In Anticipation: Comparing the 1976 Toxic Substances Control Bills

6 ELR 10138 | Environmental Law Reporter | copyright © 1976 | All rights reserved


In Anticipation: Comparing the 1976 Toxic Substances Control Bills

[6 ELR 10138]

Introduction: House Panel Acts

In early June a bipartisan, industry-supported substitute version of the proposed Toxic Substances Control Act (TSCA), cleared the House Interstate and Foreign Commerce Committee.1 Because of the substitution, agreed to by the subcommittee bill's sponsor Representative Bob Eckhardt (D.-Texas) in order to ease committee action, the House measure, H.R. 14032, differs substantially from the Senate-passed bill, S. 3149.2 Thus, for the third time in five years,3 there is some prospect that Congress may not agree on this legislation, which would greatly augment the Environmental Protection Agency's power to regulate dangerous chemicals.

Because of its bipartisan backing and industry support, the House bill sailed through markup with few changes.4 The same combination of forces is likely to assure relatively quick House passage, again with few amendments, when it reaches the floor at the end of July. It is thus timely to compare the two bills, to evaluate the merits and significance of their differences, and to address the likelihood of enactment of toxics legislation in the 94th Congress.

General Operation and Major Features of the Current Bills

The goal of the legislation in both houses is to assure adequate federal regulatory power to anticipate and prevent widespread health and environmental harms from chemical substances and mixtures.5 To this end, both bills would empower the EPA Administrator to gather data on risky chemicals from their producers, evaluate their potential environmental and health effects, and regulate any aspect of their production, marketing or disposal to the extent necessary to protect humans and the environment from unreasonable risks of harm. In addition, all new chemicals would be subject to premarket screening.

The regulatory scheme would impose affirmative duties on producers (including manufacturers, processors, and distributors). They must test certain chemicals designated by the Administrator for health and environmental effects,6 notify him at least three months prior to marketing new chemicals,7 and retain [6 ELR 10139] specified records and report to EPA concerning chemicals' identities, uses, production quantities, and risks.8

Under the bills, the EPA Administrator is authorized to require testing of risky chemicals (testing rules);9 to make rules banning, restricting or otherwise regulating production, sale, transport, use or disposition of chemicals (restrictive rules), when he finds that any of these marketing phases raise risks of harm,10 to keep certain new chemicals off the market pending completion of studies under testing rules or rulemaking proceedings leading to restrictive rules;11 and to inspect chemical facilities and issue subpoenas.12 He must also consider the possibility of regulating risky chemicals under other laws,13 consult with the Department of Health, Education and Welfare and other agencies concerning monitoring, develop data banks,14 and develop and maintain an inventory of chemicals in use.15

Other provisions of the bills concern public participation in regulation of chemicals through EPA-compensated intervention in restrictive rulemaking,16 petitions asking the Administrator to commence rulemaking proceedings,17 judicial review of regulatory rules,18 and civil actions19 preemption of state laws;20 public access [6 ELR 10140] to and confidentiality of information submitted under the TSCA;21 protection of employees against reprisals for facilitating enforcement;22 export of regulated chemicals;23 and regulation of imported chemicals.24

Detailing and Evaluating Differences in the Bills

As suggested in the preceeding footnotes, H.R. 14032 and S. 3149 differ on a number of scores. This section addresses those differences that appear most significant in view of the needs the bills address, their stated aims, and the experience with similar provisions in other laws.

The Regulatory Threshold and Judicial Review. Most regulatory actions under the TSCA must take the form of rules promulgated in expanded informal rulemaking proceedings. To trigger such proceedings and justify the issuance of rules, the Administrator must make threshold "findings" with respect to the risks to health or environment associated with manufacture, processing or other aspects of marketing of chemicals. For example, the bills formulate the threshold finding standards for testing rules and restrictive rules as follows:

ActionS.3149H.R. 14032
To require testing"may present an"may cause or
(§ 4): Administratorunreasonable risk ofsignificantly contribute
must find thatinjury to health or theto an unreasonable
marketing of aenvironment …" n25risk to health or the
chemicalenvironment …"25
To require a"find that the"finds that there is a
production or[marketing] of areasonable basis to
marketing ban or[chemical] presents orconclude that the
restriction (§ 6):is likely to present an[marketing] of a
Administrator mustunreasonable risk of[chemical] causes or
injury to health or thesignificantly contributes
environment …" n26to or will cause or
significantly contribute
to an unreasonable
risk to health or the
environment …"26
At first blush, these standards seem little different. The crucial issue, however, is whether a regulatory rule issued by the Administrator can withstand judicial review under them. Here, the differences in language may loom large due to the interaction between the applicable "substantial evidence" judicial review standard and the fact that most actions of the Administrator will be based on risk assessments rather than certain evidence of harm. Judicial institutions frequently have difficulty reviewing risk-based decisions, because they point toward the future rather than focusing, as do most lawsuits, solely on past events.27 Both bills pose a problem in this regard, for they speak in terms of "findings." But the House bill exacerbates the situation in two ways. First, H.R. 14032 repeatedly uses the terminology of causation, which is likely to elicit judicial insistence on "facts in the record" to support action. More significant is the fact that only the House bill authorizes opponents of rules to attack them in district court as well as the court of appeals.28 In general, trial judges are more likely than appellate judges to insist on tangible demonstrated facts.

For example, suppose the Administrator issues a rule banning sale of newly-developed chemical PDQ that is revealed to cause mutations in test tube tests using bacteria or other cells. Such a test result shows a probability that PDQ will cause mutations in humans too, and perhaps cancer as well.29 If the manufacturer challenges the rule, an unsophisticated court is more likely under the House than the Senate bill to strike down the rule or remand it to the Administrator for additional findings, in order to supply a "factual" basis for his action.

The problem is likely to be exacerbated with new chemicals, due to lack of data on them. It will also be more severe if the producer of the chemical has been able to market a substance for some time before it is banned, for then he will be in a position to point to concrete [6 ELR 10141] "facts" concerning its utility (customer respense) and the jobs its production creates. These certainties are likely to sway some judges more than the chemical's speculative future ill effects.

In view of the special obstacles to EPA's risk-based decisions respecting new chemicals, it is important to evaluate the adequacy of the bills' provisions empowering the Administrator to delay marketing of novel substances pending thorough evaluation and regulatory action.

Administrator's Ability to Delay New Chemical Marketing Pending Evaluation and Control. Regulation of new chemicals is likely to be particularlydifficult to sustain due to lack of data, and this difficulty will be increased if marketing is allowed during testing or proceedings for issuance of restrictive rules. At present, evaluation of chemicals for serious chronic effects, such as cancercausing potential, requires far more than the 90 days between notification and marketing.30 Both toxic substances bills provide mechanisms for delaying production and marketing of new chemicals beyond the 90-day premarket notification period,31 either to permit issuance of a testing rule and learn the results of such testing, or pending restrictive rule proceedings. The procedures differ greatly, however, in their workability.

Under the Senate bill, the Administrator may, during the 90-day period, simply issue an immediately effective order prohibiting or restricting production and marketing of a new chemical pending issuance of a testing rule and completion of such testing,32 or issuance of a permanent restrictive rule or ban.33 Under the House bill, however, the Administrator must go to court to hold up production beyond 90 days in order to make a restrictive rule;34 to hold up marketing pending testing,35 he must generally invoke a complex process to list a chemical as posing risks.

Under H.R. 14032, to secure a production delay pending proceedings for restrictive rules, the Administrator must secure an injunction from a district court; the sole standards for such injunction, as Rep. Eckhardt emphasized in the House committee markup, would be judicial findings that (1) insufficient information is available to evaluate the chemical's effects; and (2) absent such information the substance "may cause or significantly contribute to an unreasonable risk to health or the environment."37 Alternatively, the Administrator may begin § 6 proceedings to ban the chemical, secure an injunction against the chemical in a district court as an "imminent hazard" under § 7, and then make the proposed § 6 ban immediately effective.38

The latter procedure is plainly unworkable, for it is hardly reasonable to expect the Administrator to be able to convince a judge that a new chemical, about which little or nothing is known, constitutes an imminent hazard. The lack of information may threaten the workability of the earlier mechanism as well, despite Rep. Eckhardt's insistence during markup that the "risk" standard for issuing an injunction should be read to incorporate as well the large production volume standard of § 4(a)(1)(A)(ii).

With respect to delaying production pending testing, the procedure proposed in the House bill may also prove unworkable for most new chemicals. The mechanism is simple for substances already under a testing requirement. When premarket notification is given concerning them, § 5(e) precludes production until 90 days after submission of the test data required by the pre-existing rule.

It seems reasonable to predict, however, that most new chemicals will not already be subject to a testing rule when their developers notify the Administrator of intended production. New product development is a secret process, and nothing in the TSCA requires disclosure of the identity of new chemicals prior to the 90-day premarket notification point. So, lacking information, the Administrator will be in no position to issue rules for testing products under development until after he receives premarket notification.

Under the House bill, when a new chemical is not under a testing rule at the time the Administrator receives 90-day notification of its intended production, he may delay production pending testing only by commencing the rulemaking procedure, prescribed by § 5(i), to include it on a special list of risky chemicals. But, predictably, to qualify for listing under § 5(i), the Administrator must find that a chemical "shall or may cause or significantly contribute to an unreasonable risk to health or the environment…."39 But he will lack information [6 ELR 10142] sufficient to make such findings for many new chemicals. Moreover, as listings are to be done by rule,40 such decisions will be subject to judicial review under the substantial evidence test. In the judicial forum the Administrator's lack of information is likely to prove fatal.

Administrative Harrassment and the Citizen Petition Provision. The House and Senate bills are at odds over the scope and thrust of § 21, which authorizes persons to petition the Administrator to institute proceedings under the TSCA and to seek de novo district court review of the Administrator's refusal or failure to take the requested action. S. 3149 limits petitions to requesting proceedings to issue testing or restrictive rules or take actions aimed at securing the protections of the act against "unreasonable risks of injury to health or the environment." H.R. 14032, on the other hand, permits petitions to request commencement of proceedings to repeal or amend restrictive rules as well as to issue them.

While the House measure seems facially more neutral, in fact it is likely to unbalance and bedevil administration of the TSCA. First, the resources and economic interests of persons interested in repealing restrictive rules probably far outweigh the forces of those committed to securing such rules. The chemical industry is one of the largest and most profitable in the United States, and its economic self-interest will naturally lead it rationally to expend substantial resources challenging testing and restricting rules under the TSCA. Environmental groups have far fewer resources and less direct interest in assuring control of chemicals that may prove dangerous.

Related to this disproportion of resources is the fact that the limitation in the Senate petition provision probably will keep the number of petitions small enough to permit smooth administration of the TSCA, while the House measure threatens to blockade enforcement severely. To be sure, House § 21 would not, like the general judicial review provision of § 19, authorize a reviewing court to probe the basis of the challenged rule directly, but only the Administrator's decision not to commence rulemaking to repeal it. Still, a judicial order to commence rulemaking is likely to distort administrative operations substantially. In addition, an ultimate refusal by the Administrator to repeal a rule after holding court-ordered proceedings would arguably be reviewable under the broader standards of § 19.

Relation to Other Laws. The current TSCA bills differ over the extent to which the Administrator is obliged to consider and prefer regulation under other laws when there is an overlap with the TSCA. Both bills require him to review the feasibility of using other laws, those that he administers and those handled by other agencies. But S. 3149 gives him far more leeway than H.R. 14032 to decide whether to use the TSCA, rely on one of his other laws, or refer the matter to another agency to handle.

The nature of the toxic chemical problem makes the Senate provision preferable. Since no other applicable41 law (except § 211 of the Clean Air Act regarding gasoline additives) focuses directly on chemicals, and since none authorizes risk-based anticipatory regulation prior to release of chemicals into the environment, it is not likely that many situations will present themselves in which adequate regulation can be achieved under other laws. Recent experience with PCB's42 has demonstrated how difficult it can be to remove chemicals from the environment once they are released. And it is now realized that from 15 to 40 years exposure are needed to learn for sure whether a chemical causes cancer.43 In short, it seems by now beyond dispute that the corpus of existing regulatory laws is not adequate to cope responsibly with the problems posed by the burgeoning use of chemicals in the United States.

Prediction of Conference Action and Overall Evaluation

It is, to be sure, too early to anticipate the outcome of potential conference committee action to resolve the many differences between S. 3149 and H.R. 14032 particularly against the backdrop of five years of congressional intransigence.44 Still, it is worth considering the factors that may influence eventual compromise deliberations and the shape of the bill that may ultimately emerge from their interaction.

The House bill enjoys the support of the Administration and of the well-organized and obviously influential chemical industry. If past experience is any guide, these forces should prove strong enough to resist compromise in conference and, should they wish, to prevent passage of any law this term.

But for both political and policy reasons, past experience may not be reliable guide to the fate of toxic substances legislation in the fall of 1976. If Mr. Carter, as probable Democratic Party candidate, is strongly favored at that time, the strength of his environmental stand and record may convince the chemical industry that it would prefer a law this year to the prospect of a [6 ELR 10143] stronger measure in the next session. The industry may thus be willing to compromise, particularly if environmental groups are thinking of holding out for next year

In terms of the merits of the weaker House bill, recent events appear to have undermined the industry justifications for it, which have primarily been articulated in terms of costs of testing and regulation and adverse impact on inflation and unemployment.45 The economic turnaround of the last few months is one dissonant factor. Another is growing public awareness of the chemical pollutant-cancer link and the need for anticipatory risk-based regulation of latent hazards like carcinogens and mutagens,46 and the difficulty of cleaning dangerous chemicals out of the environment and human tissues once they are introduced.47 Finally, the industry may have seriously overestimated cost due to the imminent availability of quick, inexpensive tests for mutagenic and carcinogenic properties of chemicals, testswhose reliability the industry seems already to have acknowledged by making commercial use of them.48

Should the above considerations have any impact, proponents of S. 3149 may do reasonably well in conference, and the President may be willing to sign the resultant bill.

Favoring the Senate bill are its broad information gathering and report maintenance provisions (§ 8) that will supply to EPA (and through it to other-federal regulatory agencies) far more data on the nature, use and disposition of chemicals than is presently available. This data should assist enforcement of EPA's other laws and of the Occupational Safety and Health Act and the Consumer Product Safety Act as well. In addition, S. 3149 gives the EPA adequate power to assess and handle new chemicals, and so to begin to dominate the chemical pollution problem. Finally, the TSCA's flexible enforcement arsenal of criminal and civil penalties, injunctions and libel actions, operating on the basis of anticipatory action standards, gives EPA far more effectiveness than is possible under its current corpus of end-of-the-line controls.

On the debit side, perhaps the primary weakness of the Senate bill is its administrative cumbersomeness and shortage of mandatory provisions obliging the EPA Administrator to act. Rather, the bill typically uses for regulation expanded informal rulemaking initiated by the Administrator, in his discretion, subject to potentially immobilizing judicial review.

At a more basic level, it may be appropriate to question the legislative wisdom of a regulatory scheme that creates a severe conflict of interest by requiring proponents of chemicals to test their own products for defects that may keep them off the market. Recent reports by the General Accounting Office indicate that insecticide and drug manufacturers are doing a less than adequate job of testing their new products under the Federal Insecticide, Fungicide and Rodenticide Act and the Federal Food, Drug and Cosmetic Act. There may be no easy answer to the testing problem, however. Independent labs and government facilities also do a less than adequate job of testing, according to research being done for the Senate Administrative Practice and Procedure and Health Subcommittees.49

Finally, because of House committee delays,50 no authorizations will be possible for the toxics act until fiscal 1978, which begins October 1, 1977. This does not, however, appear to be a serious objection to passage of a bill this term, for the bill contemplates gradual startup deadlines, and the EPA has much to do with respect to developing testing protocols and other administrative preparations.

On balance, the new powers conferred by the Senate bill outweigh its shortcomings. Indeed, the imminent perfection of quick, cheap reliable chemical tests would also make the House bill acceptable, if the Administrator and the courts can be persuaded to accept positive results of such tests as satisfying the unreasonable risk standard for imposing testing requirements, for delaying marketing of new chemicals pending testing, and for issuing restrictive rules.

1. The predecessor bill, H.R. 10318, had been approved in December 1975 by the Subcommittee on Consumer Protection and Finance.

2. On March 25, 1976, the Senate passed S. 3149, by a vote of 60-13, with a minimum of floor amendment. It resembled H.R. 10318 closely, for the Senate Commerce Committee had used the then-current House bill as the basis for its markup.

3. Responding to a 1971 Administration proposal and a report of the Council on Environmental Quality, Toxic Substances (1971), both Houses passed toxics bills in 1972; because of wide differences — the Senate measure, S. 1478, was stronger than the House counterpart — no conference was held and the legislation died. In 1973, both chambers again passed toxic substances legislation, and again the differences were so substantial that the conference committee was unable to clear a compromise measure. See Crewdson, Toxic Substances Controversy Continues, Congressional Quarterly, Jan. 3, 1976, p. 13.

4. On June 2, 1976, the committee accepted a Rep. Murphy (D.-N.Y.) amendment exempting food additives from the Act (§ 3(2)(B)(vi)); a Rep. Eckhardt proposal to require the EPA Administrator to consult with the Director of the National Institute of Occupational Safety and Health (NIOSH) before prescribing epidemiological tests under § 4(b)(2)(A); and a broadening of the public information language in § 5(h) proposed by Rep. Moss (D.-Cal.). On June 8, the committee adopted measures adding language to § 6 requiring manufacturers to give notice of regulated products' risks, and to § 16 authorizing the Administrator in civil penalty actions to order giving of notice, recall, repurchase or replacement of dangerous chemicals found to have been marketed in violation of restrictive rules (Rep. Eckhardt); and accepted a new § 26(d) establishing an office in EPA to give technical assistance and advice concerning compliance with the TSCA to manufacturers and processors (Maguire, D.-N.J.). An amendment by Rep. Dingell (D.-Mich.) to add specific controls on polychlorinated biphenyls (PCB's) to the bill failed 19-16 on a rollcal vote. Finally, on June 9, prior to voting the bill out, the committee accepted a Maguire Amendment to add a new § 27 authorizing the Secretary of Health, Education and Welfare to conduct and support, out of existing budget, projects to develop and evaluate inexpensive and efficient tests for the health and environmental effects of chemicals.

5. Section 2(b) of both bills. Because the measures use a nearly identical section numbering system, a single section number will often be used to refer to both bills.

6. Section 4. When the Administrator makes a threshold finding concerning the risks associated with a chemical substance or mixture or the volume of its production, he must issue a rule requiring its manufacturer or processor to test it for environmental and health effects (including carcinogenesis, mutagenesis and teratogenesis). Test exemptions and data compensation provisions avoid duplicate testing. A seven-member advisory committee is established to develop a public list of substances for priority consideration by the Administrator for testing. Testing rules are to be promulgated in informal proceedings under 5 U.S.C. § 553, with additional opportunity for oral submissions.

7. Section 5. Beginning roughly at the end of 1977 (Senate) or of 1978 (House), manufacturers would be required to notify the Administrator at least 90 days in advance of intended manufacture of new chemicals (defined as substances not listed in a chemical substances inventory to be compiled by the Administrator under § 8(b)), and of significant new uses of existing chemicals. Premarket notification must include a substance's name, chemical identity and molecular structure; proposed categories of use, reasonable estimates of amounts to be manufactured or processed, insofar as possible broken down by category of use; byproducts resulting from manufacturing, processing, use or disposal of the substance; existing data concerning its health and environmental effects; and (Senate only) estimates of numbers of persons to be exposed to it in the workplace. Exempt from premarket notification are chemicals manufactured for research or experimentation; the Administrator may also exempt test marketing chemicals.

8. Section 8(a). The categories of information to be retained and reported by producers (to be established by rules) are generally the same as those required in premarket notification, supra note 7. In addition, producers and marketers must immediately inform the Administrator when they learn that their chemicals may cause risks of harm.

9. Section 4. See note 6 supra.

10. Sections 6 and 7. The former is the major regulatory provision in the TSCA. It empowers and directs the Administrator, upon making a complex of findings concerning the risks associated with a chemical, the magnitude of its production and distribution, its benefits, the costs of regulation, and (House only) availability of adequate regulatory authority under other EPA-enforced laws, to promulgate a restrictive rule prohibiting, limiting or otherwise regulating its manufacture, processing, distribution, use, or disposal. This rulemaking is governed by 5 U.S.C. § 553, supplemented by oral submissions, limited cross-examination, maintenance of a written transcript, and discretionary compensation to insure participation of otherwise unrepresented interests.

Under § 7, the Administrator may, using EPA attorneys, sue in district court to bar continued use of or to require seizure, recall or replacement of "imminently hazardous" chemicals. These are chemicals whose continued use "causes or significantly contributes to an imminent and unreasonable risk of serious or widespread harm to health or the environment" (House), or is "likely to cause an unreasonable risk to man or to the environment taking into account the economic, social, and environmental costs and benefits" of the use of a chemical (Senate, adopting the imminent hazard standard under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136(l), ELR 41306). Like FIFRA, the Senate bill also includes as imminent hazards substances that threaten the survival of species listed as endangered under the Endangered Species Act, 16 U.S.C. § 1531 et seq., ELR 41825, but erroneously cites to P.L. 91-135, the 1969 version, rather than to P.L. 93-205, the Endangered Species Act of 1973.

11. Selected provisions in §§ 5 and 6. It is with respect to premarket screening that the bills differ most sharply. S. 3149 would empower the Administrator to issue immediately effective rules holding up the production of a new chemical beyond the initial 90-day period pending rulemaking leading to testing rules and completion of testing under § 4, or rulemaking leading to bans or restrictive rules on marketing under § 6. H.R. 14032 would essentially require the Administrator to obtain a district court injunction to ban production pending § rulemaking, and to be able to make rules listing new chemica s causing risks in order to keep them off the market pending § 4 testing. These different approaches are discussed in more detail infra, text accompanying notes 27 through 34.

12. Section 11.

13. Senate § 9; House §§ 6(c)(1) and 9. Here too the bills differ significantly. Both require the Administrator to investigate the feasibility of regulating the risks of a chemical under other laws administered by him and by other agencies. The Senate bill accords him wide discretion to choose whether to regulate under the TSCA or another authority. The House measure, on the other hand, establishes a preference for regulation under other laws. This difference in emphasis is discussed further, infra, text accompanying note 34.

14. Section 10. The Administrator must cooperate with the Secretary of Health, Education and Welfare and other agency heads to conduct research and monitoring, create an interagency committee to establish a data system to facilitate dissemination to other federal agencies of data submitted under the TSCA, and develop a toxicological data retrieval system.

15. Section 8(b). This exhaustive inventory, to be compiled roughly by mid-1977 (Senate) or October 1978 (House), establishes by exclusion the substances that are "new chemicals" for purposes of premarket screening under § 5. (The earlier date is unrealistic, since the TSCA cannot be funded until fiscal 1978, beginning October 1977. See note 49).

16. House § 6(c)(3); Senate § 6(c)(5). These provisions, applicable only to restrictive rule proceedings, authorize the Administrator to promulgate rules providing for reasonable attorneys' and witness' fees to persons otherwise unable to participate effectively who represent interests that are necessary for a fair determination of issues and that would otherwise not be adequately represented.

17. Section 21. As discussed later, text accompanying notes 35 and 36, the bills differ substantially over the scope of this provision. The Senate version authorizes persons to petition the Administrator only to commence proceedings to issue protective rules or other actions aimed at protecting against the risks of chemicals. The House would broaden this to allow petitions to amend or repeal protective rules as well. Both bills provide for de novo district court review of inaction or refusal to grant petitions by the Administrator.

18. Section 19. Regulatory rules, with certain exceptions, would be reviewed in the courts of appeals under the substantial evidence test. If the administrative record appears inadequate, the court may remand the case to the Administrator for additional proceedings and findings. The potential problems posed by this standard in the context of risk-based regulatory rulemaking by the Administrator are discussed infra, text accompanying note 25 et seq.

19. Section 20. Generally suits lie in district court to challenge the Administrator's failure to perform nondiscretionary duties under the TSCA, and any person's violation of the act or regulatory rules under it.

20. Section 18. The bills selectively preempt state laws as regulatory rules under the TSCA come into effect.

21. Section 14. Both bills focus mainly on the "trade secret" exemption in the Freedom of information Act, 5 U.S.C. § 552(b)(4), ELR 41016, in determining what information need not be disclosed, but the House version makes nondisclosure mandatory, with violations punishable as a crime, while the Senate, following the Freedom of Information Act, permits but does not require nondisclosure. Scattered provisions in other sections, e.g., House § 5(b)(2), guarantee disclosure of premarket notice information, test data, and other information on chemical risks, subject to § 14. At several points, the Senate bill goes beyond the House measure to require Federal Register publication of information rather than simply public availability.

22. Section 23. The Secretary of Labor is responsible for administering this provision, which authorizes anyemployee who believes that he has been fired or otherwise discriminated against because he assisted in the enforcement of the TSCA to seek reinstatement or compensation.

23. Section 12. Regulated chemicals may be exported, but the Administrator is to forward to importing countries the risk information on which he based his decision to regulate domestic commerce in them.

24. Section 13. Imported chemicals are fully subject to the TSCA.

25. Section 4(a)(1)(A)(i). Section 4 of both bills also authorizes the Administrator to require testing of chemicals produced or to be produced in large volume, irrespective of risk.

26. Section 6(a).

27. See, e.g., H.L.A. Hart & A. Honore, Causation in the Law 58-64 (1959); Gelpe & Tarlock, The Uses of Scientific Information in Environmental Decisionmaking, 48 So. Cal. L. Rev. 371, 373-74 (1974); Note, Imminent Irreparable Injury, 45 So. Cal. L. Rev. 1025 (1972). For an example of judicial hostility to future-directed, risk-based administrative action, see Ethyl Corp. v. EPA, 5 ELR 20096 (D.C. Cir.), vacated and set for rehearing en banc, 5 ELR 20450 (D.C. Cir. 1975), reversed en banc, 6 ELR 20267 (D.C. Cir. 1976) (5 to 4), cert. denied, 44 U.S.L.W. 3715 (June 14, 1976), discussed in Comment, Precautionary Controls: D.C. Circuit Upholds EPA's Phase Down of Gasoline Lead Additives in the Interest of Public Health, 6 ELR 10100 (May 1976).

28. Section 21, discussed in more detail infra, text following note 40. Under § 21, anyone may petition the Administrator to commence proceedings to repeal a restrictive or testing rule. Should he refuse or fail to respond, the petitioner may challenge his action in district court.

29. See note 30 infra.

30. Standard animal cancer tests, using mice or rats, generally take from 2 to 3 years to complete. National Academy of Sciences, Principles for Evaluating Chemicals in the Environment 150 (1975). Although extrapolation of such animal test results to humans has been attacked, recent judicial decisions generally have accepted extrapolation "from mice to men." E.g., Synthetic Organic Chemical Manufacturing Ass'n v. Brennan, 503 F.2d 1155, 1160-61 (3d Cir. 1974) (under Occupational Safety and Health Act); Environmental Defense Fund v. EPA, 510 F.2d 1292, 1298-99, 5 ELR 20243 (D.C. Cir. 1975) (under FIFRA).

The problem would be considerably eased by adoption of a series of test tube (in vitro) tests, currently under development, that promise reliable mutagenicity and carcinogenicity screening within a week or two. See National Academy of Science, Principles for Evaluating Chemicals in the Environment 144-50 (1974). Although still somewhat controversial, the new bacterial screening tests are beginning to be employed by the chemical industry, presumably to screen products in the process of development. Kolata, Chemical Carcinogens: Industry Adopts Controversial "Quick" Tests, 192 Science 1215 (June 18, 1976). An interagency committee in the Department of Health, Education and Welfare is nearing completion of an evaluation of the new tests. Whether and to what extent in vitro tests will stand up in court remains to be seen.

31. In addition to the mechanisms discussed in text, each bill authorizes the Administrator to make one 90-day extension of the premarket period, for good cause shown. Senate § 5(d); House § 5(f).

32. Section 5(e)(1).

33. Section 5(e)(2).

34. Section 5(d)(1).

35. Section 5(e).

37. Section 5(d)(1)(A).

38. Section 6(d)(2)(A).

39. Section 5(i)(1)(A).

40. Section 5(i)(3). This also means that § 5(i) rulemaking is likely to prove unduly time consuming given the strict constraints of the premarket review period.

41. Both bills exclude drugs, food additives and pesticides from their scope. Section 3.

42. See Comment, Federal Toxics Controls: The Patchwork Attack on PCB's, 6 ELR 10056 (Mar. 1976).

43. For example, it is now estimated that from one to ten percent of synthetic organic chemicals, the annual production of which has expanded 255 percent in the last decade, cause cancer in humans. Council on Environmental Quality, Sixth Annual Report 23, 32 (1975). Typically, however, cancer does not appear immediately after exposure to a chemical. Rather, there is a latency period of roughly 15 to 40 years (depending mainly on extent and concentration of exposure). W. C. Hueper, Medicolegal Considerations of Occupational and Non-occupational Environmental Cancers 437, in C. Frankel (ed.), Lawyer's Medical Encyclopedia (1976). The situation is even more difficult respecting mutagens, whose serious effects may not become apparent until generations have passed. See S. Epstein & M. Legator, The Mutagenicity of Pesticides: Concepts and Evaluation 6-7 (1971); Council of the Environmental Mutagen Society, Environmental Mutagenic Hazards, 187 Science 503 (1975) (panel of scientists recommends prescreening of all chemicals for mutagenicity due to serious but presently unobservable risks of long-range harm).

44. See note 3 supra.

45. Id.

46. See note 43 supra.

47. See text accompanying note 42 supra.

48. See note 30 supra. In light of this situation, Rep. Maguire's June 9 markup amendment encouraging HEW funding of projects to perfect quick and efficient test methods gains practical significance.

49. See Culliton, Clinical Labs: Bills Aimed at Correcting "Massive" Problems, 192 Science 531 (May 7, 1976).

50. Because the House bill did not clear committee by May 15, it is barred from funding in fiscal 1977 by reason of the Congressional Budget and Impoundment Control Act of 1974, 31 U.S.C. § 1301 et seq.


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