Chemical Mfrs. Ass'n v. U.S. E.P.A.

• Decision Date: 21 October 1988
• Docket Number: No. 86-1718,86-1718
• Citation: 859 F.2d 977
• Parties: , 273 U.S.App.D.C. 314, 19 Envtl. L. Rep. 20,001 CHEMICAL MANUFACTURERS ASSOCIATION, et al., Petitioners, v. U.S. ENVIRONMENTAL PROTECTION AGENCY, Respondent.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 977

859 F.2d 977

28 ERC 1510, 273 U.S.App.D.C. 314, 19

Envtl. L. Rep. 20,001

CHEMICAL MANUFACTURERS ASSOCIATION, et al., Petitioners, v. U.S. ENVIRONMENTAL PROTECTION AGENCY, Respondent.

No. 86-1718.

United States Court of Appeals,

District of Columbia Circuit.

Argued Sept. 12, 1988.

Decided Oct. 21, 1988.

Robert M. Sussman, with whom William K. Rawson, David F. Zoll, Washington, D.C., and Mark N. Duvall were on the brief, for petitioners. Gabrielle H. Williamson, Washington, D.C., entered an appearance for petitioners.

Ashley Doherty, Atty., U.S. Dept. of Justice, with whom Roger J. Marzulla, Asst. Atty. Gen., Beth Ginsberg, Atty., U.S. Dept. of Justice, and Andrew G. Gordon, Atty., U.S. E.P.A., were on the brief, for respondent. Michael W. Steinberg, Atty., U.S. Dept. of Justice, Washington, D.C., also entered an appearance for respondent.

Before WALD, Chief Judge, and STARR and WILLIAMS, Circuit Judges.

Opinion for the Court filed by Chief Judge WALD.

WALD, Chief Judge:

Petitioners, Chemical Manufacturers Association and four companies that manufacture chemicals ¹ (collectively, "CMA"), seek to set aside a rule promulgated by the Environmental Protection Agency ("EPA" or "the Agency"). ² This Final Test Rule was promulgated under section 4 of the Toxic Substances Control Act ("TSCA" or "the Act"), 15 U.S.C. Secs. 2601-2629. The Final Test Rule required toxicological testing to determine the health effects of the chemical 2-ethylhexanoic acid ("EHA"), and it continues to impose on exporters of EHA a duty to file certain notices with EPA.

We uphold EPA's interpretation of TSCA as empowering the Agency to issue a test rule on health grounds where it finds a more-than-theoretical basis for suspecting that the chemical substance in question presents an "unreasonable risk of injury to health." This, in turn, requires the Agency to find a more-than-theoretical basis for concluding that the substance is sufficiently toxic, and human exposure to it is sufficient in amount, to generate an "unreasonable risk of injury to health." We hold, further, that EPA can establish the existence and amount of human exposure on the basis of inferences drawn from the circumstances under which the substance is manufactured and used. EPA must rebut industry-supplied evidence attacking those inferences only if the industry evidence succeeds in rendering the probability of exposure in the amount found by EPA no more than theoretical or speculative. The probability of infrequent or even one-time exposure to individuals can warrant a test rule, so long as there is a more-than-theoretical basis for determining that exposure in such doses presents an "unreasonable risk of injury to health." Finally, we hold that the Agency correctly applied these standards in this case and that its findings are supported by substantial evidence. Consequently, we affirm the Final Test Rule.

I. BACKGROUND

A. Statutory Structure

TSCA provides for a two-tier system for evaluating and regulating chemical substances to protect against unreasonable risks to human health and to the environment. Section 6 of the Act permits EPA to regulate a substance that the Agency has found "presents or will present an unreasonable risk of injury to health or the environment." 15 U.S.C. Sec. 2605(a). Section 4 of the Act empowers EPA to require testing of a suspect substance in order to obtain the toxicological data necessary to make a decision whether or not to regulate the substance under section 6. The Act provides, not surprisingly, that the level of certainty of risk warranting a section 4 test rule is lower than that warranting a section 6 regulatory rule. EPA is empowered to require testing where it finds that the manufacture, distribution, processing, use or One of the chief policies underlying the Act is that--

                disposal of a particular chemical substance "may present an unreasonable risk of injury to human health or the environment."    Id. Sec. 2603(a)(1)(A)(i).  The Agency's interpretation of this statutory standard for testing is the central issue in this case
                

adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture and those who process such chemical substances and mixtures.

Id. Sec. 2601(b)(1). The statute establishes an Interagency Testing Committee, comprised of scientists from various federal agencies, to recommend that EPA give certain chemicals "priority consideration" for testing. Id. Sec. 2603(e). Under section 4, the Agency "shall by rule require that testing [of a particular chemical] be conducted" if three factors are present: (i) activities involving the chemical "may present an unreasonable risk of injury to health or the environment"; (ii) "insufficient data and experience" exist upon which to determine the effects of the chemical on health or environment; and (iii) testing is necessary to develop such data. Id. Sec. 2603(a)(1)(A). The companies that manufacture and process the substance are to conduct the tests and submit the data to the Agency. Id. Sec. 2603(b)(3)(B). Costs of testing are to be shared among the companies, either by agreement or by EPA order in the absence of agreement. Id. Sec. 2603(c)(3)(A).

A test rule promulgated under section 4 is subject to judicial review in a court of appeals, pursuant to section 19(a) of TSCA, 15 U.S.C. Sec. 2618(a). A test rule may be set aside if it is not "supported by substantial evidence in the rulemaking record ... taken as a whole." Id. Sec. 2618(c)(1)(B)(i).

B. Facts and Prior Proceedings

EHA is a colorless liquid with a mild odor. It is used exclusively as a chemical intermediate or reactant in the production of metal soaps, peroxy esters and other products used in industrial settings. EHA itself is totally consumed during the manufacture of these products; as a result, no products offered for sale to industry or to consumers contain EHA. See Final Test Rule, 51 Fed.Reg. at 40,319.

The Interagency Testing Committee first designated EHA for priority consideration for health effects tests on May 29, 1984. Fourteenth Report of the Interagency Testing Committee to the Administrator, 49 Fed.Reg. 22,389, 22,391 (1984). The Committee based its recommendation in part on the structural similarity of EHA to chemicals known to cause cancer in test animals and on its finding that insufficient information existed concerning the chronic health effects of EHA. Id. at 22,399-400. Subsequently, EPA held two public meetings on EHA. Supplemental Joint Appendix ("S.J.A.") 499-504, 505-15. During these meetings, in which persons representing the petitioners made appearances, EPA sought information on a variety of issues relating to EHA uses, production and human exposure. S.J.A. 502-04, 508-11, 513-14.

EPA issued a proposed test rule on May 17, 1985. 2-Ethylhexanoic Acid Proposed Test Rule, 50 Fed.Reg. 20,678 (1985) (the "Proposed Test Rule"). The rule proposed a series of tests to ascertain the health risks of EHA, and it set out proposed standards for the conduct of those tests. Id. at 20,682-83. EPA based the Proposed Test Rule on a finding that EHA "may present an unreasonable risk" of subchronic toxicity (harm to bodily organs from repeated exposure over a limited period of time), oncogenicity (tumor formation) and developmental toxicity (harm to the fetus). Id. at 20,682. As to subchronic toxicity, EPA cited studies suggesting that both EHA and chemicals structurally similar to it cause harm to the livers of test animals. Id. As to oncogenicity, EPA cited studies suggesting that chemicals structurally analogous to EHA cause cancer in laboratory animals. Id. at 20,681-82. As to developmental toxicity, EPA cited studies indicating that both EHA and its chemical analogues have produced fetal malformations in test animals. Id. at 20,682.

The Proposed Test Rule also addressed the question of whether humans are exposed to EHA, a question of critical importance to this case. The Agency acknowledged that, since no finished products contain EHA, consumer exposure is not a concern. It likewise discounted the dangers of worker exposure to EHA vapors. Id. at 20,681. The Agency based its Proposed Test Rule solely on the potential danger that EHA will come in contact with the skin of workers. As evidence of potential dermal exposure, the Agency noted that approximately 400 workers are engaged in the manufacture, transfer, storage and processing of 20 to 25 million pounds of EHA per year. Id. at 20,679, 20,682. Further, rebutting claims by industry representatives that gloves are routinely worn during these activities, EPA noted that worker hygiene procedures "can vary widely throughout the industry," that workers are not required by existing federal regulations to wear gloves, and that the industry had not monitored work sites for worker exposure to EHA. Id. at 20,680-81.

A public comment period commenced with the publication of the Proposed Test Rule and ended on July 16, 1985. EPA held a public meeting on October 8, 1985, to discuss issues related to the Proposed Test Rule. J.A. 69-71. Industry representatives submitted extensive comments on July 15, 1985, and January 17, 1986. J.A. 96-97, 161-63. Before publication of the Final Test Rule, EPA received notice of a new study purporting to present further evidence of the potential developmental toxicity of EHA. Final Test Rule, 51 Fed.Reg. at 40,319-21.

CMA criticized the toxicology studies cited by EPA and sought to show that the use of gloves by employees of companies working with EHA prevented human exposure to the chemical, thus rendering any test rule invalid. Before publication of the final rule, CMA retained an independent consultant to conduct a survey of glove use by the employees of companies working with EHA. J.A. 32-47 (the "Glove Use Survey"). The results of the survey were...