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GAO-16-111R 1 (2015-10-09)

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cAO U.S. GOVERNMENT ACCOUNTABILITY OFFICE
441 G St. N.W.
Washington, DC 20548



October 9, 2015


The Honorable Edward Markey
Ranking Member
Subcommittee on Superfund, Waste Management, and Regulatory Oversight
Committee on Environment and Public Works
United States Senate

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

Dear Senator Markey:

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.
EPA's assessments provide a foundation for the agency's risk management decisions, such as
whether to establish air and water quality standards to protect the public from exposure to
particular toxic chemicals. Consequently, risk assessments are a critical component of EPA's
capacity to support scientifically sound environmental decisions, policies, and regulations under
a variety of statutes. Various foreign programs, such as Canada's Chemicals Management Plan
(CMP), Australia's Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework, and
the World Health Organization's (WHO)1 International Agency for Research on Cancer (IARC)
Monographs Programme and International Programme on Chemical Safety (IPCS) also conduct
risk assessments or components of risk assessments.2 In addition, foreign programs and
foreign countries, including Canada, take risk management actions to prevent and reduce
threats posed by chemicals to human health and the environment.

We have repeatedly reported that EPA's ability to fulfill its mission of protecting public health
and the environment is critically dependent on credible and timely assessments of the risks
posed by chemicals.3 In January 2009, we added transforming EPA's processes for assessing


1The WHO directs and coordinates international health within the United Nations' system. The United States is one of
194 WHO member states.
2Risk assessments typically include four components: hazard identification, dose-response assessment, exposure
assessment, and risk characterization. According to their representatives, WHO's IARC Monographs Programme
produces the hazard identification component of an assessment, while the other three programs produce all four
components. Other foreign programs, including those in the European Union, also conduct risk assessments. Due to
ongoing trade negotiations between the United States and the European Union that address, among other things,
coordination of chemical regulatory regimes, we did not include European Union entities in our review.
3GAO, Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and
Credibility of EPA's Integrated Risk Information System, GAO-08-440 (Washington, D.C.: Mar. 7, 2008); Chemical
Assessments: Challenges Remain with EPA's Integrated Risk Information System Program, GAO-1 2-42
(Washington, D.C.: Dec. 9, 2011); and Chemical Assessments: An Agencywide Strategy May Help EPA Address
Unmet Needs for Integrated Risk Information System Assessments, GAO-i 3-369 (Washington, D.C.: May 10, 2013).


GAO-16-111R Foreign Chemicals Management


Page 1

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