Introduction

My name is Martin Donohoe. I am a physician and practice internal medicine and teach courses in the School of Community Health and Women’s Studies at PortlandStateUniversity. I am on the Board of Advisors of Oregon Physicians for Social Responsibility and am the Chief Science Advisor for Oregon PSR’s Campaign for Safe Foods. I have over 100 publications of various types and speak nationally and internationally about environmental health.

The Precautionary Principle

Before discussing this measure, I would like to outline the fundamental principle of public health, the Precautionary Principle. The Precautionary Principle states that when evidence points toward the potential of an activity to cause significant, widespread or irreparable harm to public health or the environment, options for avoiding that harm should be examined and pursued, even though the harm is not yet fully understood or proven. There are four practical essentials to the precautionary principle:

  • Give human and environmental health the benefit of doubt.
  • Include appropriate public participation in the discussion.
  • Gather scientific, technological and socioeconomic information.
  • Consider less risky alternatives

Current Resolution

Oregon Physicians for Social Responsibility supports this measure, which will urge the Congress of the United States to enact legislation that requires testing, review and approval of ingredients used in cosmetic products, in particular dibutyl phthalate and diethyl phthalate. Such legislation would allow consumers to make better-informed choices to protect their health and the health of their families, and would enhance our knowledge about these chemicals.

Every day, Oregonians are exposed to phthalates, through water, food and other residues that are inhaled or ingested, but also through cosmetics and personal care products such as hair spray, deodorants, nail polish, and perfumes. Oregon PSR believes that the evidence we have is strong enough that we should act now to prevent exposure to these toxic chemicals. While acute poisonings are rare, low dose exposure is associated with a variety of detrimental health effects. Several studies suggest that the constant exposure to these chemicals may be related to widespread trends of lower sperm count, obesity and diabetes, and breast cancer.Phthalates are endocrine disruptors - exposure during fetal and child development can disrupt hormone function critical to normal development.

The Food and Drug Administration (FDA) cannot require companies to do safety testing of their cosmetic products before manufacturing. In fact, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA. The Cosmetics Ingredients Review (CIR), the industry's self-policing safety panel, falls far short of compensating for the lack of FDA oversight. An Environmental Working Group analysis found that in its 30-year history, the CIR has reviewed the safety of just 13% of the 10,500 ingredients used in personal care products. The FDA does no systematic reviews of safety. That means that nearly 90% of ingredients used in personal care products have not been evaluated for safety by any publicly accountable institution. And as people apply an average of 126 unique ingredients on their skin daily, these chemicals are raising concerns, for their potential impacts to human health and to the environment.

Health Effects of Phthalates

One billion pounds of phthalates are produced per year and are used in perfumes, children’s toys, hairspray, lubricants, wood finishers, car interiors, medical equipment, paints, adhesives and cosmetics. The Center for Disease Control conducted a study released in 2000 that found high levels of several phthalates compounds in Americans; of most concern was the disproportionate number of women of childbearing age with high levels of a particular metabolite, DBP. The CDC study also found that African Americans have higher levels of several phthalates.

Phthalates have been measured in urine, serum, breast milk and amniotic fluid. Humans are exposed through ingestion, inhalation, dermal absorption, and percutaneous exposure. While use of phthalates is declining slightly, phthalates are commonly found in household dust.

While the mechanisms of toxicity for the range of phthalates varies, several forms including DEHP, BBP, DBP, and perhaps DINP are all anti-androgens. They interfere with steroid (testosterone) synthesis.

At high levels, exposure to phthalates causes cancer and infertility. Low level exposure is of great concern because of the common use of phthalates in consumer and medical products. Low level exposure to phthalates and their metabolites is associated with developmental effects including premature birth, sperm and DNA damage and something called “phthalate syndrome:” low testosterone in fetal males, hypospadias, inhibition of normal scrotal development, undescended testes, and testicular tumors. One human infant study found phthalate levels significantly correlated with scrotal size, penile volume, and degree of testicular descent. Phthalate exposure is also correlated to allergies and asthma in children and low sperm count in adults. Most human exposure is to a combination of phthalates in products and dust. Recent animal studies found that exposure to a combination of several types of phthalates increases detrimental health effects.

The European Union has banned phthalates in cosmetics and children’s toys. Reports from the European Chemicals Commission in 2003 and 2004 minimize but do not entirely discount the health effects of phthalates. The Phthalate Esters Panel of the American Chemistry Council has vigorously promoted these reports, which are at variance with other European Union (and scientific, peer-reviewed) studies on the risk of phthalates By the its own admission, the Phthalate Esters Panel is composed of all major manufacturers and some users of the primary phthalate esters in commerce in the United States. Panel members include: BASF Corporation, Eastman Chemical Company, ExxonMobil Chemical Company, and Ferro Corporation. Teknor Apex Company, a major user of the materials, is an associate member. The European Chemicals Commission reports have not led the EU to overturn its ban on phthalates.

San Francisco has banned the sale of phthlatate and bispehno-containing toys to children under age three. Some state legislatures are considering similar bills. The Food and Drug Administration has recommended that health care providers use alternatives to IV tubing containing phthalates for certain groups, such as neonates and pregnant and lactating hemodialysis patients.

Summary

To summarize, the known and suspected health hazards of phthalates and related compounds are very serious. This measure will enhance consumer awareness, protect individuals from unwanted toxic exposures, and lead to increased understanding of the hazardous effects of phthalates.

References:

Blount, BC, MJ Silva, SP Caudill, LL Needham, JL Pirkle, EJ Sampson, GW Lucier, RJ Jackson, JW Brock. (2000) Levels of Seven Urinary Phthalate Metabolites in a Human Reference Population. Environmental Health Perspectives 108:979-982.

Shea, Katherine M. MD, MPH (2003) Pediatric Exposure and Potential Toxicity ofPhthalate PlasticizersPediatrics :111: 1467-1474

Correspondence with Ted Schettler, MD, MPH, Science Director, Science and Environment Health Network, August 24, 2006

Duty, SM, NP Singh, MJ Silva, DB Barr, JW Brock, L Ryan, RF Herrick, DC Christiani and R Hauser 2003. The relationship between environmental exposures to phthalates and DNA damage in human sperm using the neutral comet assay. Environmental Health Perspectives: doi:10.1289/ehp.5756

Swan, Shanna H, 2006. New Science on the Potential Health Impacts of Phthalates. Presentation at Oregon Environmental Council Health Environment Forum, March 22, 2006.

Swan, SH, et al. 2005. Decrease in Anogenital Distance Among Male Infants with Prenatal Phthalate Exposure. Environmental Health Perspectives113: 1056-1061.

Duty, SM, MJ Silva, DB Barr, JW Brock, L Ryan, Z Chen, RF Herrick, DC Christiani and R Hauser 2003. Phthalate Exposure and Human Semen ParametersEpidemiology 14:269 –277.

Gray Jr, L. Earl, Wilson, Vickie S. et al (2006)Adverse effects of environmental antiandrogens and androgens on reproductive development in mammals International Journal of Andrology:29:96

Natural Resources Defense Council. EPA to weaken health standard for common consumer product ingredient. Posted January 8, 2007.

Roosevelt M. What’s toxic in toyland. TIME 2006 (Dec 11). Available at Accessed 4/18/07.

US Food and Drug Administration. FDA Public Health Notification: PVC devices containing the plasticizer DEHP. Updated 7/1/02. Available at Accessed 4/18/07.

European Chemicals Commission Reports available at and and

For makeup of the Phthalates Panel, see

Re the European Chemicals Commission reports not leading to the EU overturning its ban on phthalates, see BBC News Report at

Martin Donohoe, MD, FACP
Internal Medicine, KaiserSunnysideMedicalCenter
Adjunct Lecturer, Department of Community Health, PortlandStateUniversity
Chief Science Advisor, Campaign for Safe Foodsand Member, Board of Advisors
Oregon Physicians for Social Responsibility

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