Aggregate Exposures to Phthalates in Humans, Executive Summary

Aggregate Exposures to Phthalates in Humans, July 2002
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Aggregate Exposures to Phthalates in Humans, Executive Summary

Phthalates are a family of chemicals that are produced in the millions of tons annually worldwide, and are a principal component of many diverse products that consumers come into contact with at home, at work, and in hospitals. They include products made of flexible polyvinyl chloride plastic (PVC), cosmetics and other personal care goods, pesticides, building materials, lubricants, adhesives, and film, among other items. Phthalates are released into the environment by manufacturers and escape from consumer products in which they are used.

Worldwide ecosystem contamination and direct contact with phthalate-containing products result in virtually ubiquitous human exposures.

Health effects that may be caused by exposure to phthalates differ among the various individual compounds and depend on the timing and the size of the dose. Young, developing organisms are more vulnerable to exposure to phthalates than adults. In particular, the developing male reproductive tract appears to be the most sensitive endpoint, although effects on the liver, kidneys, lungs, and blood clotting are also of concern. In animal tests considered relevant to humans, several of the phthalates, including di-(2- ethylhexyl) phthalate (DEHP), di-butyl phthalate (DBP), benzyl butyl phthalate (BBP), and perhaps di-isononyl phthalate (DINP), interfere with male reproductive tract development and are toxic to cells in the testes responsible for assuring normal sperm and hormone production.

Human exposure to DEHP from PVC medical devices used in patient care has been known for some time. Expert panels of the US National Toxicology Program (NTP) and Health Canada, as well as the US Food and Drug Administration (FDA), however, have recently reviewed the toxicology of DEHP and considered exposures to patients that may result from the use of DEHP-containing equipment. Each review concluded that some patients are likely to be exposed to potentially unsafe amounts of DEHP while receiving medical care. Testing by the US Centers for Disease Control and Prevention (CDC) recently showed that phthalate exposures are virtually ubiquitous in the general population.

Women of reproductive age experience some of the highest exposure levels to phthalates that can interfere with normal male reproductive tract development.

In this report, we summarize what is known about human exposures to phthalates and consider the potential health impacts of exposure to real-world mixtures of these chemicals. Using a relative potency approach, based on what is known about mechanisms of action and available experimental data, it becomes clear that, for a large number of women of reproductive age, their aggregate exposure to phthalates is sufficient to significantly increase the risk of abnormal development in male fetuses and baby boys.

Women of reproductive age who require medical care may be exposed to additional phthalates, largely DEHP, in the medical setting, that, depending on the procedure, can add significantly to their existing levels.

According to sample data from the CDC, an estimated 5% of women of reproductive age from the general population are contaminated with 75% or more of the level of just one of the phthalates, DBP, that may begin to impair normal reproductive tract development in their baby boys.

Many of these women are also regularly exposed to significant amounts of BBP and DEHP, so that their aggregate exposures pose even greater risks. When any of these women requires medical care that exposes them to additional DEHP from PVC medical devices, even more is added.

Where are these phthalates coming from in the general population? No one knows for certain, but perhaps the high exposures to DBP in women of reproductive age provide a clue, at least for that phthalate. DBP is used in a variety of cosmetic and personal care products. Recent testing identified DBP in some hair spray, fragrances, and deodorants. Many nail polishes also have large quantities of DBP.

Unfortunately, labeling requirements are sufficiently lax so that it is extraordinarily difficult to identify phthalate-containing products and to begin to narrow down the search for the sources of widespread general population exposures.

Chemical policy in the US is severely “Balkanized”161 and requires major revisions. For example, the Food and Drug Administration is responsible for food contaminants (including phthalates), drug ingredients (including phthalates), medical devices (including phthalate-containing PVC products), and cosmetics (including phthalates). Unfortunately, each of these activities is a responsibility of a different division within FDA, each of which carries out its work in isolation from the others. As a consequence, when the medical device division considers the safety of exposure to DEHP, they consider only medical devices and not the real world of population-wide exposures to multiple phthalates from multiple sources.

And, when the cosmetics division considers phthalates in personal care products, not only do they limit their concerns to products in their domain, but they must prove the likelihood of harm with no requirement that manufacturers will supply safety data.

When the Consumer Products Safety Commission (CPSC) considers the safety of phthalates in, for example, children’s toys, they consider only the phthalate that may leach out of the toy when a child chews on it, and not the other phthalates that the same child may be exposed to from contaminated food, contaminated air, or medical care.

And when the Environmental Protection Agency (EPA) considers whether or not to allow phthalates in a pesticide formulation, they examine those proposals one at a time, failing to consider aggregate exposures to multiple phthalates from multiple sources.

As a result, phthalates permeate the environment and contaminate large populations of people throughout the world. Phthalates are in the blood of pregnant women at levels of concern, particularly when the contaminants are considered in the aggregate.

Phthalates cross the placenta and also contaminate breast milk. Relevant animal tests show that phthalates interfere with normal fetal and infant development.

Manufacturers of phthalates continue to produce large amounts and sell them to product manufacturers who use them in thousands of products. Manufacturers consistently argue that there is no evidence that anyone has been harmed by phthalates.

As we note, however, and as confirmed by the NTP panel and FDA, no study has ever examined the impacts of phthalate exposure on the developing male reproductive tract in people. Not one. Lack of evidence can hardly be used as evidence of safety when no one has ever looked. The increasing incidence of hypospadias, undescended testes, testicular cancer, and declining sperm counts in the US and many other parts of the world suggests that a closer look at many reproductive tract toxicants and endocrine disruptors is urgently needed in people.

With respect to phthalates, however, evidence from relevant animal studies and from limited studies of non-reproductive tract impacts in hospitalized patients is sufficient to require phasing out the use of many of the phthalates. As the Health Canada panel concluded, “the status quo is not an acceptable option.”

Regulatory agencies charged with protecting medical patients, public health, and the environment must substantially revise procedures and protocols to consider the potential impacts of phthalate exposures in the aggregate, rather than as single chemical exposures.

In Europe, vigorous debate is underway regarding the phase-out of the general use of many phthalates in consumer products. Alternatives to phthalates that perform well are currently on the market for nearly every use.

Phthalates also serve as a case-study that demonstrates the failure of current chemical policy in the US. Regulatory authority is spread among agencies that compete with one another rather than cooperate. Lines of communication are limited and infrequently used. No one agency is authorized to look at the “big picture”. 2

Health Care Without Harm
Public health and the environment can only be truly protected when safer materials are substituted far upstream in the manufacturing process. Humans have demonstrated the capacity to contaminate every nook and cranny of every ecosystem and every developing fetus with synthetic chemicals that can impair normal development. Now we need to demonstrate that we can change.

First, we need to recognize that a major overhaul of current regulatory policy is long overdue. Under the current framework, government approval simply does not provide adequate real-world protection from chemical exposures. The FDA, the EPA, the CPSC, and other government agencies, with necessary authorization, must begin to transform their makebelieve regulatory framework into a new, sciencebased system that properly considers the reality of aggregate exposures to toxic chemicals and that requires meaningful pre-market testing of commercial chemicals.

Second, consumers must insist on the right to know about chemicals in commercial products and must have unhindered access to toxicity and exposure data.

Third, manufacturers can and must shift to cleaner production practices and materials that produce cleaner, sustainable products more suited to the contemporary world and the one we will leave to future generations.

Your Health and Mine