October 12, 2015
Global chemical manufacturers call for robust, consistent approach to screen and test chemicals for interaction with the endocrine system
Principles will advance scientific understanding and support development of scientific consensus
GENEVA, SWITZERLAND, September 28, 2015 – The International Council of Chemical Associations (ICCA) today released its “Principles for Identifying Endocrine-Active and Endocrine-Disrupting Chemicals,” a set of 11 recommendations to promote reliability, consistency and scientific integrity in the screening and testing of chemicals for endocrine activity and endocrine disruption. The release of the Principles comes at the beginning of the United Nations Environment Program’s Fourth Meeting of the International Conference on Chemicals Management, where stakeholders including government representatives, non-governmental organizations and industry are meeting to discuss ways to promote sound chemicals management around the globe.
The endocrine system is the collection of glands that produce hormones that help regulate many bodily functions. Some natural and man-made chemicals can and do interact with the endocrine system, or are “endocrine-active.” In some cases, this interaction is harmless: the substances lack sufficient potency or exposures are so low that no effects occur at all; in other cases, the body naturally adjusts, and the exposure causes no health effect. However, some substances under certain exposure scenarios go beyond a simple interaction and can result in adverse health effects – these substances are often referred to as “endocrine disruptors.”
Through the efforts of governments, academia and industry, considerable progress has been made to develop methods, tests and data that could help answer questions about whether and how certain chemicals may affect the endocrine system. However, some recent studies have failed to incorporate critical information including exposure and weight of evidence analysis and/or have used unreliable methods, reducing their relevancy to sound decision-making.
“Chemical manufacturers agree that more research is needed to better understand whether, how and to what effect specific chemicals interact with the endocrine system,” said ICCA Council Secretary Cal Dooley. “These common-sense principles will help enhance the reliability, credibility and relevance of research intended to identify whether chemicals interact with the endocrine system and if that activity causes harm. By improving screening and testing, we can support evidence-based decision making by regulatory agencies as they develop and implement programs intended to reduce risks associated with endocrine disrupting chemicals.”
Even as progress has been made, more work is required to better understand endocrine-active and endocrine disrupting chemicals and their effect. As testing and regulatory programs develop, the following principles should be incorporated to ensure that results are reliable and relevant to regulators and the public:
- APPLY PRECISE AND ACCURATE CHARACTERIZATIONS TO CHEMICALS – Chemicals should not be labeled as endocrine disruptors unless there is scientific consensus that they cause adverse health effects through an endocrine mediated pathway. This will prevent confusion and potential unnecessary market disruption.
- ADHERE TO CREDIBLE TESTING METHODS AND DATA – Programs should incorporate objective measures of data quality and follow Organization for Economic Cooperation and Development (OECD) guidelines for good laboratory practices.
- CONDUCT THOROUGH INVESTIGATION – Screens and tests should examine hormone related effects characterize system toxicity and consider biological factors such as absorption, distribution, metabolism and excretion.
- MUTUAL ACCEPTANCE OF DATA – Data from tests conducted according to OECD Guidelines should be acceptable for use by multiple organizations so duplicative testing can be minimized.
- ENGAGE IN TRANSPARENT DECISION-MAKING – Testing programs should engage in clear, public, and consistent decision-making processes.
- BE EFFECTIVE AND EFFICIENT – Testing programs should be designed to maximize efficiency and minimize delays.
- APPLY ADVANCED TECHNOLOGY – Programs should utilize validated, new technologies to increase progress and reduce the need for animal testing.
- CONSIDER REAL WORLD EXPOSURES – Testing programs must incorporate relevant exposure information so conclusions are based on actual risk, not solely on hazard.
- INCORPORATE WEIGHT OF THE EVIDENCE ANALYSIS – All credible evidence should be incorporated to ensure that the most reliable and relevant studies carry the greatest influence on conclusions and outliers do not skew findings.
- EMBRACE A PROTECTIVE APPROACH – Screens and tests should be highly sensitive and as accurate as possible. Screens should err on the side of over-identification, and in cases where results are ambiguous, further testing should be pursued.
- ACCEPT SAFE LEVELS OF EXPOSURE – Thorough examination can identify safe levels of exposure. The hypothesis that low levels of exposure can cause harmful effects that are not adequately captured by traditional toxicological studies is often discussed, but rigorous reviews by scientists at regulatory agencies have been unable to validate the hypothesis, so changes to current testing and safety assessment approaches are not warranted.
ICCA’s release of the Principles is the latest contribution of the global chemicals industry to advance the scientific understanding of endocrine-active and endocrine-disrupting chemicals. For example, industry has contributed significant resources to the development of screens to identify endocrine activity by specific chemicals. Through the ICCA-supported Long Range Research Initiative, chemical manufacturers have helped develop new High Throughput Screening tools that will allow dozens of chemicals to be prioritized and screened at once, leading to far greater efficiency in testing programs.