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Kids Safe Chemical Act Empowers EPA to Require Chemical Testing
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Isn't It Time We Regulated Chemicals? [
Kids Safe Chemical Act Empowers EPA to Require Chemical Testing
Environment News Service
Monday 18 July 2005
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U.S. Senator Frank R. Lautenberg, a New Jersey Democrat, held a news conference Wednesday to announce the Child, Worker and Consumer Safe Chemicals Act, coauthored with Vermont Independent Senator Jim Jeffords. The measure would require chemical manufacturers to provide health and safety information on chemicals used in consumer products like baby bottles and food wrapping instead of presuming a substance is safe until proven dangerous.
"Every day, Americans use household products that contain hundreds of chemicals," said Senator Lautenberg. "Most people assume that those chemicals have been proven safe for their families and children. Unfortunately, that assumption is wrong."
"We have laws to make sure that pesticides and medicines are safe - but we fail to require similar analysis for the chemicals used in baby bottles, water bottles, food packages and thousands of other products," said Lautenberg. This is inexcusable."
Senator Jeffords said, "Study after study has shown we have dozens, if not hundreds, of synthetic chemicals in our bodies, yet we have very little information about how they impact our health. The Kids Safe Chemical Act will for the first time require that the chemicals our children come in contact with each day are properly tested and reviewed. It is time to hold the chemicals in our consumer goods and household products to a higher standard, and fully understand their effect on our bodies."
Written by John Stephenson, director of natural resources and environment with the Government Accountability Office (GAO), the new report reviews the EPA's efforts to control the risks of new chemicals not yet in commerce, assess the risks of existing chemicals used in commerce, and publicly disclose information provided by chemical companies under the Toxic Substances Control Act.
Stephenson recommends that the agency needs the authority to require chemical companies to conduct testing, and the authority to see the confidential business information that chemical companies provide to states and foreign governments.
The report recommends that Congress consider providing the EPA with additional authorities under the Toxic Substances Control Act to improve its ability to assess chemical risks.
Today, chemical companies are not required by the Toxic Substances Control Act (TSCA) to test new chemicals before they are submitted for the EPA's review, and companies generally do not voluntarily perform such testing.
Tens of thousands of chemicals are currently in commercial use in the United States and, on average, over 700 new chemicals are introduced into commerce each year, but the EPA does not routinely assess the risks of all existing chemicals.
Because chemical companies claim that information about their chemicals is confidential business information, the agency "faces challenges in obtaining the information necessary" to assess chemical risks to the public, the GAO report states.
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Yet state environmental agencies are interested in obtaining confidential business information for use in developing contingency plans to alert emergency response personnel of the presence of highly toxic substances at manufacturing facilities.
The Toxic Substances Control Act does not facilitate the EPA's review process because it places the costly and time consuming burden of obtaining data on the EPA instead of on the chemical companies.
The failure of EPA in its efforts to protect public health is a result of statutory restrictions imposed by the Toxic Substances Control Act, Lautenberg said.
This law's procedural requirements are so daunting, he said, that, in 29 years, only five toxic substances in existence when the law passed, have been regulated by the EPA.
Given limited test data, the EPA predicts the toxicity of new chemicals by using models that compare the new chemicals with chemicals of similar molecular structures that have previously been tested.
But, the GAO found, the use of the models does not ensure that chemicals' risks are fully assessed before they enter commerce because the models are not always accurate in predicting chemical properties and toxicity, especially in connection with general health effects.
Given the lack of test data and health and safety information available to the agency, the EPA believes the models are generally useful as screening tools for identifying potentially harmful chemicals. Together with other information, such as the anticipated potential uses and exposures of the new chemicals, the models provide a reasonable basis for reviewing new chemicals, the EPA said.
Still, the agency recognizes that obtaining additional information would improve the predictive capabilities of its models.
The Kids Safe Chemicals Act of 2005 would require manufacturers to provide health and safety information prior to distributing a chemical in consumer products, instead of presuming a substance is safe until proven dangerous.
It would reduce our toxic ignorance by providing hazard and exposure information to EPA and the public.
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Five other Democratic Senators are cosponsors of the legislation - John Kerry and Edward Kennedy of Massachusetts, Barbara Boxer of California, Hillary Clinton of New York, and Jon Corzine of New Jersey.
Partly because of a lack of information on existing chemicals, EPA, in partnership with industry and environmental groups, initiated the High Production Volume (HPV) Challenge Program in 1998, under which chemical companies began voluntarily providing information on the basic properties of chemicals produced in large amounts. But this program may not be effective.
"It is unclear," Stephanson wrote, "whether the program will produce sufficient information for EPA to determine chemicals' risks to human health and the environment. EPA has limited ability to publicly share the information it receives from chemical companies under TSCA.
The GAO recommends three actions for Congress to take to improve EPA's ability to assess the health and environmental risks of chemicals.
First, provide explicit authority for EPA to enter into enforceable consent agreements under which chemical companies are required to conduct testing;
Next, the EPA needs the authority to require chemical substance manufacturers and processors to develop test data based on production volume.
And finally, the EPA needs the authority to obtain the confidential business information that chemical companies provide to the states and foreign governments, subject to procedures to protect the information from unauthorized disclosures.
To improve EPA's management of its chemical review program, the GAO recommends that the EPA Administrator develop and implement methods for using information collected through the HPV Challenge Program to prioritize chemicals for further review and to identify and obtain additional information needed to assess their risks.
Stephanson recommends a new rule requiring chemical companies to submit to EPA copies of any health and safety studies, and other information on the environmental and health effects of chemicals, that they submit to foreign governments on chemicals that the companies manufacture or process in, or import to, the United States.
The EPA should develop a strategy for improving and validating, for regulatory purposes, the models used to assess and predict the risks of chemicals and to inform regulatory decisions on the production, use, and disposal of the chemicals.
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The EPA did not disagree with the GAO report's findings and recommendations, but offered two substantive comments.
In a letter to Stephenson, Susan Hazen, EPA principal deputy assistant administrator, commented that, while a rule requiring chemical manufacturers share with the EPA what they disclose to foreign governments may bring useful information, "other targeted approaches for collecting information which are directed at EPA's domestic priorities, rather than foreign government mandates, may be more prudent."
Stephenson responds that, "We believe that having access to the information submitted to foreign governments would provide EPA with an important source of information that would be useful for assessing the risks of existing chemicals and improving the models that EPA uses to assess new chemicals.
"EPA could tailor this rule more narrowly, however, if it saw good reason to do so, such as to avoid duplication of information it already possesses," Stephenson wrote.
Hazen said the EPA does not need the Toxic Substances Control Act changed to explicitly recognize enforceable consent agreements, because she believes that "there is currently strong legal authority for these agreements."
Stephenson answers that the Toxic Substances Control Act "does not explicitly authorize EPA to enter into these agreements and a court could find that EPA lacked discretion to require testing other than through promulgation of a test rule."
Isn't It Time We Regulated Chemicals?
By Tim Montague
Rachel's Environment & Health News
Thursday 23 June 2005
If you read almost any newspaper these days, you learn the following kinds of information:
- Many plastic toys contain chemicals that can interfere with the sexual development of laboratory animals and are now thought capable of doing the same in baby boys. [1]
- Most of the rivers and streams in the U.S. are contaminated with low levels of chemicals that can change the sexual orientation of fish and can interfere with reproduction in animals that feed on fish. [2]
- Dozens of toxic chemicals have recently been measured in household dust, indicating that common consumer products are contaminating our homes with toxicants. [3]
You might ask yourself, isn't the government regulating dangerous chemicals? Unfortunately, the answer is No, not in any effective way.
About 1700 new chemicals are put into commercial use each year, almost entirely untested for their effects on humans and the natural world. [4]
After a chemical causes enough harm for someone to take notice, then the government conducts a numerical risk assessment (aka, quantitative risk assessment) on an individual chemical. The point of a numerical risk assessment is to learn how much of a chemical is "safe" to eat, drink, and breathe. Then the government may try to regulate releases of that chemical. But fewer than 1% of all chemicals are currently regulated. (See Rachel's #815.)
A scientist at the University of Oregon has described why numerical risk assessment doesn't work, and has suggested other ways we could control chemical hazards. [5] Dr. Joe Thornton - a biologist - explains that numerical risk assessment is a fundamentally inappropriate way to control persistent pollutants (such as heavy metals and chemicals containing chlorine) for two reasons:
1) It assumes that we can learn all the ways that every individual chemical can cause harm in humans and in the natural environment - but there aren't enough scientists in the world to do this.
2) Many industrial chemicals tend to stick around for a long time and move from place to place in ways that are impossible to predict, so often we don't even know what we're looking for.
Thornton proposes we adopt four new ways of regulating chemicals - zero discharge, clean production, reverse onus, and phasing out entire classes of persistent chemicals - because the old way (regulating one chemical at a time at the end of the discharge pipe) simply doesn't work.
Risk assessment assumes that damage is local, short-lived, and predictable. But organisms and the environment are complex, interconnected, and only partly understood (to put it mildly). Therefore, we cannot predict cause-and-effect in any reliable way. In the face of these insurmountable difficulties, we can take a precautionary stance: when we have good reason to suspect harm, yet we have scientific uncertainty, we can err on the side of caution. Faced with choices, we can give the benefit of the doubt to public health and to nature.
Thornton's four principles begin to clarify how the precautionary principal can work in the real world. These principles are:
Zero Discharge - Persistent and bioaccumulative toxicants are incompatible with ecological processes, and no amount of their release into the environment is acceptable. [6]
Clean Production - We can consider alternative technologies up front and avoid the use of known toxicants in manufacturing. Finding alternatives rather than approving pollutants becomes the focus. [7] For example, in dry cleaning, we can replace perchloroethylene (perc) with CO2 and water-based methods.
Reverse Onus - Apply the same logic used in drug safety: give manufacturers the responsibility to show that a product is reasonably safe for use before it can be released into the environment. This shifts the burden of proof from society to the chemical companies to provide information about their products, to monitor for harmful effects and to come clean about their findings.
Emphasis on Large Classes of Chemicals - Faced with the impossibilities of measuring the impacts of individual chemicals, simply phase out entire classes of compounds that are clearly problematic. PCBs, CFCs and lead compounds are all examples of classes of chemicals that have been phased out because of their hazards.
Thornton gives six reasons why the current risk paradigm is so flawed:
1. Accumulation of Persistent Pollutants
Risk-based approaches assume that nature and living things can absorb and assimilate synthetic chemicals, breaking them down and digesting them. This may be true for sewage, oil, and other naturally occurring substances. But persistent organic pollutants (POPs) like pesticides, solvents, refrigerants, etc. often resist natural breakdown and can persist for years, decades or centuries. (See Rachel's #284, #505, #611.)
Many POPs and metallic pollutants are fat-soluble and thus bioaccumulate as they move up the food chain. Top predators like humans, bears, and big fish can accumulate chemical concentrations that are tens of millions of times greater than typical environmental levels.
Persistence and bioaccumulation mean that even very small discharges of synthetic chemicals can build up to dangerous levels in our bodies over time. The general public's average body burden for some of the best studied pollutants is already at or near the range at which health impacts have been found in laboratory animals. To avoid this problem, we can declare that there is no level of acceptable discharge for chemicals that persist or magnify in the food chain - in other words, we can adopt a zero-discharge policy.
2. Cumulative Global Pollution
Numerical risk assessment oversimplifies the real world and considers environmental risks to be local in time and space. Once a chemical disperses beyond some horizon, it is assumed to do no further harm. So industry is encouraged to dot the landscape with sources of pollution that collectively begin to overwhelm the biosphere but which are individually within acceptable limits. As a result the entire planet has become polluted.
3. Toxicological Complexity
The science of numerical risk assessment is based on the premise that we can calculate a chemical's impact on the health of living things. Risk assessors do this by measuring the toxicity of individual chemicals on individual species - usually rats, mice and other small mammals. There are at least 70,000 synthetic chemicals being used in commerce today (up from 40,000 in 1991). Risk assessment considers the toxicity of an individual pollutant acting alone - when in reality each chemical is acting in concert with a myriad of other chemicals in the environment.
This poses a huge problem - studying multiple chemical exposures is very costly and time-consuming. It would require 33 million experiments just to learn something about the effects of 25 different chemicals on a single species over a short period of time (13 weeks). A similar study of just 1% of the 70,000 chemicals in commerce would require 10E210 experiments (that is, 10 with 210 zeroes behind it). Trillions upon trillions upon trillions of experiments - you can see that science as we know it is not prepared to tackle this problem. On the other hand, the risk-assessment solution is easy: Just ignore multiple chemical exposures.
4. Inadequate Data
Industry's capacity for inventing new chemicals has overwhelmed the regulatory system's ability to study their potential harms. The chemical industry is introducing at least 1700 new chemicals into commerce each year.[4] The U.S. National Toxicology Program conducts assessments on just 10 to 20 substances per year. At this rate we are falling at least 90 years behind in our knowledge each year that passes. A study by the National Research Council in 1997 concluded that we lack even minimal toxicity information for 70% of the most worrisome chemicals - those that are manufactured in high volume and are already suspected of harming the environment.
The risk-assessment solution: If you don't have data on the toxicity of a substance, assume the risk is ZERO. Just ignore the problem. Here, reverse onus plays an important role in putting the burden of proof on industry to collect and reveal data on new chemicals prior to their general release or manufacture.
5. Formation of Chemical Mixtures and By-Products
The nature of industrial chemistry is messy. When you mix chemicals under diverse industrial circumstances you inevitably produce new and unexpected byproducts. Joe Thornton gives three examples of how we are flying blind:
a) Paper manufacturing. The effluent from pulp mills contain over 300 organochlorine byproducts; including dioxins, furans, phenols, benzenes, thiophenes, methyl-sulfones, methanes, ethanes, acids and PCBs. We have only identified 3 to 10% of the organically bound chlorine in pulp effluent. In other words, we are 90-97% ignorant of what is coming out of the pipe.
b) Incineration. Incinerator emissions are estimated to contain over 1,000 products of incomplete combustion (complete combustion would reduce the fuel to carbon dioxide and water). Yet we have identified only 40-60% of these chemical effluents.
c) Pesticide manufacture. Byproducts account for almost 20% of DDT manufacture by weight. Many of these byproducts have never even been identified.
We don't know the names, structures or toxicity of many of the chemical byproducts formed in industrial processes. Even though we phased out purposeful manufacture of PCBs they - and dioxins, an unwanted byproduct - are still being introduced into the environment as side-effects of chlorine chemistry. To prevent global contamination with dioxin, we would need to phase out the whole class of organochlorines.
6. Pollution Control and Disposal
End-of-pipe pollution control and disposal technologies do little to prevent global environmental contamination. If you manufacture a substance that breaks down slowly and tends to accumulate in living things, it will eventually spread throughout the living world. Scrubbers, filters, precipitators, incinerators, and landfills are all just ways of temporarily moving a substance from one location or form to another (a shell-game). In the end, everything that persists will disperse into the air, water, land and living things and people will be affected. Landfills leak, incinerators generate toxic ash and gas, and even the best pollution controls are never 100% effective.
Thornton helps us realize that we are foolish to try to control chemicals with the end-of-the-pipe risk-assessment approach. Instead, we can use the precautionary principle and acknowledge that:
a) Some chemicals don't belong in the environment (zero discharge) and are best regulated away as entire classes of compounds;
b) With the right combination of carrots and sticks as motivation, industry can find clean technologies (clean production); and
c) The burden of proof (aka "reverse onus") can be placed on the industries that want to introduce new chemicals - to show that they have done their best to understand the consequences of their actions - thus motivating them to innovate and develop clean technologies. No data? No market.
[1] http://www.gsenet.org/library/11gsn/2005/gs050530.4.html.
[2] See http://www.gsenet.org/library/11gsn/2005/gs050530.7.html, http://www.gsenet.org/library/11gsn/2005/gs050420.13.html, http://www.gsenet.org/library/11gsn/2003/gs030108.7.html, http://www.gsenet.org/library/11gsn/2004/gs040302.13.html and http://www.gsenet.org/library/11gsn/2002/gs020730.7.html.
[3] http://www.gsenet.org/library/11gsn/2003/gs030108.7.html.
[4] See http://www.whitehouse.gov/omb/budget/fy2004/pma/newchemicals.xls and http://archive.gao.gov/t2pbat3/151661.pdf.
[5] Joe Thornton, Beyond Risk: An Ecological Paradigm to Prevent Global Chemical Pollution. International Journal of Occupational and Environmental Health Vol. 6 (2000) pgs. 318-330. Available at http://www.rachel.org/library/getfile.cfm?ID=536. And see Rachel's #704, which reviews Thornton's book, Pandora's Poison.
[6] International Joint Commission. Fifth Biennial Report on Great Lakes Water Quality. Windsor, ON, Canada, 1990. Available here: http://www.ijc.org/php/publications/pdf/ID603.pdf.
[7] Mary O'Brien, Making Better Environmental Decisions; An Alternative to Risk Assessment (Cambridge, Mass.: MIT Press, 2000). ISBN: 0262650533.
Tim Montague is Associate Director of Environmental Research Foundation. He holds an MS degree in ecology from University of Wisconsin-Madison and lives in Chicago.
Rachel's Environment & Health News is a publication of the Environmental Research Foundation, PO Box 160, New Brunswick, NJ 08903-0160.
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