decision - epa.govt.nz€¦ · applicant sundew solutions pty ltd purpose of the application to...

DECISION

22 September 2015

1. Summary

Substance Joseph Lyddy Flea Control Deodorising Household Flea

Spray

Application code APP202489

Application type To import or manufacture for release any hazardous substance under

Section 28 of the Hazardous Substances and New Organisms Act

1996 (“the Act”)

Application sub-type Category B

Applicant Sundew Solutions Pty Ltd

Purpose of the application To import Joseph Lyddy Flea Control Deodorising Household Flea

Spray, an aerosol insecticide containing 0.25 g/kg imidacloprid

Date application received 1 May 2015

Consideration date 22 September 2015

Further information was requested of the applicant during the

evaluation of the application in accordance with section 58 of the Act

and consequently the consideration was postponed in accordance

with section 59 of the Act

Considered by The Chief Executive1 of the Environmental Protection Authority (“the

EPA”)

Decision Approved with controls

Approval code HSR101062

Hazard classifications

(refer to Table 1, Section 4)

2.1.2A, 6.4A, 9.1D, 9.4B

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

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Decision on application for approval to import or manufacture Joseph Lyddy Flea Control Deodorising Household Flea Spray for release (APP202489)

www.epa.govt.nz

2. Background

2.1. Joseph Lyddy Flea Control Deodorising Household Flea Spray is an aerosol insecticide containing

0.25 g/kg of the neonicotinoid imidacloprid as the active ingredient to control fleas on pet bedding and

carpets.

2.2. The applicant intends to import Joseph Lyddy Flea Control Deodorising Household Flea Spray into

New Zealand fully formulated, packed and labelled in standard tinplate aerosol 300 g packs.

2.3. Joseph Lyddy Flea Control Deodorising Household Flea Spray is intended for the home owner

(domestic use).

2.4. One pack of Joseph Lyddy Flea Control Deodorising Household Flea Spray is intended to treat

approximately 35 m2.

2.5. The applicant expects that the substance will be used completely (i.e. until the container is emptied)

as an insecticide, to avoid a requirement for disposal of the substance. However, containers of Joseph

Lyddy Flea Control Deodorising Household Flea Spray can be disposed of via a liquid hazardous

waste contractor, recycling program or at a landfill which is approved to accept that type of waste.

3. Process, consultation and reasons for non-notification

3.1. The application was lodged pursuant to section 28 of the Act.

3.2. Once outstanding information was provided by the applicant, the application contained sufficient

information for the staff of the EPA (“the staff”) to undertake a full scientific assessment of the

substance.

3.3. WorkSafe New Zealand were advised of the application on 1 May 2015 and invited to comment on it

by 29 May 2015. No comments were received.

3.4. In accordance with section 53(2) of the Act, the application was not publicly notified as it was

considered that there was unlikely to be significant public interest in it. Although the active ingredient

imidacloprid is the subject of public interest regarding its potential environmental impact on bees and

other pollinators, exposure to pollinators is not anticipated to be likely in this case because the

substance is intended to be applied indoors only.

4. Hazardous properties

4.1. The staff have determined the hazard classification of Joseph Lyddy Flea Control Deodorising

Household Flea Spray based on the information provided by the applicant and other available

information as documented in Appendix B.

4.2. The overall classifications determined by the staff are different to those submitted by the applicant

(Table 1). The applicant submitted only a dangerous goods classification of 2.1 for the substance. This

corresponds to the 2.1.2A classification for a flammable aerosol. The 6.4A, 9.1D and 9.4B

classifications were assigned by the staff based on component data and the application of mixture

rules.

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Table 1 Hazard classifications of Joseph Lyddy Flea Control Deodorising Household Flea Spray as

proposed by the applicant and the staff

Hazard Endpoint Applicant classification2 EPA classification

Flammability 2.1 2.1.2A

Eye irritancy - 6.4A

Aquatic ecotoxicity - 9.1D

Terrestrial invertebrate ecotoxicity - 9.4B

5. Risk and benefit assessment

Assessment of risks to human health and the environment

5.1. Joseph Lyddy Flea Control Deodorising Household Flea Spray contains the active ingredient

imidacloprid, which is present in other approved substances. However, the proposed uses for Joseph

Lyddy Flea Control Deodorising Household Flea Spray are different to existing approvals. Therefore a

quantitative risk assessment was carried out to assess the human health risks associated with the

proposed use pattern.

5.2. Due to the proposed use pattern, exposure of Joseph Lyddy Flea Control Deodorising Household Flea

Spray to the environment during the use stage of its lifecycle is expected to be very limited.

Quantitative exposure modelling and ecological risk assessment were therefore not performed, and

evaluation of the risks to the environment were limited to a qualitative assessment.

5.3. Adverse effects to human health and the environment could also arise due to the flammability of the

substance. However, it is considered that, in most cases, these effects will be managed by the default

controls for flammable substances. Where this is not the case, additional controls have been proposed

to ensure that the resulting level of risk is negligible (see Section 6).

5.4. The staff identification and qualitative assessment of the risks arising from the physical hazards,

human health risks not covered by the quantitative risk assessment, and risks to the environment

associated with Joseph Lyddy Flea Control Deodorising Household Flea Spray are set out in Tables 2,

3 and 4 respectively.

5.5. The applicant intends to import (not manufacture) Joseph Lyddy Flea Control Deodorising Household

Flea Spray. However, it is possible that the substance could be manufactured in New Zealand in the

future. Consequently, the risks associated with the manufacture of Joseph Lyddy Flea Control

Deodorising Household Flea Spray have been evaluated so the approval of this substance will be

applicable to both the import and manufacture of Joseph Lyddy Flea Control Deodorising Household

Flea Spray.

Quantitative human health risk assessment

5.6. A quantitative human health risk assessment was carried out for use of the substance and for post-

application exposure to treated carpet. This risk assessment modelled the exposure to the user during

application of the substance, and the exposure of a child crawling on treated carpet regularly for 14

2 The applicant partially proposed hazard classifications for Joseph Lyddy Flea Control Deodorising Household Flea Spray

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days after a monthly treatment of carpet. The model indicated that the resulting risks to the user during

application of the substance, and to a child from exposure to the treated carpet are below levels of

concern. Details of the human health risk assessment are included in Appendix D.

Relationship of Māori to the environment

5.7. I have considered the potential effects of Joseph Lyddy Flea Control Deodorising Household Flea

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

the Act.

5.8. The staff have advised me that Joseph Lyddy Flea Control Deodorising Household Flea Spray triggers

several hazardous properties which give rise to the potential for cultural risk e.g. aquatic ecotoxicity

and terrestrial invertebrate ecotoxicity. Cultural risk includes the deterioration of the mauri of taonga

flora and fauna species, the environment and the general health and well-being of individuals and the

community.

5.9. In addition to its hazardous properties, this substance has the potential to inhibit the ability of Māori to

fulfil their role as kaitiaki, particularly in relation to the protection of the mauri of species and

waterways.

5.10. Based on the information provided, including the use pattern and default controls for Joseph Lyddy

Flea Control Deodorising Household Flea Spray, the staff have advised me that the risks to Māori

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

or other taonga are likely to be negligible.

5.11. The staff have advised me that the control of fleas as a result of use of Joseph Lyddy Flea Control

Deodorising Household Flea Spray could have a positive effect on taha hauora (human health),

particularly in respect of taha tinana (physical health and well-being).

5.12. If Joseph Lyddy Flea Control Deodorising Household Flea Spray is applied in the prescribed manner,

the staff have advised me that it is not likely to breach the principles of the Treaty of Waitangi, in

particular the principle of active protection.

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

5.13. The staff did not identify any risks associated with the approval of Joseph Lyddy Flea Control

Deodorising Household Flea Spray to society, communities or the market economy.

5.14. The controlled use of Joseph Lyddy Flea Control Deodorising Household Flea Spray is not expected

to have any significant adverse impacts on the social environment, apart from the effects already

discussed. Consequently, the staff consider that this aspect of potential risk need not be considered

further.

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Table 2: Risk assessment of physical hazards to the human health and the environment

Lifecycle Description Likelihood Magnitude Matrix Comment Level of risk

Manufacture

Adverse effects to human

health or the environment

resulting from fire

Highly

improbable Moderate Negligible

The staff note that manufacturing workers in New Zealand will be

alerted to the hazard properties of the substance through identifiers on

the documentation. Additionally, workers will be required to treat any

spillage in accordance with the HSNO emergency management

regulations.

Negligible

Importation,

transport and

storage

Taking into account HSNO controls (e.g. packaging controls and

controls relating to adverse effects of unintended ignition of class 2

substances (including 2.1.2A) set out in Schedule 10 of the New

Zealand Gazette Notice of Thursday, 25 March 2004, Issue Number 35

as amended) the staff consider it highly improbable that unintended

ignition of the substance will occur during importation, transport and

storage, if controls are complied with.

Negligible

Use There are potential risks to human health and the environment if the

substance were unintentionally ignited during use. The staff consider it

highly improbable that the substance will be exposed to a source of

ignition sufficient to ignite it during use. In addition, during use of the

substance, the staff consider that the requirements for approved

handlers and equipment used to handle substances will ensure the

substance is not released in quantities sufficient to cause major adverse

effects.

Negligible

Disposal Given the small quantities likely to need to be disposed of, and controls

in place provided that they are complied with, it is considered highly

improbable that disposal of Joseph Lyddy Flea Control Deodorising

Household Flea Spray will result in adverse effects to human health or

the environment resulting from the flammable properties of the

substance.

Negligible

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Table 3: Qualitative assessment of human health risks

Lifecycle Description Likelihood Magnitude Matrix Comment Level of

risk

Manufacture

and packaging

Eye irritancy Highly

improbable

Minimal Negligible Manufacturing and packaging facilities in New Zealand will be required

to meet the HSNO requirements for equipment and emergency

management. The need for compliance with HSNO information

provisions (e.g. labels, Safety Data Sheets (SDSs)), and WorkSafe New

Zealand’s Health and Safety requirements will also apply.

This means that workers handling the substance will need to be aware

of the hazards and the measures that need to be undertaken to ensure

their own safety. Provided these measures are taken, the level of risk is

negligible.

Negligible

Importation,

transport,

storage

Eye irritancy Highly improbable

Minimal Negligible Workers and bystanders will only be exposed to the substance during

this part of the lifecycle in isolated incidents where spillage occurs,

therefore only risks from acute exposure are considered here.

Compliance with HSNO controls (e.g. labels, SDS) and adherence to

the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime

Transport Act 1994 (as applicable) is required.

Negligible

Use Eye irritancy Very unlikely Minimal Negligible The substance will be labelled to identify its potential risks minimising

the opportunity for it to cause irritancy. HSNO requirements for

compressed gases, identification and emergency management must be

complied with during home and commercial use of the susbstance.

Negligible

Disposal Eye irritancy Highly

improbable

Minimal Negligible The applicant indicates that the preferred disposal method is to use the

product according to label directions. Disposal of the substance and its

used containers in New Zealand, if required, shall be in accordance with

the requirements of the Hazardous Substances (Disposal) Regulations

2001. Compliance with these will reduce the opportunity for individuals

to be exposed.

Negligible

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Table 4: Qualitative assessment of risks to the environment

Lifecycle Description Likelihood Magnitude Matrix Comment Level of

risk

Manufacture,

importation,

transport and

storage

Death or adverse effects to

aquatic or terrestrial

organisms.

Highly

improbable

Minor Negligible Provided the exercise of this approval is in adherence with the HSNO

controls (and the Land Transport Rule 45001, Civil Aviation Act 1990

and Maritime Transport Act 1994 (as applicable)), the staff consider a

spill to be highly improbable.

Negligible

Use

(application)

Death or adverse effects to


organisms.

Highly

improbable

Minor Negligible Due to the proposed use pattern (direct spray indoors on pet bedding

and carpets), exposure of the environment to Joseph Lyddy Flea

Control Deodorising Household Flea Spray during the use stage of its

lifecycle is expected to be very limited. The staff consider that the use of

labelling and compliance with controls will adequately manage the risks

to the aquatic and terrestrial environments.

Negligible

Disposal Death or adverse effects to


organisms.

Highly

improbable

Minor Negligible Users will in most cases utilise all of the substance by its normal use as

an insecticide. All cases of disposal are required to be in accordance

with the requirements of the Hazardous Substances (Disposal)

Regulations 2001.

Negligible

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New Zealand’s international obligations

5.15. The staff did not identify international obligations that may be impacted by the approval of Joseph

Lyddy Flea Control Deodorising Household Flea Spray.

Overall assessment of risks

5.16. Assuming compliance with the controls, the staff have advised me that risks to human health and the

environment associated with Joseph Lyddy Flea Control Deodorising Household Flea Spray are

mitigated by the controls applied so that the level of residual risk is negligible.

Identification of benefits

5.17. According to the applicant, the approval of Joseph Lyddy Flea Control Deodorising Household Flea

Spray will provide the following benefits:

improvement of the wellbeing of animals and homeowners exposed to flea populations by

mostly targeting the flea populations that are off the host, where they spend up to 90% of their

time

the application method is not directly on animals as a concentrate, which minimises direct

contact of the animal with the substance and increases the chance of eliminating the root

cause of flea infestation

the aerosol pack is of a lower volume than many other insecticide flea treatments on the

market that contain the same active ingredient

the substance is intended for indoor use, which minimises the risk to aquatic and terrestrial

invertebrates

The effects of the substance being unavailable

5.18. I consider that the likely effects of the substance being unavailable relate to less consumer choice

resulting in less competitive pricing. This is because other flea insecticide products are available on

the New Zealand market.

Overall assessment of benefits

5.19. I am satisfied that the availability of Joseph Lyddy Flea Control Deodorising Household Flea Spray will

provide beneficial economic effects for some businesses as well as flow-on effects to local

communities and the New Zealand economy.

5.20. I consider that use of Joseph Lyddy Flea Control Deodorising Household Flea Spray could provide

improvement of the wellbeing of animals and homeowners exposed to flea populations.

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6. Controls

6.1. The staff have identified a set of default controls of Joseph Lyddy Flea Control Deodorising Household

Flea Spray, based on the hazard classification and specified by the regulations under the Act. These

controls form the basis of the controls set out in Appendix A. The risk assessment conducted by the

staff also identified risks that were not managed by the default controls, so the staff have proposed the

following exposure limits, variations and additions to the default controls to manage those risks.

The setting of exposure limits

6.2. Tolerable Exposure Limits (TELs), Acceptable Daily Exposures (ADEs) and Potential Daily Exposures

(PDEs) can be set to limit hazardous substances from entering the environment in quantities sufficient

to present a risk to people. No TELs, ADEs or PDEs have been set for any component of Joseph

Lyddy Flea Control Deodorising Household Flea Spray at this time.

6.3. Workplace exposure standards (WESs) can be set to limit exposure of people to toxic substances in

places of work. The EPA typically adopts WES values listed in WorkSafe New Zealand’s Workplace

Exposure Standards document (effective from February 2013):

http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-

standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-

2013.pdf

WorkSafe New Zealand has set WES values for components C, E and F. The values for components

C and E should apply to the substance, but the value for component F should not apply to the

substance due to the low concentration of component F in the substance.

6.4. Environmental Exposure Limits (EELs) can be set to limit hazardous substances from entering the

environment in quantities sufficient to present a risk to it. No EELs are set for any component of

Joseph Lyddy Flea Control Deodorising Household Flea Spray at this time because the substance is

not intended to be used in a manner that would cause a significant exposure of the substance to the

environment. Accordingly, the E1 control has been deleted.

6.5. Control E2 relates to restrictions on use of substances in application areas. The default controls

require the EPA 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 the substance is not intended for

application to an area of land and no EEL has been set, this control has been deleted.

Additional controls

6.6. The staff note that the default controls do not address all the risks associated with the unintended

ignition of flammable substances. These risks include risks to human health from the effects of fire.

These risks may occur where there is inadequate separation of the substances from areas where the

general public may be present. Accordingly, controls addressing these risks are considered more

http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdf



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

substance. The additional controls are shown in Appendix A.

6.7. The draft label for Joseph Lyddy Flea Control Deodorising Household Flea Spray states that the

product can be re-applied monthly “or as required”. The draft label also advises that users “re-apply

after vacuuming”. This makes the frequency of application uncertain, as this could imply a more

frequent application than monthly. The staff carried out the quantitative risk assessment modelling

using 12 monthly applications and recommended based on the modelling that the label be changed to

make clear that use more frequently than monthly is not recommended. As a result, the staff

recommended the following control applying a maximum application frequency and a minimum interval

between applications be applied to Joseph Lyddy Flea Control Deodorising Household Flea Spray:

A maximum number of applications is set for this substance at 12 applications per year, with a

minimum of 30 days between each application.

6.8. To communicate this information regarding the maximum application frequency and interval between

applications to the users of the substance, I consider that an additional control should be applied to

Joseph Lyddy Flea Control Deodorising Household Flea Spray requiring this information be included

on the label for the substance. The control specifying additional label information is described in

Appendix A.

6.9. The risk assessment for this substance has taken into account the proposed use of this substance

indoors in treating pet bedding and carpet. With indoor use of the substance, a significant exposure to

aquatic and terrestrial environments is not anticipated. However, use of the substance outside of the

intended use pattern could lead to a significant environmental exposure. As a result, I consider that it

is necessary to apply a restriction on the application of Joseph Lyddy Flea Control Deodorising

Household Flea Spray to permit only indoor application.

6.10. While the control restricting application of the substance to indoor application only will reduce the

likelihood of a significant exposure to aquatic environments, the staff have advised me that it is

appropriate to place a restriction on the application of the substance to prohibit application into or onto

water, in order to mitigate the risk of death or adverse effects to aquatic organisms. I consider that the

application of a control prohibiting application into or onto water, and the additional control restricting

application of the substance to indoor application, will be more effective than the default controls with

respect to their effects on the risks that use of the substance presents to aquatic and terrestrial

environments. These additional controls are shown in Appendix A.

Variation and deletion of controls

6.11. Control F4 has been triggered for Joseph Lyddy Flea Control Deodorising Household Flea Spray as a

result of its 2.1.2A classification, i.e. because it presents a high flammability hazard as an aerosol.

Given its high hazard, the staff have advised me that it is appropriate to retain the approved handler

controls over the whole lifecycle of the substance with the exception of when the substance is being

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transported, as the Dangerous Goods Regulations cover the potential risks of the substance during

this stage. A variation has therefore been applied to this substance to implement this exception.

6.12. The staff have advised me that, as the threshold quantity for applying approved handler requirements

for 2.1.2A flammable aerosols is 3000 L aggregate water capacity, approved handler requirements will

not impact domestic users of the substance.

6.13. Control E3 includes requirements for the protection of terrestrial invertebrates (including bees) where

a substance is sprayed into the environment. As Joseph Lyddy Flea Control Deodorising Household

Flea Spray is not intended to be sprayed into outdoor environments, the risks to bees are considered

negligible and therefore this control has been deleted.

Review of controls for cost-effectiveness

6.14. The staff consider that the proposed controls are the most cost-effective way of managing the

identified potential risks associated with this substance, and that the additional controls and variations

described above are more effective than the default controls alone, with respect to their effect on

managing the risks.

6.15. The applicant was provided an opportunity to comment on the proposed controls as set out in this

decision and indicated that they had no concerns with the proposed controls.

7. Environmental user charges

7.1. The staff have advised me that applying controls on Joseph Lyddy Flea Control Deodorising

Household Flea Spray is an effective means of managing the risks associated with this substance.

Therefore, it is not considered necessary to apply environmental user charges to this substance as an

alternative or additional means of achieving effective risk management. Accordingly, no report has

been made to the Minister for the Environment.

8. Conclusion

8.1. Taking into account the staff assessment of the potential risks and benefits associated with Joseph

Lyddy Flea Control Deodorising Household Flea Spray, I consider that, with controls in place:

the risks to human health and the environment arising from the hazardous properties

(flammability, eye irritation, and ecotoxicity to aquatic and terrestrial environments) and the use

of Joseph Lyddy Flea Control Deodorising Household Flea Spray are negligible

significant adverse impacts on the social or economic environment from the use of Joseph

Lyddy Flea Control Deodorising Household Flea Spray are not anticipated

significant impacts on Māori culture or traditional relationships with ancestral lands, water,

sites, wāhi tapu, valued flora and fauna or other taonga that will breach the principles of Te

Tiriti o Waitangi/The Treaty of Waitangi are not anticipated

benefits will be derived for New Zealand by allowing the use of Joseph Lyddy Flea Control

Deodorising Household Flea Spray.

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9. Decision

9.1. Pursuant to section 29 of the Act, I have considered this application to import a hazardous substance

for release made under section 28 of the Act. In doing so, I have applied the relevant sections of the

Act and clauses of the Hazardous Substances and New Organisms (Methodology) Order 1998 (“the

Methodology”).

9.2. I am satisfied with the hazard classifications identified by the staff in Table 1 (Section 4) and

accordingly confer them on Joseph Lyddy Flea Control Deodorising Household Flea Spray.

9.3. I consider that, with controls in place, the risks to human health and to the environment are negligible,

and there will be benefits associated with the release of Joseph Lyddy Flea Control Deodorising

Household Flea Spray. Therefore, I consider that the substance may be approved in accordance with

clause 26, with the controls proposed by the staff and documented in Appendix A.

9.4. The importation of the hazardous substance, Joseph Lyddy Flea Control Deodorising Household Flea

Spray, is thus approved with controls as listed in Appendix A. I am also satisfied that, as the

manufacture of Joseph Lyddy Flea Control Deodorising Household Flea Spray would not impose any

additional risks over the importation of the substance, this approval should apply to both the

importation and manufacture of Joseph Lyddy Flea Control Deodorising Household Flea Spray.

Date: 22 September 2015

Chief Executive, EPA

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Appendix A: Controls applying to Joseph Lyddy Flea Control Deodorising Household Flea Spray

Notes: The controls for this substance apply for the indefinite duration of the approval of this substance.

Please refer to the Hazardous Substances Regulations3 for the requirements prescribed for each control and

the modifications listed as set out in Section 6 of this document.

Table A1: Controls for Joseph Lyddy Flea Control Deodorising Household Flea Spray – codes, regulations and

variations

Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001

Code Regulation Description Variation

F1 Reg 7

General test certification

requirements for hazardous

substance locations

F2 Reg 8

Restrictions on the carriage of

flammable substances on passenger

service vehicles

F3 Reg 55 General limits on flammable

substances

F4 Reg 56

Approved handler/security

requirements for certain flammable

substances

The following regulation is inserted

immediately after regulation 56:

56A Exception to approved handler

requirement for transportation of

packaged pesticides

1) Regulation 56 is deemed to be

complied with if:

a) when this substance is

being transported on land—

i) by rail, the person who

drives the rail vehicle

that is transporting the

substance is fully

trained in accordance

with the approved

safety system for the

time being approved

under section 6D of

the Transport Services

Licensing Act 1989;

and

ii) other than by rail, the

person who drives,

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

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

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loads, and unloads the

vehicle that is

transporting the

substance has a

current dangerous

goods endorsement on

his or her driver

licence; and

iii) in all cases, Land

Transport Rule:

Dangerous Goods

1999 (Rule 45001) is

complied with; or

b) when this substance is

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) when this substance is

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 a 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

managing this substance

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within an aerodrome; but

b) does not apply to—

i) the handling of this

substance in any place

that is not within an

aerodrome; or

ii) the loading and

managing of this

substance for the

purpose of aerial

spraying or dropping.

4) In this regulation, UN Model

Regulations means the 13th

revised edition of the

Recommendation on the

Transport of Dangerous Goods

Model Regulations, published in

2003 by the United Nations

F5 Regs 58, 59

Requirements regarding hazardous

atmosphere zones for class 2.1.1,

2.1.2 and 3.1 substances

F6 Regs 60 – 70

Requirements to prevent unintended

ignition of class 2.1.1, 2.1.2 and 3.1

substances

F11 Reg 76 Segregation of incompatible

substances

F12 Regs 77

Requirement to establish a

hazardous substance locations if

flammable substances are present

F14 Reg 81

Test certification requirements for

facilities where class 2.1.1, 2.1.2 or

3.1 substances are present

F16 Reg 83 Controls on transit depots where

flammable substances are present

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


T1 Regs 11 – 27 Limiting exposure to toxic substances

through the setting of TELs

No TEL, ADE or PDE values are set for

any component of this substance at this

time

T2 Regs 29, 30 Controlling exposure in places of work

through the setting of WESs.

WES values have been set for

Components C and E as detailed in the

Workplace Exposure Standards

document:

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http://www.business.govt.nz/worksafe/info

rmation-guidance/all-guidance-

items/workplace-exposure-standards-and-

biological-exposure-indices/workplace-

exposure-standards-and-biological-

indices-2013.pdf

T4 Reg 7 Requirements for equipment used to

handle substances

T7 Reg 10 Restrictions on the carriage of toxic or

corrosive substances on passenger

service vehicles

E6 Reg 7 Requirements for equipment used to

handle substances

Hazardous Substances (Identification) Regulations 2001


I1 Regs 6, 7, 32 –

35, 36(1) – (7)

Identification requirements, duties of

persons in charge, accessibility,

comprehensibility, clarity and durability

I3 Reg 9 Priority identifiers for ecotoxic substances

I5 Reg 11 Priority identifiers for flammable

substances

I9 Reg 18 Secondary identifiers for all hazardous

substances

I11 Reg 20 Secondary identifiers for ecotoxic

substances

I13 Reg 22 Secondary identifiers for flammable

substances

I16 Reg 25 Secondary identifiers for toxic substances

I19 Regs 29 – 31 Additional information requirements,

including situations where substances are

in multiple packaging

I21 Regs 37 – 39,

47 – 50

General documentation requirements

I23 Reg 41 Specific documentation requirements for

ecotoxic substances


flammable substances








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toxic substances

I29 Regs 51, 52 Signage requirements

Hazardous Substances (Compressed Gas) Regulations 2004


CG The Hazardous Substance (Compressed

Gases) Regulations 2004 prescribe a

number of controls relating to

compressed gases including aerosols

and gas cylinders

Hazardous Substances (Disposal) Regulations 2001


D2 Reg 6 Disposal requirements for flammable

substances

D4 Reg 8 Disposal requirements for toxic and

corrosive substances

D5 Reg 9 Disposal requirements for ecotoxic

substances

D6 Reg 10 Disposal requirements for packages

D7 Regs 11, 12 Information requirements for

manufacturers, importers and suppliers,

and persons in charge

D8 Regs 13, 14 Documentation requirements for

manufacturers, importers and suppliers,

and persons in charge

Hazardous Substances (Emergency Management) Regulations 2001


EM1 Regs 6, 7, 9 –

11

Level 1 information requirements for

suppliers and persons in charge

EM6 Reg 8(e) Information requirements for toxic

substances

EM7 Reg 8(f) Information requirements for ecotoxic

substances

EM8 Regs 12 – 16,

18 – 20

Level 2 information requirements for

suppliers and persons in charge

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EM9 Reg 17 Additional information requirements for

flammable and oxidising substances and

organic peroxides

EM10 Regs 21 – 24 Fire extinguisher requirements

EM11 Regs 25 – 34 Level 3 emergency management

requirements: duties of person in charge,

emergency response plans

EM13 Reg 42 Level 3 emergency management

requirements: signage

Hazardous Substances (Personnel Qualifications) Regulations 2001


AH 1 Regs 4 – 6 Approved Handler requirements (including

test certificate and qualification

requirements)

Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004


Tank

Wagon

Regs 4 to 43

as applicable

Controls relating to tank wagons and

transportable containers

Schedule 10 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances)

Transfer Notice 2004


Sch 10 Schedule 10 This schedule prescribes the controls for

the adverse effects of unintended ignition

of class 2 and 3.1 flammable substances.

The requirements of this schedule are

detailed in the consolidated version of the

Hazardous Substances (Dangerous

Goods and Schedule Toxic Substances)

Transfer Notice 2004, available from

http://www.epa.govt.nz/Publications/Trans

fer-Notice-35-2004.pdf

Additional controls


App Rate 77A A maximum application rate is set for this

substance.

A maximum number of applications is set

for this substance at 12 applications per

year, with a minimum of 30 days between

each application.

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

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

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App

Method

77A A restriction on the application method for

this substance

This substance must only be applied

indoors.

Water 77A A restriction on the application method for

this substance

This substance must not be applied into or onto water4

Label 77A Additional label information has been

specified for this substance.

The following information must be

included on the label for the substance:

Do not exceed 12 applications per year in

the same housing and with a minimum

interval of 30 days between each

application

4 Where ‘water’ means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tanke or cistern or watern used in the dilution of the substance prior to applicat ion or water used to rinse the container after use.

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Appendix B: Staff classification of Joseph Lyddy Flea Control Deodorising Household Flea Spray

Classification was determined using information on the effects of the individual components and mixture

rules. The classification of 9.1D was derived from a comparison to an approved substance with a similar

composition, HSR000684, ‘Flammable aerosol containing 0.25 g/kg imidacloprid’.

The mixture rules used for classifying substances can be found in the User Guide to Thresholds and

Classifications5.

The classifications of Joseph Lyddy Flea Control Deodorising Household Flea Spray are shown in Table B1.

Data quality – overall evaluation

The EPA has adopted the Klimisch et al (1997)6 data reliability scoring system for evaluating data used in the

hazard classification and risk assessment of chemicals.

The staff acknowledge that there are frequently data gaps in the hazard classification for chemicals which

have been in use internationally for a long time. International programmes such as the OECD High

Production Volume programme7, REACH8, and European Regulation 1107/2009/EC9 are progressively

working towards filling these data gaps. As new information becomes available, staff will update the

Hazardous Substances and New Organisms (HSNO) classifications for those substances.

Table B1: Summary of the applicant’s and staff’s hazard classification

Hazard Class/Subclass

Mixture classification Method of

classification

Remarks Applicant’s

classification

Staff’s

classification

Mix

ture

data

Read

acro

ss

Mix

ture

rule

s1

0

Class 1 Explosiveness No ND

Class 2, 3 & 4 Flammability 2.1 2.1.2A Flammable

aerosol

Class 5 Oxidisers/Organic

Peroxides No ND

Subclass 8.1 Metallic

corrosiveness No ND

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

6 Klimisch, H-J., Andrear, M., & U. Tillmann, 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Reg. Toxicol. Pharmacol. 25, 1–5 (1997) 7 http://www.icca-chem.org/Home/ICCA-initiatives/High-production-volume-chemicals-initiative-HPV/ 8 http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm 9 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF 10 Use of mixture rules may not adequately take into account interactions between different components in some circumstances and must be considered of lower reliability than data on the mixture itself.

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



http://www.icca-chem.org/Home/ICCA-initiatives/High-production-volume-chemicals-initiative-HPV/

http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF

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classification


classification

Staff’s

classification

Mix

ture

data

Read

acro

ss

Mix

ture

rule

s1

0

Subclass 6.1 Acute toxicity (oral) No ND

Subclass 6.1Acute toxicity

(dermal) No ND

Subclass 6.1 Acute toxicity

(inhalation) No ND

Subclass 6.1 Aspiration hazard No ND

Subclass 6.3/8.2 Skin

irritancy/corrosion No ND

Subclass 6.4/8.3 Eye

irritancy/corrosion No 6.4A

Based on

component C

Subclass 6.5A Respiratory

sensitisation No ND

Subclass 6.5B Contact

sensitisation No ND

Subclass 6.6 Mutagenicity No ND

Subclass 6.7 Carcinogenicity No ND

Subclass 6.8 Reproductive/

developmental toxicity No ND

Subclass 6.8 Reproductive/

developmental toxicity (via

lactation)

No ND

Subclass 6.9 Target organ

systemic toxicity No ND

Subclass 9.1 Aquatic ecotoxicity No 9.1D

Read-across

comparison with

approval number

HSR000684

‘Flammable

aerosol containing

0.25 g/kg

imidacloprid’

Subclass 9.2 Soil ecotoxicity No ND

Subclass 9.3 Terrestrial

vertebrate ecotoxicity No ND

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classification


classification

Staff’s

classification

Mix

ture

data

Read

acro

ss

Mix

ture

rule

s1

0

Subclass 9.4 Terrestrial

invertebrate ecotoxicity No 9.4B Imidacloprid

No: No information provided by the applicant

ND: No Data or poor quality data (according to Klimisch criteria11

) --> There is a lack of data for one or more components

11 Klimisch, H-J., Andrear, M., & U. Tillmann, 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Reg. Toxicol. Pharmacol. 25, 1–5 (1997)

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Appendix C: Staff risk and benefit assessment

The staff have evaluated the potential of Joseph Lyddy Flea Control Deodorising Household Flea Spray to

cause adverse effects to during all stages of the substance’s lifecycle. A qualitative risk assessment was

carried out to assess these risks.

The process by which the risk assessment of substances is undertaken is specified in the Methodology.

Guidance on risk assessment is provided on the EPA website.

To facilitate the assessment of risks the applicant and the staff identified the most common potential sources

of risk to the environment and to human health and safety through release, spillage or exposure throughout

the lifecycle of the substance. These are tabulated in Table C1.

Table C1: Potential sources of risks associated with hazardous substances

Lifecycle Activity Associated Source of Risk

Manufacture* / Import An incident during the manufacture or importation of the substance

resulting in spillage and subsequent exposure of people or the

environment to the substance.

Packing* An incident during the packing of the substance resulting in spillage

and subsequent exposure of people or the environment to the

substance.

Transport or storage An incident during the transport or storage of the substance

resulting in spillage and subsequent exposure of people or the

environment to the substance.

Use Application of the substance resulting in exposure of users or

bystanders or the environment; or an incident during use resulting

in spillage and subsequent exposure of users or the environment to

the substance.

Disposal Disposal of the substance or packaging resulting in exposure of

people or the environment to the substance.

* The applicant intends to import (not manufacture) Joseph Lyddy Flea Control Deodorising Household Flea

Spray. However, it is possible that the substance could be manufactured in New Zealand in the future.

Consequently, the risks associated with the manufacture of Joseph Lyddy Flea Control Deodorising Household

Flea Spray have been evaluated so the approval of this substance will be applicable to both the import and

manufacture Joseph Lyddy Flea Control Deodorising Household Flea Spray.

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Appendix D: Human health risk assessment

Quantitative worker (operator) risk assessment

Critical endpoint definition

Has an AOEL already been set by an internationally reputable regulatory authority accepted by EPA?

Yes No

Using an existing AOEL for imidacloprid12

Available

AOELs

Key systemic

effect

NOAEL

mg/kg

bw/day

Uncertainty

factors

AOEL

mg/kg

bw/day

Staff’s

modifications Remarks

EPA (NZ)

Neurotoxicity in

acute and 90

day rat studies.

8 100 0.08 None

Used in HSNO

approvals

HSR100355,

HSR100431

and

HSR100720

EFSA 2 year rat

study.

5.7

(rounded) 100 0.06 None

EFSA applied

the ADI to the

AOEL (see

comment

below).

The previous EPA AOEL was based on the earlier EFSA value. The concluding remarks in the

latest EFSA report (2013) on imidacloprid are: “As the current ARfD and AOEL may not be

protective enough for potential developmental neurotoxicity of imidacloprid, the Panel also

recommends to conservatively lowering these reference values to the same level as the ADI (0.06

mg/kg bw per day). (EFSA, 2013: http://www.efsa.europa.eu/en/search/doc/3471.pdf). EPA staff

has therefore used an AOEL of 0.06 mg/kg bw/day.

12

The toxicological endpoint used for assessment of occupational (worker), re-entry worker and bystander risks is the AOEL (Acceptable Operator Exposure Level). The AOEL is the maximum amount of active substance to which the operator/re-entry worker may be exposed with a low probability of adverse health effects amongst the healthy worker sub-population, allowing for some margin of safety. AOELs describe the internal (absorbed) dose available for systemic distribution from any route of absorption and are expressed as internal (systemic) levels (mg/kg bw/day). They are derived by dividing the most appropriate NOAEL from relevant studies by one or more uncertainty (safety) factors selected on the basis of the extent and quality of the available data, the species for which data are available and the nature of the effects observed. An absorption factor may be applied to take into account the absorbed dose in the study where this is known (this is a percentage expressed as a factor);

http://www.efsa.europa.eu/en/search/doc/3471.pdf

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Other inputs for exposure modelling

Derivation of dermal absorption value in humans

Active Physical

form

Concentration

of each active

(g/L or g/kg)

Maximum

application rate

(for each active, for

each method of

application)

mg a.i./m2

Dermal absorption

(%) AOEL

mg/kg

bw/day Concentrate Spray

Imidacloprid Aerosol 0.25g/kg

2.2 mg

imidacloprid/m2 based

on the use of the

whole spray can 300

g to treat 35 m2.

(See GAP table)

N/A 75% 0.06

EPA staff used the ConsExpo model13 to estimate the exposure of the applicator and a child post-exposure

crawling on treated carpet in a lounge room. ConsExpo is a consumer exposure model developed by the

RIVM (National Institute for Public Health and the Environment, Netherlands). The model includes an

exposure scenario for indoor spray using an aerosol for application onto surfaces which is appropriate for the

proposed use. The dermal absorption of 75% is based on the EFSA guidance (EFSA, 2012:

http://www.efsa.europa.eu/en/efsajournal/doc/2665.pdf, p17) was used for the dermal uptake fraction. The

other input parameters for ConsExpo are described and listed below with an explanation when values

different from the ConsExpo default values have been used.

The application rate mg imidacloprid per m2 is not required for the modelling, but the estimated value is

provided in the table above as it gives an indication of the low concentration of active applied to the treated

indoor surface.

Other inputs for the exposure modelling: Operator application for 4 hours

Model Parameter Value (default*/non default#) Comment

Aerosol

spray can

Frequency 12 d/yr# EPA staff used 12/year to

reflect the monthly use of the

product.

Use (spray)

duration

10 min*

Body weight 60 kg# EPA Staff used 60kg for the

13 http://www.rivm.nl/en/Topics/C/ConsExpo

http://www.efsa.europa.eu/en/efsajournal/doc/2665.pdf

http://www.rivm.nl/en/Topics/C/ConsExpo

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consumer rather than the

default of 65kg from

ConsExpo.

Inhalation exposure

Spray model Mass

generation rate

0.75 g/sec*

Exposure

duration

4 h (240 min)*

Airborne

fraction

100%*

Density non-

volatile

1.8*

Room volume 58 m3* This is the room volume for

a lounge.

Room height 2.5 m*

Weight fraction

non-volatile

0.00026# Based on the concentration

of imidacloprid in the

substance, 0.026% (as a

fraction).

Ventilation rate 0.5 hr-1

*

Median initial

particle

distribution

(CV)^

25 µm (0.4)* Lognormal distribution as

per ConsExpo guidance for

an aerosol for surface

application.

Inhalation cut-

off diameter

15 µm*

Inhalation uptake

Uptake fraction 1*

Inhalation rate 32.9 m2/day* This is the value for light

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exercise.

Non-respirable (Oral) uptake

Direct intake

model

Oral uptake

fraction

1* (100% absorption)

Exposure time 1 h*

Dermal direct product contact

Exposed area Not applicable

Dermal loading Applied to skin at constant

rate

Weight fraction

compound




fraction).

Contact rate 100 mg/min

Release

duration

10 minutes

Uptake fraction 0.75

Outcome of exposure modelling

The results of the exposure assessment for a consumer applying the product are presented below for active

ingredient. Estimated exposures are divided by the AOEL to derive Risk Quotient (RQ) values. An RQ value

of > 1 indicates that exposure is above the AOEL.

Imidacloprid – Risk to a person applying the substance to surface (carpet) and pet bedding for 4 hours

Route of exposure Acute (internal) dose

(mg/kg bw)

Chronic (internal) dose

(mg/kg bw/day)

Inhalation 0.000358 1.18 x 10-5

Dermal 0.00325 0.000107

Oral 0.000904 2.97 x 10-5

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Integrated exposure 0.00451 0.000148

Risk quotient 0.0075 0.0025

Outcomes of the user exposure assessment

The estimated exposure for an operator applying the substance is below the level of concern.

Post-application – child exposure to treated carpet

Critical endpoints definition

The AOEL derived for used above is also used for the post application exposure assessment calculations.

Other inputs for the exposure modelling: Post-application (child on treated carpet)

Model Parameter Value (default*

/ non default#)

Comments

Aerosol

spray can

Frequency 168/yr# Frequency of the exposure

- not the use. The

frequency of exposure

assumes use monthly and

14 days exposure per

application (14 x 12 = 168).

Use (spray)

duration

10 min*

Body weight 8.69 kg* The child is assumed to be

10.5 months of age, a

toddler.

Dermal exposure following application

Rubbing off

model

Transfer

coefficient

0.18 m2/h

# This value is based on a

more recent US EPA value.

Dislodgeable

amount

6.1 g/m2

Contact time 1 h*

Rubbed

surface

22 m2*

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Model Parameter Value (default*

/ non default#)

Comments

Exposed area

of skin

1170 cm2*

Weight fraction

compound




fraction).

Uptake fraction 0.75

Oral exposure following application

Direct intake

model

Ingestion rate 0.0286 mg See explanation of

calculation below$

Exposure time 1 hr*

$The total external dermal exposure to imidacloprid in the surface treatment scenario (determined from ConsExpo) was 0.0329 mg/kg

bw/day for the 8.69 kg child. This provides a total external dermal exposure of 0.286 mg (0.0329 x 8.69). ConsExpo assumes half of the

hand exposure of 20%, ie 10% of this is available for hand to mouth activity in a 1 hour period, so the oral dose is 0.0286 mg.

The results of the exposure assessment for exposure of a child to the treated carpet in a lounge are

presented below for imidacloprid, the active ingredient. Estimated exposures are divided by the AOEL to

derive Risk Quotient (RQ) values. An RQ value of > 1 indicates that exposure is above the AOEL.

Imidacloprid – Post application exposure of a child to treated carpet

Route of

exposure

Acute (internal)

dose

(mg/kg bw)

Chronic

(internal) dose

(mg/kg bw/day)

Dermal* 0.0246 0.0112

Oral 0.0000513 0.0000233

Integrated

exposure 0.0247 0.0112

Risk quotient 0.41 0.19

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* The dermal exposure value calculated by model should in theory be reduced by 10% to account for 10% of the external dermal

exposure being taken in by the oral route, but since the overall estimate was acceptable this adjustment was not performed.

EPA staff note that the assumption is that the child is not exposed during the application phase. Staff not that

the product only triggers a 6.4A classification in relation to human health hazards and assumes that the user

will keep the product out of reach of children, as is appropriate for all pesticides.

Outcomes of post-application child exposure to treated carpet

The risks to child from post-application exposure to a treated carpet for 14 days with 12 applications per year

are below the level of concern.

Summary and conclusions of the human health risk assessment

The estimated risk to a user from the application of Joseph Lyddy Flea Control Deodorising Household Flea

Spray indoors to carpet and pet bedding is estimated as being acceptable in comparison to the AOEL for

imidacloprid. The estimated risks of exposure for a child crawling on a carpet treated with Joseph Lyddy Flea

Control Deodorising Household Flea Spray regularly for 14 days after each monthly treatment were also

estimated to be acceptable.

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Appendix E: Confidential Information

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Appendix F: Standard terms and abbreviations

ai active ingredient

ALD50 approximate median lethal dose, 50%

AOEL acceptable operator exposure level

ARfD acute reference dose

as active substance

BCF bioconcentration factor

bfa body fluid assay

BOD biological oxygen demand

BSAF biota-sediment accumulation factor

bw body weight

c centi- (x10-2

)

CA controlled atmosphere

CI confidence interval

CL confidence limits

CNS central nervous system

COD chemical oxygen demand

DFR dislodgeable foliar residue

DO dissolved oxygen

DOC dissolved organic carbon

DT50 period required for 50 percent

dissipation (define method of

estimation)

DT90 period required for 90 percent

dissipation (define method of

estimation)

dw dry weight

ED50 median effective dose

ERC environmentally relevant

concentration

F field

F0 parental generation

F1 filial generation, first

F2 filial generation, second

fp freezing point

G glasshouse

GAP good agricultural practice

GC gas chromatography

GC-EC gas chromatography with electron

capture detector

GC-FID gas chromatography with flame

ionization detector

GC-MS gas chromatography-mass

spectrometry

GC-MSD gas chromatography with mass-

selective detection

GLC gas liquid chromatography

GLP good laboratory practice

GM geometric mean

H Henry’s Law constant (calculated as a

unitless value) (see also K)

ha hectare

Hb haemoglobin

HCG human chorionic gonadotropin

Hct haematocrit

HPLC high pressure liquid chromatography

or high performance liquid

chromatography

HPLC-MS high pressure liquid chromatography -

mass spectrometry

I indoor

I50 inhibitory dose, 50%

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IC50 median immobilization concentration

or median inhibitory concentration 6

ID ionization detector

Im intramuscular

inh inhalation

ip intraperitoneal

IPM integrated pest management

iv intravenous

IVF in vitro fertilization

K Kelvin or Henry’s Law constant (in

atmospheres per cubic meter per

mole) (see also H)

Kads adsorption constant

Kdes apparent desorption coefficient

Koc organic carbon adsorption coefficient

Kom organic matter adsorption coefficient

kg kilogram

LC liquid chromatography

LC-MS liquid chromatography- mass

spectrometry

LC50 lethal concentration, median

LCA life cycle analysis

LC-MS-MS liquid chromatography with tandem

mass spectrometry

LD50 lethal dose, median; dosis letalis

media

LDH lactate dehydrogenase

LOAEC lowest observable adverse effect

concentration

LOAEL lowest observable adverse effect

level

LOD limit of detection

LOEC lowest observable effect

concentration

LOEL lowest observable effect level

LOQ limit of quantification (determination)

LPLC low pressure liquid chromatography

LSC liquid scintillation counting or counter

LSS liquid scintillation spectrometry

LT lethal threshold

M molar

μm micrometer (micron)

MDL method detection limit

MFO mixed function oxidase

μg microgram

MLT median lethal time

MLD median lethal dose

mol Mole(s)

MOS margin of safety

mp melting point

MS mass spectrometry

MSDS material safety data sheet

NAEL no adverse effect level

nd not detected

NEL no effect level

ng nanogram

nm nanometer

NOAEC no observed adverse effect

concentration

NOAEL no observed adverse effect level

NOEC no observed effect concentration

NOEL no observed effect level

NR not reported

OC organic carbon content

ODP ozone-depleting potential

OM organic matter content

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Pa pascal

PEC predicted environmental

concentration

PECS predicted environmental

concentration in soil

PECSW predicted environmental

concentration in surface water

PECGW predicted environmental

concentration in ground water

PHI pre-harvest interval

pKa negative logarithm (to the base 10) of

the dissociation constant)

PNEC predicted no effect concentration

POW partition coefficient between n-octanol

and water

ppb parts per billion (10-9

)

PPE personal protective equipment

ppm parts per million (10-6

)

ppp plant protection product

ppq parts per quadrillion (10-24

)

ppt parts per trillion (10-12

)

PTDI provisional tolerable daily intake

r correlation coefficient

r2 coefficient of determination

REI restricted entry interval

Rf retardation factor

RfD reference dose

RL50 median residual lifetime

RP reversed phase

RRT relative retention time

RSD relative standard deviation

sc subcutaneous

SD standard deviation

se standard error

SF safety factor

SIMS secondary ion mass spectroscopy

SOP standard operating procedures

sp species (only after a generic name)

SPE solid phase extraction

spp subspecies

SSD sulphur specific detector

STEL short term exposure limit

t½ half-life (define method of estimation)

TCLo toxic concentration, low

TER toxicity exposure ratio

TIFF tag image file format

TOC total organic carbon

TWA time weighted average

UF uncertainty factor (safety factor)

ULV ultra low volume

UV ultraviolet

v/v volume ratio (volume per volume)

w/v weight per volume

ww wet weight

w/w weight per weight

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