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The Not-so-little Regulatory System that Couldn’t: How Toys End Up Toxic
Dr. David Wallinga
Thursday, March 13, 2008
How many times have we heard, “If it wasn’t safe, the government wouldn’t let them sell it.”? While true to some degree -- such as the FDA’s pre-market testing of pharmaceuticals -- a lot of things slip through the regulatory cracks.
A hot example from today’s headlines: hazardous chemicals used in everyday children’s products.
More and more parents wonder how this could be happening. This article plows into the somewhat arcane minutiae of why and how the chemical regulatory system that’s supposed to protect us is fundamentally flawed and fails us. Tedious though the details may be, they are worth reading. Until we understand these systemic failures, we are doomed to continue making the same mistakes, putting our children and their children in harm’s way, chemical after chemical. That is, until we put can put a better mousetrap in place. And we can.
A Broken System
“The real problem”, says Donald Kennedy, former commissioner of the U.S. Food and Drug Administration (FDA), “is that the U.S. regulatory system for toxic industrial chemicals is not effective and is a threat to public health.”
The regulatory system Kennedy admonishes is based on the Toxic Substances Control Act (TSCA) of 1976 that compels the Environmental Protection Agency (EPA) to regulate industrial chemicals, including used in toys and other everyday products. (Pesticides and cosmetics are regulated under separate laws).
Kennedy is not alone in his assessment. As early as 1988, Charles Elkins, then Director of the EPA’s Office of Toxic Substances, noted, “it is clear to me that the current level of accomplishment of the existing chemicals program is inadequate.” (Lowell Center for Sustainable Production, 2003). Congressional hearings in 1983, 1988, and 1994 stressed the flaws of TSCA in addition to the National Academy of Sciences (1984); the US General Accounting Office (1994, 2005), the University of California (2006), and a wide variety of others. Most recently, the American Public Health Association formally recognized that TSCA has fallen short of its objectives, and has not served as an effective regulatory vehicle to protect public health (2007).
How is it that the Toxic Substances Control Act is not controlling toxic substances?
Flaw #1 – Perpetuation of ignorance about the hazards of chemicals.
Prior to passage of TSCA in 1976, and mostly since World War II, some 62,000 industrial chemicals were put into commercial use without safety testing. Until quite recently, our operating presumption has been that use of these chemicals was medically harmless. Thus, little coordinated effort has been made to routinely monitor for them in human tissue or in the environment. Most thought Congressional passage of TSCA would help to address this ignorance.
Unfortunately, TSCA instead perpetuates gaps in our medical knowledge. The vast majority of TSCA chemicals have undergone little or no testing to determine whether or not they represent a hazard to humans -- mainly, because the 1976 law ‘grandfathered’ in the 62,000 chemicals then in commercial use without any additional toxicological testing. Ninety-two percent of industrial chemicals produced today at more than a million pounds per year were grandfathered in by TSCA.
TSCA also fails to require disclosure of safety data from makers of new chemicals before they are used in creating products and sold to consumers. In this way, TSCA ensures that our knowledge gap will be repeated for every chemical created. The list of TSCA-registered chemicals now numbers roughly 81,600.
Flaw #2 – TSCA requires the government to prove harm after the fact, instead of requiring manufacturers to demonstrate safety prior to use.
TSCA puts the burden for proving risk from an already-marketed chemical squarely on government. Moreover, the law fails to obligate chemical producers to provide the EPA with the basic information necessary to do so in the first place. The result: regulatory paralysis. Fewer than 5 percent of all TSCA-registered chemicals have been reviewed for safety by government agencies. And only 5 TSCA chemicals have been restricted since 1976.
In addition, TSCA grants the EPA with very limited authority to control substances in any sort of cautionary way. The small handful of times the EPA has tried to regulate a chemical, they have been sued by the manufacturers. Dr. Lynn Goldman, former EPA Deputy Administrator for the Office of Prevention, Pesticides and Toxic Substances, has effectively summarized this authoritative limitation of TSCA:
“It is fair to state that the results [of TSCA] have come nowhere close to…the original Congressional intent… Probably the weakest area concerns the management of risks from chemicals. Because of the Act’s inadequate coverage, when EPA is confronted with new risks…it is unable or unwilling to take action to reduce risks, unless industry is willing to step forward voluntarily on its own. TSCA currently places too high of a bar for the EPA to jump to assure the health of the public and protection of the environment. Under TSCA, existing chemicals are assumed safe until proven guilty, even when found in breast milk and even as toxicology evidence accumulates.” (Lowell Center for Sustainable Production, 2003).
Flaw #3 – Chemical exposures can cause decades of harm before health-protective action is taken.
Unfortunately, TSCA’s gaps ensure a huge time lag between the widespread use of industrial chemicals in commerce, the medical and scientific community’s recognition of the chemical hazards to humans, and an eventual public policy response to reduce exposure to those hazards.
What TSCA’s gaps have meant for lead, mercury, PCBs, and a handful of other chemicals now recognized as toxic to the developing brain is that generations of children, numbering in the millions, have been harmed before medical science has recognized the problems from their industrial use and environmental dispersal. These may just be the tip of a neurotoxic iceberg. Nearly 200 other industrial chemicals cause clinical neurotoxicity in adults; their impacts on the young, developing brain are unknown. (Grandjean and Landrigan, 2006) Thousands of other potential neurotoxins have simply never been assessed and as we wait for evidence, these chemicals quietly invade the womb. A recent small study of American Red Cross samples of cord blood from newborns found a total of 287 industrial chemicals, 217 of them known to be toxic to the brain and nervous system in animals or people. (Houlihan J et al. 2005. Environmental Working Group).
Exacerbating this safety gap is the ever-widening scope of chemicals and products involved. The U.S. chemical industry produces and imports 42 billion pounds of industrial chemical each day and an estimated 2,000 new chemicals are introduced every year.
Flaw #4 – Manufacturers profit from ignorance, while society shoulders an ever-increasing financial burden.
Ineffective chemical regulation is costly. Exposures to environmental chemicals are linked to an ever-increasing array of expensive-to-treat chronic diseases. Beyond medical costs to workers and the general public are the other costs imposed on government, and on ecosystems. Estimates are that hundreds of billions of dollars have been lost from the economic productivity of generations of children exposed early-in-life to lead and PCBs, and who had lower intelligence and lower lifetime earnings as a result. Economic costs also include a projected $250 billion for cleaning up 77,000 existing hazardous waste sites, plus another 600 new U.S. sites anticipated each month over the next 25 years. These costs likely will deepen with expanding global chemical production that experts predict will quadruple by 2050.
Solutions for a Healthy Tomorrow
Everyone can do something to create a healthier tomorrow.
If you are a parent, share this article with your child’s physician. And call your elected officials to demand a system for regulating industrial chemicals that works.
If you are a physician, take steps to protect your patients and your community. Physicians hold authority and a special role in creating healthier environments for children.
- Take a routine environmental history from patients that asks about chemical exposures at home, through the diet, via consumer product use and in the workplace. The Pediatric Environmental Health Toolkit, endorsed by the American Academy of Pediatrics, offers clinician guidance on taking an environmental history, a referenced guide for responding to patient questions, and anticipatory guidance for patients on how to avoid such exposures.
- Advocate for effective chemical regulation. Letters, phone calls and testimony from health professionals carry enormous weight with elected officials. While the EPA has promoted important voluntary efforts, they are insufficient to ensure that basic data are available on chemicals in commerce. The EPA also needs the capacity to act to restrict problem chemicals or broad classes of chemicals. Federal changes are imperative.
Physicians can also support localized changes as municipalities and states take action on this important issue. For example, in October California effectively phased out the manufacture or sale of young children’s products containing phthalate plasticizers by 2009, as Europe had done previously due to concerns around hormone disruption. But phthalates remain for sale elsewhere in the U.S. Likewise, baby bottles of polycarbonate plastic, which leach bisphenol-A, are no longer sold in Japan and yet are widely available in the U.S.
The good news is that we can easily make toys and household products that are both useful and safe. In fact, we should expect nothing less.
David Wallinga, MD, MPA, is director of the Food and Health Program at the Institute for Agriculture & Trade Policy, in Minneapolis, Minnesota.
This article was adapted from Dr. Wallinga’s ‘Toys, Tots, and Toxic Chemicals’ originally printed in the Jan/Feb 2008 issue of San Francisco Medicine
Sources:
1. Kennedy D. editorial. 2007. Toxic Dilemmas. Science 318:1217.
2. Wilson MP et al. 2006. Green Chemistry in California: A Framework for Leadership in Chemicals Policy and Innovation. Special Report to the California Legislature. University of California Policy Research Center, Office of the President.
3. Grandjean P, Landrigan PJ. 2006. Developmental neurotoxicity of industrial chemicals. Lancet Lancet 2006; 368: 2167?78.
4. National Research Council. Pesticides in the Diets of Infants and Children. Washington: National Academy Press, 1993.
5. World Health Organization. 2007. Principles for evaluating health risks in children associated with exposure to chemicals.
6. Lowell Center for Sustainable Production, 2003. The promise and limits of the United States Toxic Substances Control Act.
Additional resources:
*Collaborative on Health and the Environment. Note the "New Scientific Consensus Statement" on environmental agents associated with neurodevelopmental disorders
*Pediatric Environmental Health Toolkit
*University of California, Program in Green Chemistry and Chemicals Policy
*Health Observatory, Institute for Agriculture and Trade Policy
