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Adverse experience and residue results misreported

14 January 2011

Sometimes, and especially during the Christmas-New Year period, newspapers resort to sensational reporting in order to attract readers. Often, this comes at the cost of informed reporting.

The Canberra Times published two such stories in late December. The first of these, ‘Hormone level in livestock too high, survey finds’ (external site) published on December 28, reported on the findings of the 2009-2010 National Residue Survey. This is a survey, run by the Department of Agriculture, Fisheries and Forestry, that monitors residues of agricultural and veterinary chemicals and environmental contaminants in Australian food commodities. The story opened with the claim that the survey detected ‘higher than acceptable levels of growth-producing hormones in livestock bred for human consumption’, that these hormones were synthetic in origin and that such hormones created human health risks.

The journalist appears to have misread the survey. All hormones found were within relevant Australian standards. The NRS conducted around 200,000 analyses on around 15,000 samples from food producing animals. These analyses turned up 105 detections for hormones.  Of these, 52 (found in deer, cattle and sheep urine) were classified as likely to have been produced by the animals themselves while the remaining 45 detections (in cattle faeces) were classified as likely to have come from naturally occurring hormones in plants. Some 8 detections of a synthetic hormone (trenbolone) were found in cattle liver. No detections exceeded any published standard.

The second story ‘Vaccines, sprays linked to cancers and deaths in pets' (external site) was published on December 29. It reported on the publication of the APVMA’s Report on Adverse Experiences for 2009. This document summarised analyses of reports submitted to the APVMA under its Adverse Experience Reporting Program (AERP) for 2009. The story called adverse experience reports ‘complaints’ and suggested that veterinary medicines such as vaccines, flea treatments and other products were responsible for sudden deaths, illnesses and serious side effects in pets. Significantly, it was claimed that the report indicated that more than 60 dogs died in 2009 from commonly used veterinary chemicals and vaccines.

Adverse experience reports, of course, are not complaints. The Adverse Experience Reporting Program (AERP) is a key program established and promoted by the APVMA that encourages registrants, professionals and members of the public to submit reports when a registered pesticide or veterinary medicine, used as directed, does not act as anticipated. The APVMA actively uses these reports to monitor product safety in the marketplace. This feedback has prompted regulatory change in the past.

In reviewing the statistics presented in the document, the reporter appears not to have recognised that one adverse experience with a product containing multiple active constituents was listed under each active constituent. Some significant over-counting resulted.  For example, there were a little over 2000 reports in 2009, not 2600 as stated. Similarly, there were less than 16 dog deaths that the APVMA believed could possibly have been caused by vaccines and other causes rather than the 60 stated. To put this particular statistic in perspective, and to allay potential concerns of dog owners, an estimated 2.5 million vaccines were administered in 2009.  Therefore, the impression the article created– that administering veterinary medicines can be dangerous to pet health – is misplaced.

Unfortunately, in seeking to generate a focus on the sensational, the good news both reports contained was ignored. And there was good news.

The National Residue Survey, for example, reported high degrees of compliance with relevant Australian standards. For meat products, for example, there was 99.91% compliance with residue standards. For grains, compliance was 99.40% and for horticulture it was 98.90%.  For fish products (wild-caught and aquaculture) and honey there was 100% compliance. These are very positive results that point to the effectiveness of the Australian regulatory regime in maintaining food safety.

Similarly the Report on Adverse Experiences for 2009 demonstrated, for veterinary medicines, the very low number of serious adverse incidents received compared to the very large number of doses/treatments administered. This is testament to the comprehensiveness of the initial assessment process the APVMA undertakes in considering registration.

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Last updated on 2 February, 2011