TSCA and Trade Secrets: Third Circuit Upholds EPA's Broad Authority to Obtain Health Studies Under § 8(d)

The Toxic Substances Control Act (TSCA),¹ which has been in effect less than three years, represents perhaps the deepest penetration by the federal government into the activities of the private sector for the purpose of regulating environmental hazards. Recently, the Third Circuit Court of Appeals became the first federal court to interpret a key data-gathering provision of TSCA, and, in so doing, it left the regulators pleased and the chemical manufacturers unhappy. The decision highlights the tension in the law between industry's need to protect its product development activities in order to gain a competitive advantage and the government's need to obtain information about that development early enough to assure that the public health will not be threatened.

In Dow Chemical Co. v. Environmental Protection Agency,² the Third Circuit upheld the Agency's assertion of authority under § 8(d) of TSCA to obtain health and safety studies of chemical substances, even during the research and development phase of the product cycle, by adhering strictly to the statutory language and dismissing potentially conflicting indications in the legislative history. The decision gives an important boost to the view that the federal government has broad powers under the Act to pierce the veil that has shrouded corporate activities when a serious impact on the nation's environment is threatened.

Toxic Substances Control Act

The number of chemical substances and the size of the chemical industry illustrate graphically the Environmental Protection Agency's (EPA's) burden in attempting to enforce the Act. The President's Council on Environmental Quality has noted that as many as 70,000 chemicals are currently in commercial production and over four million separate chemical compounds have been registered with the American Chemical Society; furthermore, the list grows at the rate of 6,000 perweek.³ The nation's 115,000 chemical production and distribution companies generate $113 billion worth of business per year. At the same time, the magnitude of the environmental and health hazards that follow from this enormous dependence on chemicals is just beginning to be known. The litany of problems related to the use and manufacture of polychlorinated biphenyls (PCBs), asbestos, benzene, and various pesticides such as dioxin and DDT is mushrooming almost daily. Even when the toxic properties of a chemical become known, however, protective measures cannot be put in place until technical obstacles, industry recalcitrance, bureaucratic inertia, and legal difficulties are overcome.

Recognizing all of these problems, Congress labored for more than five years to produce in 1976 the Toxic Substances Control Act, a complex statute⁴ the purpose of which is to assure that the harmful effects of chemicals are discovered in the laboratory rather than after they have become entrenched in the marketplace or the environment where removal is difficult because of the economic or social disruptions. Realizing, however, that overregulation could discourage technological innovation, Congress declared in the statute a policy:

not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the [Act's] primary purpose … to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment.⁵

The key to advance interception of problem chemicals is the imposition of an extensive array of reporting and testing⁶ requirements on the chemical industry, including notification of EPA prior to the manufacture of a new chemical substance.⁷ Section 8 of TSCA⁸ contains the most important information-gathering provisions in the statute.It requires (1) EPA to maintain an inventory of all chemicals that are manufactured or processed in the United States,⁹ (2) submission of reports to EPA detailing the name, chemical identity, amount manufactured, data concerning the environmental and health effect, and information about human exposure of inventoried chemicals,¹⁰ (3) the maintenance of records of "significant adverse reactions to health or the environment,¹¹ and (4) the immediate submission to EPA of information "which reasonably supports the conclusion" that a chemical "presents a substantial risk of injury to health or the environment."¹²

[9 ELR 10164]

Section 8(d)¹³ concerns health and safety studies.¹⁴ It imposes two requirements on "any person who manufactures, processes, or distributes in commerce [including those who propose to do so] any chemical substance or mixture." First, under § 8(d)(1), such persons must submit to EPA lists of health and safety studies conducted by them, known to them, or reasonably ascertainable by them. Second, § 8(d)(2) requires such person or "any person who has possession of a study" to submit "copies of any study contained on a list submitted pursuant to paragraph (1) or otherwise known to such person." The importance of § 8(d) was stressed in the legislative history in which it was noted that § 8(d):

will be valuable in avoilding the situations that have occurred in the past … where allegations have been made that the industry and trade associations withheld information which would have revealed hazards associated with these chemicals at a much earlier date.¹⁵

EPA Implementation

Section 4 of TSCA¹⁶ gives EPA the authority to require companies to conduct tests on chemicals that the Agency suspects might be hazardous. An Interagency Testing Committee (ITC) proposed a list of chemicals to be tested and recommended testing in several general areas.¹⁷ EPA then proposed a rule¹⁸ designed to obtan existing health and safety studies on the chemicals identified by the ITC so that EPA could assess the need for and character of testing rules to be formulated under § 4. If existing studies were sufficient, additional testing would be unnecessary, and the § 4 burden on the chemical industry would be reduced.¹⁹

The proposed rule, which was aimed at persons who manufactured, processed, or distributed the ITC-listed chemicals after January 1, 1977, defined "manufacture or process" to mean "to manufacture or process for commercial purposes, which includes … product research or development."²⁰ In response to the proposed rule, several companies objected to the amount of time needed to conduct a substantial file search. In addition, industry pointed out that reporting product research and development tests would give competitors valuable information about a company's future plans.

EPA was unimpressed by these criticisms and said as much when it released its final § 8(d) regulation.²¹ Acknowledging that file searches would be burdensome, the Agency nonetheless decided that they were necessary to obtain all available data pertinent to deciding what testing should be required. EPA similary rejected the contention that product research and development should not be included in the definition of "manufacture or process."²² The final rule also expanded the coverage of the reporting requirements. Whereas the proposed rule covered only the specific health and environmental effects suggested by the ITC, the final rule required reporting all health and safety studies on the listed chemicals. EPA justified this expansion by noting that it would be "very informative to know the full range of possible toxic effects of a substance in evaluating and predicting its biological activities."²³ The listing process pursuant to § 8(d)(1) of TSCA remained limited to those ITC-listed chemicals actually manufactured, processed, or distributed by the reporting company, but the Agency invoked its sweeping powers under § 8(d)(2) to require the company to submit copies of all studies of ITC-listed substances in its possession, even if the studies were of chemicals that the company did not manufacture, process, or distribute.

Dow's Petition to the Third Circuit

Even though Dow Chemical Co. submitted a substantial amount of information under the § 8(d) regulation [9 ELR 10165] and apparently complied with it,²⁴ the company nevertheless challenged the rule in the Third Circuit Court of Appeals. Dow charged first that EPA had violated the Administrative Procedure Act by enlarging the scope of the final regulation without providing an adequate notice and opportunity to comment.²⁵ In addition, Dow claimed that the final rule exceeded EPA's substantive authority under § 8(d) in two respects. First, it argued that the manufacture of a chemical for research and development was not manufacture for a "commercial" purpose; thus, studies for research and development were not subject to the § 8(d) listing and submission requirements. Second, it urged that EPA's authority to require submission of studies under § 8(d)(2) be limited only to those studies required to be listed pursuant to § 8(d)(1).

In response to Dow's petition, EPA revoked the § 8(d) rule.²⁶ The Agency explained that as there had already been substantial compliance with the rule and it would be revised to cover additional chemicals recommended by the ITC, the issues in the dispute would be reviewed again, providing the opportunity for additional public input on the issues raised by Dow.²⁷ Nonetheless, EPA asserted "no doubt that it has the authority" under § 8(d) to require the submission of lists of studies and the studies themselves from both persons who manufacture an ITC-identified chemical for purposes of product research and development and those in possession of studies regardless of whether they manufacture, process, or distribute the chemicals. In its revocation notice, EPA did, however, request comment on whether under any § 8(d) rule it should "exercise the full extent of its authority."²⁸

Dow Chemical Co. v. EPA

The Third Circuit Court of Appeals rebuffed the petitioner on all essential issues.²⁹ Before turning to the substantive challenges to EPA's assertion of authority under § 8(d) the court disposed of several procedural issues. EPA had argued that because of its revocation of the rule, the issue was now moot. The court disagreed, however, ruling that because the Agency had not altered its posture regarding its authority but had only withdrawn the regulation for technical reasons with the intention to resubmit it, the dispute was real and concrete. The court noted especially that Dow's activities would continue to be affected by the possibility of subsequently having to provide EPA "with confidential information of considerable value of Dow's competitors." The resulting "chill" on Dow's research and development was thus deemed a present harm meriting review. Further, the court pointed out that continued litigation over the scope of EPA's power might compromise the Agency's investigation of toxic chemicals; opportune resolution of the issue would better serve both parties.

A second preliminary issue concerned whether deference was to be given EPA's interpretation of its authority under TSCA. Here too the Third Circuit held against the Agency. Such deference is accorded when an agency is especially qualified in a certain field because of its expertise in the relevant scientific area or experience with the subject matter of the regulatory scheme. The statutory limit of EPA's information-gathering authority under TSCA, however, is a question of law not uniquely subject to the special competence of the Agency. Thus, the court concluded that it could sustain EPA's assertion of authority only if it comported with the statutory language and congressional intent.

In affirming that research and development could indeed be seen as part of manufacturing for a commercial purpose under § 8(d), the court relied upon the fact that other statutory language in TSCA, though it too is subject to the "commercial purposes" limitation, specifically excludes research and development in imposing obligations upon manufacturers.³⁰ To adopt Dow's argument that the commercial purposes limitation excludes manufacture for research and development would, in the court's view, render these additional research and development exemptions superfluous.

With admirable persistence, Dow argued that the additional research and development exemptions were not in fact without significance. In this vein, the company contended that while the commercial purposes limitation does indeed protect data on chemicals used for "inhouse" research, it does not apply to chemicals which are sold to others for similar research. Therefore, the secondary research and development exemption was needed for those "test chemicals" that are sold outside the company. The court rejected this argument because neither the language of the statute nor the legislative history evinced Congress' perception that this distinction created different levels of protection. Rather, Congress intended that the exemptions in §§ 5 and 8 protect both types of research chemicals to the same extent.

While the court was compelled to acknowledge the merit in Dow's argument that EPA's reading of the statute gave rise to certain inconsistencies,³¹ the court saw no less merit in the Agency's attempt to give consistency and meaning to its construction of the various exemptions within the statute.³² Essentially, EPA views § 8(d) to apply to any chemical substances produced intentionally and in connection with profit-seeking activities, and in [9 ELR 10166] the last analysis, the court found this interpretation to be in accord with the statute as a whole.

Submission of Studies Under § 8(d)(2)

The question whether § 8(d)(2)³³ authorizes EPA to obtain copies of studies even though they were not listed by the company under § 8(d)(1) presented the Third Circuit with the converse of the common situation in which a court must construe ambiguous statutory language by reference to clear guidance in the legislative history.

Dow's argument that a reporting company should be required to submit copies of only those studies that it listed pursuant to § 8(d)(1) was based on the logical view that the requirement to submit copies of studies must be narrower than the requirement to submit lists of such studies. Dow also pointed to portions of the House and Senate reports indicating that Congress contemplated that companies would have to submit copies only of listed studies. The court noted, however, that Dow's evidence reflected an earlier version of TSCA which paralleled its reading of § 8(d)(2). Other portions of the legislative history, however, supported EPA's interpretation, particularly the conference report in which it was stated that "the conferees emphasize the importance of gaining information that errs on the side of too much rather than too little."³⁴

In the face of these conflicting directions, the Third Circuit turned to the express statutory language and found that it comported more closely with EPA's interpretation. The parenthetical reference in § 8(d)(1) to "any person who has possession of a study" could only be read, the court concluded, to extend the reach of the requirement beyond manufacturers, processors, and distributors. Second, the reference in § 8(d)(2) to "any study … otherwise known to such person" had to include, in the court's eyes, studies other than those listed pursuant to § 8(d)(1).

Dow attempted to counter the force of the statutory language by arguing that it was intended to allow EPA either to obtain copies of listed studies in the possession of third parties or to ensure that EPA could secure studies inadvertently left off the list. The court found that these theories concede not only that EPA may reach parties other than manufacturers, processors, and distributors but that itmay seek copies of studies not appearing on any submitted list. The court then concluded that the statutory language reflected the intent of Congress "that EPA possess a wider authority in securing copies of studies than in securing lists."³⁵

Implications

The Third Circuit emphasized that TSCA places "the burden of ensuring adequate research and testing on toixc substances squarely on those companies who seek to profit from the use or sale of such chemicals."³⁶ In extensive dicta, Judge Adams conceded that his decision might adversely affect the level of technological innovation if the required submission of test results to the federal government tends to reduce the competitive advantage that derives from protecting information about a company's new initiatives. With the loss of this economic incentive, companies might reduce their research on substances about which information must be submitted to EPA. This might prevent development of potentially valuable new chemicals as well as lessen research on potentially hazardous substances, ironically, the very chemicals about which research is most needed.

However, the argument that a company would forego new product research were it required to submit health and safety studies to EPA relies upon the premise that its competitors will have access to the information because EPA cannot keep its files closed. Recognizing this potential problem, Congress established detailed and stringent restrictions³⁷ on EPA's release of confidential information to the public. Specifically, health and safety studies may not be disclosed until the chemical is "offered for commercial distribution,"³⁸ at which time the need for confidentiality is arguably diminished. The industry is properly concerned whether the government can guarantee the level of confidentiality promised in the statute³⁹; nevertheless, as EPA argued and the Third Circuit agreed, the security of submissions was not before the bar in Dow. Congress chose to protect industry data by imposing rigorous security requirements on EPA via § 14, not by circumscribing the Agency's broad access to such information under § 8.

Dow's contentions tend to minimize the public interest in learning of health and environmental hazards that are gleaned during research and development of new chemical products.There can be no question that the earliest warning of danger is the best protection, and research and development tests may provide the best [9 ELR 10167] available information on the effects of chemicals. Furthermore, chemicals are often produced in large quantities even at the research and development stage⁴⁰ and therefore could even then result in significant human and environmental exposure.

The Dow Chemical Co. v. EPA lawsuit concerned the issue of what must be reported in the way of health and safety studies. The next question with which the courts are confronted is likely to be who, besides the obvious chemical companies, must report such studies. While § 8(d) clearly applies to the profit-oriented businesses such as Dow, does it similarly include other organizations such as academic institutions or charitable research foundations? This question was raised by the parties and noted by the Third Circuit but was not ripe for resolution. It is hardly a frivolous issue because here are significant economic burdens associated with compliance,⁴¹ and there is a risk of liability for failure to comply.⁴² An argument that might be expected from EPA is that all research and development activities, no matter by whom conducted, are covered because they may one day lead to commercial exploitation. Furthermore, many research-oriented organizations, though they maintain not-for-profit or educational status, have close ties with and obtain direct benefits, through research contracts, with industry. Thus, in view of the breadth of the language of § 8(d) and the support which it received from the Third Circuit, it seems fair to conclude that universities and nonprofit institutions might be drawn within the sweep of § 8(d)(2). While they may be able to avoid the reach of the listing requirements under § 8(d)(1), it seems clear that EPA now has the authority to demand health and safety studies from virtually any person possessing them. Thus question was not directly at issue in Dow, however, and its definitive resolution lies in further rule making by EPA and potential court challenges.

Conclusion

A theme often heard from the chemical industry is the high cost in time and money of compliance with TCSA. There is disagreement, however, as to the seriousness of this fear.⁴³ Dow presented the Third Circuit with a variant of this theme in its argument that the public concern for the effects of a chemical is at a minimum during the research and development phase when the public interest in protecting innovation is at a maximum.⁴⁴ It is only at the later stage of commercial exploitation, Dow continued, where the need to protect research confidentiality is diminished because the company has already obtained its competitive jump, that the public interest in protecting health and the environment becomes substantial. EPA's "unwarranted and unauthorized intrusion" into the area of research and development, as exemplified by its § 8(d) rule, was thus considered by the petitioner to be highly detrimental to the health of the American chemical industry because of its stifling effect on product innovation.

To the extent, if any, that the Third Circuit's decision in Dow Chemical Co. v. EPA has the effect of placing a barrier in the way of technological innovation by the chemical industry, it could conflict with clearly expressed congressional policies.⁴⁵ On the other hand, Congress emphasized that the primary purpose of the Act is to assure that innovations and commercial use of chemicals do not unreasonably threaten the public health or the environment.⁴⁶ Since industry's fears of a chilling effect on research should be discounted to some extent because they are necessarily premised on EPA's supposed inability to protect confidential information, Judge Adams' opinion appears to resolve the competing policies in a manner consistent with the legislative intent. Noting that corporations cannot be relied upon the exalt public health above the marketplace, the court reasonably concluded that the barrier to technological innovation created by § 8(d) was nonetheless necessary to effectuate Congress' intent to be safe rather than sorry about newly developed chemicals.

The imminent appearance of a new § 8(d) rule⁴⁷ will give both EPA and industry an opportunity to explore variations on the original. The Third Circuit's strict reading of the statutory language in Dow, however, provides a solid foundation for EPA to exercise the regulatory muscle that Congress gave it in § 8(d).

1. 15 U.S.C. §§ 2601-2629, ELR STAT. & REG. 41335.

2. __ F.2d __, 9 ELR 20640 (3d Cir. Aug. 24, 1979).

3. COUNCIL ON ENVIRONMENTAL QUALITY, NINTH ANNUAL REPORT — ENVIRONMENTAL QUALITY 178, 180 (1978).

4. For an overview of TSCA, see Gaynor, The Toxic Substances Control Act: A Regulatory Morass, 30 VAND. L. REV. 1149 (1977); Zener, The Toxic Substances Control Act: Federal Regulation of Commercial Chemicals, 32 BUS. LAWYER 1685 (1977).

5. Section 2(b)(3), 15 U.S.C. § 2601(b)(3), ELR STAT. & REG. 41336.

6. The testing requirements for chemicals that "may present an unreasonable risk of injury to health or the environment" or to which there is or may be "significant or substantial human exposure" are found in § 4, 15 U.S.C. § 2603, ELR STAT. & REG. 41336.

7. Pre-manufacture notification requirements are detailed in § 5, 15 U.S.C. § 2604, ELR STAT. & REG. 41338.

8. 15 U.S.C. § 2607, ELR STAT. & REG. 41343.

9. Section 8(b), 15 U.S.C. § 2607(b), ELR STAT. & REG. 41344.

10. Section 8(a), 15 U.S.C. § 2607(a)8 ELR STAT. & REG. 41343. For an analysis of the Inventory Reporting Regulations, see Comment, First Steps in Implementing the Toxic Substances Control Act, 8 ELR 10032 (1978).

11. Section 8(c), 15 U.S.C. § 2607(c), ELR STAT. & REG. 41344.

12. Section 8(e), 15 U.S.C. § 2607(e), ELR STAT. & REG. 41344.

13. (d) HEALTH AND SAFETY STUDIES — The Administrator shall promulgate rules under which the Administrator shall require any person who manufacturers, processes, or distributes in commerce or who proposes to manufacture, process, or distribute in commerce any chemical substance or mixture (or with respect to paragraph (2), any person who has possession of a study) to submit to the Administrator —

(1) lists of health and safety studies (A) conducted or initiated by or for such person with respect to such substance or mixture at any time, (B) known to such person, or (C) reasonably ascertainable by such person, except that the Administrator may exclude certain types or categories of studies from the requirements of this subsection if the Administrator finds that submission of lists of such studies are unnecessary to carry out the purposes of this Act; and

(2) copies of any study contained on a list submitted pursuant to paragraph (1) or otherwise known by such person.

15 U.S.C. § 2607(d), ELR STAT. & REG. 41344.

14. (6) The term "health and safety study" means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemical substance or mixture, and any test performed pursuant to this Act.

Section 3(6), 15 U.S.C. § 2602(6), ELR STAT. & REG. 41336.

15. S. REP. NO. 698, 94th Cong., 2d Sess. 8 (1976).

16. 15 U.S.C. § 2603, ELR STAT. & REG. 41336.

17. 42 Fed. Reg. 55026 (Oct. 12, 1977).

18. 43 Fed. Reg. 4073 (Jan. 31, 1978).

19. Brief for Respondents at 7, Dow Chem. Co. v. EPA, __ F.2d __, 9 ELR 20640 (3d Cir. Aug. 24, 1979).

20. 40 C.F.R. § 730.1(a) (proposed), 43 Fed. Reg. 4075 (Jan. 31, 1978).

21. 43 Fed. Reg. 30984 (July 18, 1978) (to be codified in 40 C.F.R. pt. 730).

22. Rather than specifically including "research and development" in the regulatory definition of "manufacture or process," as was done in the proposed regulations, the final regulations appended a "Note" to this effect after the definition. EPA explained this by pointing out that the definition of "manufacture or process" was now consistent with that in the inventory reporting regulations, which did not include "research and development." The "Note" makes it clear that research and development chemicals are not excluded from the § 8(d) rules, however. 43 Fed. Reg. 30984 (July 18, 1978). Because the effect is the same as in the proposed rule, the special format for the final rule seems unnecessary and possibly confusing.

23. 43 Fed. Reg. 30985 (July 18, 1978).

24. Brief for Respondents at 12.

25. See 5 U.S.C. §§ 553(b) & 553(c), ELR STAT. & REG. 41002.

26. 44 Fed. Reg. 6099 (Jan. 31, 1979).

27. The existing rule had "apparently outlived its usefulness." Brief for Respondents at 12.

28. 44 Fed. Reg. 6099 (Jan. 31, 1979).

29. Dow Chem. Co. v. EPA, __ F.2d __, 9 ELR 20640 (3d Cir. Aug. 24, 1979).

30. The manufacture of small amounts of substances for scientific experimentation or analysis, including research for product development, is specifically exempted from requirements under §§ 5(h)(3), 8(a)(1), and 8(b)(1), 15 U.S.C. §§ 2604(h)(3), 2607(a)(1), 2607(b)(1), ELR STAT. & REG. 41341, 41343, 41344.

31. The court noted Dow's suggestion that if "commercial purposes" did not exclude research, it is not clear what it does exclude. Furthermore, it recognized that the "proposes to" language appears unnecessary if, by reaching research, "commercial purposes" must necessarily include pre-proposal development. 9 ELR at 20646.

32. The "commercial purposes" exclusion could be seen as intending to distinguish "any profit-making enterprise from a non-profit institution, such as a university or foundation." Id. See also Brief for Respondents at 29, 35. Similarly, the exclusion could be viewed to insulate incidental byproducts from § 8(d). Although the legislative history mentions this type of exclusion with respect to § 5, H.R. REP. NO. 1341, 94th Cong., 2d Sess. 30-31 (1976), it appears to apply equally to § 8(d).

33. (d) HEALTH AND SAFETY STUDIES — The Administrator shall promulgate rules under which the Administrator shall require any person who manufactures, processes, or distributes in commerce or who proposes to manufacture, process, or distribute in commerce any chemical substance or mixture (or with respect to paragraph (2), any person who has possession of a study) to submit to the Administrator —

….

(2) copies of any study contained on a list submitted pursuant to paragraph (1) or otherwise known by such person.

TSCA § 8(d)(2), 15 U.S.C. § 2607(d)(2), ELR STAT. & REG. 41344.

34. H.R. REP. NO. 1679, 94th Cong., 2d Sess. 81 (1976).

35. 9 ELR at 20647.

36. 9 ELR at 20641.

37. TSCA § 14, 15 U.S.C. § 2613, ELR STAT. & REG. 41346.

38. Section 14(b), 15 U.S.C. § 2613(b), ELR STAT. & REG. 41346. Furthermore, release of data revealing manufacturing processes or mixing portions is prohibited altogether.

39. Last year, one company sought to enjoin enforcement of TSCA's inventory reporting regulations because of allegedly inadequate procedures to safeguard confidential information. See Polaroid Corp. v. Costle, ELR PEND. LIT. 65572. The suit was settled because EPA promulgated revised confidentiality regulations that were satisfactory to the company. 43 Fed. Reg. 39997 (Sept. 8, 1978) (to be codified in 40 C.F.R. pt. 2). A current dispute centers on the confidentiality of information submitted pursuant to the § 5 pre-manufacture notice provisions. EPA proposed regulations early in the year, 44 Fed. Reg. 2242 (Jan. 10, 1979), and will shortly repropose the part of the regulations dealing with how companies may claim confidentiality of the information they have submitted.

40. For example, many plastics and fibers are commonly produced in 100,000-pound quanitites during the product development phase. See 42 Fed. Reg. 64586 (Dec. 23, 1977) (Appendix A to Inventory Reporting Regulations).

41. See, e.g., Polack, Toxic Substances Control Act — One Perspective, 1 TOXIC SUBSTANCES J. 15 (Summer 1979).

42. Section 15 prohibits the failure or refusal to submit reports or other information. 15 U.S.C. § 2614, ELR STAT. & REG. 41346. Civil and criminal penalties for such actions are provided in § 16, 15 U.S.C. § 2615, ELR STAT. & REG. 41346.

43. The Senate Commerce Committee report on TSCA specifically noted that "the economic burdens that may be imposed as a result of this legislation are not substantial particularly when considered in the context of the economic, health, and other benefits." S. REP. NO. 698, 94th Cong., 2d Sess. 13 (1976). The committee also countered claims that the legislation could cost industry up to $2 billion per year by citing to EPA and General Accounting Office reports that the cost would not exceed $200 million per year. In an effort to develop more data, the Manufacturing Chemists Ass'n has commissioned a four-year, $1.5 million study of the testing and administrative costs borne by the chemical industry as a result of TSCA, as well as the Act's effects on new product development. Carter, An Industry Study of TSCA: How to Achieve Credibility?, 203 SCIENCE 247 (Jan. 19, 1979). For a view of TSCA's impact on a small chemical company, see Polack, Toxic Substances Control Act — One Perspective, 1 TOXIC SUBSTANCES J. 15 (Summer 1979).

44. Brief for Petitioner at 16-18.

45. See text at note 5 supra.

46. Id.

47. A new § 8(d) rule is currently going through internal EPA review and is expected to be formally proposed sometime in the fall.