Roles of chemistry in regulating agricultural and veterinary chemicals

1. Roles of chemistryin regulating agricultural and veterinary chemicals George Liang, Jun Wang, RajaniJagtap and Samuel Margerison | July 2017

2. Who is the APVMA?

3. The APVMA is the Australian government statutory authority for the registration of agvet chemicals into the Australian marketplace. apvma.gov.au

4. About the APVMA • The Australian Pesticides and Veterinary Medicines Authority (APVMA) is an Australian Government agency which assesses, registers and regulates agricultural and veterinary (agvet) chemicals in Australia up to the point of the retail sale that has AU$3.5 billion annual value. • Vision: Australians have confidence that agricultural and veterinary chemicals are safe and effective to use • Mission: to protect the health and safety of Australia-its people, animals and environment, and support Australian agriculture by taking a scientific and risk-based approach to regulating agvetchemicals.

5. Legal requirements for agvetchemicals According to Agricultural and Veterinary Chemicals Code Act 1994 (AgVet Code): • Safety criterion (s5A) no undue hazards to users or other people (e.g. bystanders, people consuming treated produce), and no unintended harmful effects on animals, plants, or the environment • Efficacy criterion (s5B) products must be effective and perform in accordance with the label claims • Trade criterion (s5C) use of products must not unduly affect overseas trade (mainly concerned with meeting requirements for chemical residues in export markets) • Labelling criterion (s5D) labels must contain correct instructions on the product’s application methods, times, frequency, withholding period after use, re-entry period, disposal of product and container when no longer needed, safe handling and first aid and others.

6. Chemistry and Manufacture section • APVMA has approximately 200 staff, including about 100 regulatory scientists • Chemistry and Manufacture section has 11 chemists, in four teams: • Chemistry for agricultural chemicals • Chemistry for veterinary chemicals • Chemistry for actives used in agricultural chemicals • Chemistry for actives used in veterinary chemicals. • The Chemistry for ag chemicals team is an expert group who: • assess chemistry and manufacture aspects for products proposed for registration • provide chemistry and manufacture advice to APVMA internal stakeholders • assist internal stakeholders in making a science-based decision whether assessed chemical should be registered/approved or not.

7. Key tasks of the chemistry section The three main tasks we undertake are: • Initial assessment:conducting a formulation comparison to suggest if the proposed application should be chemically assessed or not. • Chemistry assessment: evaluating the chemistry and manufacture data provided by the applicant, and then providing the assessment outcomes to the internal stakeholder to help them make a decision to register or reject it. • Activeconstituent approval: by assessing the chemistry and manufacture data to make a decision to either approve or reject the proposed active.

8. Task 1: Initial assessment (screening):formulations comparison: similarity • Aim: to reduce the regulatory burden on the applicant for an agvetchemical product application • Task: to conduct a formulation comparison between the newly proposed product and the already registered product. • As the APVMA-registered product is assumed to be safe and effective, if the proposed product has a closely similar formulation to the existing one, then the proposed product must be as safe and effective as the registered one, thus minimal assessments are needed. • On other hand, if the proposed product has a brand new formulation, then the potential risk will be the largest and comprehensive assessments for this product will be required. • Results: the initial assessment will make a decision on whether further assessment is required, and at what level.

9. Task 1: Initial assessment (screening):formulations comparison: similarity

10. Task 2: Assessing chemistry data-1 • Aim: to determine whether the assessed chemical remains stable, effective and safe during storage or not. • Tasks: if the chemistry assessment is required: • (1) we will assess the chemistry and manufacture data; • (2) we will provide the assessment results to the internal stakeholder (the risk manager) as to whether the proposed chemical has met the legislative chemistry requirements or not, and • (3) the risk manager will make a science-based decision to register or reject the application, based on the recommendation from us.

11. Task 2: Assessing chemistry data-2 Tasks we undertake for the proposed product: • Checking the correctness and accuracy of the formulation compositions • Inspecting the formulation process including quality controls • Assessing physical and chemical properties • Ensuring both product specifications and the test parameters have met the legislative safety and efficacy criteria

12. Task 2: Assessing chemistry data-2 (cont.) • Assessing the storage stability data to ensure that the product remains safe and effective after a long-term storage (the shelf life) • Evaluating the analytical methods used for determining the content of the active to ensure that the content is accurately assayed, and the associated validation data (linearity, precision and accuracy) for the analytical method • Assessing the suitability of the proposed packaging • Checking the chemistry aspect of the label claim for active content and proposed storage conditions.

13. Task 3: approval of active constituent • Aim: to assess the chemistry and manufacture data for a brand new or new-sourced technical active, to make a decision if the proposed technical active is approved or rejected. • To approve a brand new active constituent, which may require Chemistry and Toxicology assessments, and the associated product containing the new active constituent, which may require Chemistry, Toxicology, Efficacy, Environment and Residues assessments. • To set a new APVMA standard for the newly approved newtechnical active, which will be published on the website. • To approve a new-sourced active constituent, which may require Chemistry assessment only.

14. Conclusions Chemistry plays a key role in regulatingagvet chemicals by: • conducting a formulation comparison to decide if the chemistry and other assessments are needed or not • evaluating chemistry and manufacture data package, to provide chemistry advice to internal APVMA stakeholders to help them make a science-based decision to register or reject an active application. • assessing the chemistry data for a brand new or new sourced active to approve or reject the active application.

15. Acknowledgements • APVMA Chemistry and Manufacture section • APVMA Scientific Assessments & Chemical Review program • APVMA legal team • APVMA staff • YOU ALL

16. Questions?