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Table 1. EWG shoppers turned up 37 DBP-containing products from 22 companies.
Major corporations hold patents that propose to use the toxic plasticizer DBP in a broad range of consumer products, from nail polish to hair growth formulations. Company holding patent and products for which DBP is proposed as essential or possible additive
The Spoils of a Rotten System Contrary to popular belief, industrial chemicals in consumer products are essentially unregulated in the United States. Except for chemicals added directly to food, there is no legal requirement for health and safety testing or human exposure monitoring for any chemical in commerce. The same chemicals, ironically, are often tightly regulated as pollutants. For example: Phthalates are recognized as toxic substances under environmental law, but companies are free to use unlimited amounts in cosmetics. An environmental release of just 10 pounds of DBP must be reported to environmental authorities under the Superfund law. The cosmetics industry, in contrast, puts hundreds of thousands of pounds of DBP into nail polish each year, with no requirements for safety testing or reporting to anyone. In the 25 years of the Toxic Substances Control Act, the EPA has regulated exactly one toxic substance in a consumer product, lead in paint. This is largely because the agency cannot demand the health and safety tests needed to evaluate a chemical’s safety and risk. Industry recently agreed to a voluntary testing program for high production volume compounds (chemicals produced annually in amounts of at least one million pounds), but this program has many shortcomings. Many basic tests are not required, such as those for cancer, nervous system damage, and virtually all tests for toxicity to the developing and immature animal including developmental neurotoxicity or effects on the immature immune system. About 80 percent of all high production volume chemicals are not covered by the initiative. Pivotal court decisions implementing the 1976 Toxic Substances Control Act (TSCA) have rendered EPA impotent to control toxic chemicals in commerce. The agency must prove an “unreasonable risk of injury” to human health before it can remove a chemical from the market. But EPA is powerless to make that finding because the law prohibits the agency from requiring safety studies until it proves that “substantial” or “significant” exposures are occurring. The agency can almost never prove that substantial or significant exposures are occurring because exposure data are also extremely difficult to obtain. In other words, EPA cannot regulate a chemical until it makes a finding of risk based on data that the law virtually prohibits it from collecting. The law also allows industry to manufacture and sell new chemicals without conducting any toxicity studies to determine if the chemicals are safe. After a chemical enters the marketplace, there is NO requirement for human monitoring, even for those compounds to which people are routinely exposed. Except for direct food additives, the Federal Food Drug and Cosmetic Act (FDC&A) is no better (FDA 2000). DBP is allowed in food as an indirect additive via food packaging, but this use was grandfathered in and has not been subject to modern food safety standards. The FDC&A does not require pre-market safety testing, review, or approval for cosmetics or the compounds used to make them. While manufacturers might study the short-term effects in lab animals of the substances that they sell, they almost never study long term effects of their products. Industry can and DOES put chemicals into widespread commercial use without meaningful testing for toxicity and without any monitoring of people or the environment
What You Can Do Researchers are just beginning to discover the names of the hundreds of commercial chemicals that contaminate the human body. What those chemicals’ actual health effects might be are just beginning to be understood. In the meantime, scores of new chemicals are introduced into commerce each year, with no requirement that they be shown to be safe! This situation is the single biggest failure in U.S. (and UK Eds note) environmental law and is not likely to be fixed anytime soon. Until it is, people can do a few simple things to reduce exposure to the contaminants that we do know about.
Policy Recommendations When it comes to the use of potentially toxic chemicals in manufactured consumer products, the official operating principle is use first, test later, or better yet, don’t test at all. This situation is disgraceful and completely unacceptable. In the face of growing evidence that the human population is contaminated with hundreds of poorly tested hazardous industrial chemicals, we recommend the following:
Chemical Industry systematically defeats health protections No pre-market safety testing or approval is required under any federal law for chemicals in cosmetics, toys, clothing, carpets, or construction materials, to name just a few obvious sources of chemical exposure in everyday life. This little known fact is the premeditated result of an orchestrated campaign by the chemical industry to avoid testing and regulation of their products. It largely explains why products like hair spray, hair dye, pacifiers, stain repellents, glues and children’s toys get on the market, only to be found to contain highly toxic compounds at unsafe levels after decades of widespread use. Once these products are on the market, there is no practical legal mechanism by which health authorities can remove them from commerce, short of a public health disaster or consumer uproar. OSHA Since the 1950’s, the chemical industry has systematically blocked efforts to require safety studies for the compounds it produces. This strategy first played out with workplace standards adopted under the Occupational Safety and Health Administration (OSHA), and was repeated with the passage and implementation of the Toxic Substances Control Act (TSCA). The first chemical health standards in the United States were adopted by OSHA in 1972. Set in theory to protect workers, these standards were initially created in the 1940’s by representatives from the chemical industry operating under the auspices of the American Council of Governmental and Industrial Hygienists (ACGIH). At the time the standards were first introduced in 1942, ACGIH issued major caveats regarding their application to human health, stating that: “[they are] not to be construed as recommended safe concentrations” (NCGIH 1942). Toxicity tests on animals had barely been invented at that time, and the standards themselves were based on rough estimates of acutely hazardous and lethal levels of exposure. In the words of the scientist who devised many of them, the so-called threshold limit values (TLVs) were designed, “to provide a handy yardstick to be used as guidance for the routine control of these health hazards — not that compliance with the figures listed would guarantee protection against ill health” (Cook, 1945). This did not stop the chemical industry from promoting TLVs as legitimate health standards, and in 1972, OSHA adopted TLVs wholesale as the nation’s first set of enforceable health standards for chemicals in the workplace. In the process these “handy yardsticks” took on an aura of respectability that belied the fact that there was essentially no science to support their relevance to human health and safety. The best estimates are that basic toxicological data were available for only five percent of some 600 industrial chemicals for which OSHA had adopted standards by 1988 (Castleman and Ziem 1994, Roach and Rappaport 1990).
TSCA (Toxic Substances Control Act) This process of faux regulation was repeated again when the same chemical industry giants teamed up to write the nation’s major toxic chemical law, the Toxic Substances Control Act (TSCA). Passed with virtually no regulatory teeth, TSCA has been an unparalleled failure. Of the 62,000 chemicals on the market when TSCA was passed in 1976, EPA has successfully requested data for 263 compounds. Of the 15,000 chemicals marketed in quantities exceeding 10,000 pounds per year, EPA has completed regulatory actions to limit use or exposures on just 5, or 0.03 percent (3 one hundredths of one percent). Four of the five were already regulated under other statutes, and only one, lead in paint, affected a consumer product (Roe et al 1997). TSCA is best thought of as a self-defeating feedback loop. Under the law, all chemicals are presumed safe, and the burden of proof is on the EPA to demonstrate that a chemical is causing harm before it can take any regulatory action. However, the agency cannot require that industry conduct the tests needed to show that a chemical is causing harm, until the agency has shown that the compound may present an "unreasonable risk," or that human exposure is "substantial" or "significant". Substantial exposures can almost never be proven without additional data from industry, and significant exposures cannot be proven without information on the chemical’s toxicity. Of course, compelling toxicity data are almost never available for the compound in question or EPA would not be trying to publish a test rule in the first place. Even if all these hurdles are cleared, which is extremely unlikely, in order to request basic toxicity data on any single chemical the EPA must issue a test rule through the process of a rulemaking under administrative law. This roadblock is unique to TSCA. Under pesticide law, or food safety law, EPA or FDA can request virtually any test that they need to assess the safety of a compound. A defining moment in the collapse of TSCA occurred in 1990 when EPA attempted to issue test rules for the paint thinner cumene. The proposed test rules were immediately challenged by the Chemical Manufacturers Association on the grounds that EPA had not shown that human exposure was “substantial,” the basic requirement under Section 4 of the Act. The courts upheld the CMA argument that the burden of proving “substantial” exposure and risk was on the EPA and not the manufacturers (Chemical Manufacturers Ass’n v. EPA, 5th Cir. 1990). To date EPA has issued rules requiring toxicity testing for only 0.4 percent, or 263, of the 62,000 chemicals on the market when the law was passed. Even when issued, test rules generally do not require comprehensive testing. With barely any data generated via test rules the agency cannot support a finding of substantial risk for any chemical, and indeed the agency has taken only five final actions since passage of the law (Roe et al 1997). The final nail in the coffin came in 1991. EPA was trying to use TSCA to regulate asbestos, arguing that it presented an “unreasonable risk of injury” to human health. Again the TSCA feedback loop prevailed, and the court ruled that EPA had not met the burden of providing substantial evidence that asbestos presented an unreasonable risk of injury to human health (Corrosion Proof Fittings v. EPA, 5th Cir. 1991). Since this decision, EPA has undertaken no additional major regulatory actions under the Act. Under pressure from environmentalists and the Clinton administration, in 1999 the chemical industry agreed to conduct basic health screening tests for about 3,000 high production volume compounds out of a universe of more than 75,000 chemicals registered for commercial use today, 15,000 of which are marketed in quantities exceeding 10,000 pounds per year. This tiny step forward is entirely voluntary and, even if it is completed, it will not provide regulators and public health authorities with sufficient information to fully assess the long-term adverse effects of toxic chemical exposure. Tests now recognized as critical to a full understanding of a chemical’s toxicity will not be conducted at all under this initiative. These include cancer bioassays, studies on the developing nervous system, the immune system, the endocrine system, and perhaps most important, human monitoring to determine the extent of human exposure. This latter element is critical. As discussed below, a string of recent discoveries reveal that human exposure to commercial chemicals used in common cosmetics personal care and general consumer products is almost certainly much more pervasive than previously thought. This new strata of contamination is in addition to the considerable well known toxic load of pollutants (such as PCBs, dioxin, and DDT) found in the blood and body fat of virtually all people in the industrialized world.
Beauty Secrets Phthalates Back to Top Invented in the 1930’s, the versatile group of common industrial chemicals called phthalates (pronounced tha-lates) are used as ingredients in a diverse range of consumer products from cosmetics and personal care items to food wraps, toys and building materials. Currently the chemical industry produces BILLIONS of pounds of phthalates each year. They are used as plasticizers to soften plastic, as skin moisturizers and skin penetration enhancers in cosmetics, and as solvents in a wide range of applications. People are exposed to phthalates daily through their contact with consumer products and via food and indoor air. In spite of their widespread presence in cosmetics and other common consumer products, industry has only partially studied the health effects of phthalates and has never tested for the presence of phthalates in human bodies. Finally, in April 1999, over six decades after phthalates were first marketed, the federal government’s National Institute for Environmental Health Sciences (NIEHS) initiated a study of the effects of phthalates on the human reproductive system through their new Center for the Evaluation of Risk to Human Reproduction (CERHR). At the same time, scientists at the Centres for Disease Control and Prevention (CDC) were achieving the first accurate measurements of phthalates in people. Researchers there were surprised to find that people have much higher levels of some phthalates in their bodies than predicted by previous estimates Blount et al 2000). In October 2000, CDC scientists announced that levels of some phthalates in women of childbearing age, including dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP), exceed the government’s safe levels set to protect against birth defects. Estimates based on data from this study indicate that for more than 3 million heavily exposed women of childbearing age, exposures to DBP may be 20 times greater than the average exposures in the rest of the population (Kohn et al 2000). This report focuses primarily on DBP, a widely used phthalate that produces serious reproductive and developmental effects in laboratory animals. But DBP is not the only toxic phthalate to which people are routinely exposed. Many other phthalates widely detected in human urine by the CDC cause the same birth and developmental defects to the male reproductive system as DBP. Absent evidence to the contrary, it is reasonable to assume that the health effects from exposures to multiple phthalates are additive
Health effects of dibutyl phthalate At least two decades ago, scientists began building a body of work indicating that DBP can be a powerful reproductive and developmental toxicant in laboratory animals, particularly for males. Early studies focused on DBP’s ability to cause testicular atrophy (e.g., Gray et al 1980), but DBP is now known to cause a broad range of birth defects and lifelong reproductive impairment in male laboratory animals exposed in-utero and shortly after birth (Ema et al 1998, Marsman et al 1995, Mylchreest et al 1998, 1999, and 2000, Gray et al 1999, Wine et al 1997. Scientists believe that the active toxicant of DBP exposure is its first breakdown product, monobutyl phthalate (MBuP), which has been shown to harm the male reproductive system. The precise mechanism of action is not known but the pattern of reproductive harm is consistent with other so-called anti-androgens or chemicals that interfere with the male hormones called androgens.
DBP exposure damages the testes, prostate gland, epididymus, penis, and seminal vesicles in laboratory animals see, for example, Mylchreest et al, 1998). These effects persist throughout the animal’s life, and include, specifically:
Potential health effects of DBP continue to be significant for newborn animals who can be exposed to DBP by breathing phthalate-contaminated air, by touching things that contain phthalates, or by drinking their mother’s milk, which can contain phthalates as a result of her exposures. In young lab animals, DBP has been shown to cause permanent testicular atrophy and reduced sperm counts (Foster et al 1981, Marsman 1995). In animal tests DBP is also “embryolethal” — causing loss of pregnancy — and prevents implantation of the fertilized egg. In lab animals it also causes “resorption” of some or all of the foetuses in a litter,
Broad and disturbing trends in human male reproductive health include many of the same effects seen in lab animals dosed with phthalates. Although a cause and effect relationship has not been established, the ubiquity of phthalates in the human population creates a biologically plausible presumption that phthalates may be contributing to these problems. Until proven safe, phthalates should be considered as potential contributors to the following human health effects:
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