Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
APVMA Review of Fenthion Dr Raj Bhula – Pesticides Program Manager Dr Jason Lutze – Pesticides Residues Manager 18 Oct 2012 Agvet Chemical Management in Australia APVMA regulates veterinary medicines and pesticides up to the point of retail sale State/Territory Government Agencies regulate actual use of all chemicals (control of use) Work cooperatively to deliver the National Registration Scheme Legislative Criteria Can only register or continue to allow registration or use of a product if is not an undue hazard to people (handling or exposed to residues) Would not be likely to have an effect that is harmful to human beings does not have an unintended harmful effect on plants, animals or the environment does not unduly prejudice trade is shown to be effective Criteria are defined in legislation (Agvet Code Act) What is Fenthion? An Organophosphorus insecticide used to control insect pests Mostly used for Medfly and QFF control and included in Interstate Certification Assurances Labels allow use on a wide range of fruits and vegetables Can be used in a home garden setting as well as for commercial purposes Chemical Review Process - Fenthion Announced in 1994 Commenced in 1998 ARfD established Commitment received from HAL for data generation Data submitted Residues Dietary Risk report published Consultation throughout review APVMA consulted widely on likely outcomes of the review since establishment of ARfD Industry consultations commenced in 2006 Observer on Dimethoate and Fenthion Response Coordination Committee (DFRCC) Residues And Dietary Risk Assessment A residues and dietary risk assessment is required to set Maximum Residue Limits in food crops Residues data provided to the review from chemical manufacturer and HAL Agree with FSANZ on dietary risk assessment approach Methods used are consistent with international guidance Dietary Exposure Assessment Elements of a Dietary Exposure assessment - Health Standards Established by Aus Govt Department of Health – Published the Human Health Assessment – Consistent with international guidance Initial toxicology Report in December 2005 (revised with OHS information 2012) New health standards recommended for short-term and long-term exposures (ARfD & ADI ) Elements of a Dietary Exposure assessment - Health Standards Country ADI (mg/kg bw/day) ARfD (mg/kg bw) EU - - Canada (2003) 0.0001 0.002 US EPA 2001 0.00007 0.0007 WHO 2000 0.007 0.01 Australia 0.002 (2000) 0.007 (2004) • • AUS standards higher than Canada and US Based on human data, 10 fold safety factor Elements of a Dietary Exposure assessment - Health Standards Acute exposure – short term exposure (24 hour period) to the chemical from residues in food, corresponding to acute reference dose (ARfD) food consumption data for various age groups and general population Each food type (eg apple, peach) considered separately Chronic exposure – lifetime exposure to that chemical from residues in food, corresponding to ADI (acceptable daily intake) food consumption data for general population Consider all foods together Elements of a Dietary Exposure assessment - Food Consumption Data • • Provided by Food Standards Australia New Zealand (FSANZ) Adults (general population) - 1995 National Nutrition Survey • • Data from 13,858 Australians Children - 2007 Australian National Children’s Nutrition and Physical Activity Survey • Data from 4,487 Australian 2-16 year olds How Large are High Consumer Portions? Children, 5 years (24 hours) – – – – Apple – Peach – Grapes – Tomato – 332 g (about 2) 305 g (about 2) 640 g (160 av sized) about 1.3 or 10 small cherry toms NOT based on average consumption NOT based on consumption on more than 1 day NOT based eating more than one fruit type in a day Elements of a Dietary Exposure assessment - Residue Data • Provided by registrant and industry (HAL) • Must address maximum use rate allowed on label • • If it is allowed on the label, it can be done Data was not available for all uses • e.g. pome, citrus Dietary Exposure Assessment Dietary Exposure Assessment Once dietary exposure threshold is exceeded, uses must be modified or removed – MRLs must be safe for consumers Product labels varied and new instructions issued Outcomes of September 2012 Report Limit of safety margin in ARfD ARfD Outcomes of September 2012 Report Estimated exceedances above ARfD for children (2 to 6 years) for various crops grapes 5×; apples 9×; cherries 4×; peaches 10×; nectarines 6×; cucumbers 12×; tomatoes 4×; Below the ARfD and acceptable for tropical fruit with inedible peel such as mango, avocado, custard apple Olive nursery stock Melons, pre harvest peppers, post harvest chilli peppers Data requirement Outcomes of September 2012 Report How much would a 5 year old child need to eat to exceed the health standard (ARfD)? – – – – Apple – Peach – Grapes – Tomato – 0.4 of an average size apple 0.4 of an average size peach 27 average size grapes about 1.1 or <10 small cherry toms Results of chronic dietary exposure assessment At commencement of review – – Chronic exposure > 17x the acceptable standard Individual MRLs unacceptable • Citrus, stone fruit, pome fruit, grapes Acceptable after implementation of report recommendations – – After removal of uses not supported on basis of acute exposure Will need to re-assess on basis of alternate uses What Does This Mean? This means that the new health standard, the acute reference dose, provides a trigger for action based on estimated dietary exposures for children The margins of safety that are put in place to protect consumers are inadequate Some regulatory action is required to either modify, restrict or remove uses Other regulators internationally take action based on dietary risk What Does This Mean? The data indicate that margins of safety are inadequate for most uses The MRLs for these uses represent an unacceptable acute health risk Take action via a proposed suspension and then consider data gaps towards the end of the review What Does Residue Monitoring Data Tell Us? National Residue Survey residue data Exposure estimate is 9× over the acute reference dose 3 out of 1948 apples had fenthion residues One of those samples had unacceptable residues No treatment history Limited monitoring data available Data published by NSW ag covering all states (1998) Very summarised and aggregated A number of the samples had unacceptable residues What Does Residue Monitoring Data Tell Us? Random monitoring data not very useful in acute / short term dietary exposure analysis Maximum residue scenario must be addressed Random data: Worst case is international convention To adequately protect consumer health from acutely toxic pesticides Not targeted – do not know if fruit was treated May not have been treated at maximum legal rate May not have been treated as often and legally allowed May not have been harvested at minimum WHP May be an extended period between harvest and sampling More useful for chronic or long term dietary exposure assessment International Activity Fenthion not registered for food producing uses in EU, USA, Canada or NZ No fenthion MRLs established in USA for plant products – NIL tolerance for residues All fenthion MRLs in EU at limit of quantitation No fenthion MRLs in Canada No fenthion MRLs in NZ Next Steps Propose to commence suspension in October Will be further opportunity during the suspension period to generate more data to support/modify some uses Are There Any Alternatives? Some registered products for fruit fly control Had only a few requests for permits for alternative chemical options Can provide priority assessments for permit applications Consolidated requests for permits encouraged Website contains relevant permit information Permits Will be cancelled at time of suspension Application needs to be made for reissue APVMA NOT involved in ICA approvals Thank you … Questions please