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In September 2000, researchers at the Centers for Disease Control and Prevention (CDC) reported that every single one of the 289 persons tested for the plasticizer dibutyl phthalate (DBP) had the compound in their bodies. The finding passed with little public fanfare, but surprised government scientists, who just one month earlier had rated DBP of little health concern based on the scientific assumption, which later turned out to be wrong, that levels in humans were within safe limits. DBP causes a number of birth defects in lab animals, primarily to male offspring, including testicular atrophy, reduced sperm count, and defects in the structure of the penis (CERHR 2000).
The most critical population, women of childbearing age whose fetuses are exposed in the womb, appear to receive the highest exposures. Estimates based on data published by the same CDC researchers in October 2000, indicate that DBP exposures for 3 million women of childbearing age may be up to 20 times greater than for the average person in the population. The highest exposure estimates for these women were above the federal safety standard (Blount et al 2000, Kohn et al 2000, EPA 1990). EPA rates their overall confidence in the safety standard as “low”, largely because it is based on a study published in 1953 that did not examine the test animals for the birth defects that concern scientists today (EPA 1990).
DBP is just one ingredient in an alphabet soup of pollutants that contaminate every person in the industrialized world. A patchwork of studies from the federal government indicates that everyone in the United States carries more than 100 chemical pollutants, pesticides, and toxic metals in their bodies. No one knows exactly where these exposures come from, and no one has studied the effect of constant exposure to this lowlevel mixture of poisons. Nor is it possible to do so. To test 100 chemicals in combinations of three for just one health effect (cancer, for example, as opposed to birth defects) would require 162,000 new tests. There are currently 75,000 chemicals licensed for use in the United States. Approximately 15,000 are sold in volumes greater than 10,000 pounds per year. Under the Toxic Substances Control Act the EPA has regulated just five chemicals (Roe et al 1997).
Government researchers speculate that the elevated levels of DBP among women of childbearing age come from cosmetics and beauty products, but no one has done the studies to test this hypothesis. As a first step in discovering some major sources, the Environmental Working Group (EWG) shopped at a local Rite-Aid, surfed the on-line store Drugstore.com, and searched the U.S. patent office records for products that contain DBP in the patent application. We found:
- DBP in 37 popular nail polishes, top coats, and hardeners, including products by L’Oréal, Maybelline, Oil of Olay, and CoverGirl.
- Patents proposing to use DBP in a broad range of beauty and personal care products, including shampoos and conditioners, lotions, hair growth formulations, antiperspirants, and sunscreen. Even patents relating to gum, candy, and pharmaceuticals taken orally propose DBP as an ingredient.
- Many major manufacturers who propose to use DBP in cosmetics and related products. Of more than 100 patents analyzed by EWG, Procter & Gamble holds the most (37) that propose to use DBP in personal care products. Other major companies with multiple patents are L’Oréal (10), Lever Brothers (4), and Maybelline (3).
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. 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.
- Women who are pregnant, nursing or thinking about getting pregnant should look for and avoid all personal care products with the word phthalate on the label. Some common forms of phthalates in personal care products are dibutyl phthalate, diethyl phthalate, and dimethyl phthalate.
- Urge manufacturers to reformulate their products with safer alternative chemicals. Go to www.ewg.org for a list of phone numbers and e-mail addresses for some major personal care products manufacturers.
- If you use nail products, choose those that contain fewer toxins. Use products free of DBP and other common nail polish toxins like toluene and formaldehyde. Types of nail polish that are DBP-, toluene-, and formaldehyde-free include L’Oréal Paris Jet-Set Quick Dry Nail Enamel, Revlon Nail Enamel, Garden Botanika Natural Color Nail Color, and Kiss Products Kiss Colors, to name a few.
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:
- The chemical industry must immediately and completely fund a comprehensive human biomonitoring initiative in conjunction with the Centers for Disease Control and Prevention. The initiative would monitor the human population for all chemicals reasonably likely to be found in human tissue. The study design must include highly exposed and potentially vulnerable sub-populations, and must include enough individuals to support statistically meaningful conclusions and regulatory decisions for all sectors of the population, and all chemicals monitored. All of the information gathered must be made available to the public after it is peer reviewed.
- The chemical industry must expand its commitment to screening of high production volume chemicals to include tests for carcinogenicity, neurotoxicity, immunotoxicity, and endocrine system toxicity at all life stages including gestation, infancy, childhood, adolescence and adulthood.
- The chemical industry and the personal care products industry must immediately label all products containing phthalates and any other toxic substance to which there is human exposure. Labels must be improved so that they are legible.
- The current exemption for labeling requirements that applies to non-retail sales of these products to professionals, must be rescinded.
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