This consultation closed on 5 October 2021
Consultation period7 September 2021 to 5 October 2021
The Australian Pesticides and Veterinary Medicines Authority (APVMA) proposes to convert the current informal standards established mainly for active constituents in agricultural chemical products and published on its website into a formal standard (legislative instrument) established under section 6E of the Agvet Code.
Under regulation 8AF of the Agricultural and Veterinary Chemicals Code Regulations (the Agvet Code Regulations), the APVMA must publish a notice of its intention to establish a standard under section 6E in the APVMA Gazette and on the website. The draft standard must also be published on the website, and a period not less than 28 days must be allowed for comment on the proposed standard.
The draft section 6E standard is available on our website. This notice has also been published in the APVMA Gazette on 7 September 2021.
Regulation 42(3) of the Agvet Code Regulations specifies the standard prescribed for a chemical product or a constituent within that product, for the purposes of section 87 of the Agvet Code (which relates to compliance of a product or constituent with standards and includes penalties for non-compliance) as being the standard published in any of a ‘cascade’ of publications, with a publication higher in the cascade taking precedence over one lower down. The publications are, in order, a standard specified in an Order made under section 7 of the Agvet Code Act (of which there are none currently), a standard made under section 6E of the Agvet Code (as is proposed), a standard published for a listed chemical product, a monograph in the British, European or US Pharmacopoeia, or a specification by published by FAO and/or WHO.
Establishment of the active constituent standards as a standard under section 6E would mean that the APVMA standards, over which APVMA has full control, would take precedence over a potentially inappropriate and irrelevant standard from another publication.
All standards currently listed on the website are proposed for inclusion in the new section 6E standard, together with approximately 20 standards for recently approved actives which have been consulted on via a Gazette notice but are not yet published on the website. Minor errors were also corrected when found. Beyond this, it should be noted that no changes to the standards currently published on the website, in terms of changes to minimum purities, or changes to identities or levels for impurities, are proposed in conjunction with the establishment of a standard under section 6E.
This standard would operate in conjunction with the current requirements and processes for approval of active constituents, and there are no proposed changes to those processes. In particular, this standard operates in conjunction with and does not replace the conditions of approval of active constituents prescribed under regulation 17C(1) of the Agvet Code Regulations. For example, where a source of active is approved with a higher minimum purity than the minimum specified by the standard, the conditions of approval will still prescribe the higher minimum purity approved for that particular source.
Should the standard be created as a legislative instrument, it would be updated regularly to include new active constituents and to make any changes necessary to existing standards, such as in conjunction with a chemical review. All such changes would be consulted on as required by regulation 8AF.
Further information on the proposed standard can be obtained from the contact details given below.
In accordance with regulation 8AF of the Agvet Code Regulations, the APVMA therefore invites any person to make written submissions on the proposed standard.
Submissions must be received by APVMA by 5 October 2021 and be directed to the contact listed below.
Please note that submissions will be published on the APVMA’s website unless you have asked for the submission to remain confidential (see public submission coversheet).
Please lodge your submission with a public submission coversheet, which provides options for how your submission will be published.
Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.
Please send your written submission and coversheet by email or by post to:
Director Chemistry and Manufacture
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Links to the relevant legislative references are provided below:
- Agricultural and Veterinary Chemicals Code Act 1994
- Agricultural and Veterinary Chemicals Code Regulations 1995
The APVMA sought comments from interested stakeholders on its proposal to convert the current informal standards established mainly for active constituents in agricultural chemical products into a formal standard (legislative instrument) established under section 6E of the Agvet Code, in a consultation that closed on 5 October 2021.
A total of 3 submissions were received; however, one submitter requested their submission not be published.
A copy of the published submissions is available on our website.
The APVMA is currently considering all submissions received as part of this consultation.