Recombinant DNA Research: Legislative and Legal Issues

An emotional debate, heretofore waged in scientific journals¹ and university communities, has now moved to congressional hearing rooms. The debate concerns the potentially beneficial but perhaps hazardous technique of recombinant deoxyribonucleic acid (DNA) research, in which DNA molecules — the genetic material of every cell that transmits an organism's hereditary characteristics — are chemically cut and then recombined into new molecules. This technique has been both touted as man's most important scientific discovery and vilified as a hideous prologue to a Brave New World through "genetic engineering."

Benefits and Risks

Recombinant DNA research entails benefits and risks which may be classified in three broad categories — basic research, therapeutic applications, and plant and animal species alterations.² In the basic research area, recombinant DNA research may foster greater knowledge of the workings of genes and evolution in general. But the research's detractors argue that it is impossible to quantify the benefits of altering the gene pool and the risks of the "awesome irreversibility of what is being contemplated."³

As to therapeutic matters, knowledge of cell mechanics may speed cures for cancer and virulent microbial and viral diseases. Yet these experiments are being conducted with a microorganism, Escherichia coli or E. coli, that is a ubiquitous inhabitant of the human gastrointestinal tract and a contributor to some human diseases. Thus, current recombinant DNA research poses inherent risks of human infection if an altered E. coli is released into the environment. Also, recombinant molecules may show — as some viral diseases have proven — unexpected resistance to antibiotics.

Species hybridization, the third risk-benefit category, is hardly less dramatic. Possible benefits include plant conversion of atmospheric nitrogen, thus eliminating the need for fertilizer; increasing photosynthesis efficiency; and use of microorganisms to "eat" oil and chemical spills. Some of these benefits may be obtainable from classic methods of plant and animal hybridization, however, and wide use of novel microorganisms may lead to disease or ecological havoc in the absence of full information regarding the properties of such organisms.

A Short Chronology

Following expressions of concern in 1973 by some members of the scientific community regarding these possible hazards of recombinant DNA research, an international conference of researchers met in Asilomar, California in February 1975.Out of this conference came a set of guidelines⁴ that scientists voluntarily accepted to govern research in this area. These guidelines formed the basis for further work by the National Institutes of Health (NIH) and its DNA Recombinant Molecule Advisory Committee, which culminated in the issuance of NIH guidelines in July 1976⁵ followed by the publication of an environmental impact statement pursuant to the National Environmental Policy Act (NEPA) in September 1976.⁶

The NIH guidelines, which do not have the force of regulations and apply only to research funded by NIH, prohibit experiments involving recombinant DNA of certain pathogens and toxins and deliberate release into the environment of organisms containing a recombinant DNA molecule. They also establish comprehensive criteria for physical containment of recombinant DNA research activities, ranging from minimal facilities with no special engineering design (P1) to highly safe and physically isolated facilities that incorporate negative air pressure and personnel cleanliness procedures to prevent the escape of hazardous organisms (P4). In addition, the guidelines specify that "biological containment" of recombinant DNA research must be accomplished through use of weakened strains of E. coli that have reduced chances of survival outside the laboratory environment.

Most recently, a forum held at the National Academy of Sciences on March 7-9, 1977 brought together scientists for more debate, and congressional hearings⁷ have undertaken an investigation of the issues raised by the NIH guidelines and subsequent reaction, including several bills. Consensus has nearly been reached that some form of federal legislation ultimately will control recombinant DNA research. The crucial questions now are the scope and stringency of that legislation and to what degree Congress will involve itself directly in overseeing this research. Although some may feel that the fate of "free scientific inquiry" hangs in the balance, even a less apocalyptic viewpoint reveals that any legislation will stretch the limits of legal regulation. Traditionally, the law has dealt with certainty. Yet [7 ELR 10080] regulation of recombinant DNA involves double uncertainty — the precautionary regulation of hypothetical risks. Risk analysis is a new concept in the law⁸ and will meet its hardest test in the recombinant DNA area.

Perhaps more important from a public policy standpoint is the issue of public participation. It may not be sufficient merely to grant bare regulatory authority to a federal agency when ecosystem integrity may be at stake. For instance, early public involvement and scrutiny might well have mitigated the current environmental threats posed by nuclear waste disposal, pesticide residues, and contamination by PCB's and other potential carcinogens. This perspective must be considered when evaluating current congressional proposals, as must the fact that the best system of regulatory authority is moot once the containment system is breached by a recombinant DNA molecule, and mistakes cannot help but occur.⁹

Present Federal Authority and Current Proposals

Current congressional proposals are based on the assumption that the scope of existing legislation does not include regulation of all types of recombinant DNA research. No serious question exists that the federal government has the power under the Commerce Clause to regulate such activities. The conclusion of a recently issued interagency committee report¹⁰ is that present federal laws, while applicable to portions of DNA research, do not individually or collectively cover the entire range of recombinant DNA research. For instance, the Occupational Safety and Health Act¹¹ requires employers to furnish workplaces that are safe from "recognized hazards,"¹² but exempts states and their political subdivisions from the definition of "employer." Also, the Act would reach neither self-employed researchers nor recombinant DNA activities that do not necessarily present a "recognized hazard."

Similarly, the recently-enacted Toxic Substances Control Act (TSCA)¹³ exempts manfacture of chemical substances for purposes of "scientific experimentation or analysis" from regulation by the Environmental Protection Agency (EPA).¹⁴ In any event, EPA can regulate recombinant DNA research only if it finds that such research presents an "unreasonable risk of injury to health or the environment."¹⁵

Another partial regulatory scheme is provided by § 361 of the Public Health Services Act, which authorizes the Secretary of the Department of Health, Education and Welfare (HEW) to prevent the spread of communicable diseases.¹⁶ This authority was the basis for a petition filed by the Natural Resources Defense Council and the Environmental Defense Fund in November 1976 seeking direct HEW regulation of recombinant DNA activities.¹⁷ Nonetheless, before HEW could use § 361 for comprehensive regulation, it must reasonably conclude that the products of recombinant DNA research may cause human disease, a conclusion that is arguable.

Current proposals for comprehensive federal regulations all delegate authority to HEW to promulgate guidelines to control recombinant DNA activities, either by adopting the current NIH guidelines or by promulgating new regulations, which presumably would incorporate the current guidelines. The bills require licensing of recombinant DNA facilities and authorize inspection by HEW and penalties for violations. One set of proposals, though, would legislate the NIH guidelines and then set up a study commission to probe the effects of DNA research.¹⁸ Another approach, taken by the Administration's proposal arising out of the interagency committee report¹⁹ would require HEW to promulgate guidelines and use the NIH guidelines as interim regulations. A variant would impose strict liability without fault for injuries caused by recombinant DNA research.²⁰ Other differences among the bills include treatment of patent rights and the scope of their preemptive authority, issues that will be discussed below. The Administration's bill will be the focus of legislative work since it is the latest and most comprehensive proposal.

Preemption

Some scientists feel that the federal government should totally preempt the filed of recombinant DNA activities, fearing that a patchwork of local controls will hinder scientific inquiry. The seriousness of the research warrants federal — or even international — controls, but it is at the same time not clear that local and state policy makers and publics ought to be shut out from any say over whether recombinant DNA activities take place in their communities. The problems have been extensively aired already in several communities; a Cambridge, Massachusetts citizens' board was able to educate itself about DNA research and vote intelligently on controls.²¹ Also, some states, including New York and California, are actively considering regulation of DNA research.²² [7 ELR 10081] The mere fact that these efforts are underway does not necessitate the absence of federal preemption, but it does indicate that enough interest exists at the sub-federal level to warrant involvement of these decisionmakers.

S. 1217, the Administration bill, would preempt local control over DNA research. In a curiously drafted passage, however, the bill requires the HEW Secretary to exempt local control from the bill's preemptive effect if "he determines that the [local] requirement is, and will be administered so as to be, as stringent as, or more stringent than, a requirement under this Act."²³ This provision, unlike many anti-preemption statutory schemes, would require not only local legislative action in order for a local government to qualify but also that a local administrative structure be established and working before federal control would abate. Preemption would thus depend on the actual effects of local administration rather than prospective promises of local capabilities. This type of measure is well suited to the gravity of DNA research controls.

NEPA Issues

As mentioned above, NIH issued a draft environmental impact statement after its promulgation of the guidelines. It gave as a reason the urgency of issuing the guidelines to fill the regulatory vacuum concerning DNA research and the possibility of harm to the public health in the absence of guidelines.²⁴ Apart from the obvious criticism that industrial research — and possible hazards therefrom — was not and is not controlled by the NIH guidelines, the impact statement has been criticized as "totally inadequate."²⁵ Certainly NEPA's purposes of public disclosure, comment, and participation were subverted by the timing of the statement's release. This fact is especially serious because recombinant DNA research presents a paradigm situation in which extensive public involvement through the NEPA process would be called for prior to federal action.²⁶

There is a more disturbing aspect of the NIH impact statement. Section 4(a)(1) of S. 1217 would require HEW to promulgate the NIH guidelines as interim regulations and simultaneously exempt this promulgation from NEPA. Although NEPA appears to apply to further HEW promulgations of final and supplementary regulations under S. 1217, the risk arises that public involvement might be finessed at the outset when it is most useful and can have the most effect.

Patents and Proprietary Rights

The need for public involvement in recombinant DNA decisions comes up hard against the entrenched American tradition of protecting private proprietary rights in new inventions through the patent process. Several events have increased the seriousness of this issue. Two California researchers have applied for a patent on commercial uses of gene-splicing technique that would require commercial users to comply with the NIH guidelines.²⁷ Possibly in response to this and to mounting public concern, the Commerce Department's Patent and Trademark Office in January issued a ruling according "special" expedited status to patent applications involving recombinant DNA.²⁸ The announcement required a statement of compliance with the NIH guidelines but undercut this requirement by allowing exemptions for deviations "considered essential to avoid disclosure of proprietary information or loss of patent rights." In effect, this announcement substantiated the inapplicability of the NIH guidelines to private research involving recombinant DNA. Following congressional criticism of this ruling,²⁹ the Patent Office suspended its effect on March 9 except for research safety patents³⁰ although the Office explained that the retraction was to allow further federal interagency study of the private sector research.

Congressional proposals treat the patent issue differently. The Bumpers-Ottinger bills, S. 621-H.R. 3191, would prohibit patents on recombinant DNA research without compliance with the NIH guidelines and complete disclosure. In other words, these bills would defeat any private proprietary rights. The Administration bill, on the other hand, by not mentioning proprietary rights, accepts the interagency committee recommendation that patent rights be protected. While the Administration bill requires records to be kept by recombinant DNA research facilities and to be made available for government inspection, presumably exemption 4 of the Freedom of Information Act³¹ would protect this information from disclosure. Considering the seriousness to the scientific community of "covering up" matters involving what in the public's mind may be perceived as "genetic engineering," the Administration's bill is an insufficient approach. The principles of free scientific inquiry at the research level would apply equally well at the application level where the potential hazards of nondisclosure are manifest. Recombinant DNA provides an obvious situation in which public and ecosystem rights take precedence over commercial gain.

Liability Issues

As with other ubiquitous ultrahazardous activities, such as nuclear energy, the question of tort liability has arisen regarding recombinant DNA activities. Nuclear energy production, of course, is protected in part by the Price-Anderson Act,³² which places an upper limit on the total liability from any one nuclear accident should it occur. Without this mechanism, it is doubtful that the private insurance sector would insure nuclear power generation and similar fears exist that the private sector [7 ELR 10082] cannot afford to insure recombinant DNA research.³³

This fear seems to be well-grounded in view of the Bumpers-Ottinger bills, which impose strict liability "without regard to fault, for all injury to persons or property" caused by recombinant DNA activities.³⁴ This is a stringent standard, but tort claims under it would still necessarily involve all of the most troublesome problems relating to massive damage actions: designation of the class of injured persons, proof of damage, proof of causation, proximate cause, apportionment of award, and allocation of joint or vicarious liability. The Administration's bill does not solve these problems; it merely ignores them. The bill undoubtedly reflects the interagency committee's view that tort problems should be left to state law.³⁵ Nevertheless, the bill might provide a defense to tort suits by its definition in § 18 of "hazardous recombinant DNA." The definition states that such DNA must either (A) pose a "significant risk to health or environment" or (B) be located in an unlicensed facility or will be transported in an unlicensed manner and "is not known not to pose a significant risk to health or the environment." By reverse implication, nonhazardous DNA would then be that which does not pose a significant risk or is in a licensed facility, although the factual basis for this statement is tenuous at best. A licensed defendant in a tort suit could claim that the license indicates that his activity was not "hazardous" within the statutory definition and, therefore, should be judged under a lesser standard of, perhaps, negligence. Detailed congressional consideration of the liability issue is therefore needed, not only in terms of standards of care but also in terms of actors and damages.

Conclusion

Federal legislation regulating recombinant DNA activities will likely take final shape very soon. Yet much debate and discussion must still take place. Indeed, deliberations at the international level are a next step.³⁶ Congress should not, however, in its rush to control DNA research, ignore available tools, such as NEPA, for fostering public participation. The risks of nonregulation are too great to be ignored and may present Congress with a troublesome problem in fashioning appropriate legislation.

1. Compare Chargaff, On the Dangers of Genetic Meddling, 192 SCIENCE 938 (June 4, 1976) with Cohen, Recombinant DNA: Fact and Fiction, 195 SCIENCE 654 (Feb. 18, 1977). See also 196 SCIENCE NO. 4286 (Apr. 8, 1977), which devotes an entire issue to recombinant DNA research.

2. See generally Subcommittee on Science, Research and Technology of the House Committee on Science and Technology, Genetic Engineering, Human Genetics, and Cell Biology: DNA Recombinant Molecule Research (Supplemental Report II) 32-42 (1976).

3. Chargaff, supra note 1, at 938.

4. Berg, Baltimore, Brenner, Roblin & Singer, Summary Statement of the Asilomar Conference on Recombinant DNA Molecules, 72 PROC. NAT'L ACADEMY OF SCIENCES USA 1981 (1975).

5. 41 FED. REG. 27902 (July 7, 1976).

6. National Institutes of Health, Draft Environmental Impact Statement: Guidelines for Research Involving Recombinant DNA Molecules (Aug. 19, 1976), ELR Order No. 61263D, reprinted in 41 FED. REG. 38426 (Sept. 9, 1976).

7. Before the House Subcommittee on Health and the Environment (Mar. 15-17, 1977) and before the Subcommittee on Health and Scientific Research of the Senate Committee on Human Resources (Apr. 6, 1977).

8. See generally Krause, Environmental Carcinogenesis: Regulation on the Frontiers of Science, 7 ENV. L. 83 (1976). See also Ethyl Corp. v. EPA, 541 F.2d 1, 6 ELR 20267 (D.C. Cir. 1976); 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).

9. Wade, Dicing With Nature: Three Narrow Escapes, 195 SCIENCE 378 (Mar. 15, 1977).

10. Interim Report on the Federal Interagency Committee on Recombinant DNA Research: Suggested Elements for Legislation (Mar. 15, 1977).

11. 29 U.S.C. § 651 et seq.

12. 29 U.S.C. § 654.

13. 15 U.S.C. §§ 2601-2629, ELR 41335.

14. Section 5(h)(3)(A), 15 U.S.C. § 2604(h)(3)(A), ELR 41341.

15. Section 6(a), 15 U.S.C. § 2605(a), ELR 41341.

16. 42 U.S.C. § 264.

17. Petition of Environmental Defense Fund, Inc. and Natural Resources Defense Council, Inc. to the Secretary of Health, Education and Welfare to Hold Hearings and Promulgate Regulations Under the Public Health Service Act Governing Recombinant DNA Activities (HEW, filed Nov. 11, 1976), ELR Doc. [486], ELR 65410.

18. S. 945, H.R. 4232, 95th Cong., 1st Sess. (1977).

19. S. 1217, 95th Cong., 1st Sess. (1977), reprinted at 123 CONG. REC. S5335 (daily ed. Apr. 1, 1977).

20. S. 621, H.R. 3191, 95th Cong., 1st Sess. (1977), reprinted at 123 CONG. REC. s2274 (daily ed. Feb. 4, 1977).

21. Wade, Gene-Splicing: Cambridge Citizens OK Research but Want More Safety, 195 SCIENCE 268 (Feb. 21, 1977).

22. Wade, Gene-Splicing: At Grass-Roots Level a Hundred Flowers Bloom, 195 SCIENCE 558 (Feb. 11, 1977).

23. S. 1217 § 10(b), 95th Cong., 1st Sess. (1977).

24. Report, supra note 2, at 32.

25. Testimony of Friends of the Earth Before the Subcommittee on Health and Scientific Research of the Senate Committee onHuman Resources 5 (Apr. 6, 1977).

26. See Parenteau & Catz, Public Assessment of Biological Technologies: Can NEPA Answer the Challenge?, 64 GEO. L.J. 679 (1976).

27. Wade, supra note 22, at 559.

28. 42 FED. REG. 2712 (Jan. 13, 1977).

29. 123 CONG. REC. S2274 (daily ed. Feb. 4, 1977) (remarks of Sen. Bumpers).

30. 42 FED. REG. 13147 (Mar. 9, 1977).

31. 5 U.S.C. § 552(b)(4), ELR 41016.

32. 42 U.S.C. § 2210.

33. Recombinant DNA Research: The "Achilles Heel" of the Insurance Companies (A. Carstens & L. Denike, eds. 1977).

34. S. 621 § 7, 95th Cong., 1st Sess. (1977).

35. Interim Report, supra note 10, at 20.

36. See Gardner, The Potential for Genetic Engineering: A Proposal for International Legal Control, 16 VA. J. INT'L L. 1 (1976).