EXPLANATORY STATEMENT
Select Legislative Instrument 2009 No. 1
Issued by Authority of the Minister for Agriculture, Fisheries and Forestry
Agricultural and Veterinary Chemicals Code Act 1994
Agricultural and Veterinary Chemicals Code Amendment Regulations 2009 (No. 1)
Subsection 6(1) of the Agricultural and Veterinary Chemicals Code Act 1994 (the Act) provides, in part, that the Governor-General may make regulations prescribing matters required or permitted by the Agricultural and Veterinary Chemicals Code (the Code) to be prescribed by regulations within the meaning of the Code.
Subsection 5(1) of the Act provides that the Code set out in the Schedule to the Act may be referred to as the Agvet Code of the participating States and the Northern Territory.
Under current legislation, and for the purposes of paragraphs 14(3)(d) and 29(1)(d) of the Agvet Code, a veterinary chemical product for bovine intramammary infusion that contains any antibiotic substance must comply with regulation 10 of the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Principal Regulations). This regulation, which was introduced in 1996, requires that a blue dye marker (Brilliant Blue FCF) be included in intramammary antibiotic infusion products.
The use of blue dye was intended to give a visual indication of the fact that a cow’s udder had been treated with intramammary antibiotics. While it was known that the relationship between the excretion rate of the blue dye and the excretion rate of the antibiotic were not always consistent, the dye provided a ready indicator of the treatment status of the udder, thus assisting in preventing the supply of antibiotic contaminated milk to the market.
The Regulations remove regulation 10 from the Principal Regulations as use of the dye is no longer necessary with advances in knowledge and technology. The control was introduced long before the introduction of the on-farm Quality Assurance programs used by industry today and took account of the large numbers of less skilled workers on dairy farms at the time. In addition, the ability to identify and sanction producers of contaminated milk was more problematic at that time.
More recently antibiotic manufacturing companies have proposed that the inclusion of blue dye is not necessary. They argue that:
- blue dye can produce false positive milk which can cost Australian dairy farmers money when milk has to be condemned because the blue dye is still present in the milk in the absence of any antibiotic residue;
- with advances in knowledge and technology, and particularly the general use of on-farm Quality Assurance schemes, there are now new and better mechanisms for dealing with, and detecting, the presence of antibiotic residues in milk; and
- since the inclusion of blue dye is not required by other major dairy producing countries, there is a disincentive for the formulation and supply of new and more effective treatments solely for the Australian market.
The Australian Dairy Industry Council supports the proposal that the requirement be removed as soon as possible. Industry and all state and territory dairy regulators also support this amendment.
Details of the Regulations are set out in the Attachment.
The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Regulations commenced on the day after they were registered.
0826793A-081209Z
ATTACHMENT
THE AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT REGULATIONS 2009 (No. 1)
Section 1 provides the name of the Regulations is the Agricultural and Veterinary Chemicals Code Amendment Regulations 2009 (No. 1).
Section 2 provides that the Regulations commence on the day after they are registered.
Section 3 provides that Schedule 1 amends the Agricultural and Veterinary Chemicals Code Regulations 1995.
Schedule 1 – Amendment
Item [1] omits regulation 10. This removes the requirement for a blue dye marker (Brilliant Blue FCF) to be included in intramammary antibiotic infusion products.
Overview
The Agricultural and Veterinary Chemicals Code Amendment Regulations 2009 (No. 1) were enacted to address the outdated requirement for a blue dye marker in intramammary antibiotic infusion products, as outlined in the Agricultural and Veterinary Chemicals Code Act 1994. This legislation was introduced in response to technological advancements and improved on-farm Quality Assurance programs, which have rendered the dye marker unnecessary. The policy objective behind these amendments was to align the regulatory framework with current industry practices and international standards, ensuring that the Australian dairy industry remains competitive and efficient. The Regulations were issued by the Minister for Agriculture, Fisheries and Forestry under the authority granted by the Act, and they came into effect on the day after their registration. These changes reflect the consensus support from the Australian Dairy Industry Council, industry stakeholders, and all state and territory dairy regulators.
Scope and Application
The Agricultural and Veterinary Chemicals Code Amendment Regulations 2009 (No. 1) apply to entities and individuals involved in the production, distribution, and use of agricultural and veterinary chemicals in Australia, particularly those related to intramammary antibiotic infusion products for bovines. This regulation is a direct amendment to the Agricultural and Veterinary Chemicals Code Regulations 1995 under the Agricultural and Veterinary Chemicals Code Act 1994, affecting the entire Australian jurisdiction as it pertains to the participating states and the Northern Territory. These regulations remove the requirement for a blue dye marker in intramammary antibiotic infusion products, recognising the advancements in technology and the effectiveness of contemporary Quality Assurance programs in ensuring milk safety. The exclusion of the blue dye aims to address issues such as false positive milk results and aligns with practices in other major dairy-producing countries, thereby facilitating the introduction of more effective treatments in the Australian market. The changes are effective immediately upon registration and are applicable nationally, with the intent to modernise and streamline dairy industry practices while maintaining stringent quality standards.
Key Provisions
The main operative sections of these Regulations, as stated in Section 3, amend the Agricultural and Veterinary Chemicals Code Regulations 1995 (Principal Regulations) by omitting regulation 10. This regulation, which was previously a requirement for the inclusion of a blue dye marker (Brilliant Blue FCF) in intramammary antibiotic infusion products for bovine use, is being removed because advances in knowledge and technology have rendered it unnecessary. This change responds to the industry’s assertion that the blue dye can result in false positives and economic losses for dairy farmers when milk is condemned due to the presence of the dye without any antibiotic residue.
The Regulations impose obligations on the parties involved, primarily manufacturers of veterinary chemicals, by removing a specific requirement that was once critical for ensuring that treated udders could be identified visually. This change shifts the responsibility for ensuring compliance with standards from the chemical product itself to broader quality assurance programs and other industry practices. The amendment reflects a confidence in the current mechanisms for detecting antibiotic residues and managing the quality of milk production, suggesting that the industry has developed more effective controls.
The Act does not explicitly outline offences or penalties for breaches of these Regulations in the provided text. However, the overarching Agricultural and Veterinary Chemicals Code Act 1994 provides a framework for enforcement and penalties for non-compliance with regulations. Generally, non-compliance with the Code or the Regulations can result in administrative penalties, including fines, and in severe cases, criminal charges. The specific penalties would depend on the nature and severity of the breach, as outlined in the Act.
Overall, these Regulations reflect an adaptation to modern practices and industry standards, removing an outdated control that is no longer necessary. The shift to more sophisticated quality assurance programs and the acceptance of international standards underscore the regulatory body’s intent to streamline and modernise the regulatory framework for agricultural and veterinary chemicals in Australia.