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Chemicals and Environment

Chemicals and Environment

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Published by Erin Parker
About the effects of chemicals and how it effects the environment
About the effects of chemicals and how it effects the environment

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Published by: Erin Parker on Dec 11, 2009
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08/16/2010

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CHEMICALS AND ENVIRONMENT
As evidence of the hazards of di-2-ethylhexyl phthalate (DEHP)Continues to mount, the inevitable question arises, "When do we knowenough to act to protect people from unnecessary and potentially harmfulexposures?" Concerns about the safety of DEHP, a PVC plasticizer, haveintensified since it became apparent that developing organisms are far moresusceptible to DEHP exposures than adults. Hundreds of animal studiesconfirm the particular vulnerability of the developing male Reproductivesystem and have begun to define mechanisms of toxicity, including impairedtestosterone synthesis. Birth defects, pathologic testicular changes, decreasedsperm production, and altered hormone levels are caused by developmentalexposures to DEHP. Lowest adverse effect levels in developing organismsare orders of magnitude lower than doses necessary to cause reproductivesystem impacts in adults.Human studies report ubiquitous DEHP exposures in the general population, with some concluding that the reference dose is exceeded amongthose who are most highly exposed. Studies of infants in neonatal intensivecare units show even higher exposure levels from DEHP- containing medicaldevices. Based on animal tests, these exposures Occur during developmentalwindows of heightened sensitivity. Measurements of newly identifiedmetabolites of DEHP have enriched our understanding of mammaliantoxicokinetics and suggest that previous estimates of DEHP exposure are toolow. The first studies of DEHP exposure effects in infants are inconclusive but provocative.Two expert panels of the National Toxicology Program (NTP), the USFood & Drug Administration (FDA), a Health Canada expert panel, and theEuropean Union have all concluded that the animal studies of DEHP arelikely to predict human health impacts and raise serious concerns. Thesegovernment-sponsored panels say health care delivery with DEHP-containing PVC medical products can be a clinically significant source of DEHP exposure, and infants receiving intensive medical care are most atrisk. In 2002, FDA issued a Public Health Notification warning health care providers to use available DEHP-free medical devices while treating certain
 
vulnerable patient populations, including critically ill infants. A second NTPexpert panel reviewed the last several years of research findings and againexpressed "serious concern" regarding infants receiving intensive medicaltreatments with DEHP-containing devices.Recent studies of infants receiving intensive medical therapy with PVCmedical devices reported levels of DEHP metabolites in their urine similar tothose associated with adverse impacts in laboratory animals. One of thestudies also contained some good news. Comparing infants in two Harvard-affiliated Boston Neonatal Intensive Care Units, the study found significantlylower DEHP levels in the babies receiving care at the hospital that hadswitched to DEHP-free medical devices for some applications. Health care providers at that institution had taken prudent action to protect their vulnerable patients from unnecessary exposures to DEHP while continuing to provide high-quality care.Defenders of PVC/DEHP products cite studies in marmosets thatReportedly show no harm from DEHP exposures. Marmosets are members of a primate species with male hormonal regulatory systems that significantlydiffer from humans. For instance, testosterone levels are normally high inmarmosets, and they are relatively insensitive to changes in steroid hormonelevels, unlike humans. This is not a trivial detail when evaluating a chemicalthat interferes with testosterone synthesis. It limits the utility of marmosets asa model for studying DEHP toxicity In humans. Moreover, no study has ever examined the impacts of fetal or neonatal exposure to DEHP in non-human primates.The recent NTP expert panel also reviewed a relatively new butunpublished, industry-sponsored marmoset study submitted by the AmericanChemistry Council?s Phthalate Ester Panel. The NTP panel was Unconvinced by the study authors? curious rationale for omitting from the data analysissome animals that apparently showed significant impacts from exposure.Subsequently, a reproductive biologist commissioned by the Phthalate Ester Panel to review that study and comment on the appropriateness of usingmarmosets as a relevant animal model was also unable to explain why thosedata were omitted from the analysis. He further commented on the study?s poor design and execution. PVC/DEHP defenders also look for safe harbor inthe lack of proof that DEHP harms humans. Human studies will require
 
accurate DEHP exposure assessment in male fetuses and infants, followed bylong-term follow-up as these children enter their reproductive years in order to find a potential relationship between early life exposures and later reproductive function. The prospects for such a study are slim, and the resultswould not be available for decades.DEHP-free alternatives are readily available for nearly all uses in healthcare. Replacing DEHP with another plasticizer in a PVC device of courseraises questions of the safety of the alternative. To be sure, other plasticizersmust also undergo rigorous scrutiny and FDA approval. Some alternative polymers, however, such as polypropylene and polyethylene, among others,do not require plasticizer additives of any kind, and concern about their leaching is not an issue.Some major health care institutions are responding to the FDA?snotification by phasing out PVC medical devices and seeking safer alternatives -- including Kaiser Permanente, the largest non-profit health care provider in the United States; Catholic Healthcare West, Miller Children?sHospital, Lucille Packard NICU at Stanford University, and many others.The largest group purchasing organizations in the health care industry havecommitted to support labeling of PVC and DEHP medical products and offer DEHP-free alternaqtives.In the experience of clinical practitioners, DEHP-free alternatives Havesimilar costs and are just as safe and effective. Valerie Briscoe, a neonatalclinical nurse specialist at John Muir Medical Center, a 550- bed hospital in Northern California with the busiest birth center in Its county, was able toswitch her hospital?s NICU to safer non-DEHP Medical devices within sixmonths of FDA?s public health notification. "We found alternatives that wereas adequate in providing therapy with no substantial cost impact to thehospital. This was a relatively easy process for me," Briscoe said. "I wouldsay that 99 percent of the products have alternatives out there. I?ve been verysuccessful in finding alternatives."Catholic Healthcare West (CHW), the largest Catholic health-caresystem in the western United States, announced in November a five-year, $70million contract to B. Braun Medical Inc. for PVC-free/DEHP-free

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