¹ No standard legal definition of a toxic substance exists. Toxicity has been defined as “the ability of a chemical … to produce injury once it reaches a susceptible site in or on the body.” Carl B., Meyer, The Environmental Fate of Toxic Wastes, The Certainty of Harm, Toxic Torts, and Toxic Regulation, 19 ENVTL. L. 321, 322 (1988)Google Scholar (citing Newton Irving Sax, DANGEROUS PROPERTIES OF INDUSTRIAL MATERIALS 1 (3rd ed. 1968)).

² 42 U.S.C.A. §§ 7401-7641 (West 1983 & Supp. 1992).

³ 33 U.S.C.A. §§ 1251-1387 (West 1986 & Supp. 1992).

⁴ 42 U.S.C.A. §§ 9601-9675 (West 1983 & Supp. 1992).

⁵ See S. REP. NO. 698, 94th Cong., 2d Sess. (1976), reprinted in 1976 U.S.C.C.A.N. 4491, 4495 [hereinafter S. REP. NO. 94-698] (“The most effective and efficient time to prevent unreasonable risks to public health or the environment is prior to first manufacture. It is at this point that the costs of regulation in terms of human suffering, jobs lost, wasted capital expenditures, and other costs are lowest.“).

⁶ 15 U.S.C.A. §§ 2601-2671 (West 1982 & Supp. 1992).

⁷ Meyer, supra note 1, at 328.

⁸ See, e.g., Jonathan M., Samet & Mark J., Utell, The Environment and the Lung, 266 JAMA 670 (1991)Google Scholar.

⁹ See, e.g., John, Holusha, Greens Pick an Enemy: Chlorine, the Everywhere Element, N.Y. TIMES, Dec. 20, 1992, § 4, at 2.Google Scholar

¹⁰ Cancer killed an estimated 510,000 Americans in 1990. AMERICAN CANCER SOCIETY, CANCER FACTS & FIGURES 1991 1 (1991). The leading cause of death in the United States is coronary heart disease, killing almost 600,000 people per year. See Associated Press, American Death Rate Is Down 8%, CHI. TRIB., Mar. 31, 1989, § 1, at 12.

¹¹ Estimates vary on how much cancer is actually a result of environmental pollution. See Michael, Gough, How Much Cancer Can EPA Regulate Away?, 10 RISK ANALYSIS 1 (1990)Google Scholar (estimating that between two and three percent of all cancers result from exposure to environmental pollution); Troyen A., Brennan, Causal Chains and Statistical Links: The Role of Scientific Uncertainty in Hazardous Substance Litigation, 73 CORNELL L. REV. 469, 473-74 (1988)Google Scholar (noting that between 85 and 90% of all cancers are induced by “environmental phenomena” (citing PETER S., BARTH & H. ALLEN, HUNT, WORKERS’ COMPENSATION AND WORK RELATED ILLNESSES AND DISEASES 84 (1980)))Google Scholar.

¹² See, e.g., Dan, Fagin, Indoor Pollution, Quiet Epidemic Making Millions of Us Miserable, NEWSDAY, Nov. 15, 1992, at 4.Google Scholar

¹³ Merril, Goozner, Job Diseases Remain a Major Cause of Death, CHI. TRIB., Aug. 31, 1990, at CI (citing National Safe Workplace Institute).Google Scholar

¹⁴ See Larry, Tye, New Study Pinpoints Hot Spots of Cancer, BOSTON GLOBE, Aug. 2, 1989, at 1.Google Scholar

¹⁵ See S.W., Lagakos et al., An Analysis of Contaminated Well Water and Health Effects Woburn, Massachusetts, 81 J. AM. STAT. ASS'N. 583 (1986)Google Scholar (finding “positive statistical associations between access to… [well] water and the incidence rates of childhood leukemia“). The Massachusetts Department of Health had found similar cancer “hot spots” in various regions of the state. See Tye, supra note 14, at 1.

¹⁶ “ ‘EPA estimates found 149 [individual industrial plants] to be associated with lifetime cancer risks to the most exposed individual of greater than 1 in 10,000, including 52 plants with cancer risks greater than 1 in 1000, seven plants associated with cancer risks greater than 1 in 100, and one plant associated with a cancer risk greater than 1 in 10.’ “ 1 WILLIAM H. RODCERS, JR., ENVIRONMENTAL LAW: AIR AND WATER § 3.IE n.l (Supp. 1992) (quoting H.R. REP. NO. 101- 490, Pt. 1, 101st Cong., 2nd Sess. 317 (1990)); see also S. REP. NO.§ 94-698, supra note 5, at 4494 (“Almost without exception the industrial centers, where industrial chemicals are obviously found in largest concentrations, had the highest incidence of cancer.“).

¹⁷ Meyer, supra note 1, at 329 (citing Environmental Defense Fund v. EPA, 548 F.2d 998, 1008 (D.C. Cir. 1976), cert, denied, 431 U.S. 925 (1977)).

¹⁸ See Graeme, Hamilton, Chlorine Effluent Killing Wildlife: Federal Study, THE GAZETTE, NOV. 1, 1991, at A5Google Scholar; Josh, Barbanel, PCBs May Be Culprit in Seals’ Mysterious Illness, Cm. TRIB., Jan. 14, 1992, at C6Google Scholar; Sean, Ryan, Toxic Cocktail is Poisoning Arctic Wildlife, SUNDAY TIMES (London), Feb. 16, 1992, § 1, at 21Google Scholar.

¹⁹ 42 U.S.C.A. §§ 7401-7671q (West 1983 & Supp. 1992).

²⁰ 33 U.S.C.A. §§ 1251-1387 (West 1983 & Supp. 1992).

²¹ Hazardous air pollutants under the CAA, in addition to those listed by Congress, are those “which present, or may present … a threat of adverse human health effects … or adverse environmental effects “ CAA, § 112(b)(2), 42 U.S.C. § 7412(b)(2).

²² For a discussion of the regulation difficulties that these amendments aimed to address, see Natural Resources Defense Council, Inc. v. EPA, 824 F.2d 1146 (D.C. Cir. 1987) (discussing the problem of regulating toxic air emissions using both health-based and economic criteria).

²³ See CAA, § 112(b)(1), 42 U.S.C. § 7412(b)(1).

²⁴ CAA, § 112(c)(1), 42 U.S.C. § 7412(c)(1).

²⁵ CAA, § 112(c)(2), 42 U.S.C. § 7412(c)(2).

²⁶ The Clean Air Act defines a “new source” as “a stationary source the construction or reconstruction of which is commenced after the Administrator first proposes regulations under this section establishing an emission standard applicable to such source.” CAA, § 112(a)(4), 42 U.S.C. § 7412(a)(4).

²⁷ An existing source is “any stationary source other than a new source.” CAA, § 112(a)(10), 42 U.S.C. § 7412(a)(10).

²⁸ See CAA, § 112(d)(2), 42 U.S.C. § 7412(d)(2) (defining the required control technologies).

²⁹ Id.

³⁰ CAA, § 12(d)(3)(A), 42 U.S.C. § 7412(d)(3)(A).

³¹ CAA, § 112(d)(3)(B), 42 U.S.C. § 7412(d)(3)(B).

³² CAA, § 112(d)(4), 42 U.S.C. § 7412(d)(4).

³³ CAA, § 112(d)(3), 42 U.S.C. § 7412(d)(3).

³⁴ See CWA, §§ 301, 304-307, 33 U.S.C. §§ 1311, 1314-1317. But see CWA, §§ 302-303, 33 U.S.C. §§ 1312-1313 (taking into account the quality of the receiving water).

³⁵ See CWA, § 307(a)(1), 33 U.S.C. § 1317(a)(1).

³⁶ CWA, § 107(a)(2), 33 U.S.C. § 1317(a)(2). See CWA, § 304(b)(2), 33 U.S.C. § 1314(b)(2) (defining “best available control technology“).

³⁷ Meyer, supra note 1, at 325.

³⁸ See, e.g., Lakshman, Guruswamy, Integrated Environmental Control: The Expanding Matrix, 22 ENVTL. L. 77, 85 (1992).Google Scholar

³⁹ Meyer, supra note 1, at 329-30.

⁴⁰ Technology-based standards mandate the particular equipment necessary to comply with the regulation. Robert W., Hahn & Robert N., Stavins, Incentive-Based Environmental Regulation: A New Era from an Old Idea?, 18 ECOL. L.Q. 1, 5–6 (1991).Google Scholar

⁴¹ Performance standards, in contrast with technology-based-standards, attempt to achieve a particular goal. Id. Health-based standards are a type of performance standard in that the emission standard is based on safe levels of human exposure to a particular pollutant. Id.

⁴² 824 F.2d 1146 (D.C. Cir. 1987).

⁴³ CAA, § 112(b)(1)(B), 42 U.S.C. § 7412(b)(1)(B).

⁴⁴ 824 F.2d at 1148. A non-threshold pollutant is one that “appears to create a risk to health at all non-zero levels of emission.” Id.

⁴⁵ Id. at 1147.

⁴⁶ Id.

⁴⁷ Id.

⁴⁸ Id. at 1147-48.

⁴⁹ Id. at 1148.

⁵⁰ Id. at 1154.

⁵¹ Id.

⁵² Id. at 1163.

⁵³ Id. (citing CAA, § 112, 42 U.S.C. § 7412).

⁵⁴ Id. at 1164-65.

⁵⁵ Id. at 1165.

⁵⁶ I RODCERS, supra note 16, at § 3.IE.

⁵⁷ Pub. L. No. 94-469, 90 Stat. 2003 (codified as amended at 15 U.S.C.A. §§ 2601-71 (West 1982 & Supp. 1992)). Congress found that neither the Clean Air Act, Clean Water Act, Occupational Safety and Health Act, nor the Consumer Product Safety Act allowed for the discovery of adverse effects prior to the manufacture of a chemical. See S. Rep. No. 94-698, supra note 5, at 4495.

⁵⁸ TSCA defines “chemical substance” as:

• (2)(A) [A]ny organic or inorganic substance of a particular molecular identity, including—

• (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and

• (ii) any element or uncombined radical.

• (B) Such term does not include—

• (i) any mixture,

• (ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide,

• (iii) tobacco or any tobacco product,

• (iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act)….

• (vi) any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321]) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.

TSCA, § 3(2)(A), 15 U.S.C. § 2602(2)(A).

⁵⁹ TSCA also regulates the importation of chemicals into the United States for commercial use. TSCA, § 13, 15 U.S.C. § 2612. In addition to initial safety evaluations, TSCA contains various provisions for chemical regulation. The most important of these provisions pertain to the evaluation and testing of chemicals already in commercial use. TSCA, § 4(a), 15 U.S.C. § 2603(a). This Note focuses on the regulation of new chemicals under TSCA.

⁶⁰ TSCA, § 2(b)(2), 15 U.S.C. § 2601(b)(2).

⁶¹ TSCA, § 2(b)(3), 15 U.S.C. § 2601(b)(3).

⁶² 40C.F.R. § 720.1 (1992).

⁶³ A manufacturer can determine whether a chemical is “new” by checking EPA's chemical inventory. If the chemical is not listed, it is a new chemical and is subject to the pre-manufacture notice requirement. See id. § 720.3(v).

⁶⁴ TSCA charges EPA with defining significant new uses for existing chemicals. See id. § 721, pt. E (listing chemicals subject to significant new use regulation). Thus, a manufacturer may produce an existing chemical without a significant new use, thereby avoiding restrictions as to quantity or use.

⁶⁵ TSCA, § 6(a)(1), 15 U.S.C. § 2605(a)(1). A company must also notify EPA before the importation of a new chemical. 40 C.F.R. § 720.22(b)(1).

⁶⁶ Information “known or reasonably ascertainable” is “all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control or know.” 40 C.F.R. § 720.3(p).

⁶⁷ TSCA, §§ 5(d)(1)(A), 8(a)(2), 15 U.S.C. §§ 2604(d)(1)(A), 2607(a)(2). The manufacturer may also be required to submit test data for EPA evaluation with the PMN. See TSCA, § 5(b), 15 U.S.C. § 2604(b).

⁶⁸ TSCA, § 8(b), 15 U.S.C. § 2607(b).

⁶⁹ See 48 Fed. Reg. 21,722, 21,724 (1983).

⁷⁰ Id.

⁷¹ 40 C.F.R. § 720.75(d).

⁷² Id. § 720.102(a).

⁷³ Id. § 720.22(a)(1) (requiring reporting for the manufacture of new chemicals only). Certain exceptions apply under TSCA and EPA regulations for particular chemicals. See id. § 723.30.

⁷⁴ TSCA, § 5(e), 15 U.S.C. § 2604(e).

⁷⁵ TSCA, § 5(0, 15 U.S.C. § 2604(0.

⁷⁶ TSCA, § 5(e)(1)(A), 15 U.S.C. § 2604(e)(1)(A).

⁷⁷ Id. See TSCA, § 4(a)(1)(B), 15 U.S.C. § 2603(a)(1)(B); EPA Proposed Statement of Policy, 56 Fed. Reg. 32,294 (1991) (describing substantial production and exposure).

⁷⁸ TSCA, § 5(e)(1)(A), 15 U.S.C. § 2604(c)(i)(A).

⁷⁹ TSCA, § 5(e)(1)(C), 15 U.S.C. § 2604(e)(1)(C).

⁸⁰ Id.

⁸¹ TSCA, § 5(e)(2)(A)(i), 15 U.S.C. § 2604 (e)(2)(A)(i).

⁸² Grounds for issuing an injunction exist when:

• (i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance …; and

• (ii) (I)… the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, or

• (II) such substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance.

TSCA, § 5(e)(2)(B), 15 U.S.C. § 2604(e)(2)(B).

⁸³ TSCA, § 5(f), 15 U.S.C. § 2604(f).

⁸⁴ TSCA, § 6(a), 15 U.S.C. § 2605(a).

⁸⁵ TSCA, § 5(f) (2), 15 U.S.C. § 2604(f)(2).

⁸⁶ See TSCA, § 5(f)(2), 6(a), 15 U.S.C. § 2604(f)(2), 2605(a).

⁸⁷ Id.

⁸⁸ TSCA, § 6(a), 15 U.S.C. § 2605(a).

⁸⁹ TSCA, § 5(f)(3)(A)(i), 15 U.S.C. § 2604 (f)(3)(A)(i).

⁹⁰ TSCA, § 5(f)(3)(C), 15 U.S.C. § 2604(f)(3)(C).

⁹¹ TSCA, § 5(f)(3)(D), 15 U.S.C. § 2604(f)(3)(D).

⁹² TSCA, § 5(f)(3)(B), 15 U.S.C. § 2604(f)(3)(B).

⁹³ An Interagency Testing Committee recommends to the Administrator priority chemicals to undergo testing. TSCA, § 4(e)(1), 15 U.S.C. § 2603(e)(1). The committee is comprised of eight members, each of whom is from a different governmental agency. TSCA, § 4(e)(2), 15 U.S.C. § 2603(e)(2).

⁹⁴ TSCA, § 4(a)(1)(A), 15 U.S.C. § 2603(a)(1)(A).

⁹⁵ TSCA, § 4(a)(1)(B), 15 U.S.C. § 2603(a)(1)(B).

⁹⁶ Id.

⁹⁷ TSCA, § 4(a), 15 U.S.C. § 2603(a).

⁹⁸ See TSCA, § 4(b)(1), 15 U.S.C. § 2603(b)(1).

⁹⁹ Id.

¹⁰⁰ TSCA, § 19(a)(1)(A), 15 U.S.C. § 2618(a)(1)(A).

¹⁰¹ TSCA, § 19(c)(l)(B)(i), 15 U.S.C. § 2618(c)(l)(B)(i).

¹⁰² See U.S. GEN. ACCT. OFF., ASSESSMENT OF NEW CHEMICAL REGULATION UNDER THE TOXIC SUBSTANCES CONTROL ACT 20 (1984) [hereinafter GAO REPORT].

¹⁰³ See, e.g., Chemical Manufacturers Ass'n v. EPA, 899 F.2d 344 (5th Cir. 1990).

¹⁰⁴ See, e.g., Guidelines for Carcinogen Risk Assessment, 51 Fed. Reg. 33,993 (1986).

¹⁰⁵ Brennan, supra note 11, at 501-12; GAO REPORT, supra note 102, at 10.

¹⁰⁶ See Brennan, supra note 11, at 503-04; Mary L., Lyndon, Information Economics and Chemical Toxicity: Designing Laws to Produce and Use Data, 87 MICH. L. REV. 1795, 1812 n.64 (1989).Google Scholar

¹⁰⁷ “Risk management combines the risk assessment with the directives of regulatory legislation, together with socio-economic; technical, political, and other considerations, to reach a decision as to whether or how much to control future exposure to the suspected toxic agents.” 51 Fed. Reg. at 33,993.

¹⁰⁸ TSCA, § 6(c)(1), 15 U.S.C. § 2605(c)(1).

¹⁰⁹ TSCA, § 6(c)(1)(A), 15 U.S.C. § 2605(c)(1)(A)

¹¹⁰ TSCA, § 6(c)(1)(B), 15 U.S.C. § 2605(c)(1)(B).

¹¹¹ TSCA, § 6(c)(1)(C), 15 U.S.C. § 2605(c)(1)(C).

¹¹² TSCA, § 6(c)(1)(D), 15 U.S.C. § 2605(c)(1)(D).

¹¹³ See Howard, Latin, Good Science, Bad Regulation, and Toxic Risk Assessment, 5 YALE J. REG. 89 (1988)Google Scholar (discussing uncertainties inherent in risk assessment techniques).

¹¹⁴ Virtually all human carcinogens have been found to be animal carcinogens, but the reverse is not necessarily true. Brennan, supra note 11, at 505-06.

¹¹⁵ See id. at 506 (describing dose-response levels in animals).

¹¹⁶ GAO REPORT, supra note 102, at 11.

¹¹⁷ Id.

¹¹⁸ Nevertheless, certain existing chemicals must meet the reporting requirement upon commencement of manufacture or processing. EPA Premanufacture Notification Rule, 40 C.F.R. § 720.22 (1992).

¹¹⁹ TSCA, however, cannot supplant other environmental laws. TSCA only addresses inherently discharged substances. Many discharged substances are not in themselves dangerous, but nevertheless pose environmental and health threats. See, e.g., 33 U.S.C. §§ 1251-1387.

¹²⁰ See S. REP. NO. 94-698, supra note 5, at 4495.

¹²¹ See id. at 4503.

¹²² Two factors, in combination, would seem to make it very difficult to withdraw a chemical from the market. The first is the scientific uncertainty that attends the effects of most chemicals. The second factor, already mentioned, is the potential financial losses to a company that has substantially invested in the production or use of a particular chemical. See Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 1215-16 (5th Cir. 1991) (vacating an EPA rule under TSCA calling for a ban on the use and manufacture of asbestos products).

¹²³ In a market share liability scheme, the plaintiff need not show who manufactured the harmful chemical. The plaintiff need only show that the defendant used or manufactured the chemical and that the plaintiff could have been exposed to the product. See, e.g., Sindell v. Abbott Laboratories, 607 P.2d 924 (Cal. 1980).

¹²⁴ In a mass toxic tort suit, these damages could bankrupt the defendant. See Harvey J., Kesner, Future Asbestos Related Litigants as Holders of Statutory Claims under Chapter 11 of the Bankruptcy Code and Their Place in the Johns-Manville Reorganization, 62 AM. BANKR. L.J. 69 (1988)Google Scholar.

¹²⁵ The Comprehensive Environmental Response, Compensation and Liability Act was enacted in 1980 in order to hold owners and polluters of contaminated land areas liable in damages for clean-up. 42 U.S.C.A. §§ 9601-9675 (West Supp. 1992).

¹²⁶ Barry, Commoner, Don't Control Pollution, Prevent It, U.S.A. TODAY, Apr. 20, 1990, at 11A.Google Scholar

¹²⁷ Furthermore, this reduced industrial use of toxic substances may, in turn, reduce governmental expenditures for administering complex monitoring programs.

¹²⁸ See, e.g., BNA, Testing: EPA Would Require Glycidol Makers to Perform SIS Million in Health Effects Studies, 15 CHEM. REG. REP. 1140 (1992) (noting that, although toxic effects have been observed with various glycidols, newly developed glycidols could continue to be introduced into the market while testing is being conducted).

¹²⁹ GAO REPORT, supra note 102, at 14. Of the 132 chemicals that received 5(e) orders, 106 involved one transaction regarding a synthetic fuel program of a single manufacturer.

¹³⁰ Id.

¹³¹ Id. at 3.

¹³² What Ever Happened to the Toxic Substances Control Act?, Hearings Before the Subcomm. on Environmental, Energy and Natural Resources of the House Comm. on Government Operations, 100th Cong., 2d Sess. 200 (1988) [hereinafter Hearings] (statement of Charles L. Elkins, Director, Office of Toxic Substances Committee on Government Operations of the EPA).

¹³³ Id.

¹³⁴ Id.

¹³⁵ GAO REPORT, supra note 102, at 9.

¹³⁶ See id. (citing U.S. OFF. OF TECH. ASSESSMENT, THE INFORMATION CONTENT OF PREMANUFACTURE NOTICES (background paper) (1983) [hereinafter OTA REPORT]). The OTA found even less data regarding environmental toxicity. See also Hearings, supra note 132, at 195, 201.

Acute toxicity data measure the immediate effects of large chemical doses. Chronic toxicity data evaluate the health effects of low doses over a longer duration and are more analogous to human exposure. See GAO REPORT, supra note 102, at 9.

¹³⁷ EPA may receive over 1000 PMNs in a year. See E.P.A., ACCOMPLISHMENTS AND GOALS IN REDUCING TOXIC CHEMICAL RISK: FY 1989 REPORT TO CONGRESS ON THE TOXIC SUBSTANCES CONTROL ACT 112 (1990).

¹³⁸ Testing may run into the hundreds of thousands of dollars, depending on the number and complexity of the required tests. Lyndon, supra note 106, at 1812 n.64.

¹³⁹ EPA uses a method known as structural analysis to evaluate these substances. This method looks to similarly structured chemicals for which information is available. The information known about the similarly structured chemical is assumed to apply to the chemical in question. See id. at 10.

¹⁴⁰ A 1984 National Research Council study found a lack of information on the health risks of chemicals used in commerce (those on the TSCA inventory list, currently comprised of approximately 65,000 chemicals). Only minimal toxicity information existed for 20% of these chemicals. For the remaining 80%, “practically nothing” existed concerning the hazards of exposure. Id. at 10 (citing NAT'L RES. COUNCIL, TOXICITY TESTING: STRATEGIES TO DETERMINE NEEDS AND PRIORITIES (1984)); see also Hearings, supra note 132, at 196 (“I would be less than candid if I assured you that we will now cause to be generated anywhere near the amount of test data … [needed] … for decisionmaking under TSCA. In short, our vision in 1976 was much bigger than the program we have created … .“) (statement of Charles L. Elkins, Director, Office of Toxic Substances Committee on Government Operations of the EPA).

¹⁴¹ An exception exists where two criteria are met. First, EPA must have devised a significant new use rule (“SNUR“) for the particular chemical. Second, the subsequent manufacture of the chemical must qualify under that rule as a significant new use. See 40 C.F.R. § 721.5. There are currently 258 issued SNURs. Id. § 721 pt. E. TSCA also requires reporting for the commencement of manufacture for specified chemicals. Id. § 704 pt. D.

¹⁴² TSCA, § 2(b)(1), 15 U.S.C. § 2601(b)(1).

¹⁴³ TSCA, § 2(b), 15 U.S.C. § 2601(b). The Act states:

(b) Policy.—It is the policy of the United States that—

• (1) adequate data should be developed with respect to the effect of chemical substances … on health and the environment and that the development of such data should be the responsibility of those who manufacture and … process such chemical substances … and …

• (3) authority over chemical substances … should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation ….

Id.

¹⁴⁴ See, e.g., Chemical Manufacturers Ass'n. v. EPA, 899 F.2d 344 (5th Cir. 1990).

¹⁴⁵ See John S., Applegate, The Perils of Unreasonable Risk: Information, Regulatory Policy, and Toxic Substances Control, 91 COLUM. L. REV. 261, 328 (1992).Google Scholar

¹⁴⁶ 947 F.2d 1201 (5th Cir. 1991).

¹⁴⁷ Asbestos: Manufacture, Importation, Processing, and Distribution in Commerce Prohibitions, 54 Fed. Reg. 29,460 (1989) (to be codified at 40 C.F.R. § 763).

¹⁴⁸ Id.

¹⁴⁹ Corrosion Proof Fittings, 947 F.2d at 1207.

¹⁵⁰ Id. at 1230.

¹⁵¹ Id. at 1213.

¹⁵² Id. at 1214 (citations omitted).

¹⁵³ 54 Fed. Reg. 29,460, 29,468.

¹⁵⁴ Id. at 29,472. EPA noted the characteristics of asbestos:

Id.

¹⁵⁵ Id.

¹⁵⁶ Id. at 29,477 (“EPA estimated that approximately 40 million consumers and 19 million of those exposed to ambient asbestos incur risks of 1 in 1,000,000 or more of developing cancer from their exposure.“).

¹⁵⁷ Id. at 29,479.

¹⁵⁸ Id. (EPA noted that it was “especially concerned about exposures from environmental loading, which may occur long after the initial release of asbestos from a product.“).

¹⁵⁹ Id. at 29,474.

¹⁶⁰ Id.

¹⁶¹ Id.

¹⁶² Id. With regard to respirators, EPA noted that they “do nothing to reduce the quantity of asbestos released into the immediate environment of respirator wearers. Thus, during the activity that generates the airborne asbestos, persons near the respirator wearer can be exposed to levels that are quite high … . Like respirators, other control measures may reduce some shortterm exposures without having much impact on long-term exposures.” Id. at 29,475.

¹⁶³ Id.

¹⁶⁴ Id.

¹⁶⁵ Id. at 29,489.

¹⁶⁶ Id.

¹⁶⁷ Corrosion Proof Fittings, 947 F.2d at 1215.

¹⁶⁸ Id. at 1216.

¹⁶⁹ Id.

¹⁷⁰ Id. (quoting TSCA, §§ 6(c)(l)(C)-(D), 15 U.S.C. §§ 2605(c)(l)(C)-(D)).

¹⁷¹ Id.

¹⁷² Id. at 1217 (quoting Aqua Slide ‘N’ Dive v. Consumer Prod. Safety Comm'n, 569 F.2d 831, 843 (5th Cir. 1978)).

¹⁷³ 54 Fed. Reg. 29,460, 29,480.

¹⁷⁴ Id. at 29,481. “Regulatory decisions about asbestos which poses well-recognized, serious risks, should not be delayed until the risks of all replacement materials are fully quantified.” Id. at 29,483.

¹⁷⁵ Id. at 29,483.

¹⁷⁶ Corrosion Proof Fittings, 947 F.2d at 1220.

¹⁷⁷ Id.

¹⁷⁸ Id. at 1221.

¹⁷⁹ Id.

¹⁸⁰ Id.

¹⁸¹ 54 Fed. Reg. 29,484.

¹⁸² Id. at 29.485.

¹⁸³ id. at 29,480.

¹⁸⁴ Id. at 29,486.

¹⁸⁵ Id. at 29,487.

¹⁸⁶ Corrosion Proof Fittings, 947 F.2d at 1219.

¹⁸⁷ Id. at 1222.

¹⁸⁸ Id. at 1222-23.

¹⁸⁹ Similarly, this interpretation highlights the dilemma caused by TSCA's unclear policy objectives. Apparently, the Corrosion Proof Fittings court interpreted TSCA as prioritizing economic concerns over public health concerns. See id.

¹⁹⁰ This proposition is not new. The use of tiered-testing is essentially the same concept. Through tiered-testing, EPA devises test rules that work in stages. A chemical must continue on with further testing or may be discontinued in the testing process if certain qualities are indicated in preliminary testing. See, e.g., Chemical Manufacturers Ass'n v. EPA, 899 F.2d 344, 349 (5th Cir. 1990).

¹⁹¹ This cost-spreading includes the consumer, who pays for testing through increased prices. Manufacturers and producers could not practicably bear all safety costs when the consumer also benefits from the product. Conversely, those who neither profit from the chemical's manufacture nor benefit from its use should not bear the costs of the risks associated with inadequate testing.

¹⁹² Lyndon, supra note 106, at 1813 n.66 (estimating that testing of all chemicals that reach commerce annually would equal 0.2% of gross sales in the chemical industry or $140 million of its $5.5 billion after-tax profits (citing SAMUEL, EPSTEIN, POLITICS OF CANCER 72–73 (1978)))CrossRefGoogle Scholar.

¹⁹³ See 3 WILLIAM H., RODGERS JR., ENVIRONMENTAL LAW: PESTICIDES AND TOXIC SUBSTANCES § 6.6 (1988).Google Scholar

¹⁹⁴ Id.

¹⁹⁵ Some chemical testing had been done on 62% of all pesticides, 44% of cosmetic ingredients, 75% of drugs and excipients used in drug formulations, and 54% of food additives. Only approximately 20% of commercially used chemicals had at least some testing. 1 RODGERS, supra note 16, § 3.IE.

¹⁹⁶ See Lyndon, supra note 106, at 108-09.

¹⁹⁷ See supra note 141 and accompanying text.

¹⁹⁸ See supra notes 107-12 and accompanying text.

¹⁹⁹ See TSCA, § 2, 15 U.S.C. § 2601 (statement of “Findings, Policy and Intent“).

²⁰⁰ See Natural Resources Defense Council, Inc. v. EPA, 824 F.2d 1146 (D.C. Cir. 1987).

²⁰¹ See Corrosion Proof Fittings, 947 F.2d 1201 (5th Cir. 1991).

²⁰² Congress stated that the substantial evidence test was adopted so that a reviewing court could focus on the rule-making record to see if the Administrator's action was supported by that record. Congress noted that this standard of review is contrary to the arbitrary and capricious standard of review required for informal rule-making proceedings under the Administrative Procedure Act. See H.R. CONF. COMM. NO. 94-1679, 94th Cong., 2d. Sess., reprinted in 4 U.S.CC.A.N. 4581.

²⁰³ See Hearings, supra note 132, at 442. In response to the question of why EPA has put forth so few enforceable rules under TSCA, Charles L. Elkins said:

Id.

²⁰⁴ See supra notes 93-103 and accompanying text.

²⁰⁵ “It is almost inconceivable that this factor could be proven by substantial evidence— evidence is precisely what is lacking.” Applegate, supra note 145, at 327-28.

²⁰⁶ Such factors should include the potential risks of the chemical, uses of the chemical, amounts of chemical production, cost of testing, types of required testing, perceived benefits of the chemical, disposal of the chemical, and possible by-products of the chemical.

²⁰⁷ As described supra note 113 and accompanying text, the uncertainties that attend toxicological research almost always allow for plausible arguments either for or against regulation.

²⁰⁸ TSCA, § 5(f)(3)(B), 15 U.S.C. § 2604(f)(3)(B).

²⁰⁹ Troyen A., Brennan, Helping Courts with Toxic Torts: Some Proposals Regarding Alternative Methods for Presenting and Assessing Scientific Evidence in Common Law Courts, 51 U. PITT. L. REV. 1, 3 (1989).Google Scholar