Seeking comment on the APVMA draft regulatory guidelines

This consultation closed on 11 April 2014.
Consultation period: 
29 January 2014 to 11 April 2014

The outcomes of this consultation are available below.

Consultation

The APVMA is pleased to release the regulatory guidelines for public consultation.

Background

The purpose of the regulatory guidelines is to increase the transparency and predictability of APVMA decision making under the Agvet Code, taking account of legislative amendments that commence from 1 July 2014.

The APVMA regulatory guidelines are a reference point and support tool that will supersede the current Manual of Requirements and Guidelines (MORAG) for applications made from 1 July 2014. The guidelines provide comprehensive information about the APVMA, what we do and how we manage applications. They provide guidance on what information should be provided with an application, increase understanding and predictability of our decisions and demonstrate how we ensure that the agvet chemicals for supply in Australia can be used safely and are effective.

The regulatory guidelines are divided into sections that reflect the key elements of our business:

  • Using the regulatory guidelines
  • Types of applications
  • Information and assistance
  • Making an application
  • Information guidelines and standards
  • Monitoring and reporting.

They also include guidelines made under section 6A of the Agvet Code that we must have regard to in performing our functions and powers.

The regulatory guidelines are a living product and will be regularly reviewed. We are committed to continually improving our processes and the way you can access and use information to do business with us. While this is a dedicated consultation process prior to publication your feedback is welcome at any time.

Related information

Amendments to the suite of legislation that relates to the powers and functions of the APVMA in regulating agvet chemicals are commencing from 1 July 2014. The regulatory guidelines, which are the subject of this consultation process, are a key component of the support we will provide to assist you through the legislative changes.

We are also developing an application aid, which is an online portal to enable electronic submissions of all applications from 1 July 2014.  The online portal will be made available for user testing separately and training on it will also be available.

A series of high-level information sessions are being held in February and March 2014 to support people to get ready for the new legislation, with further detailed workshops and training to be rolled out from April 2014. Further information on these sessions is available from our website.

The Department of Agriculture is separately running a consultation process on the Agricultural and Veterinary Chemicals Legislation Amendment (Re-moving Reapproval and Re-registration) Bill 2013 (external site). Following completion of this process, any changes required to the regulatory guidelines content will be addressed prior to final publication.

The Department of Agriculture is also leading a consultation process on the First Principles Review of Cost Recovery at the APVMA (external site). Outcomes of this review process will not impact on the content of the regulatory guidelines to support the commencement of legislative changes from 1 July 2014.  Future reviews of the regulatory guidelines will take account of the outcomes of the First Principles Review as required.

Accessing the regulatory guidelines

The regulatory guidelines are available online.

For the purposes of consultation, a printable version of the regulatory guidelines has been generated. The printable version has been developed in seven parts to match each of the components in the website.

During the process of compiling the printable version of the regulatory guidelines, some web pages were not captured. Printable versions of this content are now available as follows:

Consultation information

Submissions on the regulatory guidelines are invited to address:

  • Comprehensiveness. This includes the level of detail and whether the information provided is sufficient for you to confidently interact with us—for example in submitting an application. Include details of any additional content you believe would be required
  • Readability. This includes ease of reading and understanding the information
  • Usability. This includes navigation, information design elements such as content structure and user experience, including system responsiveness
  • Errors. This includes concerns with factual content, grammatical/typographical errors and incorrect links to other content

You can use this template (RTF, 90KB) to assist in structuring your submission. Please make sure you reference the page number which appears on each page.

Please note there are no page reference numbers on the home page, the Definition of Terms or Abbreviations and Acronyms pages—please just reference them by page title and relevant item.

We are not seeking submissions that relate to:

  • policy underpinning the legislation including the regulations
  • broader agvet policy matters, or
  • web design elements and aesthetics including colours and images.

The due date for submissions has been extended to 11 April 2014. Following consideration of submissions, the regulatory guidelines will be finalised in May 2014.

Please lodge your written submission by email, post or fax to:

Director
Strategic Coordination
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Email: regulatoryguidelines@apvma.gov.au
Fax: +61 2 6210 4840

For enquiries, please call +61 2 6210 4883 or +61 2 6210 4751

Regulatory guidelines: outcomes of consultation

The APVMA has released an updated version of the regulatory guidelines taking account of submissions received during public consultation.

The regulatory guidelines are part of a package of tools and material that will be available for you from 1 July 2014. 

Background

Amendments to the suite of legislation that relates to the powers and functions of the APVMA in regulating agvet chemicals are commencing from 1 July 2014.

The purpose of the regulatory guidelines is to increase the transparency and predictability of APVMA decision making under the Agvet Code, taking account of legislative amendments that commence from 1 July 2014.

The APVMA regulatory guidelines are a reference point and support tool that will supersede the current Manual of Requirements and Guidelines (MORAG) for applications made from 1 July 2014. The guidelines provide guidance on what information should be provided with an application, increase understanding and predictability of our decisions and demonstrate how we ensure that the agvet chemicals for supply in Australia can be used safely and are effective.

They also include guidelines made under section 6A of the Agvet Code that we must have regard to when we make decisions in performing our functions and powers.

The regulatory guidelines are a living product and will be regularly reviewed. We are committed to continually improving our processes and the way you can access and use information to do business with us. Your feedback is welcome at any time.

Consultation information

The public consultation process ran from 29 January 2014 to 11 April 2014. During this period 19 submissions were received from a range of agricultural and veterinary medicine industry associations, chemical companies, regulatory consultants and product users. Submissions on the regulatory guidelines were invited to address:

  • Comprehensiveness – including the level of detail and whether the information provided is sufficient for you to confidently interact with us
  • Usability – including navigation, information design elements such as content structure and user experience, including system responsiveness
  • Readability – including ease of reading and understanding the information
  • Errors – including concerns with factual content, grammatical/typographical errors and incorrect links to other content.

The key themes from the submissions were:

1. Submissions raised difficulty identifying differences between the content from the current Manual of Requirements and Guidelines (MORAG) and the regulatory guidelines. There was concern that with the large volume of content in the guidelines changes may have been missed when providing comment.

The regulatory guidelines are not intended to be MORAG.  MORAG was a combination of general information, process and technical guidance material.  The processes for handling applications will change from 1 July 2014 and these changes are reflected in the regulatory guidelines.  Technical guidance and data guidelines are unchanged but have been aligned to the relevant sections of the regulatory guidelines. General information will be contained on the new APVMA website, due for launch on 1 July.  

Guideline on module descriptors

An additional guideline to support you in making an application that outlines Module Descriptors has been included in this release. It has been made as a guideline under section 6A of the Agvet Code, meaning that we must have regard to it when making decisions. This guideline is designed to help inform the APVMA and applicants of the modules that will apply for different types of applications.

Legislative Instruments

Consultation on a range of draft legislative instruments closed on 21 May 2014. Following consideration of any submissions that are received, any required changes will be incorporated and the legislative instruments will then be finalised for commencement from 1 July 2014. Draft legislative instruments are available for:

  • Pre-application assistance
  • Efficacy criteria
  • Application Requirements (information to be included in applications)
  • Manufacturing principles
  • Listable Chemical Products
    • Joint Health Product for Dogs and Horses
    • Swimming Pool and Spa Products

Submissions on technical content

Specific comments on technical content have been reviewed by the APVMA, and, where appropriate, the Department of Health and the Department of the Environment. In general, the technical content of the regulatory guidelines is found within the ‘data guidelines’ pages.

The data guidelines are intended to provide guidance to applicants on what data could be submitted to support their applications; however the guidelines are not intended to be prescriptive and should not be perceived as APVMA requirements.

In registering agricultural and veterinary chemical products, the APVMA must be satisfied of the statutory criteria related to safety, efficacy, trade and labelling, among other things. To provide assistance to applicants, the APVMA has developed or adopted data guidelines that provide guidance on how applicants may address the statutory criteria. Applicants are encouraged to review the guidance materials; however it is up to the applicant how they wish to address the statutory criteria. 

In response to the submissions received during the consultation period, the APVMA has developed a summary of the technical points raised and our response in relation to agricultural and veterinary chemical products. In some instances the APVMA has amended the content of the relevant guidelines. To ensure all applicants are aware of any changes to the guidelines, a link to the relevant regulatory guidelines content has been included in the table.

View agricultural summary and veterinary summary below.

Ongoing review

The data guidelines have been published as living documents; meaning that they can undergo review at any time. The APVMA welcomes comments and suggestions for improvements to the guidelines as science develops and in order to keep them in line with best practice.

Feedback can be provided at any time, including post 1 July 2014. The review process will be ongoing and the APVMA will provide consultation opportunities on significant changes. Changes following any consultation process will be communicated through the regulatory update process and on the website.

2. Submissions raised concerns with usability and difficulty in navigating effectively through the guidelines.

A range of changes have been made following the consultation, including restructuring some information as well as improved navigation to make it easier to get the information that you need. In addition we are enhancing the site map and print capability.

3. Submissions noted that the language in the regulatory guidelines is APVMA rather than user focused and overly legalistic in some areas.

We have made changes to the regulatory guidelines in response to specific issues identified in submissions.  However, it was not possible to do a comprehensive review and edit before 1 July 2014.  Instead, we commit to reviewing the language used in the regulatory guidelines as a priority after 1 July to ensure it better suits user needs. 

4. Submissions raised concerns with availability of associated IT tools

There are a series of information technology tools that are being developed to support applicants and holders of product registration in their interactions with:

IT tool Target date for release to production
Does my product require registration (VET) Already available
Does my product require registration (AG) 1 June 2014
Pre-application assistance Already available
Decision Tree (initial items) 1 July 2014
Application Aid (initial items) 1 July 2014
E-label template 1 June 2014
Certificates of export Already available
Online levies and fees Already available

Applicants may participate in user testing of the IT tools by emailing it_systems@apvma.gov.au. There are also opportunities for you to participate in training in June 2014.

As IT tools and supporting user information go live in the lead up to 1 July 2014, links will be added to the regulatory guidelines content in appropriate places; however this will not change any content.

Please direct any matters on the APVMA regulatory guidelines consultation process to:

Director
Strategic Coordination
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Email: regulatoryguidelines@apvma.gov.au
Fax: +61 2 6210 4840

For enquiries, please call +61 2 6210 4883 or +61 2 6210 4751

Regulatory guidelines consultation: submission feedback—veterinary

The APVMA has released an updated version of the regulatory guidelines taking account of submissions received during the public consultation process that ran from 29 January 2014 to 11 April 2014. Submissions on the regulatory guidelines included a number of comments on technical content related to veterinary chemical products. These comments have been considered by the APVMA and our responses are summarised below with links provided to the relevant content in the regulatory guidelines.

Veterinary chemical products

Miscellaneous

Reference Summary of submission APVMA Response

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. 

Metabolism and kinetics (Part 4)

Reference Summary of submission APVMA Response

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. 

Comparative metabolism studies, selection of marker residues and ratios of marker residues total residues

Reference Summary of submission APVMA Response

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.  

Residues (Part 5A)

Reference Summary of submission APVMA Response

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.  

Analytical methodology

Reference Summary of submission APVMA Response

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. 

Food safety studies for veterinary studies for veterinary drugs used in food producing animals

Reference Summary of submission APVMA Response

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. 

Overseas trade (Part 5B)

Reference Summary of submission APVMA Response

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. 

Occupational health and safety (Part 6)

Reference Summary of submission APVMA Response

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. 

Efficacy and target animal safety general guideline (Part 8)

Reference Summary of submission APVMA Response

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. 

Guidelines for registration of intramammary preparations for treatment of bovine mastitis

Reference Summary of submission APVMA Response

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. 

Guideline for variations to registered veterinary vaccines
 

Reference Summary of submission APVMA Response

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. 

Efficacy standards for ruminant anthelmintics in Australia

Reference Summary of submission APVMA Response

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%).  

Efficacy standards for equine, porcine, canine, feline and poultry anthelmintics in Australia

Reference Summary of submission APVMA Response

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. 

Preamble for the WAAVP guideline for fleas and ticks on dogs and cats

Reference Summary of submission APVMA Response

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. 

WAAVP guideline for ticks on ruminants

Reference Summary of submission APVMA Response

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. 

Statutory criteria

Reference Summary of submission APVMA Response

Safety Criteria

Unclear how poison classifications will be affected when GHS is adopted

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

Acceptable evidence of GMP compliance

Reference Summary of submission APVMA Response

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. 

Regulatory guidelines consultation: submission feedback—agricultural

The APVMA has released an updated version of the regulatory guidelines taking account of submissions received during the public consultation process that ran from 29 January 2014 to 11 April 2014. Submissions on the regulatory guidelines included a number of comments on technical content related to agricultural chemical products. These comments have been considered by the APVMA and our responses are summarised below with links provided to the relevant content in the regulatory guidelines.

Agricultural chemical products

Miscellaneous

Reference Summary of submission APVMA Response

 

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

 

Chemistry and manufacture—Approval of a new active constituent

Reference Summary of submission APVMA Response

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. 

Chemistry and manufacture—Registration of an agricultural chemical product

Reference Summary of submission APVMA Response

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.

Chemistry and manufacture—Approval of a new source of an active constituent
 

Reference Summary of submission APVMA Response

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. 

Chemistry and manufacture—Generation of storage stability data for agricultural chemical products

Reference Summary of submission APVMA Response

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. 

Toxicology (Part 3)

Reference Summary of submission APVMA Response

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. 

Residues (Part 5A)

Reference Summary of submission APVMA Response

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. 

Occupational Health and Safety (Part 6)

Reference Summary of submission APVMA Response

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. 

Environment (Part 7)

Reference Summary of submission APVMA Response

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. 

Pesticides efficacy and crop safety general guidelines (Part 8)

Reference Summary of submission APVMA Response

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. 

Efficacy experimental design and analysis

Reference Summary of submission APVMA Response

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. 

Demonstrating efficacy of pool and spa sanitisers

Reference Summary of submission APVMA Response

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. 

Preparing a study report

Reference Summary of submission APVMA Response

General

There is no reference to pool and spa efficacy requirements

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

Statutory criteria

Reference Summary of submission APVMA Response

Safety criteria

Unclear how poison classifications will be affected when GHS is adopted

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

Agricultural Labelling Code

Reference Summary of submission APVMA Response

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. 

 

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