Ectoparasiticides for sheep and goats

In addition to the standard labelling requirements, labels on ectoparasiticide products for sheep and goats should also carry the following information, as applicable.

You may apply to us with a request to include alternative statements to those described below. You will need to submit data supporting your request. We will assess the data and if we agree we may approve the requested alternative label content.

1. ‘Active constituent’ statement

Bacteriostats approved by the APVMA should be included as an active constituent on the label when included in the marketed product.

2. Indications

Claims must refer to susceptible strains of parasites. Both the common and scientific name of parasites must appear in the ‘Claims for use’ statement on the label. The scientific name must be written in italics or underlined.

Examples of ‘Claims for use’ statements:

For the [eradication/control] of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep with short wool.

For the control of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep with long wool.

For [the treatment of/protection for up to x weeks against] strike by [chemical name]-susceptible strains of blowflies (Lucilia cuprina) when applied by jetting.

Any claims for efficacy against resistant strains of ectoparasites must be supported by efficacy data.

The abbreviated (main panel) claim should indicate the length of wool on which a product is to be used, such as ‘off-shears’, ‘short wool’ or ‘long wool’. These terms should be explained when used on the label. Variations to the definitions and time periods may be allowed in some circumstances, when supported by data. Where these terms are not incorporated into the product name, they should be included in the product claim.

The following statement should appear—in bold-face capital letters that are a minimum of 2 mm in height—as the last statement under the ‘Claims (indications) for use’ section, towards the bottom of the main panel of the primary pack label:

READ DIRECTIONS FOR USE BEFORE OPENING OR USING THIS PRODUCT

3. Directions for use

3.1. Restraints, contraindications and precautions

You should refer to the statements required on labels for each product type below. The statements may be modified subject to APVMA approval. (Our expectation is that you will be able to supply appropriate data to support your requested modifications.)If the use of certain products is prohibited in certain states and territories, this should be indicated in this section.

3.2. Dosage and administration

Critical use comments are statements that are essential for the effective use of the product.

Where a premixing instruction is included, it should appear under the ‘Dosage and administration’ heading.

Dilution rates should be shown as:

[x] mL or litres [product]/100 litres water.

Ratios or percentages should not be used.

Directions for use should be simple, clear and concise and at least provide the minimum information necessary on how to use the product appropriately. Where appropriate, the dosage and administration instructions may appear in tabular form.

For products registered and approved for use on goats and sheep the directions must make reference to goats as well as sheep.

Directions for use should include a dose, volume or usage table (as outlined in examples below).

3.3. General directions

For all ectoparasiticides, the following statement must appear in bold-face, sans-serif capital letters of not less than 2 mm in height:

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION

For all new products, advice on rainfastness (the time after an application when the product may need to be re-applied if heavy rain falls) must be included on labels in the general instructions. Data should normally be available from efficacy studies.

Other information that may be included in the general directions, as appropriate for a product, includes compatibility statements, instructions to avoid settling, instructions for mixing, topping up and dipping out dips, mycotic dermatitis information and bacteriostat requirements.

3.4. Withholding periods

Appropriate withholding period statements for meat, milk and wool are to be included on labels. Meat and milk ‘Withholding period’ statements are to precede those for wool.

Note: The wool ‘Withholding period’ statement is likely to change in the near future and may include a wool harvesting interval and wool rehandling period. In the interim, a default withholding period of at least 2 months applies unless data supporting a shorter or longer withholding period are supplied.

Note: For wound dressings and fly strike treatments for individual sheep, default withholding periods of at least one month applies, unless data is supplied to support a shorter withholding period.

4. Off-shears backline products for lice

In addition to the general labelling requirements above, the labels for off-shears backline products for lice should also carry information as listed under the following sections.

4.1. Product name

Descriptive terms relevant to the type of product such as ‘pour-on’ or ‘spray-on’ should be used in the name where possible.

4.2. Indications

Where the descriptive terms such as ‘pour-on’ or ‘spray-on’ or ‘backline’ are not included in the product name they should be included in the statement of claims for use.

4.3. Directions for use

4.3.1. Restraints

The following statement should be included under the ‘Restraints’ heading:

DO NOT USE more than 24 hours after shearing

4.3.2. Critical use comments

The following ‘Critical use comment’ statements should appear on the product label:

Use only on sheep that have been cleanly shorn.

Avoid treating ewes less than [x] weeks before lambing commences, while ewes are lambing or have lambs at foot, as live lice can persist and infect the lambs.

Treated sheep should not be mixed with untreated sheep until [x] weeks after treatment.

4.3.3. Dosage and administration

All off-shears backline treatments should show the following under the heading ‘Critical use comments’:

Dose rates are to be based on the heaviest sheep (goats) in the mob.

Sheep (goats) must be weighed and where necessary, treated in separate groups based on body weight.

Dose or volume tables with appropriate weight steps extending up to at least 75 kg must be shown, to ensure that minimum rates of application are reached. You must justify these rate steps in your registration application to the APVMA. All off-shears backline treatments should show the following headings in a dose or volume table:

Animal Pest Body weight (kg) Dose (mL of product)

 

 

 

 

[This example table shows the headings: Animal, Pest, Body weight (kg), Dose (mL of product)]

A pictogram or photograph of a sheep illustrating the correct application method should appear on the label. For pour-ons, the correct method of application is generally from the poll of the head to the base of the tail. For other products (spray-on etc.), the correct method should be clearly described.

Instructions should be added as appropriate for a product, including information relating to the applicator, method of application or clean up after use.

Example 1: Suggested ancillary panel layout for an off-shears pour-on lousicide product.

EXPANDED CLAIMS: [if abbreviated on main panel] [include scientific names of pests if not included on the main panel]
For the [eradication/control] of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep off-shears.

DIRECTIONS FOR USE:
Restraints:
DO NOT USE more than 24 hours after shearing.

Critical use comments:
Use only on sheep that have been cleanly shorn.
Avoid treating ewes less than [x] weeks before lambing commences, while ewes are lambing or have lambs at foot, as live lice can persist and infect the lambs.
Treated sheep should not be mixed with untreated sheep until [x] weeks after treatment’.

Dosage and Administration:
Dose rate: [x] mL per [y] kg body weight.

Animal Pest Body weight (kg) Dose (mL of product)

Sheep

 

[x] kg

[y] mL

 

 

 

 

 

 

 

 

 

 

 

 

[This example table shows the headings: Animal; Pest; Body weight (kg); Dose (mL of product). The first row shows an example for sheep.]

Critical use comments:
Apply as a single band from poll of the head to the base of tail as in diagram below. Sheep should be weighed before treatment. Treat sheep according to the heaviest animal by live weight in each group (ewes, rams, lambs). Do not underdose. Sheep in excess of 75 kg body weight to be dosed at x mL per y kg body weight.
[Appropriate pictogram]
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER THE APPROPRIATE LEGISLATION.

5. Short-wool products—plunge and shower dips

In addition to the general labelling requirements for all ectoparasiticides above, the labels on short wool plunge and shower dips should also carry the following information as relevant for stripping or non-stripping dips.

Constant replenishment recommendations are only to apply to shower dips, unless data are provided to support use in plunge dips.

5.1. Restraints

The following ‘Restraints’ statement is required:

DO NOT dip sheep more than 6 weeks after shearing.

5.2. Contraindications

The following ‘Contraindications’ statement is required:

Dipping within 2 weeks of shearing is not recommended.

5.3. Critical use comments

The following ‘Critical use comments’ statements are required:

Dipping sheep heavily infested with grass seed is not recommended.

Where applicable, use the following statements:

For effective control of lice, thorough wetting to skin level is essential.

Dip sheep at onset of fly wave. Thoroughly saturate sheep

5.4. Stripping dips

The active constituent in stripping dips strips out of the wash through absorption by the wool. The complex dip management regimen must be clearly explained in the ‘Directions for use’ on product labels. A label statement should clearly indicate that the product is a stripping dip.

5.4.1. Dosage and administration

Directions for use must clearly show how falling sump volume requires first reinforcement and then topping up. Directions are required for both the addition of product (reinforcement) and combined product and water (topping-up) needed to maintain the dip at an effective level and strength. Both directions should be concise and clear enough to stand alone. Separate directions for ‘dipping out’ should not be used, because dipping out is covered by reinforcement. Reinforcement alone should only be used in cases where the addition of water is unwarranted or unwanted, either because the reduction in wash volume is too little to justify re-filling the dip or because dipping is nearly complete, that is, dipping out.

Where instructions for continuous replenishment are used, it must be clear on the label that this term currently refers only to shower dips and not plunge dips, unless a case can be made for use with plunge dips.

5.4.2. Critical use comments

All stripping dips should show the following:

Critical use comments
This is a STRIPPING dip. Reinforcement with undiluted concentrate is required before topping up. When dipping out, reinforce only.

Advice on exactly how to mix products into dips should be included. For some products, specific instructions are essential, such as the pre-mixing of powder products or some liquids. All such statements should be justified to the APVMA.

All stripping dips should show the following headings in a dose, volume or usage table:

Animal(pest) Treatment method Initial charge Reinforcement (always reinforce before topping up) Topping up (when dip or sump falls by approximately 25%)

 

 

 

 

 

[This example table shows the headings: Animal (pest); Treatment method; Initial charge; Reinforcement (always reinforce before topping up); Topping up (when dip or sump falls by approximately 25%).]

Example 2: Suggested ancillary panel layout for a sheep dip for lice that strips out.

Indications: [if abbreviated on main panel] [include scientific names of pests if not included on the main panel].
For the [eradication/control] of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep with short wool

DIRECTIONS FOR USE:
Restraints:
DO NOT dip sheep more than 6 weeks after shearing.
Contraindications:
Dipping within 2 weeks of shearing is not recommended.

Critical Use Comments:
Dipping sheep heavily infested with grass seed is not recommended.
For effective control of lice, thorough wetting to skin level is essential.

Dosage and Administration:
Critical Use Comments:
This is a stripping dip. Reinforcement with undiluted concentrate is required before topping up. When dipping out, reinforce only.

Animal(pest) Treatment method Initial charge Reinforcement (always reinforce before topping up) Topping up (when dip/sump level falls by approximately 25%)

Sheep (lice)

Plunge dip

[x] mL per 100 L water

Do not add water. Add [y] mL of product each time the level of dip wash falls by 500 L

Reinforce first. Then add [z] mL of product per 100 L of fresh water required

Critical use comment: Immerse heads of sheep at least twice after they enter the dip

Sheep (lice)

Standard shower dip

[x] mL per 100 L water

Add [y] mL of product each time the level of dip wash falls by 200 L

Reinforce first. Then add [z] mL of product per 100 L of fresh water required

Critical use comment: Do not use a shower dip with a sump volume less than 2000 litres and do not allow dip level in sump to fall below half full.

Sheep (lice)

Continuous replenishment shower dip

[x] mL per 100 L water

Not required

Use dip wash from the replenishment tank mixed at [y] mL per 1000 L of water

Critical use comment: Maintain sump level at least 500 mm above pump intake.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER THE APPROPRIATE LEGISLATION.

5.5. Non-stripping dips

The active constituent in non-stripping dips does not strip out of the wash through absorption by the wool. The dip management regimen must be clearly explained in the directions for use on product labels. A label statement should clearly indicate that the product is a non-stripping dip.

5.5.1. Dosage and administration

Directions for use must clearly show how falling sump volume requires topping up. Directions are required for the addition of combined product and water (topping-up) needed to maintain the dip at an effective level.

5.5.2. Critical use comments

All non-stripping dips should show the following:

Critical use comments
This is a NON-STRIPPING dip. Reinforcement with undiluted concentrate is not required when topping up. When dipping out (when the level of dip wash falls by more than 25%) add [...] mL of product per 100L of water each time the level of dip wash falls by 500 L (or 200 L for shower dips).

You should include advice on exactly how to mix products into dips. For some products, specific instructions are essential, such as the pre-mixing of powder products or some liquids. All such statements should be justified to the APVMA.

All non-stripping dips should show the following headings in a dose, volume or usage table:

Animal(pest) Treatment method Initial charge Topping up (when dip/sump level falls by approximately 25%)

 

 

 

 

[This example table shows the headings: Animal (pest); Treatment method; Initial charge; Topping up (when dip/sump level falls by approximately 25%).]

5.6. Long-wool products—jetting and spray-on products

Long wool products are for use on sheep more than six weeks after shearing. In addition to the general labelling requirements for sheep and goat ectoparasiticides, the labels on long wool products should also comply with the following requirements, as relevant.

5.6.1. Directions for use

5.6.1.1. Dosage and administration

The following ‘Critical use comment’ statements should appear on all long-wool products unless modified subject to APVMA approval based on appropriate data.

Critical use comments
For use on sheep more than six weeks after shearing.
Reduced effectiveness is likely if used on sheep with lumpy wool.

The following ‘Critical use comment’ statement should appear on products that have not been registered with a claim for eradication of lice but may be modified subject to APVMA approval based on appropriate data:

Critical use comment
After the next shearing, sheep should be treated with an effective off-shears or short-wool product.

The following ‘Critical use comment’ statement should appear on products registered for jetting of sheep for either fly or lice control but may be modified subject to APVMA approval based on appropriate data:

Critical use comment
This product is not recommended for use in jetting races because reduced efficacy and/or a reduced period of protection may result.

Where dose rates depend on the length of wool or the time since last shearing (either or both may be used), including those for jetting products for fly strike prevention or long-wool lice control, then appropriate instructions should be shown with the following headings in a dose or volume table:

Animal(pest) Treatment method Months after shearing Dose (mL of product)

 

Spray-on

 

 

 

Jetting

 

 

[This example table has four columns with the following headings: Animal (pest); Treatment method; Months after shearing; Dose (mL of product). Most of the remaining cells are empty, except for the ‘Treatment method’ column, which contains in the first row, ‘Spray-on’ and in the second row, ‘Jetting’.]

In addition:

Where mixing directions are required, they should also be included in the table above.

Information relating to the applicator, method of application or clean-up after use should be included. Statements relating to pump pressure, method of jetting, etc. should also be included. Note: the APVMA may approve the use of jetting races if appropriate data are supplied and the trade name and/or type of the jetting race(s) is included on the label.

For spray-on products, a pictogram or photograph of a sheep illustrating the correct application method should appear on the label.

Example 3: Suggested ancillary panel layout for a long-wool spray-on product for lice.

EXPANDED CLAIMS: [if abbreviated on main panel] [include scientific names of pests if not included on the main panel]
For the control of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep with long wool.

DIRECTIONS FOR USE:
Dosage and administration:

Animal (pest) Treatment method Months after shearing Dose (mL of product) Critical comments

Sheep (lice)

 

[x] months

[y] mL

Application instructions

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[This example table shows the headings: Animal (pest); Treatment method; Months after shearing; Dose (mL of product); Critical comments. The first row contains the example for sheep.]

Critical Use Comments: For use on sheep more than six weeks after shearing.
Reduced effectiveness is likely if used on sheep with lumpy wool.
After the next shearing, sheep should be treated with an effective off-shears or short-wool product.
[Appropriate pictogram]
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER THE APPROPRIATE LEGISLATION.

5.7. All fly strike control products (including wound dressings)

In addition to the general labelling requirements for sheep and goat ectoparasiticides and the specific requirements for all dips, spray-ons and jetting products above, the labels on all fly strike control products should also comply with the following requirements.

5.7.1. Indications

The approved protection period must be specified in the label claim by using one of the following alternative statements:

When applied as directed this product will protect against fly strike for [x] to [y] weeks

When applied as directed this product will protect against fly strike for up to [x] weeks.

5.7.2. Directions for use

5.7.2.1. Dosage and administration

Products registered for fly strike control on sheep or goats should also include the following ‘Critical use comments’ statements (as appropriate)

Critical use comments: Jet at onset of blowfly wave.

Critical use comments: When used on sheep with less than 6 weeks wool a reduced period of protection may result.

Critical use comments: This product is not recommended for use in jetting races because a reduced period of protection may result.

DO NOT collect and re-use fluid that runs off.

Specific directions for use should be included in the dose or volume usage table. Where claims for pests other than blowfly are also made the directions in the table must clearly distinguish between each pest for which claims are made.

Example 4: Suggested ancillary panel layout for a product that is used as a long wool jetting product for fly strike prevention and individual animal treatment of fly strike.

Expanded claims: [if abbreviated on main panel] [include scientific names of pests if not included on the main panel]
For the protection for up to [x] weeks of strike by [chemical name]-susceptible strains of blowfly (Lucilia cuprina) when applied by jetting.
DIRECTIONS FOR USE:
Dosage and Administration:

Animal (pest) Treatment Rate

Sheep (blowfly)

Jetting for prevention of fly strike

Add [y] mL product for each 100 L of water

[This example table shows the headings: Animal (pest); Treatment; Rate. The first row contains an example for sheep.]

Critical use comments:
For use on sheep more than six weeks after shearing.
Reduced effectiveness is likely if used on sheep with lumpy wool.
Jet at onset of blowfly wave.
When used on sheep with less than 6 weeks wool a reduced period of protection may result.
This product is not recommended for use in jetting races because reduced efficacy and/or a reduced period of protection may result.
Do not collect and re-use fluid which runs off.

Animal (pest) Treatment Rate

Sheep (blowfly)

Dressing for treatment

Use [z] mL product for each 1 L water

[This example table shows the headings: Animal (pest); Treatment; Rate. The first row contains an example for sheep.]

Critical use comments: Saturate struck area thoroughly
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER THE APPROPRIATE LEGISLATION.

5.8. All itch mite products

In addition to the general labelling requirements for sheep and goat ectoparasiticides above, the labels on itch mite products should also comply with the following requirements.

5.8.1. Indications

Only claims for ‘control’ of itch mite will be permitted on a label, unless a different claim can be demonstrated.

5.8.2. Directions for use

5.8.2.1. Dosage and administration

Specific directions for use should be included in the dose or volume usage table. Where claims for pests other than itch mite are made, the directions in the table must clearly distinguish between each pest for which claims are made.

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