Shifting the experiment to the lab: does EPA have a mandatory duty to require chemical testing for endocrine disruption effects under the Toxic Substances Control Act?

AuthorPettit, Holly E.
  1. INTRODUCTION

    We can never construct a society that is completely free of risk. At a minimum, however, the American people have a right to know the substances to which they and their children are being exposed and to know everything that science can tell us about the hazards.(1)

    For the last several decades, humanity has conducted a global, uncontrolled experiment, with ourselves, future generations, and all nonhuman inhabitants of the earth as test subjects. We expose ourselves to thousands of different synthetic chemicals every year without understanding the effects of those chemicals on our bodies, our minds, and the rest of the environment. All individuals--young or old, near or far--carry a legacy of persistent bioaccumulative chemicals within their tissue.(2) Each generation passes this chemical inheritance on to the next.(3) In this global experiment, there are no longer any unaffected control groups against which the impacts of exposure can be measured.(4)

    There are increasing calls for an end to this uncontrolled experiment.(5) The threats of cancer, birth defects, and other traditional chemical-exposure-related harms already present an adequate incentive to shift toward a more precautionary approach to chemical testing.(6) Additionally, scientific evidence now suggests that synthetic chemicals may interfere with our biological functions by disrupting the natural production and receipt of hormones--the chemical messengers that regulate the interactions among our organs and cells.(7) Researchers have already documented hormone, or endocrine, system disruption by synthetic chemicals in wildlife and in highly exposed human populations.(8) Some evidence, such as declining sperm counts; increased breast, testes and prostate cancer, and increased childhood hyperactivity and learning disorders, suggests that endocrine disruption also may be occurring in the general human population.(9)

    The recent discovery of endocrine disruption dramatically highlights our lack of knowledge about the effects of common chemicals.(10) This ignorance, in turn, highlights the inadequacy of past chemical testing regulation. The Environmental Protection Agency (EPA), the agency primarily responsible for requiring screening and testing of commercial chemicals used in the United States,(11) historically has been less than aggressive in requiring such testing.(12) The Toxic Substances Control Act (TSCA),(13) which purports to protect the public from the effects of chemicals not regulated under other programs,(14) has been particularly underutilized.(15)

    Recently, however, EPA has demonstrated a new willingness to require chemical screening and testing. Placing a new emphasis on the "right to know," EPA has instituted significant new screening and testing initiatives.(16) Despite the direct correlation between the purpose of these new initiatives and the purpose of TSCA, however, EPA has made a conscious effort to minimize TSCA's role in the new programs.(17) Nevertheless, TSCA's potential role in these efforts could be more significant than EPA has yet acknowledged.

    Congress passed TSCA in 1976 because other regulatory programs that focused on the release of pollutants into particular media (such as air or water) did not adequately protect the public from exposure to harmful substances.(18) The Act's policy section professes to make the development of health and environmental effects data "the responsibility of those who manufacture and those who process ... chemical substances and mixtures."(19) However, the Act places a substantial burden on EPA to make specific findings before requiring testing of new or existing chemicals or regulating the use of those chemicals.(20) Once EPA establishes these prerequisites, the statutory language imposes a nondiscretionary duty on the agency to promulgate a test rule to bridge the information gap. A reviewing court should examine whether EPA has made the prerequisite findings in fact, even if EPA has not done so officially, and the court should be willing to enforce EPA's mandatory duty to promulgate a test rule if the findings have been made. EPA's own statements indicate that it has made the requisite findings with regard to endocrine disruption effects and high production volume (HPV) chemicals. While enforcement of a mandatory test rule duty might interfere with EPA's efforts to gather information through voluntary or negotiated arrangements in some situations, the addition of endocrine disruption screening to the upcoming HPV test rule(21) may be an efficient way for EPA to satisfy its statutory obligations to gather the necessary chemical effects data.

    Part II of this Comment discusses our ignorance about the health and environmental effects of common chemicals, particularly emphasizing our lack of knowledge regarding endocrine disruption effects. Part III describes TSCA's chemical testing authority and EPA's past and present implementation of those provisions. Part IV argues that the nondiscretionary duty imposed by section 4(a) of TSCA has already been triggered with regard to endocrine discription screening of HPV chemicals. Part V considers EPA's use of voluntary alternatives to test rules and suggests that EPA seek congressional approval for its use of nonrule methods of encouraging chemical testing. The Comment concludes that eforcement of EPA's mandatory duties under section 4 of TSCA could allow the statute to play a larger and more beneficial role in EPA's new, more active testing strategy.

    H. THE CURRENT STATE OF IGNORANCE

    The recent wave of chemical testing initiatives is largely a response to new information. Research and studies conducted in the late 1990s affirmed that there are dramatic gaps in our understanding about which chemical may cause which adverse health and environmental effects.(22) More sensationally, researchers have recently concluded that chemical can adversely affect humans and wildlife in ways not even recognized a decade ago.(23) Facing such dangerous uncertainty, the public has increasingly called for more chemical testing,(24) and EPA has begun to respond.(25) The tremendous scope of our currant ignorance, however, greatly amplifies the magnitude of the task ahead.

    A. Ignorance Regarding Basic Chemical Effects

    Humanity has a history of discovering the toxic effects of particular chemicals after extensive damage to human health has already occurred.(26) Perhaps it is not surprising, therefore, that the basic health and environmental effects of many commercial chemicals are largely unknown. The extent of that ignorance, however, is staggering. In 1984 the National Academy of Sciences (NAS) surveyed our knowledge of chemical effects and found that seventy-eight percent of the most common commercial chemicals (high production volume (HPV) chemicals(27)) had never been subject to basic toxicity screening tests.(28) In 1987 NAS estimated that fewer than two percent of the chemicals in commercial use had been sufficiently tested to adequately assess their health risks.(29) When the Environmental Defense Fund (EDF) updated this research in 1997, it found that basic toxicity testing data still could not be found for seventy-five percent of the nation's HPV chemicals.(30) EPA's own survey of the data in 1998 concluded that "no basic toxicity information, i.e., neither human health nor environmental toxicity, is publicly available for 43% of the high production volume chemicals manufactured in the US[,] and ... a full set of basic toxicity information is available for only 7% of these chemicals."(31) Given this lack of information, EPA has acknowledged that it "cannot reasonably assess the effects on health or the environment from the manufacture, distribution, processing, use or disposal of these [high production volume] chemicals."(32)

    B. Ignorance Regarding Endocrine Disruption Effects

    While even the most basic health and environmental effects information is missing for most chemicals, the basic tests alone may not provide adequate information about a chemical's potential threat. A growing body of scientific research indicates that many synthetic chemicals interfere with the endocrine system, disrupting normal development, behavior, and reproduction.(33) Various studies suggest that hormone disrupting chemicals are causing widespread adverse effects, even at low levels of exposure, and are posing potentially serious risks to the environment and public health.(34) Although only recently hypothesized, the hormone disruption model has now become widely accepted, and endocrine disruption is now acknowledged as a serious threat to human beings and wildlife.(35) Beyond basic information about a chemical's acute toxicity and carcinogenicity, therefore, EPA may also need information about a chemical's endocrine disruption effects to "reasonably assess" the chemical's impact on human health and the environment.

    1. The Science of Endocrine Disruption

      The endocrine system is the set of glands and the hormones they produce that guides the development, growth, reproduction, and behavior of human beings and other animals.(36) Hormones, such as estrogen, androgen, and thyroid, travel through the body and cause specific responses when they are received by hormone receptors.(37) Hormone (or endocrine) disruptors interfere with the normal functioning of the endocrine system.(38) They can 1) mimic a natural hormone and thus fool the body into responding a certain way, 2) interfere with the reception of hormones by hormone receptors, 3) directly alter a hormone and impede its function, 4) cause the body to overproduce or underproduce natural hormones, or 5) decrease or increase the number of hormone receptors.(39) These effects are especially potent during prenatal development, when even minute exposure to hormones can severely disrupt the normal development process.(40) Potential hormone disruption effects include abnormalities of the reproductive system, birth...

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT