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How does the APVMA manage endocrine disrupting chemicals?

7 December 2010

Endocrine disrupting chemicals (EDCs) - sometimes also called endocrine-active chemicals - are substances in the environment that can alter the way hormones produced within the body carry signals between cells and tissues. This may affect metabolism, reproduction, development, and/or behaviour of the whole organism.

There are many sources of EDCs in the environment. Some, such as male and female hormones and plant oestrogens (or phyto-estrogens) occur naturally. Others are manufactured. These include synthetically produced hormones such as oral contraceptives and hormone-replacement therapies, as well as some industrial, agricultural, and consumer product chemicals.

The key concern about EDCs is that low doses of these chemicals in the environment (often from effluent from sewerage treatment plants) may adversely affect fish and other aquatic organisms. Concerns also exist for humans who may be exposed  through residues in food or water, and by using certain consumer products.

While clear cause-effect relationships have not yet been established (at least for any human health effects), potential risks have been understood by the scientific community internationally and nationally for some time. In 1996, for example, the Organization for Economic Cooperation and Development (OECD) - of which Australia is a member - established a Special Activity on Endocrine Disrupter Testing and Assessment (external site) with the objectives of:

  • developing new and revised existing Test Guidelines to detect endocrine disrupters
  • providing information and co-ordinating activities of member countries
  • harmonising hazard and risk characterisation approaches to EDCs

National and regional regulatory bodies have also responded in line with greater public recognition of the issue. The European Union (external site), for example, has developed a strategy with short, medium and long term actions. This includes identifying and assessing EDCs and limiting the use and production of harmful substances. Legislation due to be implemented in June 2011 identifies endocrine disrupting properties that may cause adverse effect in humans as a specific criterion. The United States Environmental Protection Agency (external site) also has a program in place to develop a better understanding of EDCs by specifically identifying chemicals that have endocrine disrupting potential.

Australia responded to this issue as early as 1998 when Commonwealth Government agencies involved in chemicals regulation recognised the potential risks and supported the development of international guidelines for additional testing, screening and assessment of EDCs. This interest and involvement continues. Organisations such as the CSIRO, universities, and regional water authorities have research and monitoring projects aimed at better understanding the presence, behaviour and fate of EDCs in aquatic environments.

From a regulatory perspective the current Australian position is that endocrine disruption is but one part of a spectrum of effects that chemicals can cause if animals or humans are exposed to levels which overwhelm normal metabolism and excretion processes.

Endocrine disruption is, therefore, not considered to be an adverse end-point per se, but rather a mode or mechanism of action of a chemical that can potentially lead to adverse toxicological or eco-toxicological outcomes in the whole organism, such as reproductive, developmental, carcinogenic or ecological effects.

For pesticides and veterinary medicines - one source of potential EDCs - current regulatory processes are relatively robust. Before any new pesticide or veterinary medicine can be approved for sale in Australia, it must be comprehensively assessed. This assessment process requires extensive toxicological and eco-toxicological testing with specific elements capable of identifying chemicals with endocrine disrupting potential. These processes, similar to those used by comparable overseas regulators, have ensured that regulatory settings have been conservative and protective in nature. There is ongoing international work, particularly through the OECD Test Guidelines program, to further refine the methods used to identify the risks and to develop even more sensitive assessment methods.

Further research on EDCs continues in Australia, together with associated policy development.  It is a broad field with many players.  As far as pesticides and veterinary medicines are concerned, the APVMA will continue to play an active role, cooperating with other agencies and participating in relevant national and international fora.

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Last updated on 10 December, 2010