EXPLANATORY STATEMENT
Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2016
The Agricultural and Veterinary Chemicals Code Act 1994 (Act) provides, within a Code set out in the Schedule to the Act (Agvet Code), a regulatory scheme for agricultural and veterinary chemicals.
The Agvet Code, Division 2AA provides for certain variations to the relevant particulars of registered products, approved active constituents and approved labels to be made through the process of notifiable variations (Regulation 19AE of the Agvet Code Regulations 1995). Through this process, holders can make minor changes to the details of an approved active constituent, registered product or approved labels by notice rather than by way of a new application. Multiple changes can be made in one notification to the APVMA for a single fee using the APVMA online services.
Each variation in the online notification is deemed to have taken effect from the day it is lodged. In turn the APVMA has 14 days to update the Register of Agricultural and Veterinary Chemical Products kept under section 18 of the Agvet Code to reflect the change and notify holders that the change has been made.
Through the work conducted as part of the APVMA’s Lower Regulatory Approaches to Registration project, it has been identified that there are additional low risk variations, currently requiring a formal application, which could be managed through the notifiable variation process.
The Agvet Code provides in subsection 26AB(5) that the APVMA may by legislative instrument determine a kind of variation to be a notifiable variation. That is, the APVMA may, by legislative instrument, determine that a particular kind of relevant particular could be changed without a full application or assessment. This instrument, (the instrument) the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2016, is made under subsection 26AB(5) .
The instrument provides for additional variations that can now be dealt with by way of notification rather than requiring a full application. These include:
- a variation to the address of a site at which the approved active constituent is manufactured by the manufacturer if there is no physical change of location;
- a variation to the name of any other registered products referred to within the instructions for use on the label (provided the referred to product has the same APVMA distinguishing number). This item includes a variation of an approved label but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product;
- a variation to the instructions for storage and disposal of containers of products, in line with the relevant requirements for the type of container as specified in the Agricultural Labelling Code or Veterinary Labelling Code made by the APVMA. But only if the variation will not result in other instructions for use being modified or affected. This item includes a variation of an approved label but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product;
- a variation to safety directions and first aid instructions appearing on a label to reflect the current FAISD hanbook. This item includes a variation of an approved label but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product;
- a variation of the net contents of a veterinary product but only if:
(a) the variation will not result in the instructions for use, or disposal, of the product or containers for the product, being modified or affected; and
(b) the net contents is in the range recorded in the Register for the product.
This item includes a variation to the label but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product.
Regulatory impact
No Regulatory Impact Statement has been prepared for the Instrument. The Office of Best Practice Regulations was consulted about this Instrument (OBPR ID: 20349 and 20609).
On the basis of the information provided, the OBPR considered that the proposed changes would have a minor regulatory impact on businesses, individuals and community organisations. Therefore, a Regulation Impact Statement was not required unless the proposal is to be considered by Cabinet.
Public consultation
Advice from OBPR in relation to any period of public consultation indicated that we should “Give people as much time as is reasonable to absorb the information you provide and gain a proper understanding of the issues so they can offer a considered view. Depending on the complexity of your proposal, this could be as much as 60 days but should not be less than 30.”
Taking this into account, and considering the changes proposed would be a reduction in regulatory burden for industry, the APVMA undertook a 6 week period of consultation regarding the proposed instrument (19 May 2016 through to 28 June 2016). The APVMA received 8 submissions on the proposals. These all supported the proposed additional notifiable variations however some wording revisions were suggested. These have been incorporated into the Legislative Instrument.
NOTES ON ITEMS
Item 1 Name of instrument
1. This item states that the full name of the instrument is the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2016.
Item 2 Commencement
2. This item states that the instrument commences on the day after it is registered.
Item 3 Object
3. This item provides that the object of this instrument is for the APVMA to set out additional variations to relevant particulars determined to be notifiable variations.
Item 4 Definitions
4. This item provides that words and expressions that are used in the Code and in the Regulations have the same meaning in the instrument. It also provides a definition of Labelling Code and the FAISD handbook.
Item 5 Notifiable Variations
5. This item adds a table setting out additional particulars which are determined to be notifiable variations for the purpose of subparagraph 25AB(3)(a)(i).
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2016
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The purpose of this Instrument is for the APVMA to set out additional variations to relevant particulars determined to be notifiable variations.
Human rights implications.
The Instrument does not engage any of the applicable rights or freedoms.
Conclusion
The Instrument is compatible with human rights as it does not raise any human rights issues.