4468c3a2-35dc-4fd0-8c32-f6ba6962b24c_APVMA.pdf

☣️ APVMA Created @September 16, 2024 4:17 PM Class LAWS90003 APVMA: Australian Paesticide and Veterinary Medicines Authority Purpose: regulation of agricultural chemicals including veterinary therapeutic products (medicine...

☣️ APVMA Created @September 16, 2024 4:17 PM Class LAWS90003 APVMA: Australian Paesticide and Veterinary Medicines Authority Purpose: regulation of agricultural chemicals including veterinary therapeutic products (medicines). Key Insights Understanding the roles of various regulatory agencies in ensuring the safety and efficacy of biotechnology products is crucial for compliance. The historical development of pesticide regulation illustrates the evolution of safety standards and public awareness regarding chemical use. APVMA 1  Risk management is a central theme in regulatory processes, balancing benefits against potential hazards related to chemical exposure. The assessment of international trade implications is vital for the approval of agricultural chemicals, as different countries have varying residue standards. The importance of transparency and public trust in regulatory bodies is highlighted by concerns over industry influence and the integrity of scientific evaluations. Frequently Asked Questions What is the role of the APVMA in regulating agricultural chemicals? The APVMA regulates agricultural chemicals and veterinary therapeutic products in Australia, ensuring they are safe, effective, and appropriately labeled before they can be used or sold. How does the regulatory process differ between Australia, the US, and the EU? While the fundamental aim of protecting human health and the environment is consistent across these regions, the specific regulatory frameworks, processes, and agencies involved can vary significantly. What are the implications of Maximum Residual Limits (MRLs) in chemical regulation? MRLs dictate the highest level of pesticide residues allowed in food, influencing both domestic safety standards and international trade, as different countries may have varied tolerance levels. How can companies ensure compliance with regulatory requirements? Companies can ensure compliance by conducting thorough risk assessments, adhering to safety and efficacy criteria, and working closely with relevant regulatory agencies to navigate the approval process effectively. APVMA 2  Regulation of pesticides—USA Federal Insectiside Act (1910) protected from fraudulent or adulterated products. Federal Insecticide, Fungicide and gave control to the department of the interior and Rodenticide Act (1974) Department of Agriculture. Pesticides Control Amendment established safe limits, overseen by FDA. (1954) prohibited carcinogenic pesticide residues or natural Food additives Amendment (1958) additives in foods EPA creation (1970) Took control of pesticide regulation from FDA Federal Environmental Pesticides required proof of a lack of “ unreasonable adverse Control Act (1972) effects” on human health or the environment Pesticides and US EPA today EPA: regulates pesticides under FIFRA and FQPA. USDA and FDA: set standards for pesticide residue levels on or in crops. Veterinary Medicine in the US Centre for Veterinary Medicine (CVM): Part of the FDA, ensures animal drugs are safe and effective CVM mission: protecting human and animal health. Pesticides in the EU Regulation (1107/20009): Authorized by the EU parliament European Food Safety Authority: Conducts risk assessments. Authorisation: valid for 10 years, subject to renewal Veterinary Medicines in the EU European Medicines Authority: Approves veterinary medicines APVMA 3  Directives 2001/82/EC and Regulation (EC) NO 726/2004: Lay down the authorization and monitoring of veterinary medicinal products. History of Pesticide Regulation in Australia National Registration Scheme (1992): Established under the responsibility of the National Registration Authority. APVMA (1993): centralized the registration of all agricultural and veterinary chemicals. APVMA Regulation: APVMA vision: Australians have confidence that agricultural and veterinary chemicals are safe to use. APVMA mission: protect the health and safety of Australia’s people, animals, and environment; support Australian agriculture. APVMA Regulatory Process Approval of Active Constituent: Must be approved before registering a new agevt chemical product. Label Requirements: Products must have a label containing instructions for safe and effective use, storage, handling, and disposal. APVMA Criteria Safety criteria: products must not be an undue hazard to safety, or harmful to humans, animals, plants, or the environment. Efficacy criteria: the product must work as intended. Trade criteria: the product must not prejudice international trade Labelling criteria: the label must contain adequate instructions for use, disposal, and safety. Risk Management APVMA 4  RISK = HAZARD X EXPOSURE: Hazard is the intrinsic properties of the chemical; exposure is direct or indirect contact with the product. Risk Management Matrix: Likelihood x Consequence. IARC on Glyphosate IARC: Classified glyphosate as “probably carcinogenic” Hazard Classification: Indicates the strength of evidence that glyphoaate can cause cancer. APVMA on Glyphosate Inquiry findings based on senate inquiry: Senate review deemed APVMA’s review of glyphosate as “robust”, the concern raised on the indepence of APVMA’s review process. Independent evaluations of studies referenced in IARC report. APVMA’s Regulatory Actions APVMA found no grounds for regulatory action based on Californian case evidence. Actions were taken against non-compliant products. APVMA governance The transition from an advisory body to governing board in 2022 Statutory Authorities: the governance structure in APVMA operates independently, accountable to the Agricultural Minister. Political structure: bicameral system with major political parties. changes in leadership and governance brings significant impact to APVMA’s operation. Current Minister of Agriculture - Julie Collins MP (sworn ministers of Agriculture, fisheries, and forestry) APVMA 5  Relocation issues: staff resistance and significant turnover post relocation. the majority did not move; 17 out of 170 moved. Leadership turmoil—multiple CEO changes and high staff turnover noted staffed commitment praised despite systemic issues. Brennan inquiry findings: allegations of poor governance and workplace culture. Loss of corporate knowledge: high turnover and complaints affecting APVMA’s operations. Regulatory Focus timeframe vs. compliance: APVMA’s focus on registration timeframes at the expense of compliance. Alignment with industry interests: an educational approach to enforcement rather than strict penalties. APVMA Strategy 2030 Themes: focus on improving regulatory processes and stakeholder engagement. 1. regulation 2. Future focus 3. people 4. ICT 5. communications and engagement GLYPHOSATE Risk assessment safety of glyphosate products: all registered glyphosate products undergo rigorous assessments. APVMA 6  safe to use, if used according to the label instructions Glyphosate, if used according to the label, will not result in a level of exposure that can pose a risk. uses a risk-biased, weight-of-induced assessment minimises human risk through instructions for use and safety directions Carcinogenicity of glyphosate IARC clafissification Glyphosate were classified as probably carcinogenic (group 2A) WHO Classification categories of carcinogenicity - overview of classification from Group 1 to 4 Group 2: Gorup 2B: Group 4: Group 1: Probably Probably Group 3: Not Probably not carcinogenic to Carcinogenic to Carcinogenic to classifiable carcinogenic to humans humans humans humans limited evidence Limited of evidence of evidence sufficient inadequate carcinogenicity carcinogenicity suggesting lack evidence of evidence of in humans and in humans and of carcinogenicity carcinogenecity sufficient insufficient carcinogenicity in humans and in humans and evidence of evidence of in humans and in experimental in experimental carcinogenicity carcinogenicity in experimental animals animals in experimental in experimental animals animals animals 65 agents, 274 agents, 11 agents, 504 agents, including 3 including 6 including 8 including 5 1 agent, no biological biological biological biological biological agent agents: - human agents: - BK agents: agents: - human papillmavirus polomavirus Classification of carcinogenicity: APVMA 7  Group 4 was deleted from IARC carcinogen list in 2019. Product Group Tobacco smoke and smokeles Group 1. Tea Group 3 (but very hot liquids group 2A). Coffee Group 2B Processed meats Group 1. Red meat Group 2A Gas stoves and fires emit Group 1 particulates. Solar radiation Group 1. Mobile phones Group 2B. Alcoholic beverages Group 1. Magnetic fields Group 2B/Group 3. IARC Monograph of glyphosate Findings on Glyphosate - evidence of carcinogenicity based on human and animal studies. In 2015, IARC classified glyphosate as "probably carcinogenic to humans" (Group 2A), based on limited evidence of cancer in humans and sufficient evidence of cancer in experimental animals. The study also found strong evidence for genotoxicity in both pure glyphosate and its formulations. The AHS study, despite being a comprehensive study, does not significantly impact the risk of non-Hodgkin lymphoma from exposure to glyphosate. The IARC Working Group conducted a statistical analysis of all studies, including the AHS, and found a significant association between the two. IARC vs. Regulatory Authorities Regulatory Agencies' Data Reliance on Public Domain APVMA 8  Many regulatory agencies rely on industry data from toxicological studies. IARC systematically evaluates all relevant evidence in the public domain for independent scientific review. IARC evaluations are transparent, relying only on publicly available data. IARC Working Group's evaluation of glyphosate included industry studies meeting these criteria. Data from online supplements to published articles was not included, limiting independent assessment. Joint Meeting on Pesticide Residue (JMPR) JMPR is an expert ad hoc body administered jointly by FAO and WHO, held in May 2016. To harmonize the requirement and the risk assessment on the pesticide residues, due to the recent studies suggesting toxicity JMPR conclusion 1. JMPR genotoxicity conclusions dose as high as 2000mg/kg body weight by the oral route, was not associated with genotoxic effects. 2. JMPR cancer epidemiology conclusions The only cohort study found no evidence of association at any exposure level. APVMA position on IARC glyphosate report APVMA's Scientific Assessments of Glyphosate 1996 Reconsideration: Glyphosate restricted use in sensitive waterways. EPA Request: Study showed acute toxicity to tadpoles. Proposed Regulatory Position Report: September 2016. Review of IARC Monograph 112 (Glyphosate): Tier 1 and Tier 2. APVMA 9  Final Regulatory Position: Consideration of evidence for formal reconsideration in March 2017. APVMA concluded reconsideration was not needed for glyphosate. APVMA position on IARC assessment of glyphosate APVMA's Weight-of-Evidence Evaluation and Reconsideration APVMA conducts a weight-of-evidence evaluation, including a Department of Health review. APVMA does not need to formally reconsider registration. APVMA monitors new scientific studies for revision. Relevant observations were validated through independent replication. Weight-of-evidence assessment considers a number of studies and study design quality. Strength-of-evidence assessment can be based on a single study, even with limitations or non-compliance with international protocols. Regulators do not use strength-of-evidence assessments. APVMA’s approach to chemical risk glyphosate "JMPR on Pesticide Residues" Found positive correlation between occupational glyphosate exposure and non-Hodgkin lymphoma in some studies. Only a well-designed large cohort study found no association. APVMA weight of evidence approach emphasizes AHS study. Products containing glyphosate are registered for use in Australia. APVMA-approved products can be safely used according to label directions. APVMA 10  Australian law mandates warnings on product labels, including poisons, first aid, and safety directions. APVMA emphasizes following all label instructions. APVMA considers new scientific information on glyphosate safety and effectiveness. APVMA position on IARC assessment of glyphosate Glyphosate Exposure and Safety Glyphosate exposure does not pose a carcinogenic or genotoxic risk to humans. No scientific basis exists for changing glyphosate's view. Glyphosate's effects are not harmful to humans, animals, plants, or the environment. Glyphosate products are effective and do not prejudice trade. APVMA 11  No scientific grounds for reconsidering glyphosate and its products. APVMA will monitor new assessment reports or studies for revision. Quality controls of studies IARC rely on published studies Quality control of study validity is done by: Research is bound by research ethics, eg. NHMRC code for responsible conduct of research. Peer review of published papers. Fraud happens when other researchers fail to replicate and then investigate the initial study. Regulatory Authorities e.g APVMA Rely on toxicology studies provided by the company submitting the data Quality control of study validity is done by: 1. ehtics of the toxicologists performing the studies, eg, board certification in the US. 2. Codes of Good Laboratory Practice, e.g, FDA cGLP in The US, OECD code of GLP in the rest of the world, Audit and certification process for registered laboratories and fraud uncovered during audit process. Glyphosat: Product vs Actice agent Glyphosate Product Active Agent The active agent is a chemical structure. Drum products contain other agents for dispersal. Carcinogenicity hazards lie in active agents. APVMA 12  Product in use applies hazard, label controls risk. Reducing the exposure—the Label Labels must be consistent with the globally harmonised system of classification and labelling in English and contain: 1. Signal heading 2. Product name 3. Constituent statements 4. ‘Mode of action’ indicator 5. Statement of claims for use 6. Restricted chemical product statements 7. ‘Net contents’ statement 8. Name and address of person primarily responsible for marketing the product 9. Directions for use 10. ‘Not to be used’ statement 11. Other limitations and prohibitions 12. ‘Withholding period’ statements 13. ‘Trade advice’ statements 14. General instructions 15. Resistance warnings 16. Compatibility statements 17. ‘Precaution’ statements 18. ‘Protection’ statements 19. ‘Storage and disposal’ statements 20. Safety directions APVMA 13  21. First aid instructions 22. Batch number 23. Date of manufacture and/or expiry date of product 24. APVMA label approval number 25. Dangerous Goods and worker safety legislative requirements Information required in the labels The Agvet Code stipulates that a label must contain adequate instructions relating to such of the following as are appropriate in limiting the exposure: The circumstances in which the product should be used. How the product should be used. The times when the product should be used. The frequency of the use of the product. The withholding period after the use of the product. The re-entry period after the use of the product. The disposal of the product when it is no longer required. The disposal of the product’s containers. The safe handling of the product and first aid. Agvet Code Label Instructions Prevent undue prejudice to trade or commerce between Australia and outside the country. Use appropriate signal words as per the current Poisons Standard. Store containers for date-controlled chemical products. Address any other matter determined by the APVMA CEO. Off-label use of Agricultural chemicals Off-label is when the use is not recommended and involves significant risks. APVMA 14  Assessed based on the same criteria as registered on-label use patterns. Approval is required for minor uses, emergencies, or research. AVPMA does not regulate use by farmers; each state's Department of Agriculture does. Most off-label use is unregulated. Australia's Off-Label Permit Application Process: Application to APVMA is required, including field and laboratory data. restricted category for pesticides and agricultural chemicals prevents off-label use. APVMA website shows 461 permits for off-label use of glyphosate. Glyphosate Labeling Overview APVMA considered glyphosate in 2016 but found no grounds for reconsideration. APVMA reviewed glyphosate in 1997, setting Australia's health-based guidance values as protective. Labels serve different purposes; more information can be found on the APVMA website. Large-scale pesticides provide more information than home and garden pesticides. Risk = Hazard x Exposure Hazard: intrinsic properties of chemical or formulations - evaluate from lab and field studies in regulatory submission Exposure: direct or indirect contact with the product control by using instructions, i.e. the label critical for safe and effective use APVMA 15  Risk Category Minimum Action Extreme eliminate/ strong mitigation High eliminate/ strong mitigation Moderate mitigate Low monitor In general, elimination is the best option, if not other adverse effects. Multiple tiers of risk management 1. National controls: Risk assessment of new chemicals and uses Control supply of chemicals 2. National and state National policies for chemical management maintain access to markets and facilitate trade 3. State controls Control how chemicals are used Enforce controls to protect the environment and the health of consumers, the community, and farm workers. Reducing risk without regulation 1. training in risk management for chemical users 2. advice from Department of agriculture on chemical selections, adoption of best practices for chemical application 3. reduce dependence on chemical controls and adoption of integrated pest management OHS Laws for Workers' Protection Pesticides are hazardous substances. APVMA 16  Employers must provide a safe workplace. Risk assessment is conducted to identify problems. Proper chemical storage and records are maintained. Provision of personal protective equipment. Provision of use instructions and safety data sheets. Employee training. Adherence to safe practices. Glyphosate Label Safety Guidelines Avoid contact with eyes and skin. Consult label safety directions when using other products. Wear cotton overalls and chemical-resistant gloves when opening and using the spray. Wear a face shield or goggles when mixing and loading. Wear protective waterproof clothing and impervious footwear when using a controlled droplet applicator. Wash hands after use and wash gloves, face shields, goggles, and contaminated clothing daily. Glyphosate Herbicide Efficacy A systemic herbicide that kills both annual and perennial weeds. Non-selective, allowing control of most weeds like grasses, sedges, and and broadleaves. Available in GMO crops for controlling weeds during crop growth. APVMA 17  Risk Management for Glyphosate Advantages Glyphosate has minimal soil residual. It's rapidly bound by clay particles, rendering it inactive. Spraying weeds beneath shrubs and trees without damaging desirable plants. Glyphosate is relatively inexpensive. It's considered one of the least toxic and environmentally benign herbicides. Glyphosate substitution of hazard Tilling is expensive and alternative herbicides are toxic, as commercially available alternatives with similar effects as glyphosate do not exist. Option positive effect negative effect expenses of repeated tilling. Less tilling of soil N herbicide needed effective weed control. loss of top soil very effective - no expensive and produces greenhouse Thermal control herbicide needed gases Crop rotation/other limited efficacy and complex no herbicide needed crop practices management 74-400 times more risk than glyphosate, effective broad Dicamba volatile and sprat drift significant spectrum herbicide problem does not kill grasses; exposure leads to effective broad leaf 2,4 D human fertility problem; possible herbicide carcinogen Option to mitigate glyphosate Reduce exposure, and change the label Timing spraying. APVMA 18  Stopping the use of aerial spraying. Improving use practices with transfer pumps. Implementing engineering controls. Improving handling of coveralls after use - admin control Enhancing PPE. Glyphosate Regulation in the EU Glyphosate is approved for use in EU plant protection products. The EU's next periodic review of glyphosate is set to be completed by December 2023. EU agricultural chemicals regulation involves three stages: hazard assessments by the European Chemicals Agency (ECHA), risk assessments by the European Food Safety Authority (EFSA), and approval by the EFSA. Each EU member country has its own regulatory authority. Several countries are considering or banning the use of the product. Regional bans are also in place. Glyphosate Regulation in the USA Glyphosate has been registered in the USA since 1974. The US Environmental Protection Agency (US EPA) regulates pesticides in the USA. The EPA conducts periodic reviews on a 15-year cycle. The EPA has conducted extensive assessments of glyphosate. Information on ongoing assessments and safety conclusions can be found on the US EPA website. Glyphosate in Australia APVMA 19  Council bans in Victoria, including Port Phillip, Frankston, and Brimbank, have reintroduced glyphosate, aiming for limited use with alternatives. Alternatives include steam weeding, non-glyphosate herbicides, and manual removal. Some residents have established a "no spray" register to avoid chemical herbicides on council land near their homes or childcare centres. APVMA 20