Seeking comment on the APVMA draft regulatory guidelines

Additional guidelines

A range of guidelines from Vet MORAG have been identified in submissions as not being available

The following guidelines, currently available in Vet MORAG, have been taken account of in other guidelines or are no longer required:

• bioequivalence guidelines for veterinary chemical products (Guideline 13)
• guidelines for stock foods and stock food additives (Guideline 7)

The following guidelines are currently under review and will be added to the regulatory guidelines following consultation as they are finalised:

• Guidelines for the registration of enzyme based products used in stock feeds (Guideline 10)
• Guidelines for the registration of direct fed microbial products (Guideline 9)
• Sheep Branding Substances (Guideline 42)

The following guideline is new to the regulatory guidelines and has been developed in consultation with industry through an independent process:

• APVMA guideline for autogenous vaccine permit

Guideline 49, Part 3 Vet MORAG

Previous guidance on the process to advise the APVMA of changes outlined in Guideline 49, Part 3 of Vet Morag cannot be found

The APVMA has reviewed Part 3 of Guideline 49, which related to submitting written advice of changes in the manufacturing process. The change in site of manufacture is a relevant particular and currently addressed through a variation application, with this process to continue from 1 July 2014. We will not require written advice on the remaining matters outlined in Table 2 of Part 3 of Guideline 49 from 1 July 2014.

The APVMA will continue to expect holders to maintain adequate records of all changes in manufacturing processes in accordance with good manufacturing practice as part of their quality management processes. The APVMA will consult with industry in the event future review processes identify additional requirements for industry in relation to changes in manufacturing processes.

Category 14 Vet MORAG

Amend requirement 'The components of the total residues for each collection time point for comparison to the total residue concentration' to reflect requirements in VICH Guideline 46

The APVMA has reviewed this section and updated it to provide clarification. 

3. Metabolism and data submission and application layout

Amend requirement 'The components of the total residues for each collection time point for comparison to the total residue concentration' to reflect requirements in VICH Guideline 46

The APVMA has reviewed this section and updated it to provide clarification. 

Throughout guideline

With reference to this guideline and ‘Food safety studies for veterinary drugs used in food producing animals’ it is not clear which GL applies to residues studies for WHP and ESI

The APVMA has revised and updated this section of the guideline to provide clarification. 

Throughout guideline

It is not clear where the guideline departs from or adds additional requirements to the VICH guidelines

The point raised in the submission is noted. While the APVMA has identified the additional considerations that are unique to Australia within the guideline, it is not clear exactly where these differences occur.  We intend to clarify where these differences occur in the next review of the document.  

Introduction

Opening paragraphs contain erroneous statements relating to the statutory obligations of the APVMA and confuse the concepts of hazard and risk

The APVMA has reviewed this content and removed these statements. 

1. Types of data

Clarity is required as to whether the APVMA’s approach departs or conforms to JECFA

The APVMA has reviewed and updated this statement to provide clarification that the APVMA conforms to JECFA. 

1. Types of data

The sentence 'relationship between the marker residues(s) and total residues in edible commodities at any time after treatment' should be clarified

The APVMA has reviewed and updated this statement to provide clarification. 

2. Residue data submissions

It is unclear in Table 1 what the requirements would be for applicant seeking a change in treatment regime

We have reviewed this table and agree that it could be amended to provide further clarification. We intend to update this table in the next review of the document. 

Throughout guideline

All references to 'export slaughter intervals' should be removed as they are not a requirement for registration

The references to export slaughter intervals have been removed to avoid confusion.  

Throughout guideline

It is unclear what requirements are additional to the VICH Guideline 49

The point raised in the submission is noted. While the APVMA has identified the additional considerations that are unique to Australia within the guideline, it is not clear exactly where these differences occur. We intend to clarify where these differences occur in the next review of the document. 

1.1 Introduction

Requirement to identify multi-residue methods should be removed

The APVMA has reviewed this content and agrees that the statement related to identifying multi-residues methods can be removed. 

1.4 Development of analytical methods

Requirement for applicants to 'provide details of the method development' should be removed

The APVMA has reviewed this content and agrees that the statements related to providing details of the method development can be removed. 

1.4 Development of analytical methods

Remove the following sentence 'While partitioning of the residue between the yolk and the white of the eggs should be determined, the method development should occur using the whole egg (minus shell)'

The APVMA included this guidance as additional information and explanation for applicants. This statement has been slightly amended to provide applicants with further clarification. 

1.4 Development of analytical methods

Remove requirement to conduct all residue studies in accordance with GLP standards

In line with best practice, the APVMA recommends that applicants conduct their studies in accordance with Good Laboratory Practice; however this is not a requirement. The text has not been amended. 

2.1 Performance characteristics

Remove storage stability trials from list of performance characteristics

The APVMA has reviewed this content and agrees that storage stability trials can be removed from the performance characteristics list. 

2.1.3 Accuracy

Revise accuracy requirements to be same as VICH Guideline 49

This text has been reviewed and updated in accordance with VICH Guideline 49. 

2.1.4 Precision

Revise precision requirements to be same as VICH Guideline 49

This text has been reviewed and updated in accordance with VICH Guideline 49.  

2.1.7 Selectivity or specificity

Amend reference to submitting validated method as regulatory method as it is inconsistent with the National Registration Scheme

This text was included to provide additional information to applicants; however this content has been removed in response to submissions received. 

2.1.11 Robustness

Remove sentence 'Evaluation of the robustness of regulatory methods is of major importance'

This text was included to provide information to applicants; however this content has been removed in response to submissions received. 

3.5 Food-safety studies for dairy commodities—milk

It is not clear what range of treatment to calving times residues data should be collected in order to achieve a particular TTC interval claim

The APVMA has revised and updated this section of the guideline to provide clarification. 

3.2.2 Dairy animals

Submissions requested the definition of the colostrum period

The APVMA has reviewed this content; however no changes have been made. This is a matter of industry practice and accordingly not included in the regulatory guidelines. 

3.2.2 Dairy animals

Sentence 'These Principles also apply to studies involving goats and sheep' is erroneous

The APVMA has reviewed this content. The content was found not to be clear as it referred to ‘dairy cows’ when it should refer to ‘dairy animals’. The content has been updated to reflect this. There have been no changes with respect to the inclusion of goats and sheep. The APVMA maintains that applicants should consider submitting data for goats and sheep (in this context) with their application.  

3.2.3 Sheep ectoparasiticides

This section makes reference to a 'wool residues guideline', which cannot be located

The wool residues guideline is currently under development; however as it is not complete, reference to it has been removed from the guideline.  

3.2.3 Sheep ectoparasiticides

3.9.5 Ectoparasiticide products intended for sheep

Not clear between these two sections when 'off-shears treatments' should be applied. (24 hrs vs 48 hrs)

The APVMA has reviewed this section and ’48 hours’ has been amended to read ‘24 hours’. 

3.2.4 Poultry

Requirements unjustifiably exceed that of VICH Guideline 49

The APVMA has reviewed this content and has not identified any area where the guidance exceeds VICH guideline 49. 

3.2.4 Poultry

Should remove requirement to analyse drug content before milling

The APVMA has reviewed this content and agrees that the suggestion to analyse drug content before milling can be removed. 

3.3.5 Food-safety studies in aquatic species

APVMA should revise section when VICH Guideline on issue is released

The APVMA acknowledges this request and will update this guideline when the VICH document is finalised. 

3.9.2 Injectable products

It is not clear whether data is required from animals at the upper end of the animal weight range

The APVMA has revised and updated this section of the guideline to provide clarification.  

3.9.2 Injectable products

Amend 20 ml example to industry standard 10ml example

The APVMA maintains that this reference is to an example only; therefore we are amenable to changing the example to 10mL.  

3.9.4 Ectoparasiticide products intended for cattle

3.9.5 Ectoparasiticide products intended for sheep

It is not clear whether data is required by treating animals with the maximum possible label dose even if it does not apply to animals in that weight range

It is unclear whether a different approach is required for cattle vs sheep

The APVMA has reviewed this content and updated it to provide clarification that the dosing should consider the maximum label dose rate. The guidance for cattle and sheep have been reviewed and updated to ensure consistency. 

3.9.5 Ectoparasiticide products intended for sheep

There should be no requirement to gather data by using the highest possible dose on all animals

This content has been included in line with best practice. If applicants choose not to use the highest possible dose, the results of the trial/s will be assessed on their merits. 

3.9.5 Ectoparasiticide products intended for sheep

Requirement for high dose rate does not align with requirement to use 'as proposed' in 7.2 pg 669

The APVMA has revised and updated this section of the guideline to provide clarification. 

3.11.1 General considerations

The sentence starting with 'One additional tissue' needs clarification

The APVMA has revised and updated this section of the guideline to provide clarification. 

Throughout guideline

This guideline should be combined with Page 669 – Veterinary drug residues in food commodities and overseas trade as the content overlaps

The APVMA has reviewed this content and acknowledges that there is an overlap in content between these pages. We intend to update this content in the next review of these guidelines. 

3. Data submission and application layout

Table one includes an incorrect statement 'You should indicate when the applicant would be prepared to submit an application to the Codex…'. The statement is incorrect as an individual cannot submit to the Codex

The APVMA has reviewed this content and agrees that the table should be updated. 

2.4.3.2 Animal
re-handling studies or dislodgeable residues studies

Define 'TC'

The term TC refers to transfer coefficient. The guideline has been updated to include this. 

1.4.2 Margin of safety studies

No reference is made to accepting data from studies conducted according to VICH GL 43

The APVMA has reviewed and updated this content so that specific reference is made to VICH GL 43. 

1.4.2.1 Dose rate

The guideline does not acknowledge logistical issues associated with running studies with very young animals that are still suckling

The APVMA has reviewed this content; however no changes have been made as it has been included in line with best practice. The applicant may provide justification for how their studies are conducted as part of the application submission. 

Part IV: Determination of end point antibiotic excretion in milk following intramammary treatment of lactating cows

Unclear whether Part IV provides an alternative to milk residue studies

The APVMA has reviewed this content; however no changes have been made. Part IV does not provide an alternative to milk residues studies. This section provides guidance on the dye marker/antibiotic relationship which has not changed from previous APVMA guidance. 

Throughout guideline

Submissions proposed changes to the guideline for ‘Variations to registered veterinary vaccines’ to provide for additional clarification

The APVMA has reviewed the content and has made a number of changes to the guideline to provide additional guidance and clarification. 

Table 1: Efficacy standards for anthelmintics in Australia

99% efficacy is too high

The APVMA has reviewed this content; however no changes have been made. These standards have not changed from the previous guidance provided by the APVMA. The standard for a persistency claim in sheep and goats remains at 99%; the standard for a persistency claim in cattle remains at 95%; and the standard for a control claim in sheep/goats/cattle remains at 95% (except for liver fluke which remains at 90%).  

Introduction

Delete line 'Because suboptimal efficacy can increase selection pressure for resistance'

The APVMA has reviewed this content; however no changes have been made. The use of any parasiticide can increase the selection pressure for resistance if there is a mechanism for resistance to develop. Suboptimal efficacy can increase selection pressure for resistance. 

Introduction

Data guidelines do not consider updated WAAVP Guideline (2013)

The APVMA has updated the preamble to reflect the most recent version of the WAAVP guideline. 

1. Fleas

Remove increase of 95% to 100% efficacy requirement for ‘control’ claim for 'paralysis tick'

The APVMA had included this guidance in line with best practice; however based on submissions received we have updated this guideline. 

2. Ticks

Remove efficacy studies required for brown dog tick if efficacy data is already supplied for paralysis tick

The APVMA has reviewed this content and considers it in line with best practice; therefore the content has not been changed. 

2.2. Ixodes holocyclus

Protocol for paralysis tick efficacy studies does not consider the real-life interaction between host and parasite

The APVMA has updated the preamble to reflect the most recent version of the WAAVP guideline. 

1.1 Pen and field studies

Requirement for comb counts for flea field studies should be removed

The APVMA has reviewed this content and made no changes, as this guidance is in line with best practice. WAAVP is very clear in the field trials section stating that: ‘Flea burdens should be quantified in a methodical standardised manner using a recognised method such as comb counting … Other approaches such as area and thumb counting methods are quicker and easier but are markedly less accurate.  Consequently, they should only be used for recruiting flea-infested animals.’ WAAVP cites scientific papers to support this guidance. 

5. Rainfastness

Rainfastness requirement immediately following treatment should be amended to within two hours of treatment as per guidelines for biting and nuisance flies

The APVMA has reviewed this content to provide additional guidance and flexibility for rainfastness studies. 

2. Animals

Remove requirement for testing on Bos taurus cattle

The APVMA has reviewed this content; however no changes have been made. Using Bos indicus cattle could result in animal welfare issues if studies need to be repeated due to unsatisfactory results as a result of low parasite burdens.  Furthermore, using a negative control group could be considered an animal welfare issue in field trials. 

Safety Criteria

Unclear how poison classifications will be affected when GHS is adopted

Adoption of the GHS will not impact on poison scheduling classification. 

Evidence from recognised EC and EFTA countries

Recognition of FAMI-QS standard should extend to all overseas countries, not exclusively to the European Union

The APVMA has reviewed the submissions and notes that wider recognition of FAMI-QS requires further consideration in consultation with industry. 

Additional guidelines

A range of guidelines from Ag MORAG have been identified in submissions as not being available

The following guidelines, currently available in Ag MORAG, have been taken account of in other guidelines or are no longer required:

• Post-harvest treatment
• Validating analytical methods

The following guidelines are currently under review and will be added to the regulatory guidelines following consultation as they are finalised:

• Adjuvant guidelines
• Antifouling efficacy data guidelines
• Forest herbicide efficacy guidelines
• Biological agricultural products

1.1.3 Stability data

Content of degradation products should only be required when degradation product is toxicologically significant

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

1.1.4.1 Manufacturer and manufacturing site

GPS coordinates of manufacturing sites is unnecessary

The APVMA had included this as it would assist us in accurately identifying manufacturing site locations; however based on submissions received we have removed this content. The APVMA will seek further consideration and consultation on this point prior to any change. 

1.1.4 Formulation composition

Requirement for certificates of analysis for all each constituent is too burdensome for applicants at screening. Previous requirement for a safety data sheet and technical specification is preferred

The APVMA had included this in line with best practice; however based on submissions received we have removed this content. The APVMA will seek further consideration and consultation on this point prior to any change.

2.1.14

Provision of reference standards should not be required for new source of active constituents

The APVMA had included this in line with best practice; however based on submissions received we have removed this content. The APVMA will seek further consideration and consultation on this point prior to any change. 

2.4 Real-time testing

Testing intervals

Real-time testing should be required initially and annually, not every 6 months

The APVMA had included this in line with best practice; however based on submissions received we have removed this content. The APVMA will seek further consideration and consultation on this point prior to any change. 

2.7 Containers

Concerns over requiring stability testing in smaller containers

The APVMA had included this in line with best practice; however based on submissions received we have removed this content. The APVMA will seek further consideration and consultation on this point prior to any change. 

3.1.5 Persistent Foaming

Current CIPAC method is MT 47.3, this should be updated in Test Parameter tables for formulation types

While it is available on the CIPAC website, MT 47.3 is a pre-published method and has not been formally published. Therefore we have not included MT 47.3 at this stage. 

3.1.6 Suspensibility

MT 184 is a revision of methods MT 15.1, MT 161, MT 168 and MT 177. This should be updated in the Test Parameter tables for formulation types

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

3.2 Parameters to be tested in stability trials

All 'Low temperature stability' test clauses should only apply before storage

The APVMA has reviewed and clarified this content to confirm this is not always relevant. 

3.1.1 Submission

More specific detail is required on the scientific arguments that OCS consider may be sufficient in the absence of data

The APVMA has reviewed and clarified this content. It should be noted that applications will be assessed by the APVMA and other relevant external reviewers, such as OCS, to determine whether the statutory criteria under the Agvet Code have been addressed. This will include assessment of any scientific argument included in the application. 

3.1.4 OECD format

OECD format should be 'acceptable format' for data packages, not 'preferred format'. This is repeated in Part 7

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

3.2 Animal testing

3Rs (replacement, refinement, reduction) should be followed

The regulatory guidelines are intended to provide guidance to applicants and not be prescriptive. The APVMA is supportive of the '3Rs' principle. Future review processes will further consider OECD guidance in consultation with industry with resulting changes incorporated into the regulatory guidelines.

3.7.3. Absorption, distribution, metabolism and excretion (toxicokinetics, pharmacokinetics)

Default dermal absorption level of 100% is too high

The APVMA has reviewed and clarified this content to confirm that the level of dermal absorption can be refined. 

3.7.6 Short-term toxicity studies

Are dermal short term toxicity studies required?

The regulatory guidelines are intended to provide guidance to applicants and not be prescriptive. The APVMA has not changed its guidance in this area however will consider the need for this in future review processes in consultation with industry. 

3.7.8.1 Chronic toxicity studies

Requirement for both rodent and non-rodent studies is not in line with EU and USA

The regulatory guidelines are intended to provide guidance to applicants and not be prescriptive. The APVMA has not changed its guidance in this area however will consider the need for this in future review processes in consultation with industry. 

2.1 Residues studies

The words 'confidence' and 'probable sources of variation' are too broad and should be clarified or removed

The regulatory guidelines are intended to provide guidance to applicants and not be prescriptive. The APVMA will further consider OECD guidance in future review processes in consultation with industry with resulting changes incorporated into the regulatory guidelines. 

2.7. Fate of residues during storage

A timeframe of 30 days deep-frozen storage should be accepted without having to provide storage stability data

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. The APVMA will further consider OECD guidance in future review processes in consultation with industry with resulting changes incorporated into the regulatory guidelines. 

2.11. Special requirements for seed dressings

Feeding studies using treated seed should not be considered necessary

The regulatory guidelines are intended to provide guidance to applicants and not be prescriptive. The APVMA will further consider OECD guidance in future review processes in consultation with industry with resulting changes incorporated into the regulatory guidelines. 

2.2 Data summary

The exposure models that will be used to evaluate the health risk to users/bystanders/public should be better explained

The guideline reflects current practice and the exposure models that will be used to evaluate these risks are considered on a case-by-case basis. The need for further clarification will be considered in future review processes in consultation with industry. 

2.4.4 Dermal absorption

Dermal absorption should not be 100% in the absence of data

The APVMA has reviewed and clarified this content to confirm that the level of dermal absorption can be refined. 

2 Overview of the assessment process

The reliability of the source/reference is considered a key factor to minimise waste of resources due to the use of 'false positive endpoints'. Introduce points raised in 4.1.1 to emphasise this point

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

2 Overview of the assessment process

Amend part to reflect endpoints from acute oral/contact toxicity studies with birds, mammals and honeybees

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

2 Overview of the assessment process

Add 'transport to remote areas' as an unwelcome property of a substance

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity.

2 Overview of the assessment process

Define 'major' and/or 'significant' metabolite

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

4.1.6 Formulation data

Where toxicity results are available for the product formulation and the active constituent, the most sensitive value may not be appropriate to use. The formulation may modify toxicity and accordingly formulation data may be most appropriate to use

The regulatory guidelines are intended to provide guidance to applicants and not be prescriptive. The APVMA has not changed its guidance in this area however will consider the need for this in future review processes in consultation with industry. 

4.2.1.3 Other issues

Formulation of product should not be considered with regard to the effect to the environment

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

4.2.1.5 Combination toxicity testing

Inconsistent approaches between deliberate tank mixes and compatibility

The APVMA is currently examining its policy on consideration of ecotoxicity of formulations and combination toxicity (which encompasses tank mixes or when a formulation contains more than one active constituent). The APVMA will seek further consideration and consultation with industry on this prior to any change. 

4.2.1.5 Combination toxicity testing

Inconsistent definition of combination toxicity

The APVMA is currently examining its policy on consideration of ecotoxicity of formulations and combination toxicity (which encompasses tank mixes or when a formulation contains more than one active constituent). The APVMA will seek further consideration and consultation with industry on this prior to any change. 

5.7 Spent Dipping solution disposal

Add additional means of managing used dips as the statutory criteria is not considered to be enough

The APVMA is currently finalising a report in this area and the regulatory guidelines will be updated accordingly once this is finalised. 

6 Format for submission of Part 7 environment data

OECD format should be 'acceptable format' for data packages, not 'preferred format'.  This is repeated in Part 3

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

2.1.7 Pilot, pivotal and commercial-scale studies

Pilot data should be given equal consideration as other data in evaluation of new products

The regulatoryguidelines are intended to provide guidance to applicants and not be prescriptive. The onus is on applicants to see that efficacy trial data in totality supports the proposed formulation and label claims/directions and the current wording does not prescribe the level of consideration of the data. Further consideration will be given to this issue in finalising the legislative instrument for efficacy (add link) which is currently under consideration. 

2.1.8 Optimal rate

Amend 'acceptable efficacy' to 'commercially acceptable efficacy'

The APVMA has reviewed the wording but has not amended it as commercially acceptable efficacy may vary and it is not practicable to prescribe this. Further consideration will be given to this issue in finalising the legislative instrument for efficacy (add link) which is currently under consideration. 

2.1.9 Number of trials

Number of trials specified is contradictory to extrapolation arguments being allowed

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

2.1.9 Number of trials

APVMA does not have expertise to conduct a trial protocol

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. The content has now been updated and can be found at: http://new.apvma.gov.au/node/978

2.1.11 Trial locations

There should be flexibility from an efficacy/crop safety perspective to extrapolate from a limited number of trials

The regulatory guidelines are intended to provide guidance and not be prescriptive. The current wording reflects the key elements required to be demonstrated and has not been amended. 

2.1.12 Cultivars

Efficacy trials should require the most appropriate cultivator for the product, rather than the most widely used cultivators

The regulatory guidelines are intended to provide guidance and not be prescriptive. The APVMA agrees applicants need to provide appropriate data to establish efficacy and safety and is of the view that this is the intent of the guideline. No changes have been made. 

2.1.13 Application method

Trials should allow for provision of spray droplet size and water volume data rather than efficacy of hand held booms in comparison to commercial booms

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

2.1.17 Good laboratory/trial practice

There is no need to implement a GLP policy for efficacy trials. 2.1.16 already covers the requirements

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

2.1.18 and 2.1.21 Safety to non-target crops

There should not be a requirement for crop safety data against all surrounding crops

The regulatory guidelines are intended to provide guidance and not be prescriptive. The APVMA has not changed its guidance in this area however will consider the need for this in future review processes in consultation with industry. 

2.2.1 Implications for resistance management

The requirements should not form the basis for 'Pivotal' data generation

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. The content has now been updated and can be found at: http://new.apvma.gov.au/node/978

2.4 Demonstrating bioequivalence

The results need to have 12 degrees of freedom rather than 95% confidence interval

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

3.0 Label claims and instructions

Major industry standards need to be taken into account. If product X is achieving 70% of control, and product Y is achieving 90% of control, product Y should be able to make the same claims on the label as product X

The regulatory guidelines are intended to provide guidance and not be prescriptive.  Further consideration will be given to this issue in finalising the legislative instrument for efficacy (Add link to http://new.apvma.gov.au/node/1054) which is currently under consideration. 

3.1 Recommendations for mixtures

Mixture recommendations should not be required to appear on both labels

The APVMA has reviewed this content and agree that it should be updated to provide greater clarity. 

2.2 Parametric tests

Ignores fact that 'Pivotal' data is valid if used in accordance with label

The regulatory guidelines are intended to provide guidance and not be prescriptive.  The APVMA has not changed its guidance in this area however will consider the need for this in future review processes in consultation with industry. 

6.0 Replication versus pseudo replication

The potential application of the guideline to circumstances data should be accepted with limited trial sites

The regulatory guidelines are intended to provide guidance and not be prescriptive. The APVMA has not changed its guidance in this area however will consider the need for this in future review processes in consultation with industry. 

General

There is no reference to pool and spa efficacy requirements

The APVMA has reviewed and updated this content to provide clarification. 

1.2 Field testing

Remove requirement to trial in busy public pools

The APVMA has reviewed this content and considers the guidance as best practice. Field trials for products proposed for commercial use should be designed to demonstrate that the product works as expected under actual use conditions and is reflective of the challenges posed by busy pools under Australian conditions. If an applicant wishes to propose an alternative methodology or test situation then suitable protocols may be proposed and advice should be sought from the APVMA to ensure that field tests are planned at appropriate locations and under appropriate conditions. Note that commercial field trials are only allowed to be commenced once laboratory tests have demonstrated suitable efficacy against relevant organisms under controlled conditions, and the APVMA has permitted conduct of the trials. 

General

There is no reference to pool and spa efficacy requirements

The APVMA has reviewed and updated this content to provide clarification. 

Safety criteria

Unclear how poison classifications will be affected when GHS is adopted

Adoption of the GHS will not impact on poison scheduling classification. 

Label content

Not consistent with Australian Standard for Aerosols (AS 2278)

The APVMA has not made any changes to this general labelling content, as the proposal is specific to aerosols. Applicants should refer to the content which deals specifically with aerosol products. 

Label presentation and layout

Remove specific lux requirement

The APVMA has not made any changes to this content, as the lux ratings come from Australian Standard AS1680.1 -2006 "Interior and Workplace Lighting Part 1: general principles and recommendations" and provide an objective measure of what reasonable lighting is. 

Label presentation and layout

Remove luminance requirement

The APVMA has not made any changes to this content, as colour contrast is an important consideration for product labels.