	Introduction

"Phthalates" refers to a group of chemical compounds that are heavily produced and widely used to make the plastics found in thousands of consumer products. Some (but not all) of these phthalates are known to cause reproductive damage in rodents. The six phthalates are di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-octyl phthalate (DnOP). 110 - 314 , the Consumer Product Safety Improvement Act of 2008 (CPSIA), prohibits the sale of children's toys and child care articles that contain more than 0.1% of DEHP, DBP, or BBP. Moreover, if administered at sufficient levels and at the appropriate time to pregnant females, some phthalates can cause malformations of the reproductive organs of offspring, especially males. Disruption of hormonal functions in humans is known to result in abnormal reproductive development. Many scientists believe that the phthalates toxic to rats and mice might be able to cause similar malformations in humans, because the male hormones affected by phthalates are important to the normal development of the male reproductive tract in all species of mammals. However, human health effects of phthalate exposure have not been conclusively demonstrated. Very few studies have looked at possible effects in humans, but their results have been consistent with the results of rodent experiments. More research would be needed to determine with certainty the effects of phthalates in humans. OSHA regulates worker exposure to phthalates. Federal agencies have taken several actions, some as early as the mid 1980s, to evaluate and regulate phthalates. To date, however, no phthalate-containing consumer product has been banned outright. or the Consumer Product Safety Act (CPSA, 15 U.S.C. P.L. First, what is the scientific basis for health concerns about exposure to these chemicals? Scientific Basis for Health Concerns

The scientific basis for concerns about risks to human health appears to be strong in the case of some phthalates, adequate with respect to others, and weak for the remaining chemicals. The strongest evidence with respect to developmental effects has been produced since about the year 2000. Children appear to be most heavily exposed. Data are insufficient to judge exposure for DINP, DIDP, and DnOP. The National Academy of Sciences is evaluating the risk of aggregate human exposure to multiple phthalates, and is expected to report before the end of 2008. Reducing Risks Without Generating Greater Risks

By restricting the use of six phthalates in child-care items and toys, the new law codifies the voluntary agreements reached by CPSC with product manufacturers (to keep DEHP and DINP out of nipples, pacifiers, and teething toys, and DEHP out of toys that might be mouthed) and should reduce exposure to DINP, the only phthalate currently used in the United States to produce toys.
Roughly a dozen chemicals known as phthalates are used to make the plastics found in thousands of consumer products, ranging from medical tubing to automotive dashboards to bath toys. These phthalates are not tightly held by the plastics and are released into the environment over time. Congress is concerned about possible human health effects from exposure to six of these chemicals: di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-octyl phthalate (DnOP). DEHP, DBP, BBP, and (to less extent) DINP are known to be toxic to the reproductive systems of rodents. Recent rodent experiments demonstrate that pre-natal exposure at a sufficient level to these same phthalates disrupts the normal action of hormones and can cause malformations of the reproductive organs of offspring (especially males).
Disruption of hormonal functions in humans is known to result in abnormal reproductive development. Many scientists believe that the phthalates toxic to rodents might be able to cause similar malformations in humans. However, human health effects of phthalate exposure have not been conclusively demonstrated. Very few studies have looked at possible effects in humans, but their results appear consistent with the results of rodent experiments. More research would be needed to test this hypothesis. Recent U.S. surveys have found almost universal human exposure to phthalates. Individuals may be exposed to high enough levels of phthalates to cause reproductive abnormalities. Scientists at the National Toxicology Program have expressed "serious concern" about human male infants undergoing intensive medical procedures, and "concern" about development of human males less than a year old who are exposed to DEHP. In light of these concerns, the National Academy of Sciences is evaluating the risk of aggregate human exposure to multiple phthalates.
Federal agencies have taken several actions, some as early as the mid 1980s, to evaluate and regulate phthalates, but no consumer product to date has been banned outright. The agency responsible for regulating toys and most other child-care products is the Consumer Product Safety Commission (CPSC). The Consumer Product Safety Improvement Act of 2008 (P.L. 110-314, enacted August 14, 2008) includes a provision intended to ensure protection of children from six phthalates by restricting their use in toys and child-care products.
The scientific basis for concerns about human health risks appears to be strong in the case of some phthalates (such as DEHP), adequate with respect to others (perhaps DINP), and weak for the remaining chemicals (for example, DIDP and DnOP). The strongest evidence with respect to developmental effects has been produced since about the year 2000. The new law codifies voluntary agreements previously reached by CPSC with product manufacturers, and should reduce exposure to one particular phthalate. New formulations for toys and child-care products may pose greater or fewer risks than current formulations.