Public Release:  EPA should pursue cumulative risk assessment of phthalates and other chemicals

National Academy of Sciences

WASHINGTON -- The U.S. Environmental Protection Agency should examine whether combined exposures to chemicals known as phthalates could cause adverse health effects in humans, says a new report from the National Research Council. In addition, this analysis, called a cumulative risk assessment, should consider other chemicals that could potentially cause the same health effects as phthalates, instead of focusing on chemicals that are similar in structure, which is EPA's current practice. Furthermore, EPA should consider using the recommended approach for future cumulative risk assessments on other kinds of chemicals.

Phthalates are used in a wide variety of consumer products, such as cosmetics, medical devices, children's toys, and building materials. In light of concerns, the European Union and the United States have passed legislation that restricts the concentrations of several phthalates in children's toys, and the European Union has also banned several phthalates from cosmetics. EPA asked the Research Council to recommend whether it should conduct a cumulative risk assessment for phthalates, and if so, how it should be framed. Accordingly, the National Research Council report is not a comprehensive profile on the health effects of phthalates.

Recent animal studies have increased understanding of the potential risks from phthalates, although few human studies on the health effects of phthalates are available, said the committee that wrote the report. To decide whether a cumulative risk assessment is warranted, two factors needed to be determined: whether humans are exposed to multiple phthalates at any given time, and whether sufficient evidence exists linking exposures to similar adverse health effects. The committee established that recent studies have shown widespread human exposure to multiple phthalates, including in utero exposure.

Then, the committee reviewed animal research and found that exposure to various phthalates in lab animals produced similar health outcomes, including a range of effects on the development of the male reproductive system. The most notable effects in male rats are infertility, undescended testes, malformation of the penis, and other reproductive tract malformations. However, the severity of effects differs among phthalates; some exhibit less severe or no effects. Furthermore, the age of the animals at the time of exposure is critical to the severity of the effects. For example, the fetus is most sensitive. Given that multiple human exposures to phthalates occur and that research shows exposure to different phthalates leads to similar outcomes in lab animals, a cumulative risk assessment is called for, the committee said.

The animal studies reviewed by the committee also indicated that some phthalates reduce testosterone concentrations. Depending on when this drop occurs, it can cause a variety of effects in animals that are critical for male reproductive development. Other chemicals known as antiandrogens, which prevent or inhibit male hormones from working, can produce similar effects in lab animals. The committee recommended that phthalates and other chemicals that affect male reproductive development in animals, including antiandrogens, be considered in the cumulative risk assessment. A focus solely on phthalates to the exclusion of other chemicals would be artificial and could seriously underestimate risk, the committee emphasized.

Currently when conducting cumulative risk assessments, EPA often considers only chemicals that are structurally related, on the assumption that they have the same chain of reactions that lead to a final health outcome. That practice ignores how exposures to different chemicals may result in the same health effects. The conceptual approach taken for phthalates -- to consider chemicals that cause similar health effects -- should also be applied when completing any cumulative risk assessment, the committee said. For instance, EPA could evaluate the risk of combined exposures to lead, methylmercury, and polychlorinated biphenyls because all contribute to cognitive deficits consistent with IQ reduction in children.

In addition, further research should be conducted to allow greater refinement of the cumulative risk assessment associated with phthalates and reduce uncertainty associated with such an assessment, the report says. Moving beyond the constraints of grouping chemicals based on structural similarity may appear challenging, but it is feasible to evaluate the multiplicity of human exposures. It also directly reflects EPA's mission to protect human health, the committee noted. Such a shift in approach would entail substantial efforts by EPA, such as defining and setting priorities among the most prominent adverse health effects. However, a focus on similar outcomes facilitates the process by identifying the groups of chemicals that should be included.

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The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are independent, nonprofit institutions that provide science, technology, and health policy advice under an 1863 congressional charter. Committee members, who serve pro bono as volunteers, are chosen by the Academies for each study based on their expertise and experience and must satisfy the Academies' conflict-of-interest standards. The resulting consensus reports undergo external peer review before completion. For more information, visit http://national-academies.org/studycommitteprocess.pdf. A committee roster follows.

Copies of PHTHALATES AND CUMULATIVE RISK ASSESSMENT: THE TASKS AHEAD are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at HTTP://WWW.NAP.EDU. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

[ This news release and report are available at HTTP://NATIONAL-ACADEMIES.ORG ]

NATIONAL RESEARCH COUNCIL
Division on Earth and Life Studies
Board on Environmental Studies and Toxicology

COMMITTEE ON HEALTH RISKS OF PHTHALATES

DEBORAH CORY-SLECHTA (CHAIR)
Professor
Department of Environmental Medicine
University of Rochester School of Medicine and Dentistry
Rochester, N.Y.

EDMUND CROUCH
Senior Scientist
Cambridge Environmental Inc.
Cambridge, Mass.

PAUL FOSTER
Acting Chief
Toxicology Operations Branch, and
Deputy Director
Center for the Evaluation of Risks to
Human Reproduction
National Institute of Environmental Health
Sciences
Research Triangle Park, N.C.

MARY FOX
Assistant Professor
Department of Health Policy and Management
Johns Hopkins Bloomberg School of Public Health
Baltimore

KEVIN GAIDO
Director
Center for Integrated Genomics, and
Senior Investigator
Division of Biological Sciences
Hamner Institutes for Health Sciences
Research Triangle Park, N.C.

MAIDA GALVEZ
Assistant Professor
Departments of Community and Preventive Medicine and of
Pediatrics
Mount Sinai School of Medicine
New York City

CHRIS GENNINGS
Professor of Biostatistics
Department of Biostatistics
Virginia Commonwealth University
Richmond

PAUL GILMAN
Senior Vice President and Chief Sustainability Officer
Covanta Energy Corp.
Fairfield, N.J.

RUSS HAUSER
Professor of Environmental and Occupational Epidemiology
Departments of Environmental Health and Epidemiology
Harvard School of Public Health
Boston

ANDREAS KORTENKAMP
Professor and Head
Centre for Toxicology
University of London
London

JEFFREY PETERS
Associate Professor of Molecular Toxicology
Pennsylvania State University
University Park

DONNA VORHEES
Principal Scientist
The Science Collaborative - North Shore
Ipswich, Mass.

MARY SNOW WOLFF
Professor of Community and Preventive Medicine and of
Oncological Sciences
Mount Sinai School of Medicine
New York City

RESEARCH COUNCIL STAFF

ELLEN MANTUS
Study Director

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