1. Regulating Toxic Substances

Toxic substances differ from other environmental pollutants in that they serve a valuable role industrial and agricultural pollution, pesticide and herbicide control and in serving consumer needs. Furthermore, it is not always clear the extent of risk that these substances pose to either human or environmental health. 

Legislation that serves to control the production and use of toxic substances include:

• The Clean Air Act (CAA),

• The Clean Water Act (CWA),

• The Safe Drinking Water Act (SDWA),

• The Resource Conservation and Recovery Act (RCRA),

• The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA),

• The Federal Fungicide and Rodenticide Act (FIFRA),

•  The Food and Drug Act (FDA),

• The Occupational Safety and Health Act (OSHA),

• The Toxic Substances Control Act (TSCA);

• The Food Quality Protection Act (FQPA).

2. The Difficulties Regulating Toxic Substances

Beyond reading chapter 6 in the text, your second required assignment for this session is to read the article by Carl Cranor entitled "Regulating Toxic Substances Through a Glass Darkly: Using Science Without Distorting the Law" which appears in the 1997 proceedings of the Distinguished Humanist Achievement Lecture at the Center for Ideas and Society, the University of California, Riverside.

1. Tolerable Risk or Oxymoron

Risk: EPA defines risk as "Risk (in the context of human health): The probability of adverse effects resulting from exposure to an environmental agent or mixture of agents." A related term is "acceptable risk" which is an elusive concept in that "No fixed level of risk [can] be identified as acceptable in all cases and under all regulatory programs...," Consequently, "the acceptability of risk is a relative concept and involves consideration of different factors. Considerations in these judgments may include: The certainty and severity of the risk; the reversibility of the health effect; the knowledge or familiarity of the risk; whether the risk is voluntarily accepted or involuntarily imposed; whether individuals are compensated for their exposure to the risk; the advantages of the activity; and the risks and advantages for any alternatives."

Oxymoronic: To get a feel for the "oxymoronic" quality of the debate over the application of toxic chemicals you might want consider the case of the use of pesticides in agricultural settings as reflected in the article "Organophosphates and the Risk Cup" by Richard Fenske of the University of Washington. He refers to these pesticides and herbicides as "economic poisons." The term "risk cup" comes from the Food Quality Protection Act and involves apportioning "the risks associated with dietary and non-dietary exposure to pesticides with a common method of toxicity in the absence of reliable data."

Industrial Union Department, AFL-CIO v. American Petroleum Institute (The "Benzene" Case): Central to this famous court case is language found under Section 6(b)(5) of the Occupational Health & Safety Act (OSHA) which specifies that 

"The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standards which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this section shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of standards, and experience gained under this and other health and safety laws." [Section 6(b)(5)].

The language in this section that "most adequately assures" stands in sharp contrast to language found in Section 3(8) that instructs the Secretary (of HHS) to be: 

"reasonably necessary or appropriate" "within the meaning of section 3(8) if it meets the following criteria: (1) The standard will substantially reduce a significant risk of material harm; (2) compliance is technologically feasible in the sense that the protective measures being required already exist, can be brought into existence with available technology, or can be created with technology that can reasonably be developed; (3) compliance is economically feasible in the sense that industry can absorb or pass on the costs without major dislocation or threat of instability; and (4) the standard is cost effective in that it employs the least expensive of equally protective measures capable of reducing or eliminating significant risk."

Controversy over this language emerged in the late 1970's when the Department of Labor (DOL), having become convinced that there was no known "safe level" of exposure to benzene, decided to reduce exposure levels in industrial settings from 10 parts per million (ppm) to 1 ppm. The DOL decision was eventually reversed by the Supreme Court who interpreted OSHA as only authorizing the Department of Labor to only ban levels of exposure to toxic substances that constitute a "significant risk of material health impairment." As expressed in the U. S. Department of Labor Regulations (Section 2 - II. Pertinent Legal Authority):

"The Supreme Court has said that section 3(8) applies to all permanent standards promulgated under the Act and requires the Secretary, before issuing any standard, to determine that it is reasonably necessary and appropriate to remedy a significant risk of material health impairment. The "significant risk" determination constitutes a finding that, absent the change in practices mandated by the standard, the workplaces in question would be "unsafe" in the sense that workers would be threatened with a significant risk of harm. This finding, however, does not require mathematical precision or anything approaching scientific certainty if the "best available evidence" does not warrant that degree of proof. Rather, the Agency may base its findings largely on policy considerations and has considerable leeway with the kinds of assumptions it applies in interpreting the data supporting it."

2. The Problem of Uncertainty

Uncertainty and Risk: Uncertainty and risk are not necessarily the same. According to Norman Schultz of the University of Colorado at Boulder "The two [concepts] are closely associated with one another, but are not identical. Uncertainty may involve things that are completely unknown, whereas risks are often understood via calculable probabilities. For example, though you don't know exactly what will happen after placing a bet on a roulette table, technically the risk of you losing when you bet on red is just slightly over 50 percent. It also must be noted that uncertainty doesn't necessarily imply risks -- something undesirable might happen, but it might be that any of the possible outcomes is OK. This is seldom the case, though, so uncertainty and risk usually run hand-in-hand."

A Paucity of Information: According to the 1984 report from the Commission on Life Sciences of the National Academy of Sciences entitled "Toxicity Testing: Strategies to Determine Needs and Priorities," "The information available on the potential toxicity of most chemicals is scanty, and the resources available for toxicity testing do not suffice to test all chemicals for every possible health effect." In the "Executive Summary" of this report, panelists reported that "On the great majority of the substances, data considered to be essential for conducting a health-hazard assessment are lacking." Since it would be cost prohibitive to test "all" potentially harmful substances, recent Congressional legislation requires that manufactures extensively test chemicals of high concern such as those on EPA's national priority list (NPL).

Recent amendments to FIFRA and TSCA have sought to improve the adequacy of toxicity data. For instance under TSCA EPA is authorized to mandate additional testing if it deems that data is insufficient to assure that such information is necessary to "eliminate unreasonable risks to health or the environment associated with a chemical substance or mixture."

Difficulty of Determining Cancer Risk: For an overview of "risk assessment" you might want to look at the "Risk Assessment: Background" white paper that is published on the web by  Extoxnet and archived at Oregon State University. According to California Office of Environmental Health Hazard Assessment, the difficulty of determining cancer risk is associated with "several factors" For instance: 

"Cancer appears to be a progressive disease because a series of cellular transformations is thought to occur before cancer develops. In addition, cancer in humans often develops many years after exposure to a chemical. Also, the best information available on the ability of chemicals to cause cancer often comes from studies in which a limited number of laboratory animals are exposed to levels of chemicals that are much higher than the levels humans would normally be exposed to in the environment. As a result, scientists use mathematical models based on studies of animals exposed to high levels of a chemical to estimate the probability of cancer developing in a diverse population of humans exposed to much lower levels. The uncertainty in these estimates may be rather large. To reduce these uncertainties, risk assessors must stay informed of new scientific research. Data from new studies can be used to improve estimates of cancer risk."

Today, according to the National Academy of Science in its 2006 report Toxicity Testing for Assessment of Environmental Agents: Interim Report three basic approaches are utilized to determine cancer risks posed by chemicals or agents: animal bioassays following exposure / toxicity assessment, epidemiological studies (of exposed populations - often in the workplace) and in-vitro studies. In conducting risk assessment, data pertaining to cancer risk are ultimately categorized as involving either human derived data, animal bioassay data, or data from other sources - this according to the 1983 NAS report Risk Assessment in the Federal Government: Managing the Process.

Values Informing and Influencing Risk Assessment: As noted in the 1983 NAS report on Risk Assessment in the Federal Government, there is significant controversy as to whether risk assessment is primarily influenced by scientific or political considerations. According to that report: "Familiar assertions include:

• Risk assessment is inherently scientific in nature; it should be done in isolation from political influences, which can only distort true scientific judgment.

• The basic problem in risk assessment is that political appointees in the agencies conceal their value judgments under the mantle of science.

• The basic problem in risk assessment is that scientists conceal their personal value judgments in risk assessment with the mantle of "science" or alternatively, "All scientific judgments must ultimately be made by scientists, however, not all judgments made by scientists are scientific.

• All risk assessments are inherently political. Since science cannot fully characterize carcinogenesis,  there is no alternative but to apply value judgments in areas of scientific uncertainty."

Four-Step Risk Assessment Process: According to the EPA, (you will want to go to this site and become familiar with this process) risk assessment involves (1) hazard identification, (2) exposure assessment (3) dose-response (toxicity) assessment and (3) risk characterization.

Regulating Under Uncertainty: Regulating under uncertainty often has a lot with how the courts construe the concept of "endangerment." One can get a good feel for how this term is construed under different case law and regulatory scenarios by comparing two famous environmental cases: Reserve Mining v. EPA and Ethyl Corp. v. EPA. Fortunately, a memo (entitled  "The Meaning Of "Endangers" Or "Imminent And Substantial Endangerment") between two attorney's representing the University of Illinois Medical center ( preserved from 1988) illustrates how the courts variously construe "endangerment." The net effect of such uncertainty is so-called "precautionary regulation" (as defined in Agenda 21) which can be defined as "regulation, which cannot be based on a complete cost-benefit analysis."

3. Major Regulatory Options

Regulatory Standards:

1. Health Based: The Stockholm Convention on Persistent Organic Pollutants (POPs) defines health-based regulations as those that are based upon "significant adverse human health or environmental effects." Comparatively, the U.S. Food Quality Protection act defines "health-based" as involving standards under which there is "reasonable certainty of no harm.”

2. Feasibility Based: The Supreme Court construes the "feasibility principle" "in terms of what one is capable of doing." Consequently,

"This implies that government agencies need not require the impossible. Rather, the feasibility principle imposes two constraints on the stringency of environmental standards. [1] It authorizes government agencies to forego physically impossible environmental improvements, a technological constraint. The feasibility principle also [2] embodies a cost constraint, a presumption against requirements so costly as to require widespread plant shutdowns. The cost and technology constraints together demand that industry implement those environmental and safety improvements that industry can make while continuing to produce goods for consumers. While the feasibility principle guards against widespread economic harm, it does not allow the inability of a few poorly managed firms to meet generally reasonable standards to limit the stringency of general rules governing an industry."

3. Cost-Benefit Based: This regulatory approach is based upon "an analysis of the cost effectiveness of different alternatives in order to see whether the benefits outweigh the costs."

Pertinent Statues:

1. Pure Health-Based Statutes: Only rarely does Congress mandate a so-called "zero-risk" threshold. One glaring example of this policy pertains to pesticide residues found in processed foods which are regulated (as food additives) under Section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA), which includes the "Delaney Clause."  "This Clause has a fixed risk standard, "zero cancer risk," for food additive pesticide residue tolerances."  Representatives from the pesticide and food industries are petitioning Congress to substitute a "negligible risk" standard for the current "zero risk" approach - thereby providing a common standard for the food and chemical industries that open the door for the development and sale of safer pesticides, despite their risk of carcinogenicity. These industries, however, are opposed by supporters of the Delaney Clause who are adamant that no carcinogenic substance should be knowingly be added to food. This zero sum approach has been enforced in several prominent cases, including Public Citizen v. Young,  and Monsanto Co. v. Kennedy.

2. Feasibility Statutes: 

• Safe Drinking Water Act (SDWA) (Specifies the maximum containment level goal (MCLG) which is defined as "The maximum level of a contaminant in drinking water at which no known or anticipated adverse effect on the health of persons would occur, and which allows an adequate margin of safety. Maximum contaminant level goals are non-enforceable health goals."

• Occupational Safety and Health Act (OSHA) (Specifies maximum containment levels (MCL), defined as "The maximum permissible level of a contaminant in drinking water provided to the public." This federally enforceable standard is set as close as possible to the MCLG with consideration given to the cost and achievability of the level of the current treatment technology."

3. Risk Benefit Statutes

• Federal Insecticide, Fungicide, and Rodenticide Act, (FIFRA)

• Toxic Substances Control Act, (TSCA)

• Paralysis by Analysis: This term implies that "the regulatory process has been so burdened by analytical requirements that agencies are not able to respond nimbly and quickly to pressing needs for public protection." This is best illustrated in the case Corrosion Proof Fittings v. EPA.

Criticisms of Risk-Benefit Analysis and Cost-Benefit Analysis: For a really good overview of the benefits and weaknesses of Risk-Benefit Analysis, look to the paper by Rod Bodell and Ted Parson (1986). For a thorough review of how risk-benefit analysis see the piece by Lisa Heinzerling and Frank Ackerman of Georgetown University Law Center entitled "Pricing the Priceless: Cost-Benefit Analysis of Environmental Protection."

3. Informational Approaches

• The Toxic Release Inventory: According to the EPA "The Toxics Release Inventory (TRI) is a publicly available EPA database that contains information on toxic chemical releases and other waste management activities reported annually by certain covered industry groups as well as federal facilities.

• California's Proposition 65: According to the California Office of Environmental Health Hazard Assessment " Proposition 65 was enacted as a ballot initiative in November 1986. The Proposition was intended by its authors to protect California citizens and the State's drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposures to such chemicals. Proposition 65 requires the Governor [of California] to publish, at least annually, a list of chemicals known to the state to cause cancer or reproductive toxicity."