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 A ToSCA Quiz & Primer
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Find Out How the U.S. System of Chemicals Regulation Is Broken
by Sharon S. Tisher

True or False:


1. ToSCA is a famous Italian opera. Answer.

2. An environmental law textbook describes ToSCA as “perhaps the simplest, clearest, and most effective of all our federal environmental protection statutes.” Answer.

3. ToSCA requires the EPA to review the risks of chemicals in commerce. Answer.

4. EPA has the discretion to require companies to provide testing data on the safety of chemicals in commerce wherever it concludes that would be “prudent and in the public interest.” Answer.

5. Over the thirty years since ToSCA was enacted, EPA has required safety testing of at least ten percent of the 62,000 chemicals in production in 1979. Answer.

6. Although there were inadequate safeguards regarding chemicals already in commerce when ToSCA was passed, ToSCA does require chemical companies to submit data demonstrating a new chemical’s safety to the EPA before it can market the chemical in consumer products, or for industrial processes. Answer.

7. ToSCA reviews have resulted in some action to reduce the risk of new chemicals in approximately 10% of the 32,000 new chemicals developed since ToSCA’s enactment. Answer.

8. The EPA has authority to prohibit production or impose controls on chemicals that it finds pose an “unreasonable risk” of injury to health or the environment. Answer.

9. Health, safety and environmental harm are the sole criteria considered by the EPA in determining when an “unreasonable risk” warrants restrictions on the use or production of a chemical. Answer.

10. Since ToSCA’s enactment in 1976, the number of chemicals or classes of chemicals the EPA has taken regulatory action against for presenting an “unreasonable risk” can be counted on the fingers of one hand, and the EPA has banned no chemical in the last 16 years. Answer.

11. A 1997 analysis by the Environmental Defense found that of high-volume chemicals produced in the US, less than half failed to meet minimum data requirements for preliminary health hazard screening. Answer.

12. The same study found that there are insufficient data to conduct safety assessments for approximately one quarter of chemicals in the U.S. Answer.

13. We don’t need to worry about ToSCA’s inadequacies because we are a highly litigious society and the threat of lawsuits will ensure that companies adequately test their products. Answer.

14. This is a federal problem, not a state problem. Under the U.S. Constitution, primary authority and responsibility to protect the public health and welfare rests with the federal government. Answer.

15. Mainers are less likely to be exposed to toxic chemicals than people in other parts of the country. Answer.

16. There’s nothing I can do about this problem. Answer.









Answers:


1. ToSCA is a famous Italian opera.

True, but it’s also the acronym for the federal law that regulates production and use of chemicals in the United States -- the Toxic Substance Control Act. ToSCA’s passage in 1976 was intended to provide a framework for federal regulation of chemicals found to present “an unreasonable risk of injury to health or the environment,” and to encourage industry to develop adequate data with “respect to the effect of chemical substances and mixtures on health and the environment.” 15 U.S.C. secs. 2601 et seq. ToSCA has, however, fallen far short of its objectives.
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2. An environmental law textbook describes ToSCA as “perhaps the simplest, clearest, and most effective of all our federal environmental protection statutes.”

False. Plater, Environmental Law and Policy, 3rd Ed. (2004), describes this law as “perhaps the most complex, confusing, and ineffective of all our federal environmental protection statutes.” (p. 830).
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3. ToSCA requires the EPA to review the risks of chemicals in commerce.

False. With the exception of one class of chemicals (PCB's) of particular concern at the time ToSCA was enacted, ToSCA does not require the EPA to review the risks of chemicals in commerce.
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4. EPA has the discretion to require companies to provide testing data on the safety of chemicals in commerce wherever it concludes that would be “prudent and in the public interest.”

False. The EPA has the discretionary authority to issue “testing orders” to manufacturers, but only after the EPA has met the significant burden of finding “substantial evidence” that the chemical may present an “unreasonable risk.” ToSCA creates a “Catch 22”: the EPA has to already have data in order to require testing to develop data to determine the safety of chemicals. There is no requirement, however, that these data be generated. ToSCA provides penalties against manufacturers for failure to disclose certain information regarding toxicity, but not for failure to gather it. Very little information exists regarding the toxicity or ecotoxicity of the majority of chemicals in commerce.
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5. Over the thirty years since ToSCA was enacted, EPA has required safety testing of at least ten percent of the 62,000 chemicals in production in 1979.

False. Over the 30 years since ToSCA was enacted, EPA has issued testing orders for fewer than 200 of the 62,000 chemicals that were in production in 1979. In 1994, the United States Government Accountability Office (GAO) found that the EPA had managed to review the risks of about 1,200 (2%) of the 62,000 “existing chemicals.” (GAO, Chemical Regulation: Approaches in the United States, Canada, and the European Union (GAO-06-217R)(2005)) The EPA reported, however, that about 16,000 (26%) of these chemicals were potentially of concern on account of their production volume and chemical design. A recent study found that this body of 1979 chemicals “continues to constitute the great majority of chemicals in commercial circulation in the U.S. (by volume), many of which have reached high levels of use despite very little information about their toxicity or ecotoxicity.”
(Wilson, M., Green Chemistry in California: A Framework for Leadership in Chemicals Policy and Innovation. California Policy Research Center, 2006. (“California Report”), p. 17)
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6. Although there were inadequate safeguards regarding chemicals already in commerce when ToSCA was passed, ToSCA does require chemical companies to submit data demonstrating a new chemical’s safety to the EPA before it can market the chemical in consumer products, or for industrial processes.

False. There is similarly no requirement in ToSCA that new chemicals entering the market for the first time be tested for safety. ToSCA simply requires that manufacturers submit Pre-market Notifications (PMNs) to the EPA, to which the EPA must normally respond within 90 days. Only half of PMNs submitted under ToSCA contain any toxicity information, and less than 20% include data on long-term toxicity. (Plater, p. 837; see also GAO, 2005, p. 5) The EPA has acknowledged that 85% of PMNs lack data on chemical health effects, and 67% lack health or environmental data. (California Report, p. 19). The “Catch-22” that providing any data suggestive of toxicity issues might lead to an EPA testing order has led some environmental lawyers to conclude that testing one’s new chemical under ToSCA is “like volunteering for an IRS audit. Understandably, no one does.” (Roe D., Pease, W., Toxic Ignorance. The Enviornmental Forum. May/June 1998; 28)(“Roe and Pease”). Essentially, ToSCA creates a presumption that a chemical is safe unless the EPA can prove that it is unsafe.
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7. ToSCA reviews have resulted in some action to reduce the risk of new chemicals in approximately 10% of the 32,000 new chemicals developed since ToSCA’s enactment.

True. The approximate number of cases over the previous 30 years in which use of a new chemical has been restricted, other regulatory or voluntary action has been taken, or a new chemical has been withdrawn prior to regulatory action, is 3,500. (GAO, California Report). Noting that there are approximately 2000 new chemicals that enter the market each year, a recent study concluded that “The result is an enormous lack of information on the toxicity and ecotoxicity of chemicals in commercial circulation.” (California Report, p. 19).
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8. The EPA has authority to prohibit production or impose controls on chemicals that it finds pose an “unreasonable risk” of injury to health or the environment.

True, 15 USC sec. 2605.
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9. Health, safety and environmental harm are the sole criteria considered by the EPA in determining when an “unreasonable risk” warrants restrictions on the use or production of a chemical.

False. Unlike other major environmental statutes, regulatory action under ToSCA must be predicated upon an analysis of the economic consequences of the action “after consideration of the effect on the national economy, small business, technological innovation, the environment and public health.” Additionally, before the EPA can ban a chemical, it must conduct a full risk analysis of the costs and benefits of all less burdensome regulatory alternatives, demonstrating that the risk presented by these alternatives is unacceptable; it must also conduct an analysis of the risks of all substitute chemicals for the banned product. These hurdles act as an effective roadblock to most agency action.
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10. Since ToSCA’s enactment in 1976, the number of chemicals or classes of chemicals the EPA has taken regulatory action against for presenting an “unreasonable risk” can be counted on the fingers of one hand, and the EPA has banned no chemical in the last 16 years.

True. The EPA has only taken final regulatory action restricting the use of five chemicals or classes of chemicals: PCBs, CFCs, dioxins, asbestos, and hexavalent chromium. The EPA’s regulation of asbestos, promulgated after the agency spent ten years gathering evidence, was overturned by the federal court because the EPA failed to meet its high burden of proof under ToSCA. (Corrosion Proof Fittings v. U.S. EPA, 947 F.2d 1201(5th Cir. 1991).
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11. A 1997 analysis by the Environmental Defense found that of high-volume chemicals produced in the US, less than half failed to meet minimum data requirements for preliminary health hazard screening.

False. Nearly 3/4. This landmark 1997 report, Toxic Ignorance , found that there are gaps in even the most basic testing data that are publicly available for more than 70% of the top-volume chemicals in commercial use. In other words, the public cannot tell if a large majority of the most common chemicals in the United States pose health hazards, much less how serious the risks might be. (Roe and Pease). In response to this report, and because of the substantial weaknesses of ToSCA, EPA has opted to rely on voluntary efforts to obtain more information on chemicals. The most notable of these is the U.S. HPV Challenge, which enlists producers of high production volume chemicals (those manufactured and used in the U.S. in amounts over one million pounds annually) to develop and make public a “base set” of screening-level hazard information on their chemicals. The target date for completion of this work was the end of 2005. As of March 2007, of the 2,359 chemicals in this program, only 39% had final submissions; 15% did not yet have even initial submissions, and 10% were “orphans” which no chemical company had agreed to test. Of the 265 “orphans”, EPA has issued ToSCA test rules to require data development for only 16. Moreover, since the launching of the HPV Challenge, more than 700 additional chemicals have reached HPV levels, and chemical companies have voluntarily agreed to test only 231 of these. For a detailed update on this program, see Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, April 2007, p. IV-13-15, at www. environmentaldefense.org. As the California Report concluded: “Voluntary initiatives on the part of the chemical industry to correct some of these weaknesses are positive but do not make up for TSCA’s structural weaknesses.” (California Report, 18)
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12. The same study found that there are insufficient data to conduct safety assessments for approximately one quarter of chemicals in the U.S.

False. In order to tell how serious the risk from a chemical might be, regulators traditionally conduct a “risk analysis” which combines information on the toxicity of the chemical with information on how and to what extent humans are exposed to the chemical. The voluntary HPV Challenge only addresses the first step: categorizing the toxicity of the chemical. There are no systematic efforts in the United States to gather the data required for a full risk analysis of chemicals in commerce, and no legal requirement that this be done. The 1997 Environmental Defense Toxic Ignorance study found that there were insufficient data to conduct a risk analysis for 93% of chemicals released to air or water and reported under the federal Toxics Release Inventory. This is essentially the same today.
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13. We don’t need to worry about ToSCA’s inadequacies because we are a highly litigious society and the threat of lawsuits will ensure that companies adequately test their products.

False. This may be true for risks of some acute injuries that are easily traceable to a particular chemical, but for chronic diseases like cancer with long latency periods, or endocrine, reproductive, or neurological impairments, chances that an industry will be on the hook for adjudicated damages in individual cases is extremely slim, even with strong epidemiological and animal testing data indicating causal connections. Companies prefer not to test, under the current “don’t ask, don’t tell” regulatory system.
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14. This is a federal problem, not a state problem. Under the U.S. Constitution, primary authority and responsibility to protect the public health and welfare rests with the federal government.

False. It rests with the so-called “police powers” of the States. And nothing in ToSCA preempts state action for chemicals for which the EPA has not prescribed a testing rule or regulatory restrictions. As one commentator noted, “states serve as vital laboratories for shaping the policy ideas, messages, and organizing strategies necessary for eventual breakthrough on a national chemicals policy. Historically, many U.S. policy advances, including safety, environmental and civil rights laws, won first within leading states.” (Center for International Environmental Law, “Cloudy Skies, Chance of Sun: A Forecast for U.S. Reform of Chemical Policy,” (2006))

Maine has taken significant steps as a “vital laboratory” for reforming chemicals policy, including restrictions on the sale of products containing mercury and brominated flame retardants, manufacturer responsibility laws regarding old automobile switches and thermostats containing mercury, and electronic waste. In February, 2006, Governor John Baldacci signed an Executive Order “Promoting Safer Chemicals in Consumer Products and Services,” which declared that “it is in the best interests of the people of Maine to continue and expand state leadership in promoting sustainable economic development and environmental public health protection through the elimination of the use of and environmental release and discharge of hazardous chemicals of concern within the next generation.” The Order took immediate steps to reduce or eliminate pesticide use in state owned and managed office buildings, to enhance state administered environmentally preferable purchasing policies to eliminate the use of persistent bioaccumulative toxics and carcinogens when safer alternatives are available, and to create a Task Force to Promote Safer Chemicals in Consumer Products, directed to “develop recommendations for a more comprehensive chemicals policy that requires safer substitutes to priority chemicals in consumer products and creates incentives to develop safer alternatives..” (http://www.maine.gov/tools/whatsnew/index.php?topic=Gov_Executive_Orders&id=21193&v=Article) In January 2007, the Task Force released its Interim Report, which confirmed many of the findings enumerated in this Quiz. The Report specifically declared, “ToSCA does not provide sufficient chemical safety data for public use by consumers, businesses and workers; is inadequate to ensure the safety of chemicals in commerce in the United States; and fails to create incentives to develop safer alternatives.” Interim Report, p. 4 (http://www.maine.gov/dep/oc/saferchemintrpt.htm) The Task Force’s Final Report is due in October 2007.
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15. Mainers are less likely to be exposed to toxic chemicals than people in other parts of the country.

False. Because many toxic chemicals are released from common consumer products, they are ubiquitous in this country. Maine people are routinely exposed to hazardous industrial chemicals including pththalates from cosmetics and vinyl plastic, brominated flame retardants from televisions and furniture, Teflon chemicals from stain-resistant and non-stick coatings, bisphenol A from reusable water bottles and baby bottles, and toxic metals such as lead, mercury and arsenic. In “Body of Evidence: A Study of Pollution in Maine People” (2006), the Alliance for a Clean and Healthy Maine found a total of 46 different toxic chemicals (or 71 tested) in samples of blood, urine, and hair in Maine people. On average, each of the 13 participants in the study had measurable levels of 36 toxic chemicals. www.CleanAndHealthyMe.org.
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16. There’s nothing I can do about this problem.

False!!!! First, learn about the Alliance for a Clean and Healthy Maine, at www.CleanandHealthyMe.org.

Second, join any of the members of the Steering Committee of the Alliance:
Environmental Health Strategy Center
Learning Disabilities Association of Maine
Maine Labor Group on Health
Maine Organic Farmers and Gardeners Association
Maine People's Resource Center
Maine Public Health Association
Natural Resources Council of Maine
Physicians for Social Responsibility/Maine Chapter
Toxics Action Center

Through these Maine organizations, the Alliance works for a safer chemicals policy.

Third, get more information about the chemicals you’re exposed to every day, and safer alternatives. A good source of information about how to reduce your family’s exposure to toxic chemicals at home is the booklet, “Healthy Homes and Families,” published by the Learning Disabilities Association of Maine, available at www.ldame.org. Also, consult the National Library of Medicine’s Household Products Database, a consumer’s guide that provides information on the potential health effects of more than 2,000 ingredients contained in more than 5,000 common household products used inside and around the home. www.householdproducts.nlm.nih.gov
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References

  • Alliance for a Clean and Healthy Maine, “Body of Evidence: A Study of Pollution in Maine People,” (2006), www.CleanAndHealthyMe.org
  • Center for International Environmental Law, “Cloudy Skies, Chance of Sun: A Forecast for U.S. Reform of Chemical Policy,” (2006)
  • Environmental Defense, Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, April 2007, www. environmentaldefense.org
  • General Accountability Office (GAO), “Chemical Regulation: Approaches in the United States, Canada, and the European Union,” (GAO-06-217R), 2005.
  • Governor John E. Baldacci, Executive Order Promoting Safer Chemicals in Consumer Products and Services, February 22, 2006, http://www.maine.gov/tools/whatsnew/index.php?topic=Gov_Executive_Orders&id=21193&v=Article
  • Governor John E. Baldacci’s Task Force Promoting Safer Chemicals in Consumer Products, Interim Report, January 10, 2007, http://www.maine.gov/dep/oc/saferchemintrpt.htm
  • Learning Disabilities of Maine, “Healthy Homes and Families” (2006), www.ldame.org
  • National Library of Medicine, Household Products Database, www.householdproducts.nlm.nih.gov
  • Plater, Environmental Law and Policy: Nature, Laws, and Society, 3rd Ed. New York: Aspen Publishers, 2004. 
  • Roe, D. and Pease, W., “Toxic Ignorance,” The Environmental Forum, May/June 1998, p. 24-35.
  • Toxic Substances Control Act, 15 U.S.C.A. sec. 2601-2692 (1976).
  • Wilson, “Green Chemistry in California: A Framework for Leadership in Chemicals Policy and Innovation,” California Policy Research Center, 2006.
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