THE Australian Pesticides and Veterinary Medical Authority (APVMA) has dismissed allegations that mulesing analgesic product Tri-Solfen had been given a sale permit without thorough evaluation.
However APVAM program manager Allen Bryce also indicated the product had had its permit renewed without residue testing.
He said there was sufficient scientific data available about the two most active ingredients of Tri-Solfen, lignocaine and bupivacaine, to issue and renew a minor use permit, initially in 2005 and again in December last year.
“The product has been widely used and there haven’t been any residue concerns neither within Australia nor in export markets,” Mr Bryce told Rural Press.
“Several safeguards have been enforced including that it’s only available through veterinary surgeons, and for animals sold for slaughter there is a 90-day withholding period.”
But, according to one informed source, speaking anonymously, the fact that Tri-Solfen has failed to secure registration should sound alarm bells for the sheep industry.
For users of Tri-Solfen, said the source, there is a risk that overseas sheepmeat markets could discriminate lambs that were treated with a chemical that did not have through residue testing.
The source also raised questions about the human health risks the analgesic posed after Rural Press revealed in 2008 incidences of health problems occurring in Western Australia.
Mr Bryce, speaking as APVMA was working through a residue data package submitted by Tri-Solfen’s applicant company, Animal Ethics Proprietary Limited, played down the risk that users of Tri-Solfen had been poorly informed.
“Part of our process issuing the permit is to consider human health aspects of both users and consumers and we obtained advice from the Department of Health in both of those processes,” he said.
He insisted the APVMA had made the right choice re-issuing Tri-Solfen a minor use permit, even though he confirmed he was aware of “two or three” cases of “minor symptoms” occurring to people who used the chemical.
Tri-Solfen is a topical local anesthetic used by sheep producers as a pain relief for lambs during surgical mulesing.
It is applied directly to the wound to achieve local anesthesia.
After it was first released onto the commercial market in 2005, Australian sheep producers have leapt on the product with 55 per cent of producers using the product as a pain relief during surgical mulesing, figures from the Department of Agriculture and Food Western Australia 2009 sheep flock demographic study identified.
This is not the first time the pain relief drug has faced controversy over its commericial status.
Two directors of the drug, Dr Meredith Sheil and Mr Chick Olsson were dragged into conflict of interest allegations by the Victorian Liberal senator Julian McGuaran due to their positions as directors on the Australian Wool Innovation board where they were approving funding for pain relief research and commercial stake in Tri-Solfen.
Mr Olsson and Dr Sheil said they had disclosed their relationship with Tri-Solfen, and were co-operating with AWI.
Bayer Animal Health, the commercial permit holder of Tri-Solfen, declined to say if the product had been under question.
But a company spokesperson said Bayer had followed up on health complaints involving three mulesing contractors and written a report to the APVMA in February 2009.
“To date Bayer has received no correspondence on the issue from the APVMA,” the spokesperson said.
Veterinary officers offered mixed responses to potential concerns.
Australia Veterinary Association president of Australian sheep Kim Abbott said the drug had not been assessed for absorption and excretion levels however he was confident the drug was safe to use.
“The 90 day withholding period is a very excessive withholding period,” he said.
Veterinarian David Rendell at David Rendell and Associates, Hamilton, said it was “not unusual” to have products sold without residue testing.
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