In addition to the wider reform package to streamline the regulation of agvet chemicals, we have identified further improvements in agvet chemical regulation. These improvements build on efficiencies already gained from the passage of legislation in 2013 and 2014 to reform how the APVMA operates. The changes have been drafted as amendments (Amendment Regulation) to the Agricultural and Veterinary Chemicals Code Regulations 1995.
About the amendment regulation
The package of amendments will consist of seven measures.
Simplify routine variations to a formulation
Chemical manufacturers have advised the department that significant effort is expended in making routine applications to the APVMA to amend mundane information about the constituents of products. Often changes are made only to respond to changes in supply arrangements for chemical manufacturers and have no effect on the safety or efficacy of the product.
This reform would provide a streamlined mechanism to allow substitution of non-active constituents in formulation of a registered chemical product in limited circumstances.
All substitutions would be on the basis:
- the concentration of the substituted constituent is the same (or within allowable tolerances for variations) as the original constituent; and
- the substituted constituent performs the same function in the chemical product as the original constituent.
Non-active constituents would be permitted to be substituted through a notification process:
- if the CEO of the APVMA has determined, by legislative instrument, that the two constituents are interchangeable within products; or,
- the non-active constituents have similar chemical appearance and similar chemical behaviour
Simplify the process for registering or varying a suite of chemical products
Chemical manufacturers have advised the department they prefer to release a complete suite of agvet chemical products at a single time. Examples of suites of agvet chemical products are products with the same active constituent but different formulation types (granule, powder and concentrate) or a product range for large, medium and small dogs.
This reform would provide applicants with the ability to link applications and decision dates across a suite of products. The period for determining all the applications for products in a suite would be coupled to the first application for a product in that suite.
Simplify the process for variations to the name of overseas veterinary product manufacturers
This reform would provide for variations to the name of a manufacturer of a veterinary chemical to be a prescribed variation. This simplified approach has already been applied to variations of the name of Australian manufacturers of a chemical product, and the overseas sites of manufacture for agricultural chemical products.
Include another international list of animal feed ingredients
Following the implementation of the animal feed reforms in March 2015 discussions with animal feed manufacturers have identified an opportunity to include as an acceptable list of ingredients in an excluded nutritional or digestive products the ingredients listed the Canadian animal feed regulations.
Exclude from regulation bulk material that incorporates excluded animal feed products
Currently, the Code Regulations declare that products that include registered chemical products are not to be veterinary chemical products. The exclusion is conditional on the claims and label instructions of the bulk product are consistent with the incorporated registered product.
This reform would provide that products incorporating an excluded nutritional or digestive product, consistent with the instructions for the included product, would also be declared not to be veterinary chemical products.
Declare a new restricted chemical product
Products containing para-aminopropriophenone (or 4-aminopropiophenone, PAPP) as an active constituent are intended to act as a lethal agent for vertebrates such as foxes and wild dogs. Due to the acute toxicity to humans and non-target species the APVMA has certified that it is in the public interest to declare products incorporating PAPP as restricted chemical products.
This reform would declare PAPP containing products to be restricted chemical products. Limiting supply of the product to qualified and experienced individuals
Change the registration period for renewal
This proposed amendment would allow registration holders to choose either a five-year or single-year renewal period, as permitted by legislation passed in 2014.
Public consultation now closed
An exposure draft of the Amendment Regulation was released for public consultation on 23 October. We received four submissions commenting on the exposure draft. Stakeholders expressed support for all measures, but some requested the government increase the flexibility of one measure.
The exposure draft described a process to allow applications to register or vary a suite of chemical products to be made and determined at the same time. Chemical suppliers would like to make applications for some products in a suite to be made after the first application instead of at the same time as the first application.
The APVMA has advised the department it is not able to implement the suppliers’ preferred approach at this stage. Operational constraints mean industry’s preferred approach to this one measure cannot be rolled out in the time available. We consider we should not delay the benefits that will flow from implementation of the other supported measures to implement a change in that one measure. However, we will look to implement an approach that provides the requested and supported additional flexibility at the next occasion regulations are made.
The department is now preparing the final legislation package for the Minister of Agriculture and Water Resources based on the draft regulation.