not alter the outcomes of the Agency‘s assessments, and that the


findings of the CDPR do not require the modification of the controls in

the E&R report;

4.9.2 The CDPR‘s proposed decision aligns with the proposals of the

Agency‘s assessment. Where more stringent controls have been

proposed by the CDPR, the Committee considers that these have arisen

as a result of the different approach used by the CDPR. The Committee

considers that, based on the New Zealand use pattern and as its

assessment is sufficiently precautionary, the proposals of the CDPR do

not alter the outcome of the Agency‘s assessment.

4.10 In addition, the Committee notes that a number of amendments to the controls

proposed in the E&R report have been identified, and have been incorporated

into the final controls detailed in Appendix 4.

Assessment of the potentially non-negligible benefits of the substance

4.11 The applicant considers that the approval to release the substance and Ripper

980 will result in a net benefit to the environment and human health as the

substance will replace methyl bromide which is known to be an ozone depleting

chemical. The Committee considers that this is not a valid claim as the use of

methyl bromide as a soil fumigant is being phased out, and this phase out is not

contingent on the identification of a replacement substance.

4.12 The applicant identified a benefit to society and community through the

availability of a soil treatment for use in strawberry growing, but the Committee

acknowledges that it was unable to assess the benefit in terms of its effect on

society and community.

4.13 The applicant provided some information regarding the level of benefit that the

substance and Ripper 980 may provide to the market economy.

4.14 The Committee notes that, based on the information provided in the application

and the E&R report, it had insufficient information to be able to determine

whether the level of benefit outweighs the risk posed by the substance and

Ripper 980, and whether there are effective and available alternatives.

4.15 Further information was provided by the applicant and industry bodies in

response to an information request from the Committee. Additionally, further

information was provided to the Committee at the hearing, as noted in paragraph

3.11 above. The Committee considers that, while many of the benefits described

in the information provided to it are difficult to measure and test, they are

sufficient to enable the determination that the benefits arising from the use of

Ripper in the strawberry growing industry outweigh the risks.

4.16 The Committee notes that the level of benefit provided by use of the substance

on other high value crops is unknown. In addition, the use patterns for other

crops are also not known so the level of risk posed by use on other crops cannot

be determined, In order to be considered for use on other high value crops or for

other purposes (such as for biosecurity purposes), the Authority would need to

consider new use, risk and benefit information for those purposes to determine

whether grounds exist to undertake a modified reassessment of this approval.


Variations to default controls and setting of exposure limits

4.17 A number of variations to the default controls for the substance and Ripper 980

were proposed in the E&R Report. These variations and the setting of exposure

limits and application rates are discussed below.

Setting of exposure limits and application rates

4.18 Control T1 relates to the requirement to limit public exposure to toxic

substances by the setting of Tolerable Exposure Limits (TELs). The Committee

notes the following, in regard to the setting of TELs for the substance and

Ripper 980:

4.18.1 A TEL has been set previously for chloropicrin, as detailed in the

transfer notice for fumigants1.

4.18.2 No ADE has been set for chloropicrin or iodomethane.

4.18.3 No acute TEL has been proposed for chloropicrin in relation to the

substance or Ripper 980, because methyl iodide is more volatile than

chloropicrin, therefore an acute TEL for chloropicrin is less relevant

than for methyl iodide. Furthermore, the application is not a

reassessment of chloropicrin.

4.18.4 The Agency proposed a single TEL value for iodomethane in the E&R

report. Upon further consideration, the Agency proposes that an acute

TEL value for iodomethane is also appropriate, as the exposure

modelling was carried out in reference to an acute reference dose.

4.18.5 The Committee confirms that the existing TEL for chloropicrin is set

for the substance and Ripper 980, and establishes acute and chronic

TEL values for iodomethane in the substance and Ripper 980 as

follows:

Substance (Component) TEL

ppm mg/m3

Chloropicrin

CAS 76-06-2 Chronic 0.000059 0.0004

Iodomethane (methyl iodide)

CAS 74-88-4

Acute 0.15 0.94

Chronic 0.03 0.19

4.19 Control T2 relates to the requirement to limit worker exposure to toxic

substances by the setting of Workplace Exposure Standards (WESs). The

Committee note the following with regard to setting WES values for the

substance and Ripper 980:

4.19.1 WES values are set for both chloropicrin and iodomethane, adopting

the Department of Labour WES values:

1 Hazardous Substances (Fumigants) Transfer Notice 2004.


Substance (Component) Comments WES (TWA)

2

ppm mg/m3

Chloropicrin

CAS 76-06-2 - 0.1 0.67

Iodomethane (methyl iodide)

CAS 74-88-4

Representing risk through skin

absorption 2 12

4.19.2 No WES STEL values have been established for chloropicrin or

iodomethane by the Department of Labour. Since WES TWA values

have been set, the standard three fold excursion limit applies3.

4.20 Control E1 relates to the requirements to limit exposure of non-target organisms

in the environment through the setting of Environmental Exposure Limits

(EELs). The Authority is reviewing the setting of EELs. As this review has not

been completed, no EELs are being set for the substance or Ripper 980 and the

default values are deleted.

4.21 Control E2 relates to the requirement to set an application rate for a class 9

substance that is to be sprayed on an area of land (or air or water) and for which

an EEL has been set. As no EEL has been set for the substance or Ripper 980,

the Committee is not able to set maximum application rates under this

regulation. However, given the high ecotoxicity hazard of the substance, an

application rate for the substance has been set as an additional control under

section 77A, restricting the maximum application rate of the substance to those

proposed by the applicant for Ripper 330 and Ripper 500, which will assist in

mitigating exposure to the environment. The Committee considers that this is

appropriate on the grounds that the risk assessment (summarised in paragraph

4.6) has not considered the risks that may be associated with applications of the

substance at rates higher than the maximum proposed by the applicant. The

Committee considers that it is not appropriate to set an application rate Ripper

980, as it is only to be used as a manufacturing concentrate.

Additions and modifications to controls

4.22 The Committee notes that the risk assessment indicates that certain restrictions

on use are necessary to mitigate the risks to human health and to the

environment. Accordingly, the Committee considers that the application of

controls addressing these risks will be more effective than the specified (default)

controls in terms of their effect on the management, use and risks of the

substance (section 77A(4)(a)). The additional controls detailed in the following

paragraphs should be read in the context of the interpretations in Table 3.2:

Table 3.1. Key definitions for controls for the substance and Ripper 980

Definitions – unless the context otherwise requires:

Application Block

2 WES (TWA) is defined on page 9 of the Department of Labour publication:

http://www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf 3 General Excursion Limit is defined on page 8 of the Department of Labour publication:

http://www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf




Application Block means the area within the boundary defined by the outer extremity

of all soil to which the substance has been applied in any 24 hour period and includes

any untreated areas within the boundary of the Application Block.

Application Rate

Application Rate means the kilograms of iodomethane applied per hectare of soil

treated with the substance.

Buffer Zone

Buffer Zone means an area extending outward from the perimeter of each

Application Block to the relevant distance specified in the control entitled ―Buffer

zones‖.

Buffer Zone Period

Buffer Zone Period means the period of time starting when the substance is first

applied to the soil within the Application Block, and lasts until 48 hours after the

substance has stopped being applied to the soil within an Application Block.

Fumigation is Complete

Fumigation is Complete means:

(a) when the residual soil level of chloropicrin is below 0.1ppm; and

(b) after a Minimum Period has elapsed since the substance was last applied to

the soil within the Application Block, where the Minimum Period means:

(i) 5 days (120 hours), if standard plastic sheeting is used; or

(ii) 10 days (240 hours) if Highly Retentive Film is used.

Highly Retentive Film

Highly Retentive Film means sheeting with a permeability rating of 0.1 perms or

less, and used to cover the fumigated soil.

Maximum Broadcast Equivalent Application Rate (MBEAR)

Maximum Broadcast Equivalent Application Rate (MBEAR) means the

maximum quantity of the substance that can be applied per hectare of the Application

Block if the entire Application Block is treated.

Personal Protective Equipment (PPE)

PPE means the clothing and equipment required to handle the substance in

accordance with regulation 8 of the Hazardous Substances (Classes 6, 8, and 9

Controls) Regulations 2001.

Start of Fumigation

Start of Fumigation means the moment when the substance is first applied to the soil

within the Application Block.

4.23 The Committee notes that, based on the risks to the environment, the approved

handler requirements in respect of ecotoxicity only (control E7) can be deleted.

However, the approved handler requirements in respect of the risks to human

health (control T6) are retained.

4.24 The Committee notes that it is the applicant‘s intention to train all operators

according to its own product specific training programme. The Committee


notes that the Agency has reviewed this programme and that the risk assessment

has assumed that the training will be undertaken. The Committee considers that

the substance and Ripper 980 should at all times, with the exception of the

transport of the substance or Ripper 980 be under the control of an approved

handler who has successfully completed the product-specific training course to

be able to handle, distribute or use the substance or Ripper 980 in a manner

consistent with all relevant controls, label restrictions and user directions. As

such, the approved handler certification will include specific endorsement for

the substance or Ripper 980. In order to ensure that the product-specific training

requirement forms part of the Approved Handler certification process, control

AH1 is varied under section 77A by adding the following control:

5 Qualifications for approved handlers

(2A) The person must also have successfully completed a product-specific

training course approved by the Authority.

4.25 The Committee considers it necessary for all operators involved in operations

involving the substance or Ripper 980 to have successfully completed product-

specific training. Additionally, the Committee considers that operations carried

out in the Application Block before Fumigation is Complete may pose a risk

to human health, such as slicing and removal of the plastic sheeting. Personnel

involved in such operations are required to have successfully completed the

product-specific training programme and are either an approved handler, or

under the supervision of an approved handler in order to ensure that the quantity

of fumigant substances are reduced to a safe level (a residual soil level of less

than 0.1 ppm chloropicrin) prior to slicing, removal or disposal of the plastic

sheeting).

4.26 Control T6 allows persons that are not approved handlers to handle the

substance or Ripper 980 if they have been provided guidance by an approved

handler. The Committee considers that, in line with the applicant‘s intent to

train all operators involved in fumigation operations using the substance or

Ripper 980, an additional control is required to ensure the guidance is of an

appropriate standard.

4.27 The Committee notes that patents are in place until 2016. After 2016, it is

possible that other manufacturers may introduce equivalent products. In such a

situation, equivalent training and stewardship programmes will be required. The

training programme will require an assessment by the Authority to ensure that

the appropriate level and content of training achieved.

4.28 Thus, for the substance, control T6 is varied by replacing regulation 9(2) as

follows:

(2) No person may —

(a) handle the substance unless that person is an approved handler;

(b) slice or remove the plastic sheeting used to cover soil treated with the

substance within 14 days of the Start of Fumigation unless —


(i) that person is an approved handler; and

(ii) at least one other person is present.

(c) Despite paragraphs (a) and (b) above, and regulation 9(1) of the

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

2001, the substance may be handled, or the slicing and/or removal may

be undertaken, by a person who is not an approved handler if —

(i) at the place where the substance is being handled or the

slicing or removal is being carried out an approved

handler is present; and

(ii) the approved handler has provided guidance to the person

in respect of the handling or slicing and/or removal; and

(iii) the approved handler is available at all times to provide

assistance, if necessary, to the person while the substance

is being handled by the person; and

(iv) the approved handler has ensured that the person has

successfully completed a product-specific training course

approved by the Authority.

4.29 For Ripper 980, control T6 is varied by adding the following after subclause

9(2)(c):

(d) the approved handler has ensured that the person has successfully

completed a product-specific training course approved by the Authority

4.30 In keeping with the variations to the controls that apply to existing fumigant

approvals, the Committee has varied control T6, to exempt the substance and

Ripper 980 from the requirements as they relate to approved handlers and

controlled substances licences (CSLs – paragraph 3.47) during transport, such

that the following regulation is inserted immediately after regulation 9:

9A Exception to approved handler requirements for the transportation of

packaged substances

(1) Regulation 9 is deemed complied with if-

(a) in the case of [the substance or Ripper 980] being transported on

land-

(i) in the case of [the substance or Ripper 980] being transported

by rail, the person who drives the rail vehicle that is

transporting the substance is fully trained in accordance with

an approved safety system under section 6D of the Transport

Services Licensing Act 1989 or a safety system which is

referred to in an approved safety case under the Railways Act

2005; and


(ii) in every other case, the person who drives, loads, and unloads

the vehicle that is transporting [the substance or Ripper 980]

–

A. for hire or reward, or in quantities which exceed those set

out in Schedule 1 of the Land Transport Rule 45001/1:

Dangerous Goods 2005, has a current dangerous goods

endorsement on his or her drivers licence; or

B. in every other case, the Land Transport Rule 45001/1:

Dangerous Goods 2005 is complied with; or

(b) in the case of [the substance or Ripper 980] being transported by

sea, one of the following is complied with:

(i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous

Goods (MR024A):

(ii) International Maritime Dangerous Goods Code; or

(c) in the case of [the substance or Ripper 980] being transported by

air, Part 92 of the Civil Aviation Rules is complied with.

(2) Subclause (1)(a)—

(a) does not apply to a tank wagon or transportable container to which

the Hazardous Substances (Tank Wagons and Transportable

Containers) Regulations 2004 applies; but

(b) despite paragraph (a), does apply to an intermediate bulk container

that complies with chapter 6.5 of the UN Model Regulations.

(3) Subclause (1)(c)—

(a) applies to pilots, aircrew, and airline ground personnel loading and

handling a hazardous substance within an aerodrome; but

(b) does not apply to the storage and handling of [the substance or

Ripper 980] in any place that is not within an aerodrome, or within

an aerodrome by non-airline ground personnel.

(4) In this regulation, UN Model Regulations means the 16th revised

edition of the recommendation on the Transport of Dangerous Goods

Model Regulations, published in 2009 by the United Nations.

4.31 The Committee notes that the control that governs use of personal protective

equipment (PPE) to prevent exposure (control T5) is not prescriptive.

Additionally, a number of the additional controls contain reference to use of

―appropriate PPE‖. Persons using the substance or Ripper 980 will be informed

of the PPE requirements, as part of the manufacturer‘s product specific training

course. In addition, the PPE required to prevent exposure is required to be


included on the accompanying product information (i.e. safety data sheet). The

Committee notes that the PPE requirements differ, depending on the stage of

operation. While the Committee considers the control T5 and the product-

specific training programme will provide adequate protection for users with

regard to PPE requirements, the Committee notes that the applicant has

identified the following PPE requirements as part of their training programme

and draft product label as the minimum that should be used until the

Fumigation is Complete:

(1) The following PPE is required for persons present in the Application Block

or Buffer Zone from the Start of Fumigation until the Fumigation is

Complete –

(a) loose fitting or well ventilated long-sleeved shirt and long pants; and

(b) shoes plus socks; and

(c) an air-purifying respirator with cartridge filter for organic vapors, acid

gases and particulates (MSHA/NIOSH approval number prefix TC-23C,

or equivalent); and

(d) if the chloropicrin concentration is –

(i) less than 0.1ppm, a full face shield or safety glasses with brow,

temple and side protection must be worn; or

(ii) between 0.1ppm and 4 ppm, a full face respirator or face-sealing

goggles with a half-face respirator must be worn; or

(iii) greater than 4 ppm –

A. wear a supplied-air respirator (MSHA/NIOSH approval

number prefix TC-19C, or equivalent) or:

B. a self contained breathing apparatus (SCBA) (MSHA/NIOSH

approval number prefix TC-13F, or equivalent).

(2) The following PPE is required for persons present in the Application Block

or Buffer Zone after the Fumigation is Complete –

(a) loose fitting or well ventilated long-sleeved shirt and long pants; and

(b) shoes plus socks; and

(c) full face shield or safety glasses with brow, temple and side protection.

4.32 The Committee notes that, as required by the Hazardous Substances (Tracking)

Regulations 2001, the location and movement of the substance or Ripper 980

must be recorded at each stage of its lifecycle until its final disposal (Control

TR1). In addition, the controls T3 and E5 relate to the requirements for

keeping records of use. The Committee considers that these regulations should

apply to the substance and Ripper 980 as follows:

4.32.1 Ripper 980 is intended for use within a manufacturing facility and it is

proposed that Ripper 980 may not legally be applied outdoors for the


purposes of causing biocidal action. Thus controls T3 and E5 are not

considered relevant and are deleted for Ripper 980.

4.32.2 The substance is intended to be applied for the purpose of causing

biocidal action. As required by control T3, the records of use must

include the name of the substance, the date and time of each

application, the classification of the substance, the amount of substance

applied, the location where the substance is applied, wind speed and

direction for substances discharged in or applied to the air, and the

name of the user and the user‘s address. Although the substance is not

intended to be applied to, or discharged in, the air the Committee has

varied control T3 to ensure that details of wind speed and direction

during application are recorded. Additionally, in order to demonstrate

that surface temperature inversion conditions have been considered, a

number of meteorological conditions should be recorded. Furthermore,

the Committee considers that weather conditions at the time of slicing

or removal of the plastic sheeting should be recorded to demonstrate

that avoidance of wet conditions have been considered. Thus control

T3 is varied under section 77A so that clause 6(1)(f) reads as follows:

(6)(1)(f) meteorological information, to include —

(i) the wind speed and direction when the substance was

applied; and

(ii) surface temperature inversion conditions when the

substance was applied; and

(iii) a consideration of potential surface temperature

inversion conditions for the 24 hour period after the

substance has stopped being applied to the soil within

the Application Block ; and

(iv) the weather at the time of slicing or removal of the

plastic sheeting, including the local weather forecast

and source for the 48 hour period following slicing or

removal of the plastic sheeting.

4.32.3 In addition to this information, the Committee considers that the person

in charge of the substance at the fumigation site should also be required

to maintain records that indicate the size of the buffer zone,

demonstrate the method of the buffer zone calculations and the factors

taken into account when determining the buffer zones (in accordance

with additional controls 13 and 15. The record should also include

information which indicates who has been notified of the intended

fumigation. Control T3 is varied under section 77A so that the

following clause is added after regulation 6(1)(g), as follows:

(6)(1)(h) who has been notified of the intended fumigation;


(i) the size of the Buffer Zone, the method by which the Buffer

Zones were calculated, and the factors taken into account

when determining the Buffer Zone (including identification

of any neighbouring properties and buildings within the

Buffer Zone);

(j) any written permission obtained when establishing a Buffer

Zone.

4.33 Control EM11 relates to emergency response plans (Regulations 25 – 34 of the

Hazardous Substances (Emergency Management) Regulations 2001). This

control is triggered by both the class 6 and 9 hazard classifications of Ripper.

These regulations relate to the requirements for an emergency response plan to

be available at any place where hazardous substances are held (or reasonably

likely to be help on occasion) in quantities greater than those specified in

Schedule 4 of the Emergency Management Regulations. According to Schedule

4, the substance and Ripper 980 trigger these requirements when held in

quantities greater than 100L. The Committee considers that, should a spill of

the substance or Ripper 980 occur, the physical properties may tend to increase

the likelihood of human exposure, therefore it is appropriate to vary the trigger

quantity for this control to 50L in accordance with 77(3)(a).

4.34 The Agency considers that the following controls may be combined under

section 77(5) as they relate to the same requirements:

4.34.1 for the substance and Ripper 980:

Controls T4 and E6 which relate to requirements for equipment

used to handle hazardous substances;

Controls D4 and D5 which relate to requirements for disposal.

4.34.2 for the substance only:

Controls T3 and E5 which relate to requirements for keeping

records of use.

4.35 The following additional controls and label statements in the following

paragraphs are set, and equivalent label statements are required for the

substance (and Ripper 980 where specified), to reduce the level of risk to human

health and to the environment:

Additional Control 1 – Application rate

Additional Control 18 –Label Statement

The maximum application rate for the substance to be applied to soil is 250

kg iodomethane per hectare, (0.025 kg iodomethane per square metre) with

a maximum frequency of once per year.

Additional Control 2 – Use restriction


The substance shall not be applied onto or into water.




The substance may only be used –

(a) for pre-plant soil fumigation only; and

(b) in areas intended for commercial strawberry growing.



The maximum volume of the substance stored in a container shall be 70L.

Additional Controls and Label Statements for Ripper 980;

The maximum volume of Ripper 980 stored in a container shall be 70L;

Ripper 980 shall be used as a manufacturing concentrate only.

4.36 Several new controls, additional to the default controls, were applied to

fumigants approved under the Act upon transfer. The Committee considers that

it is appropriate to adopt these controls for the substance, with some

modifications. The fumigants transfer notice4 included requirements to notify

certain parties of intended fumigation; including the nearest Communications

Centre of the New Zealand Fire Service if the fumigation is to be undertaken on,

or adjacent to, certain locations. The Committee considers that it is appropriate

to retain this control, including the requirement to notify the New Zealand Fire

Service of all intended fumigations, as it is likely to be the first respondent in

the case of an emergency. The additional controls are applied as follows:

Additional Control 5 – Notification of intended fumigation

(1) The person in charge of fumigation using the substance must notify –

(a) the person in charge of the place; and

(b) the nearest Communications Centre of the New Zealand Fire Service;

and

(c) every other person who may be affected by the fumigation;

(2) A notification required under subclause (1) must not be given less than 24

hours prior to the Start of Fumigation.

Additional Control 6 – Signage

(1) The person in charge of fumigation using the substance must ensure that

signs are erected around the perimeter of the Buffer Zone at every intended

point of entry to the Buffer Zone. Signs must be posted from the Start of

Fumigation, until the end of the Buffer Zone Period.

(2) Signs erected in accordance with subclause (1) must –

(a) state that fumigation is being carried out; and



(b) identify the hazardous substance being used and state that it is toxic to

humans; and

(c) describe the general type of hazard associated with the substance.

(3) Signs erected in accordance with subclauses (1)and (2) must –

(a) comply with regulation 34(1), (2), and (4) and regulation 35(1), (3), and

(5) of the Hazardous Substances (Identification) Regulations 2001, but

as if the distances referred to in regulation 35(3) were a distance of not

less than 10 metres; and

(b) identify the person in charge of the fumigation and provide sufficient

information to enable the person to be contacted during normal business

hours; and

(c) state the day on which the fumigation commenced; and

(d) state the actions that must be taken in an emergency.

(4) Signs must be removed within 3 days (72 hours) of the end of the Buffer

Zone Period.

Additional Control 7 - Notice of completion

The person in charge of fumigation must notify each person to whom notice was

given in accordance with the control entitled ―Notification of intended

fumigation‖ when Fumigation is Complete.

4.37 The Committee considers that it is appropriate to require that certain criteria are

met regarding the operations involving the plastic sheeting. Further, the

Committee considers that measures should be taken to prevent ground water

contamination. The Committee highlights the need to keep records of the

weather at the time of slicing or removal of the plastic sheeting, and an up-to-

date local weather forecast (including identification of the source) for 48 hours

following slicing or removal of the plastic sheeting. Additionally, an aeration

requirement prior to plastic sheeting removal is included to aid dispersal of any

residual fumigant substance. The following control is applied:

Additional Control 8 – Use of plastic sheeting

The person in charge of fumigation must ensure that —

(a) soil fumigated with the substance is covered immediately with plastic

sheeting appropriate for use in fumigation operations; and

(b) the plastic sheeting must remain in place until the Fumigation is

Complete; and

(c) the plastic sheeting is not sliced or removed until the Fumigation is

Complete; and


(d) despite paragraph (c), the plastic sheeting is not sliced or removed after

this time period if it is raining, or if rain is expected to fall within 48

hours; and

(e) where the plastic sheeting is sliced for removal, it is not removed within

24 hours of slicing.

4.38 The Committee considers that disposal of the plastic sheeting should be carried

out in a manner that is consistent with the requirements for disposal of

packaging. In order to ensure that the risks associated with operations related to

removal and disposal of the plastic sheeting are minimised, the following

controls apply:

Additional Control 9 - Disposal of Plastic Sheeting

The plastic sheeting must be disposed of in a manner that is consistent with the

requirements in regulation 10 of the Hazardous Substances (Disposal)

Regulations 2001 for disposal of a package that contained the substance.

4.39 The Committee notes that the condition restricting entry of unauthorised people

into the Buffer Zone, as noted in the E&R report, has been redrafted to allow

entry into a buffer zone by emergency service personnel responding to an

emergency situation and HSNO enforcement officers. In addition, entry into the

Application Block before the Fumigation is Complete should be restricted to

only allow certain people into the Application Block and for specific purposes.

Additional Control 10 – Entry restriction for Application Block

(1) From the start of the Buffer Zone Period until the Fumigation is Complete

no person may be present in or enter an Application Block, unless—

(a) the person has successfully completed a product-specific training

course; and

(b) the person is wearing personal protective equipment (PPE); and

(c) entry is for the purposes of —

(i) handling the substance; or

(ii) installing, inspecting and/or repairing the plastic sheet by an

approved handler or persons under the supervision of an

approved handler; or

(iii) carrying out flood prevention activities by an approved handler or

persons under the supervision of an approved handler; or

(iv) determining whether Fumigation is Complete and the person is

an approved handler or is under the supervision of an approved

handler.

(2) Despite subclause (1), from the start of the Buffer Zone Period until the

Fumigation is Complete a person may be present in or enter an Application

Block if the person is wearing PPE and is —


(a) a member of the emergency services responding to an emergency

situation; or

(b) a HSNO enforcement officer.

4.40 The Committee notes the uncertainty regarding the effects of the substance on

non-target plants. In order to mitigate the risks to non-target plants, the

following control applies:

Additional Control 11 – Non-target plant protection

The substance shall not be applied within 1 metre of the roots of non-target

plants.

4.41 The Committee considers that the atmospheric conditions during which

fumigation activities can be undertaken should be limited on the basis of air

dispersion modelling has indicated that fumigation which takes place outside of

certain daylight hours may require greater buffer distances (due to differences in

average weather conditions) to ensure the buffer zones applied will provide an

adequate level of exposure mitigation. In addition, certain atmospheric

conditions (i.e. still or surface temperature inversion conditions) should be

avoided. The Committee highlights the need to keep a record of up-to-date local

weather forecast (including identification of the source) for the period of

application and for 24 hours following completion of the fumigant application.

The Committee notes that, in addition to a use restriction control, a label

statement is required detailing these specific restrictions:

Additional Control 12 – Timing and conditions for operation

Additional Control 18 – Label Statement

The substance shall not be applied to the soil —

(a) before 30 minutes after sunrise; or

(b) after 1 hour before sunset; or

(c) when the wind speed is less than 5 k.p.h.; or

(d) during surface temperature inversion conditions; or

(e) when the conditions in (c) or (d) are forecast for the 24 hour period

following the last application of the substance within an Application

Block.

4.42 The Committee considers that buffer zones should be applied to plots of land

fumigated with the substance to reduce the risks to bystanders. A buffer zone is

an area of restricted access for members of the public and those that may be

occupationally exposed to the substance applied to the application block. The

Committee notes the following points regarding use of buffer zones for

application of the substance:

4.42.1 Use of buffer zones is consistent with the controls imposed by the US

EPA on the approval of iodomethane;


4.42.2 The person in charge of the fumigation to be responsible for

establishing the buffer zone and ensuring that workers or bystanders do

not enter the buffer zone for 48 hours following the end of the

application;

4.42.3 A buffer zone is an area around an application block that could exceed

the acute TEL for iodomethane and pose a risk to bystander. As a

result, public entry into the buffer zone is severely restricted. Entry into

the buffer zone is allowed for workers involved in the fumigation

operation, and certain other parties, but again access is restricted with

PPE conditions applied.

4.42.4 The air dispersion modeling highlighted a requirement to prevent the

fumigation of adjacent plots of land on sequential days, as these

activities are likely to impact the dispersion of the vapours resulting

from fumigation, thus increasing risks to bystanders at greater

distances.

4.43 The Committee considers that the following control should be set under section

77A, in conjunction with the buffer zones, prohibiting the use of Ripper within

400m of any sensitive site. Sensitive sites are locations where particularly

susceptible members of society (e.g. children, the elderly, the infirm) are likely

to be present, or people are confined to locations from which they cannot leave,

and include schools, day care facilities, nursing homes, hospitals, prisons,

playgrounds. The Committee previously noted at the consideration meeting that

roads should be identified as sensitive sites. However, based on the

determination that the concentrations of iodomethane outside of the are

acceptable (the iodomethane concentration will be even lower than within the

buffer zone in the area from the edge of the buffer zone to within 400m of the

application block) and that the use of roads is required for access to the

application site and to allow vehicular transit through the buffer zone (which is

an allowed activity), the Committee considers, therefore, that roads should not

be included as sensitive sites.

4.44 The Committee has applied a restriction that limits the maximum area permitted

to be fumigated in one day to 3 hectares. A maximum plot size of 3 hectares per

day is based on the information, which was used in the modelling, that

strawberry plots in New Zealand are relatively small and that equipment

limitations prevent the fumigation of areas much greater than 2 hectares in size.

Additional Control 13 – Restrictions for fumigation applications areas

(1) The person in charge of fumigation must ensure that the substance must not

be applied within 400 m of any sensitive site where the public may lawfully

be present, such as schools, playgrounds, day care facilities prisons, and

hospitals and nursing homes.

(2) The person in charge of fumigation must ensure that the substance must not

be applied within an area whereby the Buffer Zone will include any of the

following:

(a) any part of the Buffer Zone of another Application Block; and


(b) residential areas (including employee housing, private property,

buildings, commercial, industrial, and other areas that people may

occupy or outdoor residential areas, such as lawns, gardens, or play

areas); and

(c) buildings used for storage (such as sheds, barns, garages, etc.), unless:

(i) persons will not be present in the storage buildings during the

Buffer Zone Period; and

(ii) the storage buildings do not share a common wall with a structure

where persons will be present during the Buffer Zone Period; and

(d) bus stops or other locations where persons wait for public transport; and

(e) agricultural areas owned/operated by persons other than the

owner/operator (owner/operator of an affected agricultural area) of the

Application Block, unless:

(i) the person in charge of fumigation ensure that the Buffer Zone

will not overlap with a Buffer Zone from any adjacent property

owners; and

(ii) the owner/operator of an affected agricultural area provides

written agreement to the person in charge of fumigation that the

owner/operator of an affected agricultural area, and other

persons legally on their property will stay out of those parts of the

Buffer Zone that are under the control of the owner/operator of

an affected agricultural area during the entire Buffer Zone

Period;

(f) publicly owned and/or operated areas (e.g., parks, rights of way, foot

paths, walking paths, athletic fields, etc.), unless:

(i) the area is a road; or

(ii) members of the public will not be present in the area during the

Buffer Zone Period; or

(iii) the person in charge of fumigation has taken all practicable steps

to ensure that no members of the public enter the area during the

Buffer Zone Period.

(3) An Application Block must not be greater than 3 hectares.

4.45 The Committee considers that reductions to the buffer zone distances may be

appropriate if the plastic sheeting used to cover the fumigated soil meet the

requirements to be classed as a Highly Retentive Film (HRF) and has included

a provision by which the minimum distance to the perimeter of the buffer zone

can be reduced by up to 10%.

4.46 The Committee considers that adjustments to the buffer zone distances may be

appropriate in certain circumstances, for example if users provide New Zealand

specific ―flux‖ data, or if users carry out air dispersion modelling in respect of a

particular site to determine a more appropriate buffer zone. The Committee

notes that Buffer Zone adjustments will be considered by the Authority on a


case-by-case basis. This will allow users to demonstrate that a location-specific

buffer zone is more appropriate than the default buffer zones.

4.47 The Committee notes that the application rates used to determine the size of the

Buffer Zones are Maximum Broadcast Equivalent Application Rates

(MBEAR), which are used to accommodate the different application regimes

(i.e. broadcast or row-application) and require the proportion of the Application

Block treated to be considered in determining the Buffer Zones. The MBEAR is

the maximum quantity of iodomethane that may be applied per hectare to the

entire Application Block. If, for example, only 70% of the Application Block is

treated, then the maximum quantity of iodomethane per hectare of the

Application Block is 70% of the MBEAR.

4.48 The Committee notes that the applicant has expressed concerns that the buffer

zones proposed in the E&R report were overly conservative. The Committee

notes the following points in regard to the air dispersion modelling assessment,

that was the main basis for the magnitude of the buffer zones:

4.48.1 In the absence of any New Zealand-specific flux data (soil and film

type, etc.), the highest rates from the US data were used. The

Committee acknowledges that this may be conservative, but considers

this an appropriate basis for assessment;

4.48.2 The modelling was based on "worst case" sites in NZ based on 5 year

meteorological data sets for NZ. The Committee considers that this is

not over precautionary, because the locations were chosen where still

conditions were most likely at the time of year when the application is

likely;

4.48.3 The Committee notes that the air dispersion modelling indicated that

the buffer zones proposed would be inadequate for night-time

application. The Committee has set a control to restrict the time of day

that applications can take place on the basis of this information.

4.48.4 The assessment and resulting buffer zones are based on the results

using the CALPUFF model, rather than the alternative, PERFUM. The

Committee notes that CALPUFF is better at addressing low wind

speeds, when the exposure risks are greatest. It is acknowledged that

the buffer zones required are "slightly" higher based on CALPUFF than

would be the case for PERFUM, but it is unlikely to be overly

conservative.

4.48.5 The Committee notes that the determination of magnitude of the buffer

zones is reliant on the modelling that was carried out, for which New

Zealand specific data was not available and that the applicant has

agreed to the buffer zones detailed in the subsequent paragraphs,

though the applicant is of the opinion that the magnitudes of the buffer

zones are excessive;

4.48.6 The Committee considers that re-evaluation of buffer zones with New

Zealand-specific data would require further modelling. While provision

has already been made to allow specific data to be supplied for site-

specific buffer zone reduction, a modified reassessment would be

required in order to modify the default buffer zones specified in


controls for the substance, based on New Zealand-specific data, to

assess whether reduced buffer zones will sufficiently mitigate risks to

bystanders.

4.49 The Committee has applied the following controls regarding buffer zones and

access restrictions:

Additional Control 14 - Entry restriction for Buffer Zones

For the duration of the Buffer Zone Period, the person in charge of fumigation

must ensure that the only persons within the Buffer Zone are —

(f) permitted to enter the Application Block from the start of the Buffer

Zone Period until the Fumigation is Complete in accordance with the

control titled ―Entry restriction‖ and wearing PPE; or

(g) in transit through the Buffer Zone by vehicular traffic (including

bicycles) on roads provided that the total transit time within any 24 hour

period is less than 15 minutes.

Additional Control 15 –Buffer Zone Distances

(1) The following table states the minimum distance between the perimeter of

the Application Block and any point of the perimeter of the Buffer Zone for

the following Maximum Broadcast Equivalent Application Rates

(MBEAR):

Application block area / ha

Distance to perimeter of

Buffer Zone / m

MBEAR iodomethane

200 kg / ha 250 kg / ha

below 0.5 30 40

between 0.5 and 1.0 50 65

between 1.0 and 3.0 70 100

(2) The distances in (1) may be —

(a) reduced by up to 10% if the plastic sheeting used meets the requirements

to be classed as Highly Retentive Film (HRF); and

(b) adjusted, after approval of the Authority, if users provide New Zealand

specific flux data or if users carry out air dispersion modelling for their

site in order to determine a more appropriate Buffer Zone.

4.50 The risks to human health and safety have been assessed as low to medium

during the manufacture and associated storage of the substance and Ripper 980.

The Committee notes that this assessment relies to a significant degree on the

assumption that all controls will be complied with. Given the reliance on

compliance with controls, the Committee requires the manufacturing site and

any locations that the substance or Ripper 980 may be stored (with the exclusion

of fumigation sites) to obtain a test certificate, under section 82 of the Act,

providing an additional level of assurance that the appropriate measures, such as

emergency management plans, are in place in accordance with the controls. The


Committee notes that it does not intend that the sites of fumigation operations

require test certificates. The control is applied as follows:

Additional Control 16 - Location Test Certification

Additional Control for Ripper 980 – Location Test Certification

(1) The person in charge of a place where [the substance or Ripper 980] is

present means a person who is—

(a) the owner, lessee, sublessee, occupier, or person in possession of the

place, or any part of it; or

(b) any other person who, at the relevant time, is in effective control or

possession of the relevant part of the place.

(2) When [the substance or Ripper 980] is present at a place (not including the

property where [the substance or Ripper 980] is to be applied, a vehicle,

ship, aircraft, or other means of transport) in quantities exceeding 50 litres

for a period exceeding 2 hours, the person in charge of that place must

ensure that the place has a current test certificate certifying in respect of

[the substance or Ripper 980], that—

(a) notification has been made to the territorial authority in the area

where the place is located, the Department of Labour and the New

Zealand Fire Service or local fire authority in the area where the

place is located, at least 30 working days before the commissioning

of the place as a place for accommodating [the substance or Ripper

980], of—

(i) the street address of the place; and

(ii) the maximum quantity and hazard classification of [the substance

or Ripper 980] that the place is designed or constructed to

accommodate; and

(b) the person in charge of the place is an approved handler for [the

substance or Ripper 980], or can demonstrate that a person is

available who is an approved handler for such substance; and

(c) [the substance or Ripper 980] can be secured so that a person

cannot gain access to [the substance or Ripper 980] without tools,

keys, or any other device used for operating locks; and

(d) the place has signage in place as required by the Hazardous

Substances (Identification) Regulations 2001 and the Hazardous

Substances (Emergency Management) Regulations 2001; and

(e) a site plan is available for inspection that shows the physical

position, in relation to the legal boundary of the place, of all

locations within the place that contain [the substance or Ripper

980]; and

http://www.brookersonline.co.nz/databases/modus/lawpart/regs/link?id=REG-NZL-PUB-Y.2001-124&si=57359





(f) minimum separation distances from [the substance or Ripper 980]

locations to the legal boundary shall be as determined in AS/NZS

4452: 1997: The storage and handling of toxic substances; and

(g) the equipment used to handle [the substance or Ripper 980] complies

with regulation 7 of the Hazardous Substances (Classes 6, 8, and 9

Controls) Regulations 2001; and

(h) there is available at the place, to persons who handle [the substance

or Ripper 980], protective clothing or equipment that complies with

section 8 of the Hazardous Substances (Classes 6, 8, and 9 Controls)

Regulations 2001; and

(i) that an emergency response plan is in place, and that emergency

management controls are complied with, as required by the

Hazardous Substances (Emergency Management) Regulations 2001;

and

(j) the workplace exposure standards set in relation to [the substance or

Ripper 980] can be monitored and complied with.

(3) The test certificate issued in accordance with this control must be renewed

at intervals of not more than 12 months.

4.51 The Committee notes that fumigants currently approved under the Act, as

detailed in the Fumigants transfer notice5, were approved with an additional

control requiring controlled substance licences, and considers it appropriate to

apply this requirement to the substance and Ripper 980:

Additional Control 17 - Controlled Substance Licence Requirements

Additional Control for Ripper 980 - Controlled Substance Licence

Requirements

(1) No person may possess [the substance or Ripper 980] unless that person

has a licence under section 95B of the Act from the Authority that is

obtained before the person takes possession of [the substance or Ripper

980].

(2) Despite subclause (1), a person who does not have a licence may possess

[the substance or Ripper 980] if —

(a) in any other case, a person who has such a licence is present and

available immediately to the person in possession of [the substance

or Ripper 980]; or

(b) the person is deemed to comply with regulation 9 of the Hazardous

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

regulation 9A of those regulations (as varied under control T6).



5 Overall evaluation of risks and costs

5.1 On the basis of the assessment of risks and costs and taking into account the

controls imposed, including the additional controls, the Committee considers

that the substance and Ripper 980 pose low risks and costs to human health and

the environment.

6 Review of controls for cost-effectiveness

6.1 The Committee considers that the proposed controls are the most cost-effective

means of managing the identified potential risks and costs associated with this

application.

6.2 The applicant was given an opportunity to comment on the proposed controls as

set out in the E&R Report, and indicated that the controls are acceptable. The

applicant commented that, whilst in their opinion the controls, in particular the

magnitude of the buffer zones, were conservative, the inclusion of a control to

allow for provision of location specific reduction in buffer zones will be

workable.

7 Comparison of risks, cost and benefits

7.1 As the Committee considers that the risks to the environment and human health

are low with the controls in place, the Committee may approve the manufacture

or import for release of the substance or Ripper 980 if it is evident that the

benefits associated with the substances outweigh the costs.

7.2 As no costs not associated with risks have been identified, the Committee is

satisfied that the potential benefits associated with release of the substance for

use as a soil fumigant in commercial strawberry growing outweigh the costs.

8 Recommendations

8.1 The Committee recommends that, should inappropriate or accidental use,

transport or disposal of the substance or Ripper 980 result in the contamination

of waterways, the appropriate authorities, including the relevant iwi authorities

in the region, should be notified. This action should include advising them of

the contamination and the measures taken in response.

9 Environmental user charges

9.1 The Committee considers that the application of controls to the substance and

Ripper 980 will provide an effective means of managing risks associated with

this substance. At this time no consideration has been given to whether or not

environmental charges should be applied to this substance as an alternative or

additional means of achieving effective risk management.

10 Confirmation and setting of controls

10.1 The controls listed in Appendix 3 will apply to the substance and Ripper 980.


11 Decision

11.1 The Committee determines that:

11.1.1 The Ripper range (the substance) and Ripper 980 have the following

hazard classifications:

Hazardous Property Classification

Ripper range Ripper 980

Acute Toxicity (Oral) 6.1B 6.1C

Acute Toxicity (Dermal) 6.1B 6.1D

Acute Toxicity (Inhalation) 6.1A 6.1C

Skin Irritancy 8.2C 6.3A

Eye Corrosivity 8.3A 8.3A

Inhalation Sensitisation 6.5A 6.5A

Contact sensitisation 6.5B 6.5B

Carcinogenicity 6.7B 6.7B

Reproductive/developmental toxicity 6.8B 6.8B

Target Organ Toxicity 6.9A 6.9A

Aquatic Ecotoxicity 9.1A 9.1A

Soil Ecotoxicity 9.2A 9.2A

Ecotoxicity to terrestrial vertebrates 9.3A 9.3B

11.1.2 Only the strawberry growing industry has demonstrated any level of

benefit through use of the substance. The positive effects of use release

of the substance for use as a soil fumigant in commercial strawberry

growing outweigh the adverse effects.

11.1.3 Both importation and manufacture have been assessed, and this

approval should apply to both importation and manufacture of the

substance and Ripper 980.

11.1.4 The application for importation or manufacture and release of the

hazardous substances, Ripper range (30 – 55% iodomethane and 45% -

70% chloropicrin) and Ripper 980, is thus approved with controls as

listed in Appendix 4.

Ms Helen Atkins Date: 21 June 2010

Chair

ERMA New Zealand Approval Codes:

Ripper range (30 – 55% iodomethane

and 45% - 70% chloropicrin) HSR100349

Ripper 980 HSR100350


Appendix 1: Decision Path

Context This decision path describes the decision-making process for applications to import or

manufacture a hazardous substance. These applications are made under section 28 of the

HSNO Act, and determined under section 29 of the Act.

Introduction The purpose of the decision path is to provide the Authority with guidance so that all

relevant matters in the HSNO Act and the Methodology have been addressed. It does not

attempt to direct the weighting that the Authority may decide to make on individual aspects

of an application.

In this document ‗section‘ refers to sections of the HSNO Act, and ‗clause‘ refers to clauses

of the HSNO (Methodology) Order 1998 ―(the Methodology‖).

The decision path has two parts –

Flowchart (a logic diagram showing the process prescribed in the Methodology and the

HSNO Act to be followed in making a decision), and

Explanatory notes (discussion of each step of the process).

Of necessity the words in the boxes in the flowchart are brief, and key words are used to

summarise the activity required. The explanatory notes provide a more comprehensive

description of each of the numbered items in the flowchart, and describe the processes that

should be followed to achieve the described outcome.

For proper interpretation of the decision path it is important to work through the

flowchart in conjunction with the explanatory notes.


Figure 1 FLOWCHART

Decision path for applications to import or manufacture a hazardous substance,

application made under section 28 of the Act and determined under section 29.

For proper interpretation of the decision path it is important to work through the flowchart in conjunction

with the explanatory notes


1

Review the content of the

application and all relevant

information

2

Is this information sufficient

to proceed?

5

Identify the composition of the substance,

classify the hazardous properties of the

substance, and determine default controls

6

Identify all risks, costs and benefits that are

potentially non-negligible

7

Assess each risk assuming controls in place.

Add, substitute or delete controls in

accordance with clause 35 and sections77,

77A, 77B

8

Undertake combined consideration of all risks

and costs, cognisant of proposed controls

9

Are all risks with controls in place

negligible?

10

Review controls for cost-effectiveness in

accordance with clause 35 and sections 77,

77A, 77B

11

Is it evident that benefits outweigh

costs?

16

Confirm and set controls

Approve

(section 29(1)(a))

3

Seek additional

information

4

Sufficient?

Decline (section 29(1)(c))

12

Establish position on risk averseness

and appropriate level of caution

13

Review controls for cost-effectiveness

in accordance with clause 35 and

sections 77, 77A, 77B

14

Assess benefits

15

Taking into account controls,

do positive effects outweigh adverse

effects?

Decline

(section 29(1)(b))

Clause 27

Clause 26

No

No

No

No

Yes

Yes

Yes

Yes

Yes

No


Figure 1 EXPLANATORY NOTES

Item 1: Review the content of the application and all relevant information

Review the application, the E&R Report, and information received from experts and that provided

in submissions (where relevant) in terms of section 28(2) of the Act and clauses 8, 15, 16 and 20 of

the Methodology.

Item 2: Is this information sufficient to proceed?

Review the information and determine whether or not there is sufficient information available to

make a decision.

The Methodology (clause 8) states that the information used by the Authority in evaluating

applications shall be that which is appropriate and relevant to the application. While the Authority

will consider all relevant information, its principal interest is in information which is significant to

the proper consideration of the application; ie information which is ―necessary and sufficient‖ for

decision-making.

Item 3: (if no) Seek additional information

If there is not sufficient information then additional information may need to be sought from the

applicant, the Agency or other parties/experts under section 58 of the Act (clause 23 of the

Methodology).

Item 4 Sufficient?

When additional information has been sought, has this been provided, and is there now sufficient

information available to make a decision?

If the Authority is not satisfied that it has sufficient information for consideration, then the

application must be declined under section 29(1)(c).

Item 5:

(If „yes‟ from item 2 or from item 4) Identify the composition of the substance, classify the

hazardous properties, and determine default controls

Identify the composition of the substance, and establish the hazard classifications for the identified

substance.

Determine the default controls for the specified hazardous properties using the regulations

‗toolbox‘.

Item 6: Identify all risks, costs and benefits that are potentially non-negligible6

Costs and benefits are defined in the Methodology as the value of particular effects (clause 2).

However, in most cases these ‗values‘ are not certain and have a likelihood attached to them. Thus

costs and risks are generally linked and may be addressed together. If not, they will be addressed

separately. Examples of costs that might not be obviously linked to risks are direct financial costs

that cannot be considered as ‗sunk‘ costs (see footnote 1). Where such costs arise and they have a

market economic effect they will be assessed in the same way as risks, but their likelihood of

occurrence will be more certain (see also item 11).

Identification is a two step process that scopes the range of possible effects (risks, costs and

6 Relevant effects are marginal effects, or the changes that will occur as a result of the substance being

available. Financial costs associated with preparing and submitting an application are not marginal effects

and are not effects of the substance(s) and are therefore not taken into account in weighing up adverse and

positive effects. These latter types of costs are sometimes called ‗sunk‘ costs since they are incurred

whether or not the application is successful.


benefits).

Step 1:

Identify all possible risks and costs (adverse effects) and benefits (positive effects)

associated with the approval of the substance(s), and based on the range of areas

of impact described in clause 9 of the Methodology and sections 5 and 6 of the

Act7. Consider the effects of the substance through its lifecycle (clause 11) and

include the likely effects of the substance being unavailable (sections 29(1)(a)(iii)

and 29(1)(b)(iii)).

Relevant costs and benefits are those that relate to New Zealand and those that

would arise as a consequence of approving the application (clause 14).

Consider short term and long term effects.

Identify situations where risks and costs occur in one area of impact or affect one

sector and benefits accrue to another area or sector; that is, situations where risks

and costs do not have corresponding benefits.

Step 2: Document those risks, costs and benefits that can be readily concluded to be

negligible8, and eliminate them from further consideration.

Note that where there are costs that are not associated with risks some of them

may be eliminated at this scoping stage on the basis that the financial cost

represented is very small and there is no overall effect on the market economy.

Item 7: Assess each risk assuming controls in place. Add, substitute or delete controls in accordance

with clause 35 and sections 77, 77A and 77B of the Act.

The assessment of potentially non-negligible risks and costs should be carried out in accordance

with clauses 12, 13, 15, 22, 24, 25, and 29 to 32 of the Methodology. The assessment is carried out

with the default controls in place.

Assess each potentially non-negligible risk and cost estimating the magnitude of the effect if it

should occur and the likelihood of it occurring. Where there are non-negligible financial costs that

are not associated with risks then the probability of occurrence (likelihood) may be close to 1.

Relevant information provided in submissions should be taken into account.

The distribution of risks and costs should be considered, including geographical distribution and

distribution over groups in the community, as well as distribution over time. This information

should be retained with the assessed level of risk/cost.

This assessment includes consideration of how cautious the Authority will be in the face of

uncertainty (section 7). Where there is uncertainty, it may be necessary to estimate scenarios for

lower and upper bounds for the adverse effect as a means of identifying the range of uncertainty

(clause 32). It is also important to bear in mind the materiality of the uncertainty and how

significant the uncertainty is for the decision (clause 29(a)).

Consider the Authority‘s approach to risk (clause 33 of the Methodology) or how risk averse the

Authority should be in giving weight to the residual risk, where residual risk is the risk remaining

after the imposition of controls.

See ERMA New Zealand report ‗Approach to Risk‘ for further guidance9.

Where it is clear that residual risks are non-negligible and where appropriate controls are available,

add substitute or delete controls in accordance with sections 77 and 77A of the Act to reduce the

residual risk to a tolerable level. If the substance has toxic or ecotoxic properties, consider setting

7 Effects on the natural environment, effects on human health and safety, effects on Maori culture and

traditions, effects on society and community, effects on the market economy. 8 Negligible effects are defined in the Annotated Methodology as ―Risks which are of such little significance

in terms of their likelihood and effect that they do not require active management and/or after the

application of risk management can be justified by very small levels of benefits. 9 http://www.ermanz.govt.nz/resources/publications/pdfs/ER-OP-03-02.pdf

http://www.ermanz.govt.nz/resources/publications/pdfs/ER-OP-03-02.pdf


exposure limits under section 77B. While clause 35 is relevant here, in terms of considering the

costs and benefits of changing the controls, it has more prominence in items 10 and 13

If changes are made to the controls at this stage then the approach to uncertainty and the approach

to risk must be revisited.

Item 8: Undertake combined consideration of all risks and costs, cognisant of proposed controls

Once the risks and costs have been assessed individually, if appropriate consider all risks and costs

together as a ‗basket‘ of risks/costs. This may involve combining groups of risks and costs as

indicated in clause 34(a) of the Methodology where this is feasible and appropriate, or using other

techniques as indicated in clause 34(b). The purpose of this step is to consider the interactions

between different effects and determine whether these may change the level of individual risks.

Item 9: Are all risks with controls in place negligible?

Looking at individual risks in the context of the ‗basket‘ of risks, consider whether all of the

residual risks are negligible.

Item 10:

9


negligible?

Clause 26 Yes

(from item 9 - if „yes‟) Review controls for cost-effectiveness in accordance with clause 35 and

sections 77, 77A and 77B

Where all risks are negligible the decision must be made under clause 26 of the Methodology.

Consider the practicality and cost-effectiveness of the proposed individual controls and exposure

limits (clause 35). Where relevant and appropriate, add, substitute or delete controls whilst taking

into account the view of the applicant, and the cost-effectiveness of the full package of controls.

Item 11: Is it evident that benefits outweigh costs?

Risks have already been determined to be negligible (item 9). In the unusual circumstance where

there are non-negligible costs that are not associated with risks they have been assessed in item 7.

Costs are made up of two components: internal costs or those that accrue to the applicant, and

external costs or those that accrue to the wider community.

Consider whether there are any non-negligible external costs that are not associated with risks.

If there are no external non-negligible costs then external benefits outweigh external costs. The

fact that the application has been submitted is deemed to demonstrate existence of internal or

private net benefit, and therefore total benefits outweigh total costs10

. As indicated above, where

risks are deemed to be negligible, and the only identifiable costs resulting from approving an

application are shown to accrue to the applicant, then a cost-benefit analysis will not be required.

The act of an application being lodged will be deemed by the Authority to indicate that the

10Technical guide ‘risks, costs and benefits’ page 6 - note that, where risks are negligible and the

costs accrue only to the applicant, no explicit cost benefit analysis is required. In effect, the authority takes the act of making an application as evidence that the benefits outweigh the costs”. See also protocol series 1 ‘general requirements for the identification and assessment of risks, costs, and benefits’.


applicant believes the benefits to be greater than the costs.

However, if this is not the case and there are external non-negligible costs then all benefits need to

be assessed (via item 14).

Item 12:

9


negligible?

Clause 27No

(from item 9 - if „no‟) Establish Authority‟s position on risk averseness and appropriate level

of caution

Although ‗risk averseness‘ (approach to risk, clause 33) is considered as a part of the assessment of

individual risks, it is good practice to consolidate the view on this if several risks are non-

negligible. This consolidation also applies to the consideration of the approach to uncertainty

(section 7)

Item 13: Review controls for cost-effectiveness in accordance with clause 35 and sections 77, 77A and

77B

This constitutes a decision made under clause 27 of the Methodology (taken in sequence from

items 9 and 12).

Consider whether any of the non-negligible risks can be reduced by varying the controls in

accordance with sections 77 and 77A of the Act, or whether there are available more cost-effective

controls that achieve the same level of effectiveness (section 77A(4)(b) and clause 35(a)).

Where relevant and appropriate, add, substitute or delete controls whilst taking into account the

views of the applicant (clause 35(b)), and making sure that the total benefits that result from doing

so continue to outweigh the total risks and costs that result.

As for item 7, if the substance has toxic or ecotoxic properties, consider exposure limits under

section 77B.

Item 14: (if „no‟ from item 11 or in sequence from item 13) Assess benefits

Assess benefits or positive effects in terms of clause 13 of the Methodology.

Since benefits are not certain, they are assessed in the same way as risks. Thus the assessment

involves estimating the magnitude of the effect if it should occur and the likelihood of it occurring.

This assessment also includes consideration of the Authority‘s approach to uncertainty or how

cautious the Authority will be in the face of uncertainty (section 7). Where there is uncertainty, it

may be necessary to estimate scenarios for lower and upper bounds for the positive effect.

An understanding of the distributional implications of a proposal is an important part of any

consideration of costs and benefits, and the distribution of benefits should be considered in the

same way as for the distribution of risks and costs. The Authority will in particular look to identify

those situations where the beneficiaries of an application are different from those who bear the

costs11

. This is important not only for reasons related to fairness but also in forming a view of just

how robust any claim of an overall net benefit might be. It is much more difficult to sustain a claim

of an overall net benefit if those who enjoy the benefits are different to those who will bear the

costs. Thus where benefits accrue to one area or sector and risks and costs are borne by another

area or sector then the Authority may choose to be more risk averse and to place a higher weight on

the risks and costs.

As for risks and costs, the assessment is carried out with the default controls in place.

11

This principle derives from Protocol Series 1, and is restated in the Technical Guide ‗Risks, Costs and

Benefits‘.


Item 15: Taking into account controls, do positive effects outweigh adverse effects?

In weighing up positive and adverse effects, consider clause 34 of the Methodology. Where

possible combine groups of risks, costs and benefits or use other techniques such as dominant risks

and ranking of risks. The weighing up process takes into account controls proposed in items 5, 7,

10 and/or 13.

Where this item is taken in sequence from items 12, 13 and 14 (i.e. risks are not negligible) it

constitutes a decision made under clause 27 of the Methodology.

Where this item is taken in sequence from items 9, 10, 11 and 14 (i.e. risks are negligible, and there

are external non-negligible costs) it constitutes a decision made under clause 26 of the

Methodology.

Item 16: 11

Is it evident that benefits outweigh

costs?

15

Taking into account controls,

do positive effects outweigh adverse

effects?

YesYes

(if „yes‟ from items 11 or 15) Confirm and set controls

Controls have been considered at the earlier stages of the process (items 5, 7, 10 and/or 13). The

final step in the decision-making process brings together all the proposed controls, and reviews

them for overlaps, gaps and inconsistencies. Once these have been resolved the controls are

confirmed.


Appendix 2: Information Request under Section 58


23 November 2009

Brian Smith

Elliott Technologies Limited

PO Box 838

Pukekohe

New Zealand

Dear Brian

Request for further information

The Committee has begun to consider your application to have Ripper approved. We

have the information that you submitted in support of your application and the Agency‘s

Evaluation and Review (E&R).

At this point in time we have determined that your application does not include all the

information necessary in order for us to determine it.

We are therefore requesting (under Section 58 of the Hazardous Substances and New

Organisms Act 1996 (the Act)) further information from you (as set out below).

We have adjourned the consideration of this application under section 58(3) of the Act

pending receipt of the additional information.

Information Required

There are two areas where we require further information, namely:

- On the benefits of having Ripper available; and

- On the alternatives to Ripper.

1. Level of benefits

As you will note from the E&R Report the Agency has concluded that there are non-

negligible risks presented by the Ripper substances. At this stage, without more

information on the benefits of the Ripper substances, the Committee is unable to


determine whether the level of benefits which may result from release of the

substances, outweigh the risks. What the Committee requires is further detailed

information on the level of expected benefits that may result from the release of

substances from the Ripper range. This information should include an estimate of the

size of the benefit (i.e. in monetary terms), and an estimate of the likelihood that the

benefit will accrue. Evidence supporting these estimates should be provided where

possible. In particular, what we expect is that you will be able to provide an estimate

of the cost to the strawberry industry (in particular) if the Ripper substances are not

available. We understand you may need to get this information directly from that

industry.

2. Use of alternative substances

The Committee is also requesting further information in relation to the availability

and use of alternative substances. What the Committee specifically requires is

information on how Ripper products compare to other substances available for the

same purpose. For example, Telone C35 is specifically identified in the application as

an alternative fumigant. If you could provide further information regarding

comparisons of the Ripper substances with alternatives, such as Telone C35 (and

other substances where possible) that would greatly assist the Committee in its

deliberations. As part of the information that you provide, it would be beneficial to

include further details on the pests that the Ripper substances and alternatives are

intended to target, to allow comparisons to be made.

There was also a question the Committee had about the difference in the proposed

application rates to those used in the US. Any information that you are able to provide

to explain the difference would be most helpful.

If you are able to let me know when the information is likely to be provided that would be

much appreciated. If you have any queries or concerns about this request do not hesitate

to contact Matthew Allen at ERMA in the first instance.

Yours sincerely

Helen Atkins

Chair of the Decision-Making Committee of the Authority


Appendix 3: Impact of the Californian Department of

Pesticide Registration assessment

Ecological Assessment

The Agency’s conclusion Reasoning

The findings of the CDPR

ecological assessment do not alter

the outcomes of the Agency‘s

assessment.

CDPR environmental fate information does not significantly differ from

the US EPA, which was included in the Agency‘s assessment;

CDPR conclusions on the effects on the aquatic environment are the same

as the US EPA conclusions, which have already been considered in the

Agency‘s assessment;

CDPR did not provide risk assessment of the soil environment. The

terrestrial fate values used for the CDPR assessment are similar to those

used by US EPA, that was included in the Agency‘s assessment.

Human Health Assessment

The Agency’s conclusion Reasoning

The findings of the CDPR human

health assessment do not alter the

outcomes of the Agency‘s

assessment.

CDPR established acute Human Equivalent Concentration (HEC) values

by a different approach to that used by the US EPA, generally resulting in

lower values, but the Agency does not consider that US EPA values (used

in the Agency‘s assessment) have been shown to be incorrect;

CDPR derived HEC values for repeat dose exposure scenarios (sub-

chronic and chronic), but due to the proposed use pattern for iodomethane

in New Zealand, the Agency does not consider it appropriate to do an

assessment against any repeat dose HEC values. The Agency notes this is

consistent with the US EPA‘s position even though a wide range of uses

was provided for in its approval;

CDPR proposes the use of HEC values derived to reflect child and infant

exposures, which was not done by either US EPA or the Agency, but

notes the precautionary nature of the US EPA HEC values.

The buffer zones calculated in the Agency‘s assessment were based on

the acute US EPA HEC values for an adult bystander, and are considered

by the Agency to be sufficiently precautionary, due to the assumptions

already inherent in the Agency‘s risk assessment, specifically the use of

the higher US EPA flux estimates, the use of meteorological data from

the sites associated with stable air conditions; and considering adverse

seasonal conditions (winter);

The US EPA review provides a suitable basis for decision making, and no

adjustment to take account of the Cal EPA review is considered necessary

Overall Conclusion:

The CDPR‘s proposed decision aligns with the proposals of the Agency‘s assessment. Where more stringent

controls have been proposed by the CDPR, the Committee considers that these have arisen as a result of the

different approach used by the CDPR. The Committee considers that, based on the New Zealand use pattern and

as its assessment is sufficiently precautionary, the proposals of the CDPR do not alter the outcome of the

Agency‘s assessment.


Appendix 4: Controls for Ripper

Note: Please refer to the regulations for the requirements prescribed for each control and

the modifications listed as set out in section 5 of this document.

Table A4.1: Key definitions for controls for the Ripper range [30% - 55%

iodomethane/45 – 70% chloropicrin] (“the substance”).

Definitions – unless the context otherwise requires:

Application Block

Application Block means the area within the boundary defined by the outer extremity of all soil to

which the substance has been applied in any 24 hour period and includes any untreated areas within

the boundary of the Application Block.

Application Rate

Application Rate means the kilograms of iodomethane applied per hectare of soil treated with the

substance.

Buffer Zone

Buffer Zone means an area extending outward from the perimeter of each Application Block to the

relevant distance specified in the control entitled ―Buffer zones‖.

Buffer Zone Period

Buffer Zone Period means the period of time starting when the substance first applied to the soil

within the Application Block, and lasts until 48 hours after the substance has stopped being applied

to the soil within an Application Block.

Fumigation is Complete

Fumigation is Complete means:

(a) when the residual soil level of chloropicrin is below 0.1ppm; and

(b) after a Minimum Period has elapsed since the substance was last applied to the soil within

the Application Block, where the Minimum Period means:

(i) 5 days (120 hours), if standard plastic sheeting is used; or

(ii) 10 days (240 hours) if Highly Retentive Film is used.

Highly Retentive Film

Highly Retentive Film means sheeting with a permeability rating of 0.1 perms or less, and used to

cover the fumigated soil.

Maximum Broadcast Equivalent Application Rate (MBEAR)

Maximum Broadcast Equivalent Application Rate (MBEAR) means the maximum quantity of

the substance that can be applied per hectare of the Application Block if the entire Application

Block is treated.

Personal Protective Equipment (PPE)

PPE means the clothing and equipment required to handle the substance in accordance with

regulation 8 of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001.

Start of Fumigation

Start of Fumigation means the moment when the substance is first applied to the soil within the

Application Block.


Table A4.2a: Controls for the Ripper range [30% - 55% iodomethane/45 – 70%

chloropicrin] (“the substance”) – codes, regulations and variations.

The following controls apply to substances in the Ripper range [30% - 55% iodomethane/45

– 70% chloropicrin]:

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Topic Variations and Comments

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

Controls

T1 11-27 Limiting exposure to toxic

substances

No ADE values have been set for iodomethane

or chloropicrin.

The following TELair values apply to the

substance: Substance

(Component)

TEL

ppm Mg/m3

Chloropicrin

CAS 76-88-4 Chronic 0.000059 0.0004

Iodomethane (methyl

iodide) CAS 74-88-4

Acute 0.15 0.94

Chronic 0.03 0.19

T2 29, 30 Controlling exposure in

places of work

The following WES14

values apply to the

substance: Substance

(Component)

Comments WES (TWA)

ppm Mg/m3

Chloropicrin

CAS 76-88-4

- 0.1 0.67

Iodomethane (methyl

iodide)

CAS 74-88-4

Representing

risk through

skin absorption

2 12

T3,

E5

5, 6 Requirements for keeping

records of use

Controls T3 and E5 are combined.

Under s77A, the control imposed by regulation 6(1)(f) is replaced by the following control:

(6)(1) (f) meteorological information, to include —

(i) the wind speed and direction when the substance was applied; and

(ii) surface temperature inversion conditions when the substance was

applied; and

(iii) a consideration of potential surface temperature inversion conditions

for the 24 hour period after the substance has stopped being applied

12 Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New

Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control

Regulations. 13 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for

definitions and exemptions. The accompanying explanation is intended for guidance only. 14 Occupational Safety and Health Service: http://www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf

http://www.ermanz.govt.nz/resources



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to the soil within the Application Block ; and

(iv) the weather at the time of slicing or removal of the plastic sheeting,

including the local weather forecast and source for the 48 hour

period following slicing or removal of the plastic sheeting.

The following clause is in addition to the requirements for keeping records of use in control

6(1), added after control 6(1)(g):

(6)(1) (h) who has been notified of the intended fumigation;

(i) the size of the Buffer Zone, the method by which the Buffer Zones were

calculated, and the factors taken into account when determining the

Buffer Zone (including identification of any neighbouring properties and

buildings within the Buffer Zone);

(j) any written permission obtained when establishing a Buffer Zone.

T4

E6

7 Requirements for

equipment used to handle

hazardous substances


T5 8 Requirements for

protective clothing and

equipment

T6 9 Approved handler

requirements

Under s77A, the control imposed by regulation 9(2) is replaced by the following control:

(2) No person may —

(a) handle the substance unless that person is an approved handler;

(b) slice or remove the plastic sheeting used to cover soil treated with the substance

within 14 days of the Start of Fumigation unless —

(i) that person is an approved handler; and

(ii) at least one other person is present.

(c) Despite paragraphs (a) and (b) above, and regulation 9(1) of the Hazardous

Substances (Classes 6, 8, and 9 Controls) Regulations 2001, the substance may be

handled, or the slicing and/or removal may be undertaken, by a person who is not

an approved handler if —

(i) at the place where the substance is being handled or the slicing or removal is

being carried out an approved handler is present; and

(ii) the approved handler has provided guidance to the person in respect of the


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handling or slicing and/or removal; and

(iii) the approved handler is available at all times to provide assistance, if

necessary, to the person while the substance is being handled by the person;

and

(iv) the approved handler has ensured that the person has successfully completed

a product-specific training course approved by the Authority.

Under section 77A, the controls are varied by adding the following::

9A Exception to approved handler requirements for the transportation of the substance

when packaged

(1) Regulation 9 is deemed complied with if —

(a) in the case of the substance being transported on land-

(i) in the case of the substance being transported by rail, the person who drives

the rail vehicle that is transporting the substance is fully trained in

accordance with an approved safety system under section 6D of the

Transport Services Licensing Act 1989 or a safety system which is referred to

in an approved safety case under the Railways Act 2005; and

(ii) in every other case, the person who drives, loads, and unloads the vehicle

that is transporting the substance –

A. for hire or reward, or in quantities which exceed those set out in

Schedule 1 of the Land Transport Rule 45001/1: Dangerous Goods 2005,

has a current dangerous goods endorsement on his or her driver’s

licence; or

B. in every other case, the Land Transport Rule 45001/1: Dangerous Goods

2005 is complied with; or

(b) in the case of the substance being transported by sea, one of the following is

complied with:

(i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods

(MR024A):

(ii) International Maritime Dangerous Goods Code; or

(c) in the case of the substance being transported by air, Part 92 of the Civil Aviation

Rules is complied with.


(a) does not apply to a tank wagon or transportable container to which the Hazardous


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Substances (Tank Wagons and Transportable Containers) Regulations 2004

applies; but

(b) despite paragraph (a), does apply to an intermediate bulk container that complies

with chapter 6.5 of the UN Model Regulations.


(a) applies to pilots, aircrew, and airline ground personnel loading and handling a

hazardous substance within an aerodrome; but

(b) does not apply to the storage and handling of the substance in any place that is not

within an aerodrome, or within an aerodrome by non-airline ground personnel.

(4) In this regulation, UN Model Regulations means the 16th revised edition of the

recommendation on the Transport of Dangerous Goods Model Regulations, published in

2009 by the United Nations.

T7 10 Restrictions on the

carriage of hazardous

substances on passenger

service vehicles

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

Controls

E1 32-45 Limiting exposure to

ecotoxic substances

No EEL values are set at this time and the

default EELs are deleted.

E2 46-48 Restrictions on use within

application area

As no EEL is set at this time, an application rate

cannot be set under this control. An application

rate is proposed as an additional control under

s77A.

Hazardous Substances (Identification) Regulations 2001

I1 6, 7, 32-35,

36 (1)-(7)

General identification

requirements

Regulation 6 –

Identification duties of

suppliers

Regulation 7 –


persons in charge

Regulations 32 and 33 –

Accessibility of

information

Regulations 34, 35, 36(1)-

(7) – Comprehensibility,

Clarity and Durability of


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information

I2 8 Priority identifiers for

corrosive substances


ecotoxic substances


certain toxic substances

I9 18 Secondary identifiers for

all hazardous substances




ecotoxic substances


toxic substances

I17 26 Use of Generic Names

I18 27 Use of Concentration

Ranges

I19 29-31 Alternative information in

certain cases

Regulation 29 –

Substances in fixed bulk

containers or bulk

transport containers

Regulation 30 –

Substances in multiple

packaging

Regulation 31 –

Alternative information

when substances are

imported

I20 36(8) Durability of information

for class 6.1 substances

I21 37-39, 47-

50

Documentation required in

places of work

Regulation 37 –

Documentation duties of

suppliers

Regulation 38 –


persons in charge of

places of work


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Regulation 39 – General

content requirements for

documentation

Regulation 47 –

Information not included

in approval

Regulation 48 – Location

and presentation

requirements for

documentation

Regulation 49 –

Documentation

requirements for vehicles

Regulation 50 –

Documentation to be

supplied on request

I22 40 Specific documentation

requirements for corrosive

substances


requirements for ecotoxic

substances


requirements for toxic

substances

I29 51-52 Duties of persons in

charge of places with

respect to signage

I30 53 Advertising corrosive and

toxic substances

Hazardous Substances (Disposal) Regulations 2001

D4

D5

8

9

Disposal requirements for

toxic, corrosive, and

ecotoxic substances

Controls D4 and D5 are combined.

D6 10 Disposal requirements for

packages

D7 11, 12 Disposal information

requirements

D8 13, 14 Disposal documentation

requirements

Hazardous Substances (Emergency Management) Regulations 2001


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EM1 6, 7, 9-11 Level 1 emergency

management information:

General requirements

EM2 8(a) Information requirements

for corrosive substances

EM6 8(e) Information requirements

for toxic substances

EM7 8(f) Information requirements

for ecotoxic substances

EM8 12-16, 18-

20

Level 2 emergency

management

documentation

requirements

EM11 25-34 Level 3 emergency

management requirements

– emergency response

plans

The trigger quantity for this control is varied to

50 L in accordance with s77(3)(a).



– secondary containment

EM13 42 Level 3 emergency


– signage

Hazardous Substances (Personnel Qualification) Regulations 2001

AH1 4-6 Approved Handler

requirements

Under section 77A the control imposed by regulation 5 is varied by adding the following

control:



Hazardous Substances (Tracking) Regulations 2001

TR1 4(1), 5, 6 General tracking

requirements

Hazardous Substances (Compressed Gases) Regulations 2004

Regulations 4 to 80

where applicable

The Hazardous Substance

(Compressed Gases)

Regulations 2004

prescribe a number of

controls relating to

compressed gases

including aerosols and gas

cylinders and must be

complied with as relevant.

Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004


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Regulations 4 to 43

where applicable

The Hazardous Substances

(Tank Wagons and

Transportable Containers)

Regulations 2004


controls relating to tank

wagons and transportable

containers and must be


Table A4.2b: Additional controls set for the substance.

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Control Description

1. Application rate

The maximum application rate for the substance to be applied to soil is 250 kg iodomethane

per hectare, (0.025 kg iodomethane per square metre) with a maximum frequency of once

per year.

2. Use restriction

The substance shall not be applied into or onto water.

3. Use restriction

The substance may only be used –

(a) for pre-plant soil fumigation; and

(b) in areas intended for commercial strawberry growing.

4. Container volume restriction

The maximum volume of the substance stored in a container shall be 70L.

Notification and Signage

5. Notification of intended fumigation

(1) The person in charge of fumigation using the substance must notify –

(a) the person in charge of the place; and

(b) the nearest Communications Centre of the New Zealand Fire Service; and

(c) every other person who may be affected by the fumigation;

(2) A notification required under subclause (1) must not be given less than 24 hours prior

to the Start of Fumigation.

6. Signage (1) The person in charge of fumigation using the substance must ensure that signs are


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Control Description

erected around the perimeter of the Buffer Zone at every intended point of entry to the

Buffer Zone Signs must be posted from the Start of Fumigation, until the end of the

Buffer Zone Period.

(2) Signs erected in accordance with subclause (1) must –

(a) state that fumigation is being carried out; and

(b) identify the hazardous substance being used and state that it is toxic to humans;

and

(c) describe the general type of hazard associated with the substance.

(3) Signs erected in accordance with subclauses (1) and (2) must –

(a) comply with regulation 34(1), (2), and (4) and regulation 35(1), (3), and (5) of the

Hazardous Substances (Identification) Regulations 2001, but as if the distances

referred to in regulation 35(3) were a distance of not less than 10 metres; and

(b) identify the person in charge of the fumigation and provide sufficient information

to enable the person to be contacted during normal business hours; and

(c) state the day on which the fumigation commenced; and

(d) state the actions that must be taken in an emergency.

(4) Signs must be removed within 3 days (72 hours) of the end of the Buffer Zone

Period.

7. Notice of completion

The person in charge of fumigation must notify each person to whom notice was given in

accordance with the control entitled ―Notification of intended fumigation‖ when

Fumigation is Complete.

Operational Controls

8. Use of plastic sheeting

The person in charge of fumigation must ensure that —

(a) soil fumigated with the substance is covered immediately with plastic sheeting

appropriate for use in fumigation operations; and

(b) the plastic sheeting must remain in place until the Fumigation is Complete; and

(c) the plastic sheeting is not sliced or removed until the Fumigation is Complete;

and

(d) despite paragraph (c), the plastic sheeting is not sliced or removed after this time

period if it is raining, or if rain is expected to fall within 48 hours; and

(e) where the plastic sheeting is sliced for removal, it is not removed within 24 hours


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Control Description

of slicing.

9. Disposal of Plastic Sheeting

The plastic sheeting must be disposed of in a manner that is consistent with the

requirements in regulation 10 of the Hazardous Substances (Disposal) Regulations 2001 for

disposal of a package that contained the substance.

10. Entry restriction for Application Block.

(1) From the start of the Buffer Zone Period until the Fumigation is Complete no person

may be present in or enter an Application Block, unless —

(a) the person has successfully completed a product-specific training course; and

(b) the person is wearing personal protective equipment (PPE); and

(c) presence or entry is for the purposes of —

(i) handling of the substance; or

(ii) installing, inspecting and/or repairing the plastic sheeting by an approved

handler or persons under the supervision of an approved handler; or

(iii) carrying out flood prevention activities by an approved handler or persons

under the supervision of an approved handler; or

(iv) determining whether Fumigation is Complete and the person is an

approved handler or is under the supervision of an approved handler.

(2) Despite subclause (1), from the start of the Buffer Zone Period until the Fumigation

is Complete a person may be present in or enter an Application Block if the person is

wearing PPE and is —

(a) a member of the emergency services responding to an emergency situation; or

(b) a HSNO enforcement officer.

11. Non-target plant protection

The substance shall not be applied within 1 meter of the roots of non-target plants.

12. Timing and conditions for operation






(e) when the conditions in (c) or (d) are forecast for the 24 hour period following the

last application of the substance within an Application Block.


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Control Description

13. Restrictions for fumigation applications areas

(1) The person in charge of fumigation must ensure that the substance is not be applied

within 400 m of any sensitive site where the public may lawfully be present, such as

schools, playgrounds, day care facilities prisons, and hospitals and nursing homes.

(2) The person in charge of fumigation must ensure that the substance must not be applied

within an area whereby the Buffer Zone will include any of the following:

(a) any part of the Buffer Zone of another Application Block; and

(b) residential areas (including employee housing, private property, buildings,

commercial, industrial, and other areas that people may occupy or outdoor

residential areas, such as lawns, gardens, or play areas); and

(c) buildings used for storage (such as sheds, barns, garages, etc.), unless:

(i) persons will not be present in the storage buildings during the Buffer Zone

Period; and

(ii) the storage buildings do not share a common wall with a structure where

persons will be present during the Buffer Zone Period; and

(d) bus stops or other locations where persons wait for public transport; and

(e) agricultural areas owned/operated by persons other than the owner/operator

(owner/operator of an affected agricultural area) of the Application Block,

unless:

(i) the person in charge of fumigation ensure that the Buffer Zone will not

overlap with a Buffer Zone from any adjacent property owners; and

(ii) the owner/operator of an affected agricultural area provides written

agreement to the person in charge of fumigation that the affected

owner/operator of an affected agricultural area, and other persons

legally on their property will stay out of those parts of the Buffer Zone that

are under the control of the owner/operator of an affected agricultural

area during the entire Buffer Zone Period;

(f) publicly owned and/or operated areas (e.g., parks, rights of way, foot paths,

walking paths, athletic fields, etc.), unless:

(i) the area is a road; or

(ii) members of the public will not be present in the area during the Buffer

Zone Period; or

(iii) the person in charge of fumigation has taken all practicable steps to ensure

that no members of the public enter the area during the Buffer Zone

Period.

(3) An Application Block must not be greater than 3 hectares.

Buffer Zone Controls


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Control Description

14. Entry restriction for Buffer Zones

(1) For the duration of the Buffer Zone Period, the person in charge of fumigation must

ensure that the only persons within the Buffer Zone are —

(a) permitted to enter the Application Block from the start of the Buffer Zone

Period until the Fumigation is Complete in accordance with the control titled

―Entry restriction‖ and wearing PPE; or

(b) in transit through the Buffer Zone by vehicular traffic (including bicycles) on

roads provided that the total transit time within any 24 hour period is less than 15

minutes.

15. Buffer Zone Distances

(1) The following table states the minimum distance between the perimeter of the

Application Block and any point of the perimeter of the Buffer Zone for the following

Maximum Broadcast Equivalent Application Rates (MBEAR):

Application block area / ha

Distance to perimeter of

Buffer Zone / m

MBEAR iodomethane

200 kg / ha 250 kg / ha

below 0.5 30 40

between 0.5 and 1.0 50 65

between 1.0 and 3.0 70 100

(2) The distances in (1) may be —

(a) reduced by up to 10% if the plastic sheeting used meets the requirements to be

classed as Highly Retentive Film (HRF); and

(b) adjusted, after approval of the Authority, if users provide New Zealand specific

flux data or if users carry out air dispersion modelling for their site in order to

determine a more appropriate Buffer Zone.

Qualifications and Certification

16. Location Test Certification

(1) The person in charge of a place where the substance is present means a person who

is—

(a) the owner, lessee, sublessee, occupier, or person in possession of the place,

or any part of it; or

(b) any other person who, at the relevant time, is in effective control or

possession of the relevant part of the place.

(2) When the substance is present at a place (not including the property where the

substance is to be applied, a vehicle, ship, aircraft, or other means of transport) in

quantities exceeding 50 litres for a period exceeding 2 hours, the person in charge

of that place must ensure that the place has a current test certificate certifying in

respect of the substance, that—


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Control Description

(a) notification has been made to the territorial authority in the area where the

place is located, the Department of Labour and the New Zealand Fire

Service or local fire authority in the area where the place is located, at least

30 working days before the commissioning of the place as a place for

accommodating the substance, of—


(ii) the maximum quantity and hazard classification of the substance

that the place is designed or constructed to accommodate; and

(b) the person in charge of the place is an approved handler for the substance,

or can demonstrate that a person is available who is an approved handler

for such substance; and

(c) the substance can be secured so that a person cannot gain access to the

substance without tools, keys, or any other device used for operating locks;

and

(d) the place has signage in place as required by the Hazardous Substances

(Identification) Regulations 2001 and the Hazardous Substances

(Emergency Management) Regulations 2001; and

(e) a site plan is available for inspection that shows the physical position, in

relation to the legal boundary of the place, of all locations within the place

that contain the substance; and

(f) minimum separation distances from the substance locations to the legal

boundary shall be as determined in AS/NZS 4452: 1997: The storage and

handling of toxic substances; and

(g) the equipment used to handle the substance complies with regulation 7 of

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

and

(h) there is available at the place, to persons who handle the substance,

protective clothing or equipment that complies with section 8 of the

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

(i) that an emergency response plan is in place, and that emergency

management controls are complied with, as required by the Hazardous

Substances (Emergency Management) Regulations 2001; and

(j) the workplace exposure standards set in relation to the substance are

monitored and complied with.

(3) The test certificate issued in accordance with this control must be renewed at

intervals of not more than 12 months.






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Control Description

17. Restrictions On Persons Who May Possess The Substance

(1) No person may possess the substance unless that person has a licence under section

95B of the Act from the Authority that is obtained before the person takes

possession of the substance.

(2) Despite subclause (1), a person who does not have a licence may possess the

substance if—

(a) in any other case, a person who has such a licence is present and available

immediately to the person in possession of the substance; or

(b) the person is deemed to comply with regulation 9 of the Hazardous

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

9A of those regulations (as varied under control T6).

18. Label statements

The following statements (or equivalent) are required to be included on the substance

product label:

The maximum application rate for the substance to be applied to soil is 250 kg

iodomethane/ha, with a frequency of once per season;

The substance must not be applied onto or into water;

The substance may only be used for pre-plant soil fumigation only in areas intended for

commercial strawberry growing;






(e) when the conditions in (c) or (d) are forecast for the 24 hour period

following the last application of the substance within an Application

Block.


Table A4.3: Controls for Ripper 980 [98% iodomethane / 2% chloropicrin] – codes,

regulations and variations. C

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

Controls

T1 11-27 Limiting exposure to toxic

substances

No ADE values have been set for iodomethane

or chloropicrin.

The following TELair values apply to Ripper

980: Substance

(Component)

TEL

ppm Mg/m3

Chloropicrin

CAS 76-88-4 Chronic 0.00006 0.0004

Iodomethane (methyl

iodide) CAS 74-88-4

Acute 0.15 0.86

Chronic 0.03 0.19

T2 29, 30 Controlling exposure in

places of work

The following WES values apply to Ripper 980:

Substance

(Component)

Comments WES (TWA)

ppm Mg/m3

Chloropicrin

CAS 76-88-4

- 0.1 0.67

Iodomethane (methyl

iodide)

CAS 74-88-4

Representing

risk through

skin abdsorption

2 12

T4

E6

7 Requirements for

equipment used to handle

hazardous substances


T5 8 Requirements for

protective clothing and

equipment

T6 9 Approved handler

requirements

Under section 77A the control imposed by regulation 9(2) is varied by adding the following

control after subclause 9(2)(c):

(9)(2) (d) the approved handler has ensured that the person has successfully

completed a product-specific training course approved by the Authority.

This control is varied so that the following regulation is inserted immediately after

regulation 9:

15 Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This

links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New

Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control

Regulations. 16 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for

definitions and exemptions. The accompanying explanation is intended for guidance only.

http://www.ermanz.govt.nz/resources


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9A Exception to approved handler requirements for the transportation of the substance

when packaged

(1) Regulation 9 is deemed complied with if-

(a) in the case of Ripper 980 being transported on land-

(i) in the case of Ripper 980 being transported by rail, the person who drives the

rail vehicle that is transporting the substance is fully trained in accordance

with an approved safety system under section 6D of the Transport Services

Licensing Act 1989 or a safety system which is referred to in an approved

safety case under the Railways Act 2005; and

(ii) in every other case, the person who drives, loads, and unloads the vehicle

that is transporting Ripper 980 –

A. for hire or reward, or in quantities which exceed those set out in

Schedule 1 of the Land Transport Rule 45001/1: Dangerous Goods 2005,

has a current dangerous goods endorsement on his or her driver’s

licence; or

B. in every other case, the Land Transport Rule 45001/1: Dangerous Goods

2005 is complied with; or

(b) in the case of Ripper 980 being transported by sea, one of the following is

complied with:

(iii) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods

(MR024A):

(iv) International Maritime Dangerous Goods Code; or

(c) in the case of Ripper 980 being transported by air, Part 92 of the Civil Aviation

Rules is complied with.


(c) does not apply to a tank wagon or transportable container to which the Hazardous

Substances (Tank Wagons and Transportable Containers) Regulations 2004

applies; but

(d) despite paragraph (a), does apply to an intermediate bulk container that complies

with chapter 6.5 of the UN Model Regulations.


(c) applies to pilots, aircrew, and airline ground personnel loading and handling a

hazardous substance within an aerodrome; but


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(d) does not apply to the storage and handling of Ripper 980 in any place that is not

within an aerodrome, or within an aerodrome by non-airline ground personnel.

(4) In this regulation, UN Model Regulations means the 16th revised edition of the

recommendation on the Transport of Dangerous Goods Model Regulations, published

in 2009 by the United Nations.

T7 10 Restrictions on the

carriage of hazardous

substances on passenger

service vehicles

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

Controls

E1 32-45 Limiting exposure to

ecotoxic substances

No EEL values are set at this time and the

default EELs are deleted.

Hazardous Substances (Identification) Regulations 2001

I1 6, 7, 32-35,

36 (1)-(7)

General identification

requirements

Regulation 6 –


suppliers

Regulation 7 –


persons in charge

Regulations 32 and 33 –

Accessibility of

information

Regulations 34, 35, 36(1)-

(7) – Comprehensibility,

Clarity and Durability of

information




ecotoxic substances


certain toxic substances


all hazardous substances




ecotoxic substances



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toxic substances

I17 26 Use of Generic Names

I18 27 Use of Concentration

Ranges

I19 29-31 Alternative information in

certain cases

Regulation 29 –

Substances in fixed bulk

containers or bulk

transport containers

Regulation 30 –

Substances in multiple

packaging

Regulation 31 –

Alternative information

when substances are

imported

I20 36(8) Durability of information

for class 6.1 substances

I21 37-39, 47-

50

Documentation required in

places of work

Regulation 37 –


suppliers

Regulation 38 –


persons in charge of

places of work

Regulation 39 – General

content requirements for

documentation

Regulation 47 –

Information not included

in approval

Regulation 48 – Location

and presentation

requirements for

documentation

Regulation 49 –


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Documentation

requirements for vehicles

Regulation 50 –

Documentation to be

supplied on request


requirements for corrosive

substances


requirements for ecotoxic

substances


requirements for toxic

substances

I29 51-52 Duties of persons in

charge of places with

respect to signage

I30 53 Advertising corrosive and

toxic substances

Hazardous Substances (Disposal) Regulations 2001

D4

D5

8

9

Disposal requirements for

toxic, corrosive, and

ecotoxic substances

Controls D4 and D5 are combined.

D6 10 Disposal requirements for

packages

D7 11, 12 Disposal information

requirements

D8 13, 14 Disposal documentation

requirements

Hazardous Substances (Emergency Management) Regulations 2001

EM1 6, 7, 9-11 Level 1 emergency

management information:

General requirements

EM2 8(a) Information requirements

for corrosive substances

EM6 8(e) Information requirements

for toxic substances

EM7 8(f) Information requirements

for ecotoxic substances

EM8 12-16, 18-

20

Level 2 emergency

management

documentation

requirements



– emergency response

The trigger quantity for this control is varied to

50 L in accordance with s77(3)(a).


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plans



– secondary containment

EM13 42 Level 3 emergency


– signage

Hazardous Substances (Personnel Qualification) Regulations 2001

AH1 4-6 Approved Handler

requirements

Under section 77A the control imposed by regulation 5 is varied by adding the following

control:



Hazardous Substances (Tracking) Regulations 2001

TR1 4(1), 5, 6 General tracking

requirements

Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004

Regulations 4 to 43

where applicable

The Hazardous Substances

(Tank Wagons and

Transportable Containers)

Regulations 2004


controls relating to tank

wagons and transportable

containers and must be


Hazardous Substances (Compressed Gases) Regulations 2004

Regulations 4 to 80

where applicable

The Hazardous Substance

(Compressed Gases)

Regulations 2004


controls relating to

compressed gases

including aerosols and gas

cylinders and must be


Additional controls set under s77A

Use Restriction

Ripper 980 may only be used as a manufacturing concentrate.

Label Statement

The following statements (or equivalent) are required to be included on the substance product label:

Ripper 980 may only be used as a manufacturing concentrate.

Container volume restriction

The maximum volume of Ripper 980 stored in a container shall be 70L.


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Location Test Certification Requirements

(1) The person in charge of a place where Ripper 980 is present means a person who is—

(a) the owner, lessee, sublessee, occupier, or person in possession of the place, or any

part of it; or

(b) any other person who, at the relevant time, is in effective control or possession of the

relevant part of the place.

(2) When Ripper 980 is present at a place (not including the property where Ripper 980 is to be

applied, a vehicle, ship, aircraft, or other means of transport) in quantities exceeding 50 litres

for a period exceeding 2 hours, the person in charge of that place must ensure that the place

has a current test certificate certifying in respect of Ripper 980, that—

(a) notification has been made to the territorial authority in the area where the place is

located, the Department of Labour and the New Zealand Fire Service or local fire

authority in the area where the place is located, at least 30 working days before the

commissioning of the place as a place for accommodating Ripper 980, of—


(ii) the maximum quantity and hazard classification of Ripper 980 that the place

is designed or constructed to accommodate; and

(b) the person in charge of the place is an approved handler for Ripper 980, or can

demonstrate that a person is available who is an approved handler for such

substance; and

(c) Ripper 980 can be secured so that a person cannot gain access to Ripper 980 without

tools, keys, or any other device used for operating locks; and

(d) the place has signage in place as required by the Hazardous Substances

(Identification) Regulations 2001 and the Hazardous Substances (Emergency

Management) Regulations 2001; and

(e) a site plan is available for inspection that shows the physical position, in relation to

the legal boundary of the place, of all locations within the place that contain Ripper

980; and

(f) minimum separation distances from Ripper 980 locations to the legal boundary shall

be as determined in AS/NZS 4452: 1997: The storage and handling of toxic

substances; and

(g) the equipment used to handle Ripper 980 complies with regulation 7 of the

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

(h) there is available at the place, to persons who handle Ripper 980, protective clothing

or equipment that complies with section 8 of the Hazardous Substances (Classes 6,

8, and 9 Controls) Regulations 2001; and






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(i) that an emergency response plan is in place, and that emergency management

controls are complied with, as required by the Hazardous Substances (Emergency

Management) Regulations 2001; and

(j) the workplace exposure standards set in relation to Ripper 980 are monitored and

complied with.

(3) The test certificate issued in accordance with this control must be renewed at intervals of not

more than 12 months.

Restrictions On Persons Who May Possess The Substance

(1) No person may possess Ripper 980 unless that person has a licence under section 95B of the

Act from the Authority that is obtained before the person takes possession of Ripper 980.

(2) Despite subclause (1), a person who does not have a licence may possess Ripper 980 if—

(a) in any other case, a person who has such a licence is present and available

immediately to the person in possession of Ripper 980; or

(b) the person is deemed to comply with regulation 9 of the Hazardous Substances

(Classes 6, 8, and 9 Controls) Regulations 2001 by regulation 9A of those

regulations (as varied under control T6).

ENVIRONMENTAL RISK MANAGEMENT...particular reference to benefits in comparison to existing fumigants...

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Transcript of ENVIRONMENTAL RISK MANAGEMENT...particular reference to benefits in comparison to existing fumigants...