Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity (2001) / Chapter Skim
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Introduction
Introduction
Pages 11-23
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From page 11... ...
Adverse reproductive outcomes include abnormal mate and female hormone profiles, altered menstrual and ovarian cycles, longer than normal time-to-pregnancy, abnormal semen characteristics, gynecolog~cal and urological disorders, spontaneous abortion, ectopic pregnancy (i.e., a pregnancy occurring elsewhere than in the uterus) , and premature reproductive senescence.
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From page 12... ...
Known causes of reproductive and developmental disorders include genetic defects; maternal metabolic imbalances; infection; and occupational, therapeutic, and environmental exposures to chemical and physical agents. This report primarily addresses reproductive and developmental defects that might be attributable to chemical and other agent occupational exposures.
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From page 13... ...
, the cost to society for developmental defects is massive (i.e., the lifetime costs for children born annually with 17 of the most common birth defects and cerebral palsy is over $8 billion (CDC 1995~. However, these abnormalities affect only 22% of children with birth defects, and the cost estimate does not consider costs associated with many other developmental disorders.
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From page 14... ...
In 1997, Congress passed a law, as part of the National Defense Authorization Act, concerning health care coverage for children with medical conditions caused by parental exposure to hazardous materials while serving as members of the Armed Services (Public Law 104-201, Section 704~. The law states, in part, that a plan would be developed for ensuring the provision of medical care to any natural child of a member of the Armed Forces who has a congenital defect or catastrophic illness, proven to a reasonable degree of scientific certainty on the basis of scientific research to have resulted from exposure of the member to a chemical warfare agent or other hazardous material to which the member was exposed during active military service.
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Although the Navy reviews available data on the reproductive and developmental toxicity potential of those agents, its health hazard evaluation process is not currently designed to emphasize assessment of reproductive and developmental effects. Because the Navy wishes to protect its male and female military and civilian personnel from reproductive and developmental hazards, it seeks to incorporate a formalized, state-of-the-art process for identifying hazards in its current health hazard evaluation process.
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From page 21... ...
When the data set is inadequate, the level of confidence in assessing the degree of concern in lessened. The process described by the subcommittee requires the exercise of considerable judgment, brought to bear in assessing the adequacy of data for estimating potential reproductive and developmental toxicity of agents under specific conditions of exposure.
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From page 22... ...
The subcommittee recommends that an assessment not be considered complete unless it includes consideration of potential adverse reproductive and developmental consequences ofexposure of both the male and thefemaZe. 77ze absence or inadequacy of data on one or more of the components of reproductive toxicity (i.e., male reproductive effects, female reproductive effects, or developmental effects)
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From page 23... ...
This report also contains four appendixes: Appendix A contains examples of the application of the proposed evaluative process to two specific chemical agents, Appendix B describes and evaluates various sources of information on reproductive and developmental toxicity, Appendix C describes and evaluates human study designs, and Appendix D describes experimental animal study designs and discusses qualities and limitations for each type of study.
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