APVMA's response to Noosa Taskforce report
7 September 2012
The Noosa Fish Health Investigation Taskforce (NFHIT) was established by the Queensland Government in January 2009 to investigate a range of fish health problems at the Sunland Fish Hatchery, including fish deaths and abnormalities. The APVMA was not represented on the Taskforce.
The final report of the chair of the NFHIT (external site) was released in June 2011. A total of 29 recommendations were made to various individuals and organisations including:
- the macadamia industry
- the macadamia farm operator
- the freshwater native finfish aquaculture industry
- the Sunland hatchery operator
- the Australian Pesticides and Veterinary Medicines Authority (APVMA)
- Queensland government's 'Fisheries Queensland'
- the Queensland government, local government and relevant authorities, and
- research providers (government, universities).
Of the 29 recommendations, five were addressed to the APVMA. These were:
- Recommendation 10: Utilise the package of material presented from this investigation (report and raw data) to assess Adverse Experience Reports received recently in relation to incidents at the Sunland Fish Hatchery.
- Recommendation 11: Review the labels for products containing, methidathion, carbendazim, trichlorfon, methoxyfenozide and beta-cyfluthrin to ensure that products containing these pesticides have appropriate label statements for the protection of aquaculture.
- Recommendation 12: Review the priority for the Chemical Review Program for the environmental consequences of the use of methidathion, carbendazim, trichlorfon, methoxyfenozide and beta-cyfluthrin. (Note that methoxyfenozide had a modern environmental assessment in 2002, carbendazim and methidathion are currently under review but not for environmental risk and trichlorfon is listed priority 1 by the APVMA for a review.)
- Recommendation 13: Review the labels for Chorulon® Chorionic Gonadotrophin (APVMA no. 37225, 53659 and 37226) for the clarity of the instructions for use on fish.
- Recommendation 14: Provide advice and discuss the development of regulatory approaches to address concerns raised regarding the potential impacts of mixture toxicity (combined effects of more than one chemical used at a time) and the use agricultural chemicals that have potential to be endocrine-disrupting agents.
APVMA actions prior to the release of the final report of the QLD Taskforce
Adverse experience reports involving farmed fish
The reported fish hatchery incidents considered by the Taskforce had been reviewed by the APVMA. Seven draft veterinary reports, pathology reports and an initial report from Dr Matthew Landos's Future Fish Veterinary Services were submitted to the APVMA's Adverse Experience Reporting Program (most of them by a member of the Taskforce) as adverse experience reports (AERs).
To assist the APVMA in classifying the reports relating to fish, expert opinions were sought from:
- Associate Professor Barbara Nowak of the School of Aquaculture, University of Tasmania, whose area of expertise is aquatic animal health, especially finfish; and
- Drs Paul Hardy-Smith and John Humphrey of Panaquatic Health Solutions Pty Ltd (‘Panaquatic’) (external site), a company with expertise in the health and wellbeing of aquatic animals including fish, molluscs and crustaceans.
These consultants were asked to consider whether the information provided in the various draft reports supported the conclusions reached by the report authors. The Panaquatic report (PDF, 1.00Mb) | (RTF, 1.97Mb) was provided to the APVMA in September 2010 and the University of Tasmania report (DOC, 81kb) in October 2010.
Taking into account the advice from the two expert consultants, the incidents related to the reports in farmed fish were classified by the APVMA1 and the classifications provided to the reporting person, together with copies of the consultants' advice. The fish AERs were classified by the APVMA as either 'unlikely' [either sufficient information exists to establish that the described adverse experience was not likely to have been associated with use of the chemical product(s), or other more plausible explanations for the reported effects exist] or 'unknown' [reliable data are either unavailable or are insufficient to make an assessment].
An updated report from Panaquatic, An independent assessment of adverse experience reports of fish mortalities and deformities —Additional Report (PDF, 518kb) | (RTF, 824kb), dated 28 June 2012, considered additional information which was made available since the publication of their initial report of September 2010, but its conclusions were unchanged from the original report. Thus the APVMA has not made any changes to its classifications of the fish AERs.
1 AERP classifications are 'Probable', 'Possible', 'Unlikely' or 'Unknown'—these classifications relate to the likelihood of the reported adverse experience being linked to the chemical product which was the subject of the adverse experience report—see Adverse experience reporting program for agricultural chemicals (PDF, 106kb).
Adverse experience reports involving other animals kept on the fish farm
The scope of the QLD Taskforce investigation did not include additional adverse experience reports (AERs) involving horses, tadpoles, pigs, bees and chickens (most of which were received by the APVMA in February 2011). In response to a request from the APVMA, the Queensland Government Department of Employment, Economic Development and Innovation (now the Queensland Department of Agriculture, Fisheries and Forestry) provided more information about these AERs to the APVMA and they were classified by the APVMA as follows:
- The AERs in pigs, bees and a horse were all classified as 'Unlikely' because of (1) the evidence of heavy parasitism in the pigs; (2) the very limited numbers of bees affected and the presence of unaffected hives on the macadamia farm where the spraying occurs; and (3) there are many better explanations for symptoms described in the horse than any effects of chemical spray drift or runoff.
- Reports of adverse effects on wild birds, ducks, tadpoles and chickens were classified as 'Unknown' due to the lack of any significant evidence to link them to pesticide drift or run-off.
Adverse experience reports involving human health
Three human AERs reporting symptoms including headache, nausea, throat irritation, a burning feeling on the skin and tiredness were classified as 'Possible' based on advice from the Office of Chemical Safety (OCS) in the Australian Government Department of Health and Ageing that the reactions which were reported could possibly have been related to exposure to xylene, a solvent in a beta-cyfluthrin product used on the neighbouring macadamia farm. Effects seen are known reactions to xylene and evidence provided indicated a potential for exposure to the chemical.
APVMA actions following the release of the final report of the QLD Taskforce
The APVMA is working through the five recommendations of the NFHIT directed to it. A summary work plan is provided below, indicating approximate timings for these responses.
APVMA work plan to address the five Taskforce recommendations
Receive package of material from NFHIT investigation (report and raw data)
|By July 2011||Report and data received|
|10||Use information received from QLD DEEDI to help assess non-fish Adverse Experience Reports||By July 2011||Completed|
|10||Complete and publish outcomes of the terrestrial animal and human adverse experience report assessments||By Oct 2011||Assessments completed
AERP classifications published above on 13 October 2011
|10||Publish external expert reports commissioned by the APVMA in 2010 when it was provided with draft Taskforce reports (and related reports) relating to fish health incidents at the Noosa fish hatchery||By Oct 2011||Two external expert reports published above on 13 October 2011 (see above)|
|10||Update/revise expert reports as necessary to take into account any new information contained in the final Taskforce report and related material provided to the APVMA by the Queensland Government||By Dec 2011||Panaquatic has looked at additional information made available following publication of the final NFHIT report. A further report titled An independent assessment of adverse experience reports of fish mortalities and deformities —Additional Report (PDF, 518kb) | (RTF, 824kb) dated 28 June 2012 was prepared.|
|11||Seek advice from the Department of Sustainability, Environment, Water, Population & Communities (DSEWPaC) on label amendments suitable to protect aquaculture||By Sept 2011||Referred to DSEWPaC for advice. Advice received and APVMA’s Chemical Review Program will work towards revision of labels of products used in macadamia orchards to add or revise water body protection statements.|
|12||Seek advice from DSEWPaC on the priority of chemicals for review||Referred to DSEWPaC for advice. Products used in macadamia orchards were recommended for spray drift reviews but DSEWPaC concluded that full chemical reviews were not warranted.|
|13||APVMA’s Veterinary Medicines Program and the product registrant to consider the adequacy of the label for Chorulon® Chorionic Gonadotrophin||By Dec 2011||APVMA has requested the product registrant to reconsider the information on its label.
The applicant has volunteered to update the label; once an application for a label variation is received and accepted, a link will be provided to the application summary.
Issue of mixtures toxicity and of endocrine-active chemicals to be addressed by APVMA’s Principal Scientist, in consultation with APVMA’s advisory agencies
|2012||Technical policy issues are being considered by the APVMA, the Office of Chemical Safety (OCS) in the Department of Health & Ageing, and DSEWPaC. Staff from the APMA and its advisory agencies attended a workshop on the assessment of chemical mixtures in July 2012 and the APVMA is helping to organise a national workshop on the regulation of endocrine disrupting chemicals in 2013.|
DSEWPaC—Australian Government Department of Sustainability, Environment, Water, Population and Communities
- The Queensland Department of Employment, Economic Development and Innovation sought Independent comment on the NFHIT report (external site) from Toxikos Toxicology Consultants.
- The Queensland Government's Noosa fish health investigation (external site) website.
- Media release, 8 June 2011: APVMA to examine Noosa Fish Health Investigation Taskforce final report.
|13 October 2011||Regulatory News: Update on APVMA's response to Noosa Taskforce report|
|8 June 2011||APVMA to examine Noosa Fish Health Investigation Taskforce final report|
|29 November 2010||Independent comment on the NFHIT report (external site)|
|2 September 2010||An independent assessment of adverse experience reports of fish mortalities and deformities (PDF, 1Mb) | (RTF, 1.97Mb)|
|January 2009||Noosa fish health investigation (external site)|
Phone: +61 2 6210 4701 (select option 3)