Reproductive ELSEVIER l Toxicology, Vol. 1 I, Nos. 213. pp. 221-222, 1991 Copyright 0 1997 Elrevier Science Inc. Printed in the USA. All rights reserved 0890.6238/97 $17.00 + .OO zyxwvuts 0890-6238(96)00105-O Special Contribution ASSESSMENT OF REPRODUCTIVE DISORDERS AND BIRTH DEFECTS IN COMMUNITIES NEAR HAZARDOUS CHEMICAL SITES: INTRODUCTION zyxwvutsrqponmlk R. W. AMLER Agency for Toxic Substances and Disease Registry, The Agency for Toxic Substances and Disease Registry (ATSDR) is a federal agency (part of the U.S. Department of Health and Human Services) that is charged with conducting public health assessments and studies in communities at risk of exposure to toxic substances at hazardous waste sites, chemical spills, or other point sources of pollution. These assessments pose a considerable challenge, because in most instances it is not possible to fully characterize the toxicants, the levels and duration of exposure, and the segments of the community most likely to have been exposed (1). To address the health concerns of communities more directly, the Agency has chosen to focus its efforts on seven priority health conditions; one of them, disorders of human reproduction (2). Georgia use Tier 1 tests, to compare the incidence or prevalence of illness in a “target” group (presumed to be exposed to site-related toxicants) with that of a demographically similar comparison group (remote from the site). ATSDR has adopted batteries of Tier 1 tests to evaluate immune (3), kidney (4), liver (5), lung (6), and neurobehavioral disorders (7, 8), and implemented those test batteries in communities that needed to be studied. ATSDR’s national workshop on birth defects and reproductive disorders was cosponsored by the University of Cincinnati Medical Center. The workshop participants provided extensive information on the complex phenomenon of human reproduction and its intricate balance between several highly specialized organ systems in both women and men. Their discussions, summarized in an ATSDR report (9), are the subject of three articles contained in this issue of zyxwvutsrqponmlkjihgfedcbaZYX Reproductive Toxicology that examine female reproductive disorders (lo), male reproductive disorders (1 l), and birth defects and developmental disorders (12). These articles describe, in cogent detail, the availability, strengths, and limitations of different assessment methods, ranging from baseline questionnaires to highly sophisticated biomedical tests performed on blood, urine, breast milk, semen, and germ cells. The workshop discussions revealed that no simple battery of Tier 1 tests is available to assess the reproductive health of a community. Reproductive functions entail unique considerations-such as timing of menstrual cycles, early detection of pregnancies, and collection of semen or breast milk-that are not typically required to assess other organ systems. The level of effort required to collect specimens and test them reliably was considered too great for a population-based field investigation. Moreover, in the past, more reproductive health studies have been compartmentalized according to particular functions (e.g., early pregnancy loss in women, infertility To guide its efforts, ATSDR has convened experts, representing a broad range of disciplines, in a series of national workshops cosponsored by university-based environmental health research centers, to assist the Agency in developing standardized methods to assess these disorders in its community-based field studies. The participants in each workshop discussed the appropriateness of available methods for measuring adverse health effects in communities and identifying those methods that were most suitable for ATSDR’s studies. They also identified areas where further research and test development were needed. Each workshop considered a three-tier approach to assessment in order of increasing specificity, complexity, and cost. For example, Tier 1 tests are highly sensitive, well standardized, noninvasive, economical, valid measures of pathology, and robust enough to be administered under field conditions. Most ATSDR studies primarily correspondence to R. W. Amler, ATSDR Senior Medical 1600 Clifton Road NE (E-28), Atlanta, GA 30333. Address Advisor, Atlanta, 221 222 Reproductive Toxicology Volume 11, Numbers 2/3, 1997 3. Straight JM, Kipen HM, Vogt RF, Amler RW. Immune function in men, and developmental disabilities in the infants and test batteries for use in environmental health field studies. Atlanta: children). A clear need emerged for a standardized baseU.S. Department of Health and Human Services, Public Health line questionnaire that encompass most adverse reproService, Agency for Toxic Substances and Disease Registry, ductive effects-among women, men, and their chilI994 Aug. dren-in a format that is practical for use in field 4. Stellings FL, Jones PA, McGeehin MA, et al. Final report: mulinvestigations. tisite lead and cadmium exposure study with biomarkers incorporated. Atlanta: U.S. Department of Health and Human Services, The three articles contained in this section represent Public Health Service, Agency for Toxic Substances and Disease continued progress in the field of environmental health, Registry, 1995 April. in prioritizing the most appropriate methods to charac5. Centers for Disease Control and Agency for Toxic Substances and terize the adverse reproductive effects of toxic subDisease Registry Subcommittee on Biomarkers of Organ Damage stances released from hazardous waste sites. ATSDR is and Dysfunction. Biomarkers of organ damage or dysfunction of the renal hepatobiliary and immune systems, summary report. Atindebted to the workshop participants and planners, in lanta: U.S. Department of Health and Human Services, Public particular the workshop cochairs, Drs. Grace K. LemasHealth Service, 1990 August 27. ters (University of Cincinnati) and Gina J. Terracciano 6. Metcalf SW, Samet J, Hanrahan J, Schwartz D. Hunninghake Cl. A (currently with the Centers for Disease Control and Prestandardized test battery for lung and respiratory disease for use in vention). The rapid growth of knowledge in the field of environmental health field studies. Atlanta: U.S. Department of human reproduction indicates the need for periodic reHealth and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry, 1994 Sept. view of the issues examined in these pages. ATSDR 7. Amler RW, Anger WK, Siaemore OJ. Adult environmental neuencourages comprehensive studies of reproductive health robehavioral test battery. Atlanta: U.S. Department of Health and in communities exposed to toxic substances from hazHuman Services, Public Health Service, Agency for Toxic Subardous waste sites, especially if results can be combined stances and Disease Registry, 1995 Sept. with biomarkers of other organ systems. Long-term use 8. Amler RW, Gibertini M. Pediatric environmental neurobehavioral of consistent assessment methods to evaluate women, test battery. Atlanta: U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and men, and their children, will contribute additional inforDisease Registry, 1996 Sept. mation that is otherwise not available from individual 9. Terracciano GJ, Lemasters GK, Amler RW. Standardized assesscross-sectional studies. zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA publication was supported partially by funds from the Comprehensive Environmental Response, Compensation, and Liability Act trust fund through the Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services. Acknowledgments-This REFERENCES I. Amler RW, Lybarger JA. Research program to evaluate neurotoxic disorders and other adverse health outcomes at hazardous chemical sites in the United States of America. Environ Res. 1993;61: 279-84. 2. Agency for Toxic Substances and Disease Registry. Hazardouswaste sites: Priority health conditions and research strategiesUnited States. MMWR. 1992;41:724. ment of birth defects and reproductive disorders in environmental health field studies. Atlanta: U.S. Department of Health and Human Services. Public Health Service, Agency for Toxic Substances and Disease Registry, 1996 Sept. IO. Scialli AR et al. Assessment of reproductive disorders and birth defects in communities near hazardous chemical sites. II. Female reproductive disorders. Reprod Toxicol. 1997; I I :23 l-242. 11. Wyrobek AJ et al. Assessment of reproductive disorders and birth defects in communities near hazardous chemical sites. III. Guidelines for field studies of male reproductive disorders. Reprod Toxicol. 1997: I 1:243-259. 12. Savitz DA et al. Assessment of reproductive disorders and birth defects in communities near hazardous chemical sites. 1. Birth defects and developmental disorders. Reprod Toxicol. 1997; I I :223-230.