Human Milk Biomonitoring Data: Interpretation and Risk Assessment Issues
Authors:
Judy S. LaKind ab;
Robert L. Brent c;
Michael L. Dourson d;
Sam Kacew e;
Gideon Koren f;
Babasaheb Sonawane g;
Anita J. Tarzian hij;
Kathleen Uhl k
| Affiliations: | a Department of Pediatrics, Milton S. Hershey Medical Center, Pennsylvania State University, College of Medicine, Hershey, Pennsylvania, USA |
| b LaKind Associates, LLC, Catonsville, Maryland, USA | |
| c Jefferson Medical College of Thomas Jefferson University, A. I. duPont Hospital for Children, Wilmington, Delaware, USA | |
| d Toxicology Excellence for Risk Assessment, Cincinnati, Ohio, USA | |
| e Department of Pharmacology, University of Ottawa, Ottawa, Ontario, Canada | |
| f Division of Clinical Pharmacology and Toxicology, Hospital for Sick Children Molecular Toxicology, University of Western Ontario, Ontario, Canada | |
| g National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC, USA | |
| h Ethics and Research Consultant, Baltimore, MarylandM, USA | |
| i Law and Health Care Program, School of Law, University of Maryland, Baltimore, Maryland, USA | |
| j School of Nursing, University of Maryland, Baltimore, Maryland, USA | |
| k U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Pregnancy Labeling Team, Rockville, Maryland, USA |
DOI:
10.1080/15287390500225724
Publication Frequency:
24 issues per year
Published in:
Journal of Toxicology and Environmental Health, Part A,
Volume
68,
Issue
20
October
2005
, pages 1713
- 1769
Formats available:
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Abstract
Biomonitoring data can, under certain conditions, be used to describe potential risks to human health (for example, blood lead levels used to determine children's neurodevelopmental risk). At present, there are very few chemical exposures at low levels for which sufficient data exist to state with confidence the link between levels of environmental chemicals in a person's body and his or her risk of adverse health effects. Human milk biomonitoring presents additional complications. Human milk can be used to obtain information on both the levels of environmental chemicals in the mother and her infant's exposure to an environmental chemical. However, in terms of the health of the mother, there are little to no extant data that can be used to link levels of most environmental chemicals in human milk to a particular health outcome in the mother. This is because, traditionally, risks are estimated based on dose, rather than on levels of environmental chemicals in the body, and the relationship between dose and human tissue levels is complex. On the other hand, for the infant, some information on dose is available because the infant is exposed to environmental chemicals in milk as a “dose” from which risk estimates can be derived. However, the traditional risk assessment approach is not designed to consider the benefits to the infant associated with breastfeeding and is complicated by the relatively short-term exposures to the infant from breastfeeding. A further complexity derives from the addition of in utero exposures, which complicates interpretation of epidemiological research on health outcomes of breastfeeding infants. Thus, the concept of “risk assessment” as it applies to human milk biomonitoring is not straightforward, and methodologies for undertaking this type of assessment have not yet been fully developed. This article describes the deliberations of the panel convened for the Technical Workshop on Human Milk Surveillance and Biomonitoring for Environmental Chemicals in the United States, held at the Hershey Medical Center, Pennsylvania State College of Medicine, on several issues related to risk assessment and human milk biomonitoring. Discussion of these topics and the thoughts and conclusions of the panel are described in this article.
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