Chemicals Management: Observations on Human Health Risk Assessment and Management by Selected Foreign Programs

What GAO Found

The foreign programs GAO reviewed—Canada’s Chemicals Management Plan (CMP), Australia’s Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework, and the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) Monographs Programme and International Programme on Chemical Safety (IPCS)—assess the human health risks of chemicals using similar analytic approaches, such as using specific criteria to determine which assessments to prioritize. However, there are some notable differences emphasized in these programs. Canada’s and Australia’s programs emphasize the use of screening assessments—assessments that vary in complexity ranging from a rapid screen of information to using more complex approaches, depending on what officials determine is needed to adequately understand relevant risks, and WHO’s IARC Monographs Programme and IPCS emphasize expert review by selecting internationally recognized experts to conduct or review assessments. Specifically:

• Canada completed a process through its CMP of prioritizing roughly 23,000 chemicals and other substances to identify those that warranted further assessment. That multiyear process identified about 4,300 substances for further review, and Canadian officials told us they aim to address them all by 2020. Officials reported that, as of June 2015, they have completed screening assessments for about 2,700 substances (about 63 percent).
• Australia prioritized a list of about 38,000 industrial chemicals through its IMAP framework to identify those for further assessment. Program officials committed to assessing a list of 3,000 priority chemicals between 2012 and 2016, and they recently told us that they have met this deadline, having completed 3,185 assessments of individual chemicals by July 2015.
• WHO’s IARC Monographs Programme appoints expert working groups composed of internationally recognized experts to evaluate existing information on selected chemicals and other agents to form a conclusion about their carcinogenic risks to humans. According to its website, the IARC Monographs Programme has assessed the carcinogenic risks of more than 900 chemicals and other agents since 1971.
• WHO’s IPCS uses a panel of international peer reviewers selected for their scientific expertise to review an initial draft assessment of the human health risks of selected chemicals, then sends the draft to a second set of experts who determine, among other things, whether peer review comments were appropriately addressed. According to its website and a program official, since 1976, IPCS has completed about 287 assessments.

Canada uses various approaches to manage the human health risks of toxic chemicals under the Canadian Environmental Protection Act, 1999 (CEPA 1999). Specifically, for all chemicals and other substances determined to be toxic under CEPA 1999, and proposed for CEPA 1999’s List of Toxic Substances, officials may use a variety of mechanisms to manage identified human health risks, such as regulations, pollution prevention plan notices, and Significant New Activity provisions.

To manage the thousands of chemicals in commercial use, decision makers around the world rely on information derived from assessments that examine the risks these substances may pose to human health and the environment. The Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program and others conduct such assessments, which provide the foundation for the agency’s risk management decisions. GAO added EPA’s processes for assessing and controlling toxic chemicals to the list of government operations that are high risk in January 2009 as a result of GAO’s reports on EPA’s IRIS Program and EPA’s work under the Toxic Substances Control Act (TSCA).

Foreign programs conduct risk assessments and take risk management actions to prevent and reduce threats posed by chemicals to human health and the environment. Given EPA’s interest in addressing long-standing problems and questions raised among lawmakers about chemicals management, GAO reviewed methods used by four foreign entities—Canada’s CMP, Australia’s IMAP framework, and WHO’s IARC Monographs Programme and IPCS—that EPA and the Congress may find informative while considering improvements to the IRIS Program, TSCA, or other chemicals management efforts. Specifically, this report examines: (1) how selected foreign programs conduct risk assessment activities to understand the human health risks of certain chemicals and (2) how Canada manages the human health risks of chemicals identified as toxic under CEPA 1999. GAO focused on risk assessment in these Canadian and Australian programs, and in the WHO IARC Monographs Programme and IPCS because of their quality assessments. GAO focused on Canadian risk management actions because Canada’s approach is regularly discussed in the TSCA reform debate and because Environment Canada and Health Canada are the only programs in GAO’s study that also conduct risk management activities. GAO met with representatives of the four foreign programs selected, reviewed relevant documentation, and interviewed stakeholders from industry and environmental organizations.