of the Hazardous Substances and New Organisms Act 1996

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Application for the Reassessment of a Hazardous Substance under Section 63

of the Hazardous Substances and New Organisms Act 1996

Name of Substance(s):

Trichlorfon

Application Number:

HRC08005

Applicant:

Chief Executive ERMA New Zealand

July 2010

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EXECUTIVE SUMMARY

Key Issues

The application

This application is made by the Chief Executive of ERMA New Zealand for the reassessment under the Hazardous Substances and New Organisms Act 1996 of trichlorfon and of products containing trichlorfon. Following a submission and hearing process, the Environmental Risk Management Authority will make a decision on the future use of trichlorfon in New Zealand.

The Authority’s decision will be based on whether or not the positive effects (benefits) of using trichlorfon outweigh the negative effects (risks and costs) of its use – after taking account of all controls that might be imposed and the likely effects of the substance being unavailable.

If the benefits outweigh the risks and costs, the Authority may approve the continued use of trichlorfon in New Zealand for some or all of its current uses (possibly with stricter controls or with further restrictions on use). If the benefits do not outweigh the risks or costs then the Authority may decide to revoke the approval for substances containing trichlorfon.

To assist in preparing this application, ERMA New Zealand has obtained information from a variety of sources both in New Zealand and overseas. In particular, information from the following sources has proven to be of considerable assistance in preparing this application:

Bayer New Zealand Limited;

Egg Producer's Federation of New Zealand;

Federated Farmers of New Zealand;

Foundation of Arable research (FAR);

Horticulture New Zealand;

New Zealand Equine Veterinary Association;

New Zealand Feed Manufacturer's Association;

New Zealand Pork Industry Board;

New Zealand Salmon Farmers Association;

Plant and Food Research;

The Poultry Industry Association of New Zealand;

Zelam Limited.

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Precautionary approach

In the absence of New Zealand-specific exposure data, the assessment largely uses environmental and human health models to estimate exposure. These models use conservative assumptions and may overestimate risks.

This precautionary approach is consistent with the requirements of the HSNO Act and regulations. These provide that where there is scientific and technical uncertainty, the Authority must consider the materiality of the uncertainty and if the uncertainty cannot be resolved to its satisfaction, must take into account the need for caution in managing the adverse effects of the substance.

Use of trichlorfon in New Zealand

Formulations containing trichlorfon have been registered for use in New Zealand since 1968.

In New Zealand trichlorfon is used as shown in Table ES1 and Table ES2.

Table ES1: Summary of use of trichlorfon as a plant protection product in New Zealand

Used on: To control:

Cereal, Pasture Grass Seed

Army Caterpillar

Maize Sweetcorn

Corn Earworm Brassicas

Tomatoes

Cutworm

Brassicas Diamond-back Moth Beans

Tomatoes

Green Vegetable Bug

Pasture Porina

Tomatoes Tomato Fruit Worm Brassicas White Butterfly

Table ES2: Summary of use of trichlorfon as a veterinary medicine product in New Zealand

Used on: To control:

Horse Bots (Gastrophilus spp.) and Ascarids Sheep Oestrus ovis (Nasal Bots)

Haemonchus

Pigs Roundworms (Ascarids)

Whipworms (Trichuris suis) Lice

Haematopinus suis Sarcoptic mange Sarcoptes scabiei

Poultry Lice

Red Mites

Dermanyssus gallinae

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The use of trichlorfon in plant protection or veterinary medicine products in New Zealand is currently low. Exact sales volume data are unavailable for the plant protection product but the sales situation has been reported by Plant & Food Research. Approximately 30 kg of the veterinary medicine is sold annually. One trichlorfon-containing product is registered with ACVM for use in New Zealand as a plant protection product, and another trichlorfon- containing product is registered by ACVM for use as a veterinary medicine.

In preparing this application, the responses from importers, manufacturers, and some users have indicated that they only wish to support the continuing approval of trichlorfon for use as a veterinary medicine.

Classification

As a result of the review of effects performed as part of this reassessment, trichlorfon and trichlorfon-containing substances are classified as in Table ES3 and Table ES4 respectively (see Appendix D and Appendix G for details):

Table ES3: Classification and summary of proposed changes to the hazard classifications of trichlorfon.

Hazard Class

Trichlorfon (Approval # HSR002885) Existing

classification

Proposed revised classification

Acute toxicity (oral) 6.1C 6.1C

Acute toxicity (dermal) 6.1D 6.1E

Acute toxicity (inhalation) 6.1D 6.1D

Eye irritancy/corrosion 6.4A 6.4A

Contact sensitisation 6.5B 6.5B

Mutagenicity 6.6B 6.6B

Carcinogenicity 6.7B 6.7B

Reproductive/developmental effects 6.8B No

Target organ systemic toxicity 6.9A 6.9A

Aquatic ecotoxicity 9.1A 9.1A

Soil ecotoxicity 9.2B 9.2B

Terrestrial vertebrate ecotoxicity 9.3A 9.3A

Terrestrial invertebrate ecotoxicity 9.4C 9.4B

The classifications of registered formulations of trichlorfon proposed in this reassessment are as follows:

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Table ES4: Summary of proposed changes to the hazard classifications of registered trichlorfon-containing substances.

Hazard Class/Subclass

Emulsion (oil in water) containing 500 g/litre

trichlorfon

Emulsifiable concentrate (micro emulsion) containing 20 g/litre cypermethrin and

400 g/litre trichlorfon

Solid containing 950-990 g/kg trichlorfon

(Approval # HSR000204) (Approval # HSR000205) (Approval # HSR001951) Existing

classification

Existing classification

Flammability 3.1D 3.1D 3.1D 3.1D No No

Acute toxicity (oral) 6.1C 6.1D 6.1C 6.1C 6.1C 6.1C

Acute toxicity (dermal)

6.1E No 6.1E No 6.1D 6.1E

Acute toxicity (inhalation)

6.1D 6.1D No No 6.1D 6.1D

Eye

irritancy/corrosion

6.4A 6.4A 6.4A 6.4A 6.4A 6.4A

Contact sensitisation 6.5B 6.5B 6.5B 6.5B 6.5B 6.5B

Mutagenicity 6.6B 6.6B 6.6B 6.6B 6.6B 6.6B

Carcinogenicity ND 6.7B ND 6.7B ND 6.7B

Reproductive/develop mental toxicity

6.8B No 6.8B 6.8B 6.8B No

Target organ systemic toxicity

6.9A 6.9A 6.9A 6.9A 6.9A 6.9A

Aquatic ecotoxicity 9.1A 9.1A 9.1A 9.1A 9.1A 9.1A

Soil ecotoxicity 9.2B 9.2B 9.2B 9.2B 9.2B 9.2B

Terrestrial vertebrate ecotoxicity

9.3A 9.3A 9.3A 9.3A 9.3A 9.3A

Terrestrial invertebrate ecotoxicity

9.4C 9.4B 9.4A 9.4A 9.4C 9.4B

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Overseas regulatory status of trichlorfon

As summarised in the table below, trichlorfon products have been reviewed in a number of countries. These reviews have resulted in restrictions, prohibitions or voluntary removal from the market.

Table ES5: Summary of overseas regulatory reviews

Country Review Outcome

Australia Trichlorfon is prioritised for review (priority 1), but no review is currently available.

United States Restricted the use of trichlorfon to non-food uses (1997).

Mitigation measures to minimise risks to handlers and workers (2006):

Prohibit broadcast treatment to golf course fairways; spot treatment to fairways is permitted.

Require 7-day application interval for application to turf, and limit applications to no more than 3 per calendar year Require applicators to use a truck-drawn spray rig for ornamental fish and bait ponds over 1 acre.

Prohibit foliar application to ornamentals; allow only direct soil spray application to base of plant.

The registrant voluntarily cancelled hand treatment of home perimeter and ant mounds to reduce risks to homeowners.

Mitigation measures to minimize environmental risks (1995):

To reduce risks to avian and aquatic species exposed to trichlorfon when applied to turf sites;

- prohibition of aerial application, prohibition of residential lawn use with bait;

- formulations, buffer strips from aquatic habitats, mandatory watering-in to reduce potential run-off to aquatic habitats as well as reduce exposure to avian species through ingestion of granules or vegetative residues.

To reduce risks to aquatic life,

- mandatory watering-in for turf and golf courses - buffer strips from aquatic habits to minimize any run-

off that could occur after the watering-in.

- reduced usage through eliminating sod farm and food/feed uses

To reduce reproductive concerns for avian species (specifically, impaired egg shell thickness) exposed to trichlorfon from turf applications:

- timing of application should reduce this risk since the period of egg formation is the early Spring but the most efficacious application time of trichlorfon is late Spring to early Summer.

Canada Mitigation measures to minimize risks to human health:

Residential uses of trichlorfon, including municipal parks, are

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proposed for phase-out (by-stander risks);

Proposed for phase-out of use on outdoor ornamentals unless additional data to refine the occupational exposure assessment are received;

Proposed phase out the aerial application of trichlorfon unless additional information is received to refine the assessment and/or mitigate environmental risks.

Europe Trichlorfon not included in Annex 1, and trichlorfon-containing formulations withdrawn, with existing stocks used by November 2008.

Risks, costs and benefits of use in New Zealand

The assessment of the risks, costs and benefits of the use of trichlorfon in New Zealand is based on the following use scenarios:

Table ES6: Use scenarios evaluated in this application

Use

Scenario Application rate/assumptions

Pasture 1 1200 g a.i. / ha, 1 time per year, low boom.

Vegetables, cereals 2 1800 g a.i. / ha, 1 time per year, high boom.

Vegetables, cereals 3 1800 g a.i. / ha, 2 times per year, high boom, 7 day interval.

Vegetables 4 1800 g a.i. / ha, 1 time per year, bait application.

Horses 5 0.032 g a.i./kg bodyweight

(24 g/animalbased on 750kg animal weight), drench application.

Sheep 6 0.076-0.0805 g a.i. /kg body weight. (0.97-3.6 g/animal based on 45 kg animal weight), drench application.

Pigs 7 0.054 g a.i. /kg bodyweight (5.4 g/animal based on 100 kg animal weight), in-feed application.

8 208 g/ 1000 m² (topical spray).

Poultry, poultry houses

9 208 g/ 1000 m² (topical spray).

Risks and benefits to the environment and human health

ERMA New Zealand did not identify any beneficial effects to the environment or human health from the use of trichlorfon.

ERMA New Zealand’s interim evaluation indicates that there are significant (non-negligible) risks associated with the use of trichlorfon as a plant protection product or veterinary

medicine in New Zealand, which outweigh the benefits, and are detailed in Table ES7:

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Table ES7: Sources of non-negligible risk arising from use of trichlorfon

Source of unacceptable exposure Details Use Scenario

(refer to Table ES.6)

Plant protection

Aquatic environment

1 Risks to crustacea from single application.

2 Risks to crustacea from single application.

3 Risks to fish and crustacea from multiple applications.

Ground water 2 Risks from single application on vegetables or cereals.

3 Risks from multiple application on vegetables or cereals.

Exposure of birds 1-4 Risks to birds to be reduced/refined Soil-dwelling

invertebrates

1-3 Risks posed within the application area Terrestrials

invertebrates

1 Risk to bees from single application on pasture to be reduced/refined.

2 Risk to bees from single application on vegetables or cereals to be reduced/refined.

1 Risks to other terrestrial invertebrates from single application on pasture.

2, 4 Risks to other terrestrial invertebrates from single application on

vegetables/cereal.

3 Risks to other terrestrial invertebrates from multiple applications on

vegetables/cereal.

Operator exposure 1-4 Risks to health of operator during mixing, loading,

application if PPE requirements are not met.

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1-3 Risks to health of operator during mixing, loading,

application if PPE requirements are not met.

Bystander exposure

4 Risks to health of children if exposed to baits

Veterinary medicine

Operator exposure 5-7 Risks to health of operator during mixing, loading, application of drenches or feed treatment if PPE requirements are not met.

7, 8 Risks to health of operator during application of spray onto pigs or poultry if PPE

requirements are not met.

9 Risks to health of operator during application of spray to animal houses if PPE

requirements are not met.

5-7 Risks to health of operator by re-entry, following mixing, loading or application of drenches or feed treatment if PPE requirements are not met.

8, 9 Risks to health of operator by re-entry following topical treatment of pig or poultry if PPE requirements are not met.

9 Risks to health of operator by re-entry into sprayed animal houses if PPE requirements are not met.

The risks to consumers exposed to trichlorfon residues in food have not been considered by ERMA New Zealand in this reassessment. Dietary exposures and risks are evaluated by the New Zealand Food Safety Authority under the Food Act 1981.

ERMA New Zealand has identified alternative products that are based on different active ingredients for all of the label use patterns of trichlorfon as both a plant protection product and a veterinary medicine. The alternatives present a range of hazard classifications, some of lower, some of greater hazard than trichlorfon. Hazard assessment is not an indication of the risk posed by a substance, since exposure is not taken into account, but can be used as an indicator of potential to cause effects.

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Risks and benefits to society and communities

ERMA New Zealand’s interim evaluation indicates that:

no reports of adverse effects have been identified by ERMA New Zealand;

no potentially significant benefits have been identified by ERMA New Zealand.

Risks and benefits to the market economy

The review of the risks and benefits to the New Zealand market economy concludes that:

there are no potentially significant adverse or positive effects on the market economy from the continued availability and use of trichlorfon;

trichlorfon provides a treatment for lice and red mites on poultry, for which industry has indicated there is no alternative treatment, though the level of current usage is low and providing negligible benefits.

Relationship of Māori to the environment

In preparing this application, ERMA New Zealand has not conducted a specific Māori consultation but the impression gained from a hui with iwi/Māori resource managers is that unless substances provide clear benefits to outweigh potential risk, they generally oppose the ongoing use of hazardous substances. In the absence of further information regarding

benefits, it is expected that submissions from Māori would seek the revocation of the approvals for trichlorfon and its formulations.

Overall evaluation

ERMA NZ concludes that, with current controls in place, the risks from the use of trichlorfon as a plant protection product are non-negligible for the aquatic environment, birds, bees / non-target invertebrates, re-entry by operators and to by-standers.

ERMA NZ concludes that, with current controls in place, the risks from the use of trichlorfon as a veterinary medicines are non-negligible to operators from spray application and

subsequent re-entry.

In making this overall evaluation, ERMA New Zealand has identified the following data gaps, with respect to use of trichlorfon as a plant protection product:

risks to aquatic plants;

risks to sediment-dwelling organisms;

risks to soil dwelling organisms;

risks to operators from re-entry into treated crops;

risks to bystanders from spray-drift exposure;

the absence of data to be able to carry out refined (higher tier) modelling for the risks posed to birds;

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the absence of data to be able to carry out refined (higher tier) modelling for the risks posed to non-target organisms

In making this overall evaluation, ERMA New Zealand has identified the following data gaps, with respect to use of trichlorfon as a veterinary medicine:

human exposure to exposure through use of trichlorfon as a veterinary medicine for topical application to pigs or poultry, and subsequent re-entry.

ERMA New Zealand considers that the non-negligible risks to the environment cannot be reduced to negligible by the application of practicable additional controls to the existing approvals (Table ES8); the non-negligible risks to human health can be reduced to negligible by the application of practicable controls to the existing approvals.

ERMA New Zealand considers that the non-negligible risks to human health arising from use as a veterinary medicine can be reduced to negligible by the application of additional controls to the existing approvals (Table ES8).

Table ES8: Comparison of non-negligible effects for the available approval scenarios evaluated in this application

Assessment of Effect

Outcome Scenario

(a)

(continued use)

(b)

(restricted use/addition

al controls)

Outcome Scenario (c)

(discontinued use)

Use Scenario 1

Adverse (-ve) Non-

negligible

Non- negligible

None Positive (+ve) Negligible Negligible None

Overall -ve > +ve -ve > +ve 

Adverse (-ve) Non-

negligible

Non- negligible

Adverse (-ve) Non-

negligible

Non- negligible

Adverse (-ve) Non-

negligible

Non- negligible

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Assessment of Effect

(a)

(continued use)

(b)

(restricted use/addition

al controls)

Outcome Scenario (c)

(discontinued use)

Adverse (-ve) Negligible Negligible None Positive (+ve) Negligible Negligible None

Overall -ve ≤ +ve -ve ≤ +ve

^‡

Adverse (-ve) Non-

negligible

Non- negligible

Adverse (-ve) Non-

negligible

Negligible None Positive (+ve) Negligible Negligible None

Overall -ve > +ve -ve ≤ +ve

^‡* *

 Proposed Outcome Scenario

‡

*

It is proposed that PPE requirements are varied to be more prescriptive.

Spray application onto poultry houses is proposed to be continued;

spray application onto poultry or pigs proposed to be prohibited.

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Preliminary recommendations

The recommendations set out below are preliminary only. An important part of the reassessment process is public submissions on the application. The impact of any public submissions on these recommendations will be assessed and considered alongside the application.

ERMA New Zealand proposes the following preliminary recommendations to ensure that the risk for people and the environment is minimised:

Plant protection usage (Use Scenarios 1-4) shall be removed (Outcome Scenario (c)), on the basis that:

- certain risks posed to the environment from plant protection usage cannot be practicably managed;

- uncertainty regarding the risks posed to operators from re-entry into treated crops cannot be practicably managed;

- there is little demand for trichlorfon-containing plant protection products;

- there is a range of alternative products available for all of the plant protection label uses;

- trichlorfon does not provide any significant level of benefit;

- the adverse effects outweigh positive effects.

Some veterinary medicine uses should continue (Use Scenarios 5, 6, 7, 9 (spray application to poultry houses)) but with additional controls imposed (Outcome Scenario (b)):

- the Personal Protective Equipment (PPE) requirements for the retained uses, while adequate to ensure insignificant exposure, should be prescriptive and required to be detailed on the label, and included as a variation to the PPE requirements for use as a veterinary medicine, as non-compliance could result in severe consequences;

- use of trichlorfon-containing veterinary medicines is retained for use as a spray for the treatment of poultry housing, but use is restricted to empty poultry houses;

- a control is proposed to only permit re-entry into treated poultry houses after the treated surfaces have dried.

Use of trichlorfon-containing veterinary medicines for use as a spray treatment to animals (Use Scenario 8, 9 (spray application to poultry)) is removed (Outcome Scenario (c)) for the following reasons:

- appropriate PPE requirements have not been determined because of

uncertainty surrounding its use as a topical treatment for pigs and poultry;

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- qualitative assessment of the risks posed from this particular use indicate a low-medium level of risk;

- information received from users indicates negligible usage for that purpose, with negligible level of benefit.

The controls that apply to the approval for trichlorfon (HSR002885) should be varied to include a restriction for use only in veterinary medicines.

Based on these recommendations ERMA New Zealand proposes that:

approvals for trichlorfon-containing plant protection substances (HSR000204, HSR000205) shall be revoked;

approvals for trichlorfon-containing veterinary medicines (HSR001951) shall be amended to include the proposed controls;

the approval for trichlorfon (HSR002885) shall be amended to include the proposed control to restrict use to as a component in veterinary medicines.

Submissions

Submissions are now invited on the appropriateness or workability of the above recommendations. In particular, ERMA New Zealand would like information on the following:

information they might have on the social aspects of use of trichlorfon as a plant protection product as well as any additional social effects from the use of trichlorfon;

data to allow refined, higher tier environmental assessments to be undertaken for the risks posed to birds and non-target organisms.

Submissions on this application must be made within a 30 working day period. Electronic responses using the form on our web site are encouraged. Please return your submission, whether electronic or by post, fax or email to:

ERMA New Zealand PO Box 131

Wellington Fax: 04 914 0433

Email: reassessments@ermanz.govt.nz www.ermanz.govt.nz

All submissions must be received by 5 pm, 1 September 2010.

Submissions must state the reasons for making the submission and state whether the

submitter wishes to be heard at a public hearing. The submission may also state any decision sought.

For more information on the reassessment process see http://www.ermanz.govt.nz/hs/reassessment/index.html