13 ELR 10366 | Environmental Law Reporter | copyright © 1983 | All rights reserved

Biotechnology Released From the Lab: The Environmental Regulatory Framework

Editors' Summary: The biotechnology revolution has arrived, bringing the promise of great benefits in medicine, agriculture, and pollution control, but also the potential for serious harm from deliberate releases of new organisms into the environment. Already, federal agencies are assessing the need for regulation. The regulators must grapple with questions about the nature and magnitude of the risks of biotechnology, and about whether existing statutes or comprehensive genetic engineering control law is the best way to protect the environment from the new technologies. The authors describe the new directions in biotechnology and the potential for releases of man-made organisms into the environment. They agree that a regulatory scheme requiring expert risk analysis prior to releases, coupled with authority to control the conditions of the releases, is needed. The authors then review federal environmental statutes assessing their suitability for regulating the environmental impacts of living organisms. They conclude that a new statute is not needed if gaps in the coverage of existing statutes can be filled and the several federal agencies with fragments of necessary authority can coordinate their efforts.

Ms. McChesney received a J.D. from Northwestern School of Law of Lewis and Clark College, a B.S. in Genetics from University of California, Davis, and is now Associate Editor of the ENVIRONMENTAL LAW REPORTER. Mr. Adler received a J.D. from George Washington University National Law Center and is an attorney with Lowe, King, Price & Becker in Arlington, Virginia. He was formerly a biochemist at the National Cancer Institute and teaches classes in biotechnology law and policy at the NIH graduate school.

[13 ELR 10366]

Recent headlines from leading newspapers — "U.S. Approves Dissemination of Gene-Engineered Microbe,"¹ "NIH Weighing Plans to Release Altered Bacteria,"² "Giant Mice Grow From Rat Hormone Gene Transplant,"³ "The Test Tube Babies of Agriculture"⁴ — signal the early stages of a modern industrial revolution. The industry is biotechnology, which is based on techniques involving the alteration of an organism's basic genetic material (deoxyribonucleic acid or DNA),⁵ and other genetic engineering techniques, as well as millenniaold fermentation methods. We are now facing rapidly expanding commercialization and dissemination of biotechnological products.⁶ Like most revolutions, this one is full of promise, but also poses unique risks because it is reaching a stage where it is likely to affect the environment through the deliberate release of organisms.

Already the potential applications of the biotechnology industry are staggering. Not only do the techniques now in practice offer the possibility of curing genetically related diseases in humans and livestock, but offer efficient new methods for the fermentation industries (food processing, chemicals, and pharmaceuticals), agriculture (including both plant and animal breeding and growth and pest control), and the pollution control industries. The federal Office of Technology Assessment's (OTA's) list of possible applications includes the production of pharmaceuticals, such as hormones, vaccines, and antibiotics,; industrial chemicals, such as plastics, polymers, and pesticides; food products, such as sweeteners and enzymes; and microbes that degrade environmental pollutants and extract metals from ores.⁷ By the year 2000, products made through biotechnology may reach sales of $40 billion; by the end of the 1980s, sales of $6.5 billion are predicted for microbes used for pollution control.⁸

However, while the benefits of the new technologies are numerous and obvious, public criticism and concern are mounting.⁹ In the 1970s, some scientists proposed a moratorium on genetic engineering research because of concerns over the possibility of human exposure and resultant epidemics caused by the accidental release of novel pathogenic microorganisms from research labs.¹⁰ [13 ELR 10367] In response to the controversy, the National Institutes of Health (NIH) promulgated guidelines that prescribe safe containment practices for recombinant DNA research labs receiving federal funding.¹¹ Since then, the fears have largely subsided as scientists and the public, for the most part, appear to be satisfied that the risk of harm posed by the accidental release of microorganisms created through recombinant DNA techniques is minimal and acceptable.¹²

As concern over laboratory containment has waned, the environmental application and regulation of these techniques and their products has raised new worries.¹³ Unlike inanimate chemical substances widely familiar as environmental pollutants, biological products are living matter and may pose significantly different types of risk. Like existing pollutants, bioengineered products can exhibit acute toxicity, carcinogenicity, or other harmful environmental and health effects. In addition, however, they reproduce, multiply, and could compete effectively with existing species for resources such as nutrients or sunlight in their shared ecological niches. Moreover, biotechnological organisms may evolve through natural selection into organisms with unexpected characteristics. Thus, while a given organism might be harmless as released, it may exhibit or develop harmful characteristics after interaction with the residents of its host ecosystem, or after its numbers have increased.¹⁴

Critics of the new biotechnology industry are troubled by these uncertainties. For example, when NIH recently announced its precedential permit approval for the release into the environment of genetically engineered microbes intended to control freezing of plants, it was challenged in court.¹⁵ Another example is the "oil-eating" microbe of Diamond v. Chakrabarty¹⁶ fame, which represents a great advance in pollution control technology, but raises concerns that the widespread release of such "bugs" makes actual control of them difficult.¹⁷ There is, of course, no certainty that a microorganism will die out when its "preferred" or intended food supply is gone or that it will not display harmful traits undiscovered in the lab. Furthermore, recent advances in the genetic engineering technologies as applied to plants and animals are creating novel organisms with potential selective advantages in certain ecological niches.¹⁸

Given the concern about the ecological and human health effects of deliberate releases of the products of biotechnology, federal and state regulation are likely. While the magnitude of the risks to health and the environment posed by biotechnology and the likelihood of those risks occurring are unknown, the current crisis over hazardous byproducts of the post-war chemical revolution counsels a cautious aproach to this new technology. Already, NIH has established procedures for approving releases and the Environmental Protection Agency (EPA) has announced plans to study the need for regulation of biotechnology under the Toxic Substances Control Act (TSCA),¹⁹ which is designed to address the hazards to health and the environment from new chemical substances. The extremely diverse technology and its effects are not directly addressed in existing federal environmental statutes, but this broad body of law may already cover some aspects of the problem.

This article is an analysis of the extent to which present federal environmental statutes satisfy the requisites for effective regulation of deliberate releases of organisms created through biotechnology. The prospects are encouraging since some statutes, particularly several implemented by EPA and the Department of Agriculture (USDA), provide authority for a reasoned response to biotechnology — procedures for risk assessment and power to regulate uses and require cleanup of harmful releases to the environment. However, questions remain over whether the general authority of these statutes can be shaped into a workable, comprehensive system for protecting health and the environment. Newly created organisms do not ncessarily fit and definitions of substances regulated under existing pollution control statutes. Nor does EPA or USDA have the staff expertise in the new technologies and their effects necessary to fashion and implement reasonable and effective regulatory programs. If biotechnology continues to develop at its current pace and the environmental risks prove significant, fragments of current environmental programs may have to be melded into a comprehensive biotechnology control system, either through new legislation or the establishment of an interagency coordinating committee.

Deliberate Releases and Their Consequences

The deliberate release of genetically engineered microorganisms into the environment is expected to produce [13 ELR 10368] great benefits. Gene-spliced microorganisms may be used to degrade hazardous substances, recover minerals and oil, control agricultural pests, and protect plants from frost.²⁰ Genetically engineered plants are projected to have herbicide resistance and the ability to thrive in presently unfavorable regions such as saline soil or unfertilized fields.²¹ Insects and vertebrate animals have also been genetically engineered, but their uses are more speculative.²² All such organisms might also present risks of harm to the environment, in greater or lesser degrees, depending on their genetic modification and the target ecosystem. Most, however, will be benign.

The deliberate introduction of a biotechnological product into the environment may cause direct harm through acute toxicity or through pathogenicity or predation. A bioengineered organism, like familiar pollutants, may be inherently toxic to something else in the target ecosystem or it may form toxic products or byproducts.²³ Unlike inanimate chemical pollutants, however, biotechnological products also could produce a significant variety of indirect effects.

A genetically engineered organism may have been given new traits that give it a selective advantage in its target ecosystem and allows it to displace a desirable and natural analogous resident from its ecological niche.²⁴ Such organisms might harm other members of the escsystem by depleting available nutrients. For example, a bacterium released into a waterway to digest spilled oil could persist after consuming the spill. By feeding on hydrocarbon substances naturally present, the organism might flourish and could deprive the waterway of sufficient oxygen or other nutrients necessary to support the growth of sensitive insects, fish, or plants. The risks posed by bioengineered material could be exacerbated if the new organisms have no natural predator to keep them in check. Even though the risks could be eliminated by using conventional herbicides or pesticides to control proliferating man-made organisms, this solution poses its own all-too-familiar environmental risks.

The long-term fate of biotechnological products in the environment may differ from that of inanimate pollutants. Some pollutants degrade naturally in the environment into harmless substances or are safely buried in sediment layers of a riverbed. The same benign fate might befall bioengineered organisms. Other pollutants persist, building up in the food chain or in the natural environment. Genetically engineered organisms also might persist; living organisms are mobile and capable of migrating in response to food and weather conditions — not only to where winds or water currents carry them. Furthermore, living organisms reproduce and multiply, mutate, and through natural selection, evolve. These characteristics may expand their initial environmental harm, or produce new problems in the future.²⁵

The proposed deliberate release of a genetically recombined bacterium approved by the NIH Recombinant DNA Advisory Committee (RAC) illustrates the concerns over such releases.²⁶ The experiment is intended to replace with genetically engineered bacteria, wild-type bacteria that live on plants and trigger the formation of ice crystals at relatively high temperatures. The replacement organisms are nearly identical genetically to the wild-type but trigger ice formation at temperatures nine degrees lower.²⁷ Success in this use of biotechnology could have significant practical impact; the value of crops lost to frost has been estimated at up to $1 billion per year.²⁸

Widespread dissemination of "anti-freeze" bacteria could produce harmful outcomes as well, but the likelihood is impossible to estimate. The scientist to whom permission for the experiment was granted admitted that "it's hard to tell for sure" what effect on global weather might be caused by the presence of the modified organisms once carried into the upper atmosphere.²⁹ In fact, uncertainty about the risks of releasing genetically engineered material into the environment is the salient feature of the problem.

Much of the concern over releasing man-made organisms stems from experience with certain imported nonrecombinant organisms that have been released into new ecological systems in the United States.³⁰ The kudzu vine [13 ELR 10369] (used initially for erosion control in the southeastern United States) is now a widespread and uncontrolled pest weed. The starling is now an agricultural pest. Organisms such as the gypsy moth (imported for research purposes in the late 1800s) or the chestnut blight (which is nonpathobenic on its natural Asian host) and Dutch elm disease became very harmful in their new environments. The Acting Assistant Administrator at EPA's Office of Pesticide and Toxic Substances noted that "[u]nfortunately, we have no clue at this time whether similar events are probable with genetically-engineered microbes, nor how to estimate or minimize the risk if it does exist."³¹

It is not that we are without experience in applied uses of organisms such as microbes.³² Indeed, natural microorganisms have been used for centuries to produce foodstuffs and have been applied to ore deposits to leach valuable metals from low-grade ores. However, novel organisms having enhanced ability to serve environmental or agricultural functions through genetic engineering may also be imbued with enhanced abilities to survive and proliferate in nearby or related ecological niches. Their escape to such other areas may be inevitable and not readily susceptible to monitoring or containment.

Given the range of unknown effects stemming from the deliberate release into the environment of man-made organisms, "[t]he first step should be 'let's stay prudent.'"³³ The question is, does the incredibly complex and seemingly all-inclusive existing system of federal environmental laws provide the tools necessary for prudent evaluation and treatment of environmental releases of bioengineered organisms?

Federal Statutory Framework

To respond effectively to the environmental risks of biotechnology a regulatory scheme must have several basic attributes. It must apply to the creation, use, and release of living organisms — microorganisms, plants, and animals. The regulatory scheme must require the prior assessment of the risks of use and releases by a group with the expertise to understand those risks. It must provide the authority to block or regulate use of the products of bioengineering where necessary to protect public health and the environment. Biotechnology control law should include authority to clean up released materials that pose health or environmental threats, and perhaps, since the threats are hard to predict and may not be realized for decades, should include a mechanism to compensate for damages that cannot be abated.

A review of federal environmental law indicates that while there are gaps, there is substantial legal authority that might be applied to these critical points in the development and use of biotechnology. At present, there is limited regulation of deliberate releases of genetically engineered organisms. The NIH, largely by default, is the only federal agency regulating such uses. The NIH recombinant DNA research guidelines, established to provide safety standards for federal or federally funded laboratory research, prohibit deliberate releases without approval by NIH. The guidelines provide a somewhat informal system for assessing the risks of releases of all types of organisms by people with the necessary expertise in the biological sciences. The National Environmental Policy Act (NEPA)³⁴ may be useful because it sets up formal procedures for experts to consider the environmental impacts of all federal agency actions. Two statutes, TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),³⁵ require assessment of the risks of new chemicals prior to use and provide authority for prohibiting or regulating uses. The Federal Water Pollution Control Act (FWPCA),³⁶ the Resource Conservation and Recovery Act (RCRA),³⁷ and several pest-control statutes, including the Federal Plant Pest Act³⁸ and the Noxious Weed Act,³⁹ administered by USDA, provide authority that might be used to regulate releases of microorganisms, and in some cases, plants and invertebrate animals as well. Finally, the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)⁴⁰ provides authority to clean up released hazardous materials. The following sections of this article analyze each of the pieces of federal environmental law that appear applicable to biotechnology regulation, indicating whether their general purposes, applicability, and basic regulatory mechanisms are suitable for the new regulatory task. Each statute has distinct advantages and limitations in protecting public health and the environment from the risks of deliberate releases of the products of biotechnology.

* The NIH Guidelines. The NIH "Guidelines for Research [13 ELR 10370] Involving Recombinant DNA Molecules"⁴¹ were promulgated under the general powers and duties of the Public Health Service Act,⁴² and are administered by the Director of NIH⁴³ through the RAC.⁴⁴ The guidelines⁴⁵ apply to all recombinant DNA research in the United States conducted at or sponsored by an institution that receives support for recombinant DNA research from NIH⁴⁶ or from other federal agencies.⁴⁷ However, research by privately funded biotechnology firms is not covered by the guidelines.⁴⁸

The guidelines are applicable only to genetic engineering techniques that involve "molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell,"⁴⁹ i.e., recombinant DNA. Thus, organisms such as genetically engineered "oil eating" microorganism developed by Dr. Chakrabarty would not be covered by the guidelines.⁵⁰ Research involving the transfer of recombinant DNA to intact nonhuman vertebrates may be performed under appropriate containment levels,⁵¹ as well as transfer to other whole animals and plants.⁵²

The deliberate release into the environment of any organism containing recombinant DNA requires the approval of the institutional biosafety committee, the RAC, and NIH.⁵³ Certain plants, however, may be released upon approval granted by the Office of Recombinant DNA Activities (ORDA) in consultation with the RAC Plant Working Group without the requirement for full RAC review.⁵⁴ Those plants for which full RAC and NIH approval is not required are plant species that are "a cultivated crop of a genus that has no species known to be a noxious weed,"⁵⁵ and the introduced DNA consists "of well-characterized genes containing no sequences harmful to humans, animals, or plants";⁵⁶ the vector used to introduce the DNA satisfies certain criteria;⁵⁷ and the plants are "grown in controlled access fields under specified conditions" including containment to prevent "plants containing recombinant DNA from becoming established in the environment."⁵⁸

The guidelines note that "[p]rocedures for assessing alterations in and the spread of organisms containing recombinant DNA must be developed."⁵⁹ The Director of NIH is further charged with weighing each proposed action, through appropriate analysis and consultation, to determine that it complies with the guidelines and presents no significant risk to health or to the environment.⁶⁰ However, significantly, no standards are provided to determine levels of acceptable risk or for approving experiments. Although the guidelines are generally applicable to the production and release of organisms containing recombinant [13 ELR 10371] DNA, no emergency response or remedial actions are authorized by the guidelines. NIH has considered the deliberate release of genetically recombined organisms in three experiments,⁶¹ resulting in a court challenge.⁶²

A federal interagency advisory committee advises the Secretary of Health and Human Services and the Director of NIH on the coordination of all federal programs and activities relating to recombinant DNA research.⁶³ Some agencies, such as USDA, also have internal recombinant DNA advisory committees that serve, in part, as agency clearinghouses for recombinant DNA information. The USDA committee consults with the Plant Working Group of the RAC in connection with experiments involving deliberate releases.

The NIH guidelines are a useful, though limited, tool in ensuring the safety of biotechnology. Their principle strength is in requiring an expert assessment of the risks entailed in experiments and releases of gene-spliced organisms. However, they are of limited applicability since they have no mandatory effect on private actions and only cover recombinant DNA technologies. In addition, they provide no authority for action should a problem develop after release of a man-made organism.

* National Environmental Policy Act. The biotechnology industry is distinguished not only by the diversity of the contemplated production techniques and field uses, but by the degree of uncertainty concerning the environmental impacts of deliberate releases. While significant environmental impacts are not likely, at least from most uses now under consideration, no releases have occurred and there is no empirical evidence to support the appearance of safety or risk. NEPA is a good mechanism for analyzing proposed deliberate releases and their possible environmental impacts. NEPA requires agencies to make predictions about the full range of eventual consequences of proposed actions.⁶⁴ It requires agencies to fully consider and disclose to the public environmental impacts and uncertainties,⁶⁵ to speculate on all but highly remote consequences,⁶⁶ and to divulge competing scientific views.⁶⁷

Whether compliance with NEPA is required for projects involving the deliberate release of microorganisms, plants, or animals into the environment depends on the answer to a number of threshold questions. First, NEPA applies only to federal agencies. A number of federal agencies, including NIH,USDA, the Department of Energy, and the National Science Foundation, have responsibilities over biotechnology activities, either through funding, their own research efforts, or regulation.⁶⁸ NIH, which provides major funding for basis biotechnology research, although not the recently approved release experiment, has taken regulatory responsibility under its guidelines for approving deliberate release experiments.⁶⁹ However, much of the research, experimentation, and commercial use of products will be performed by private biotechnology companies, and NEPA does not apply to them.⁷⁰

Many of the federal agency activities involving biotechnology appear to be "federal actions" requiring compliance with NEPA. The agency must at the minimum conduct an environmental assessment of its actions to determine whether an environmental impact statement (EIS) is necessary. NIH prepared an EIS for its initial guidelines.⁷¹ And in 1983, the initial prohibition on releases was removed; NIH made a very significant change in those regulations by authorizing approval of deliberate releases. Such a change also is a deferal action requiring compliance with NEPA. In addition, both NIH's approval of deliberate releases and its, or other agency, funding of basic biotechnology research or release experiments are federal actions that require compliance with NEPA.

The more difficult question, which will likely require case-by-case determination, is whether these federal actions are environmentally significant. While NEPA applies to all federal agencies, the EIS requirement applies only to "major Federal actions significantly affecting the quality of the human environment."⁷² Federal actions include new and continuing activities, such as projects financed, conducted, regulated, or approved by federal agencies. And they include new or revised agency rules, regulations, plans, policies, and procedures.⁷³ Environmentally [13 ELR 10372] significant actions include those that are individually insignificant but cumulatively significant, are highly controversial, involve highly uncertain, unique, or unknown risks, as well as those that may establish a precedent for future actions with significant effects.⁷⁴

The deliberate release of products of biotechnology appears to meet many of these "significance" criteria, even where no environmental harm is certain. Testimony before the House Committee on Science and Technology suggested that the release of new organisms, for example a new plant species, might devastate an agronomically important species and need to be controlled by using herbicides. The release of microorganisms may be even more significant "since it is more difficult to recall or control microorganisms than plants."⁷⁵

In spite of the significant possible impacts of deliberate releases, NIH did not prepare an EIS when it changed its guidelines to allow such releases. Its failure to do so has been challenged in court.⁷⁶ Assuming these threshold questions are answered affirmatively and an EIS is required, the next question is, What must be included in the EIS? NEPA is an "environmental full disclosure law":

The "detailed statement" required by § 102(2)(C) should, at a minimum, contain such information as will alert the President, the Council on Environmental Quality, the public and, indeed, the Congress, to all known possible environmental consequences of proposed agency action.⁷⁷

Subsequent case law makes clear that agencies must also indicate the extent 10 which environmental effects are unknown or uncertain.⁷⁸ Thus, the fact that many of the environmental impacts of deliberate releases are unknown or uncertain does not preclude preparation of an EIS.And the fact that there is a difference of opinion among scientists about the potential environmental impacts of such releases does not change the requirement. EISs must also disclose the opposing views of experts on environmental impacts.⁷⁹

The Council on Environmental Quality's NEPA regulations have codified the case law by specifically requiring agencies to consider scientific uncertainty in their decisions. The "worst case" rule provides that where there is significant scientific uncertainty, each agency must perform a "worst case" analysis, i.e., an analysis of the environmental effects of a low probability/high risk action associated with the project and of the probability of the action, before it may proceed with the proposed action.⁸⁰

The worst case rule appears particularly applicable to deliberate releases of genetically engineered organisms. Substantial uncertainty exists over the environmental effects of a deliberate release. And while most experts agree that there is a low probability that a worst case would occur, the possible consequences may be serious.⁸¹ While not many courts have considered the need for a worst case analysis, at least one has ordered its preparation for an analogous environmental release — herbicide spraying where the effects are uncertain.⁸²

While NEPA could be a strong factor in assuring the safety of biotechnology releases, the earlier EIS may prove an Achilles heel. The EIS itself has been criticized.⁸³ If NIH wins the pending legal challenge to its [13 ELR 10373] failure to supplement the EIS before changing the guidelines to allow deliberate releases,⁸⁴ that EIS will be the foundation of the NEPA review of NIH recombinant DNA regulation. Indeed, one court rejected a NEPA challenge to an NIH experiment, ruling that the EIS for the guidelines satisfied NEPA for all research conducted pursuant to those guidelines.⁸⁵

While NEPA applies only to federal agency actions and has had a limited impact on recombinant DNA work to date, it appears well suited to biotechnology research regulation. NEPA provides an analytical framework for considering uncertainties before action. However, while NEPA sets out elaborate goals and purposes, for example, recognizing the impact of "new and expanding technological advances," it has been interpreted as a procedural and not a substantive statute. It requires agencies to consider environmental impacts, but does not require a specific decision or that actions be halted because of potential harm. Other statutes will have to carry the burden of protecting the environment from releases.

Regulation of Manufacture & Use of Substances

* Toxic Substances Control Act. Both EPA and commentators have suggested TSCA as a likely source of legal authority for monitoring and regulating the products of biotechnology.⁸⁶ It is specifically directed at commercial application of chemicals, and is not hampered by the media-oriented approach of some other statutes. While the statute appears appropriate for some aspects of such use, questions that may only be decided through litigation have been raised about whether it is broad enough in scope to apply to living organisms. In addition, the effectiveness of TSCA in forcing adequate preliminary testing of new chemicals' environmental and health effects is open to question.

TSCA was enacted in 1976 to establish federal regulatory authority to anticipate and prevent harm to human health and the environment from new chemical substances and mixtures. TSCA grants EPS broad authority to regulate the manufacture, processing, distribution in commerce, use, and disposal of chemicals. Under TSCA, EPA may require the testing of any chemical substance that "may present an unreasonable risk of injury to health or the environment,"⁸⁷ or where there are "insufficient data and experience" to determine the actual risk or effects on health or the environment.⁸⁸ EPA may also require testing if a chemical is likely to be produced and enter the environment in substantial quantities or result in human exposure.⁸⁹

Section 5 of TSCA authorizes EPA to evaluate the potential hazards of new chemicals before they are manufactured for commercial purposes.⁹⁰ Manufacturers must give EPA notice at least 90 days before the manufacture of a new chemical substance or the creation of a significant new use of a known chemical substance.⁹¹ Manfacturers are required to submit test data in their possession or control, descriptions of "known or reasonably ascertainable" test data, and "known or reasonably ascertainable" information on the chemical substance's identity, proposed uses, volume of production, by-products, work-place exposure, and manner of disposal.⁹² If EPA then has a reasonable basis to conclude that commerical use will present unreasonable risks it can regulatethe chemical. Potential EPA responses include prohibiting manufacture of the harmful chemical, limiting its use, or requiring that it be labeled.⁹³ While § 5 is potentially a tough regulatory provision, it has not been implemented in that fashion. EPA has not set minimum standards for the test data to be submitted through most manufacturers voluntarily conduct extensive tests or collect voluminous safety data, and EPA rarely has used its authority to restrict chemicals.⁹⁴

The key to determining whether TSCA would be effective in regulating commercial uses and intentional releases of organisms created through biotechnology lies in the statutory definitions. The question is whether recombinant DNA, or a genetically engineered organism, is a "chemical substance or mixture." Only chemical substances and mixtures are regulated under TSCA. Section 3(2)(A) defines the term "chemical substance" as

any organic or inorganic substance of a particular molecular identity, including —

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

(ii) any element or uncombined radical.⁹⁵

And the term "mixture" is defined as

any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction….⁹⁶

[13 ELR 10374]

Congress intended TSCA to have a wide impact. The legislative history reveals that Congress intended the term "chemical substances or mixtures" to be very inclusive, and attempts to limit the definition were not successful.⁹⁷ But neither the statute nor the legislative history specifically mentions living organisms. While bioengineered organisms include "organic and inorganic" substances, these terms do not usually encompass organisms. Further, the statute refers to substances of a "particular molecular identity," while the precise molecular structure of most biotechnology products will be unknown. It is likely that in 1976 Congress never considered the nascent biotechnology industry. Nevertheless, the tendency of the courts to construe the environmental statutes broadly in order to achieve their remedial purposes may allow extension of TSCA to biotechnology products.

EPA has taken the position that TSCA provides authority to regulate recombinant DNA organisms.⁹⁸ The EPA Office of Toxic Substances has concluded that DNA clearly fits the legal definition of a "chemical substance" under TSCA. Using genetic engineering techniques to change DNA results in recombinant DNA, a new chemical substance. Therefore, recombinant DNA is a new chemical substance subject to the requirements of § 5.⁹⁹ However, other genetic engineering techniques involve the insertion of a plasmid into a host bacterium, thereby producing novel organisms, but not changing the bacterial or plasmid DNA. Therefore, no discrete new chemical substance is actually made.¹⁰⁰ Such organisms may be regulated by EPA as "mixtures." By extension, plants and higher animals could also be mixtures.

If the definitional hurdle can be overcome, TSCA has several useful features for regulating the products of biotechnology. Its comprehensive data gathering provisions allow EPA to monitor production, use of, and exposure to chemical substances. The § 5 premanufacture notice provisions allow review of new chemical substances before they are put to widespread use. However, there also are limitations. The "unreasonable risk" standard is more stringent than some standards in other environmental statutes and is difficult to apply because it is general. EPA has little expertise or experience in genetic engineering and has not gone far in its implementation of TSCA, only enacted in 1976. Furthermore, TSCA only applies to chemical manufacturers and processors, and excludes pesticides, food, and food additives.¹⁰¹

* Federal Insecticide, Fungicide, and Rodenticide Act. Under FIFRA pesticide manufacturers must register pesticides with EPA before marketing them in interstate commerce.¹⁰² The manufacturer must submit data demonstrating a product's safety and efficacy prior to obtaining the registration. While the scope of FIFRA is narrower than TSCA, its review process is stronger, making it a useful possible model for biotechnology regulation.

A pesticide is defined as "any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest or intended for use as a plant regulator, defoliant or desicant."¹⁰³ Prior to 1979, EPA reviewed microorganism pesticides on an ad hoc basis and issued several registrations.¹⁰⁴ In 1979 EPA established an official policy to regulate living organisms intended for use as pesticides as defined in FIFRA.¹⁰⁵ It determined that such organisms are "biological control agents" and are "substances" subject to regulation.¹⁰⁶

EPA announced that some biotechnology products, particularly genetically engineered microorganisms, would be covered by this regulatory authority.¹⁰⁷ Generally, however, EAP recognized that both USDA and the Department of the Interior had regulatory jurisdiction over living organisms and, in deference to these agencies, exempted all living organisms from its oversight as pesticides except viruses, bacteria, protozoans, fungi, and certain unicellular plants.¹⁰⁸ Because FIFRA defines "pesticide" as a "substance," EPA regulation of living organisms [13 ELR 10375] under this statute may be subject to legal challenges and uncertainties similar to those raised by regulation under TSCA, although given the broad intent of the term, a court is likely to defer to the agency interpretation.

Any genetically engineered organisms to be regulated as "biorational pesticides" under FIFRA must be tested for several effects before a registration will be granted by EPA.¹⁰⁹ The data required primarily concern direct toxicity effects upon various animal species.¹¹⁰ However, the deliberate release of genetically engineered microorganisms may cause harm to an ecosystem's resident species through a variety of indirect effects; therefore, some ecologically damaging pesticide organisms might escape adequate testing if regulated under the present proposed FIFRA testing regulations because they do not cause direct toxic effects on test animals.¹¹¹

Regulation of Releases

* Federal Water Pollution Control Act. The FWPCA establishes a comprehensive water quality planning, sewage treatment construction, and water pollution regulation program designed to "restore and maintain the chemical, physical and biological integrity of the Nation's waters."¹¹² The regulatory programs of the FWPCA appear to provide mechanisms for reviewing and controlling certain environmental releases of bioengineered organisms. These programs are administered by EPA and the states.

The FWPCA prohibits the discharge of any "pollutant" through a "point source" to the surface waters of the United States without a national pollutant discharge elimination system (NPDES) permit.¹¹³ Whether the NPDES permit program applies to the use of biotechnology depends on whether the material involved qualifies as a pollutant,¹¹⁴ and whether it is placed in the nation's rivers, lakes, wetlands, or coastal waters in a manner qualifying as a point source discharge. There is little question that the products of biotechnology could qualify as pollutants under the FWPCA. The statute defines "pollutant" broadly and includes "biological materials" in the definition.¹¹⁵ Thus, it appears that EPA has authority to regulate point source discharges of biotechnology products. "Point source" also is defined broadly in the Act, including essentially any man-made "discernible, confined and discrete conveyance" from "pipes" to "discrete fissures" and all manner of floating craft.¹¹⁶ Thus, spraying bioengineered organisms on an oil spill appears to be a point source discharge, as is dumping waste bioengineered organisms directly or through some conduit into a river or other water body.

If an NPDES permit is required for an application of or discharge of biotechnological products, the applicant must satisfy several types of requirements. The permits are issued by EPA or by states that have been delegated the authority.¹¹⁷ None may be issued unless the state determines that the discharge will not result in violation of state water quality standards required by the FWPCA.¹¹⁸ The permit must require compliance with national effluent limitations promulgated by EPA for categories of industries, based on the effectiveness and cost of control technologies available for those industries. For industries for which EPA has not promulgated limitations, EPA will apply standards for an analogous industry or the permit writer must apply the statutory technology and cost analysis on an ad hoc basis, using the "best engineering judgment." The permit must also include monitoring and reporting requirements and may include a compliance scheduled and other requirements. Permits for discharge to the ocean must satisfy special ocean discharge criteria.¹¹⁹

The FWPCA regulatory framework is applicable to certain uses of biotechnology and it could be applied to some aspects of biotechnology pollution. The review of compliance with state water quality standards could be the most important step in the FWPCA process, although state water quality standards probably do not address all the potentially harmful effects of releases of biotechnology products. These standards do address one way in which such materials could coopt a particular ecological niche: by using up dissolved oxygen needed by other species. All states set minimum levels of dissolved oxygen for their waters. If the concern about a particular manmade organism was its toxic effects, state water quality standards also could be useful. States typically regulate concentrations of specific toxic substances, but also prohibit discharges of toxics "in amounts that will interfere with" uses specified for a given water body.¹²⁰ The ocean discharge criteria constitute federal water quality standards that also may be useful in regulating biotechnology. Congress intended that the disposal of pollutants be [13 ELR 10376] evaluated according to their effects, upon disposal, on the "transfer, concentration, and dispersal of pollutants or their by-products through biological, physical, and chemical processes" and that "changes in marine ecosystem diversity, productivity, and stability" be considered along with "species and community population changes."¹²¹ Such criteria appear to anticipate the types of indirect risks associated with the release of genetically engineered organisms.

The effluent limitations only cover a few living organisms (e.g., fecal coliform bacteria) or their effects (e.g., biological oxygen demand).¹²² If the impact of concern is oxygen demand, permit writers should have little difficulty finding appropriate effluent limits. If other ecological impacts are possible, there probably are no applicable standards in existing regulations.

* Federal Plant Pest Act. The Federal Plant Pest Act¹²³ was intended to "facilitate the regulation, control and eradication of plant pests," such as the imported South American fire ant, the soybean cyst nematode, and witchweed.¹²⁴ The Act forbids the import or interstate movement of any plant pest without authorization under a general or specific permit from the Secretary of Agriculture.¹²⁵

A "plant pest" is broadly defined as any living stage of any:

insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof, viruses, or any organisms similar to or allied with any of the foregoing, or any infectious substances, which can directly or indirectly injure or cause disease or damage in any plants or parts thereof, or any processed, manufactured, or other products of plants.¹²⁶

The definition includes insects and other nonvertebrate animals as well as microorganisms and parasitic plants and "similar" organisms. Not included within the definition of pest are vertebrate animals (i.e., mammals, fish, and birds) and nonparasitic plants. Thus, genetically engineered microorganisms of all kinds that might be used for direct field applications — for example, as insect pesticides or for infection of plants to provide nitrogen fixation — would be covered by this statute if they "can injure" plants.¹²⁷ A narrow reading of the "can injure" language would require a reasonable certainty that the regulated organisms are harmful to plants. This may limit applicability of the Act given the uncertainty surrounding the effects of bioengineered organisms.

The Federal Plant Pest Act does not apply to the production of genetically engineered organisms, but to their sale, transportation, and release. The Secretary is empowered to promulgate regulations "requiring inspection of products and articles" to prevent dissemination of plant pests.¹²⁸ In ruling on permit applications, the Secretary may consider the relative risks and benefits of the movement of a plant pest, and may deny an application when such movement would involve a danger of dissemination of the pest.¹²⁹ Such danger is deemed to exist when "the destructive potential of the plant pest … outweighs the probable benefits to be derived from the proposed movement and use of the pest."¹³⁰

The Department of Agriculture is authorized to stop and inspect articles, persons, and means of conveyance moving either interstate or intrastate, without a warrant, and to make any inspections and seizures necessary.¹³¹ The Act also provides emergency authority to "seize, quarantine, treat, apply other remedial measures to, destroy or otherwise dispose" of plant pests or infested articles when the Secretary determines than an "extraordinary emergency exists."¹³² Remedial action may be required of the owner of the goods or pests in question,¹³³ and such action is at the owner's expense unless it is established that the requirement for destruction or disposal was unauthorized;¹³⁴ however, the Secretary of Agriculture "may pay compensation to producers and other persons for economic losses incurred by them as a result of" emergency actions.¹³⁵

When reviewing a permit application, the Deputy Administrator may consult with any other federal officials, [13 ELR 10377] state officials, or "other qualified governmental or private research laboratory, institution, or individual."¹³⁶ Such a provision would be of great value to the Department in regulating the deliberate release of genetically engineered organisms, because such a program requires the interdisciplinary approach as adopted by NIH. Additionally, the Deputy Administrator is further authorized to "modify by makng less stringent the restrictions contained in any of such regulations" when existing conditions as to pest risk make such action safe.¹³⁷

The Federal Plant Pest Act is only a partial answer to the question of biotechnology regulation. It is of interest because it is generally applicable to the kinds of organisms involved in biotechnology and it directly addresses one of the likely categories of harm from such organisms. Its key limitations are that it addresses only one category of possible harm, injury to plants; it appears to require certainty that the organism is harmful (not a risk of harm); and it offers few remedies, primarily prohibition against sale, transportation, or releases.

* Federal Noxious Weed Act. The Federal Noxious Weed Act of 1974¹³⁸ was enacted to expand the federal response to noxious weeds beyond that prescribed by the Federal Plant Pest Act and other statutes.¹³⁹ This Act broadly sets forth congressional findings that the

importation or distribution in interstate commerce of noxious weeds, except under controlled conditions, allows the growth and spread of such weeds which interfere with navigation, cause disease, or have other adverse effects upon man or his environment and therefore is detrimental to the agriculture and commerce of the United States and to the public health.¹⁴⁰

The term "noxious weed" is defined in a manner that might provide the Secretary of Agriculture with broad regulatory authority over genetically engineered plants:

"Noxious weed" means any living stage (including but not limited to, seeds and reproductive parts) of any parasitic or other plant of a kind, or subdivision of a kind, which is of foreign origin, is new to or not widely prevalent in the United States, and can directly or indirectly injure crops, other useful plants, livestock, or poultry or other interests of agriculture, including irrigation, or navigation or fish or wildlife resources of the United States or the public health.¹⁴¹

This definition complements the coverage of the Federal Plant Pest Act, providing USDA with authority to regulate the environmental release of plant life that can harm plant or animal life or interfere with use of water resources.

Interstate movement of any noxious weed requires a permit from the Secretary of Agriculture,¹⁴² and the Act also applies to releases.¹⁴³ However, the production of genetically engineered organisms does not appear to be covered unless the production itself can distribute the weed in violation of the Act. The listing of a noxious weed by regulation does not require certainty as to its effects because the Secretary may act after a determination that the weed's "dissemination … may reasonably be expected to have to a serious degree, any effect specified."¹⁴⁴

The Secretary is authorized to conduct warrantless searches of persons, goods, and facilities in order to determine whether movement of noxious weeds is occurring without a permit.¹⁴⁵ Additionally, quarantines and other regulations requiring inspections may be established to prevent dissemination of noxious weeds.¹⁴⁶ Emergency response authority is also provided when action is "necessary as an emergency measure in order to prevent" dissemination.¹⁴⁷ The owner of such goods or facilities may be ordered to "treat, destroy, or make other disposal" of them "without cost to the Federal Government."¹⁴⁸

The Secretary is also authorized to cooperate with other governmental agencies (federal and state) and with farmers' associations and similar organizations to "eradicate, suppress, control, or prevent or retard the spread of any noxious weed."¹⁴⁹ However, in performing actions under this "cooperation" section of the statute, the cooperating state or other governmental agency is responsible for carrying out the operations or measures on nonfederally owned or controlled land. Such cooperation authority is not required for the permit, inspection, and emergency powers granted to the Secretary by the other provisions. The Noxious Weed Act is applicable to prevent or ameliorate harm to crops, livestock, navigation, fish, wildlife resources, and the public health through direct or indirect effects. Indeed, it might even be the basis for a comprehensive regulatory program. The Secretary might determine that all genetically engineered plants may be expected to have a serious effect, absent a contrary showing. Accordingly, the Secretary could by regulation prohibit the transport or release of such organisms until they had passed specified tests.¹⁵⁰

[13 ELR 10378]

* "Exotic Organisms" Executive Order. By an executive order (E.O.) entitled "Exotic Organisms,"¹⁵¹ President Carter extended to executive agencies the requirements of the Lacey Act¹⁵² and NEPA as they apply to the introduction of exotic species into natural ecosystems of the United States. The term "exotic species" is defined to mean "all species of plants and animals not naturally occurring either presently or historically, in any ecosystem of the United States."¹⁵³ The "introduction" of an exotic species means the "release, escape, or establishment" of such a species "into a natural ecosystem."¹⁵⁴ The E.O. applies to all species of plants and animals not naturally occurring and, thus, appears to include genetically engineered species, but may not include genetic modifications to plants or animals that fall short of creating a new species.¹⁵⁵

By this E.O., executive agencies are required to restrict the introduction of exotic species into the natural ecosystems on lands and waters that they own or administer.¹⁵⁶ Furthermore, executive agencies are required to restrict the introduction of exotic species into any natural ecosystem of the United States.¹⁵⁷ The E.O. does not apply to the introduction of exotic species that the Secretaries of Agriculture or the Interior find will not have an adverse effect on natural ecosystems.¹⁵⁸

Unlike the Federal Plant Pest Act and the Federal Noxious Weed Act, the Lacey Act does not concern the interstate shipment of harmful organisms but instead regulates the importation and release of various types of injurious life forms. The Secretary of the Interior could prohibit the importation of animals that are injurious, including those that may be genetically engineered in foreign areas. The E.O. instructs the Secretary of the Interior to consider the effects of exotic species on natural ecosystems when implementing the Lacey Act.

Regulation of Cleanup

* Comprehensive Environmental Response, Compensation, and Liability Act. CERCLA could prove to be an important source of legal authority if releases of products of biotechnology pose health or environmental threats warranting cleanup. CERCLA provides for the expeditious cleanup of "hazardous substances" released into the environment either by direct government "response"¹⁵⁹ or by private action forced by government litigation or financed by monies from a $1.6-billion Hazardous Substances Response Trust Fund.¹⁶⁰ CERCLA also can compensate federal or state governments for hazardous substance damage to natural resources under their control.¹⁶¹ Whether CERCLA applies to living organisms intentionally released into the environment turns essentially on whether these organisms pose a threat to human health or the environment.

The response and liability provisions of CERCLA are triggered when:

any hazardous substance is released or there is a substantial threat of such a release into the environment, or

there is a release or substantial threat of release into the environment of any pollutant or contaminant which may present an imminent and substantial danager to the public health or welfare ….¹⁶²

The Act first requires releases or threats of releases. The term "release" is extremely broadly defined as "any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing into the environment."¹⁶³ The definition is not limited to accidental releases and is easily broad enough to include methods used to release bioengineered organisms into the environment.

The second requirement for CERCLA coverage is releases or substantial threats of releases of "hazardous substances" or "pollutants or contaminants."¹⁶⁴ CERCLA's definition of "hazardous substances" incorporates hazardous and toxic substances regulated under other federal statutes and "elements, compounds, mixtures, solutions, and substances" designated under § 102 of CERCLA, which present "substantial danger to the public health or welfare or the environment."¹⁶⁵ "Pollutants and contaminants" is defined as "any element, substance, compound, or mixture, including disease-causing [13 ELR 10379] agents," that may cause "death, disease, behavioral abnormalities, cancer, genetic mutation, physiological malfunctions … or physical deformations" in any organism.¹⁶⁶

Whether products of biotechnology will qualify as "hazardous substances" or "pollutants" allowing clean-up under CERCLA is not certain. EPA could list as hazardous substances under § 102, organisms that threaten to disrupt existing ecosystems or to damage crops or other resources supporting the public welfare. Organisms that may be regulated under other statutes, such as TSCA, would be incorporated by reference. The fact that the Act focuses to a significant degree on toxic and disease-producing substances would seem to rule out most genetically engineered organisms to be deliberately released. There is little doubt that "pollutants" includes living organisms, although not all potentially dangerous bioengineered organisms are "disease causing agents," and plants and animals are not likely to be included. Whether the organism is labelled a hazardous substance or a pollutant makes a difference since EPA may only recover from liable parties expenditures from the Superfund for responses to hazardous substances, not pollutants.¹⁶⁷ Given that there is a limit to the fund, EPA is less likely to respond to pollutants than to hazardous substance releases. Another limitation to CERCLA is that it provides for cleaning up past pollution, while the critical problem at this stage of environmental regulation of biotechnology is accurately assessing the potential for harm from proposed releases and controlling the releases to avoid the harm.

Conclusion

The biotechnology revolution has arrived, bringing dramatic new approaches to human health protection, agriculture, food processing, industrial activities, and pollution control. While this revolution generates philosophical and ethical debates, it also raises practical concerns about uncertainties, particularly with regard to the deliberate environmental releases of genetically engineered organisms.

It is appropriate to consider "environmental biotechnology" as a diverse group of industries that create environmental risk at traditional technological junctures, e.g., production, dissemination,and use of products and cleanup of waste. The nascent biotechnology industry will be made up of numerous and diverse subindustries, such as pollution control, crop breeding, or pest management. Several genetic engineering techniques produce, or will produce, a variety of products for quite different purposes, and create risks that cannot be measured now, but that are certain to vary considerably in degree and type. Accordingly, it is too early to design an omnibus biotechnology environmental protection statute at this time.

The existing federal statutory framework appears to provide a reasonable starting point.¹⁶⁸ Several statutes provide the first prerequisites for controlling environmental impacts of biotechnology: jurisdiction over living organisms. Several statutes, though not necessarily the same ones, can address the ecological distruption that is likely to be the major environmental harm of biotechnology. Many existing regulatory schemes provide for the prior, expert assessment of risks of disseminating bioengineered organisms, although at present, most of the experts are found in NIH's RAC, made up primarily of recombinant DNA, microbiological, and genetics experts. TSCA, FIFRA, and NEPA are the primary sources of risk assessment authority. TSCA, FIFRA, FWPCA, and the Federal Plant Pest and Noxious Weed Acts provide authority to block or regulate use of the products of biotechnology in order to protect public health and the environment. Finally, CERCLA, TSCA, and the agricultural pest acts provide authority to clean up or otherwise respond to released materials that pose threats of environmental harm, and CERCLA might allow compensation for harms not prevented.

While a sharp-eyed observer can see the outlines of an effective biotechnology regulatory scheme in these statutes, the law and the institutional framework for implementing it leave something to be desired. None of the statutes are broad enough to address risks from all the types of living organisms that are likely to be bioengineered in coming years. Most notably, TSCA regulates chemical substances, and may therefore be limited to DNA molecules, not the organisms containing the DNA. The NIH guidelines concern only recombinant DNA research, excluding several other genetic engineering techniques. The Federal Plant Pest and Noxious Weed Acts cover microorganisms and plants, but exclude vertebrates, and these pest acts apply primarily to importation or interstate shipment, not to all intrastate activities.

There are also limits to jurisdiction and agency expertise. The necessary authority to regulate biotechnology is scattered across numerous statutes and an executive order. Neither the NIH Guidelines, the only existing regulatory system, nor NEPA apply to private organizations. Also, most of the agencies lack expertise concerning biotechnology. Moreover, even the experts have no accepted methodologies for evaluating the ecological safety of genetically engineered products, particularly with respect to indirect or competition effects. Even NIH, which has the most experience, has focused mainly on the laboratory containment of recombinant DNA products rather than their deliberate release — and the agency is not a regulatory agency. Furthermore, its RAC presently has no ecologist. The agencies are, however, taking steps to remedy some of these problems. EPA and USDA have established agency-wide working groups to study regulation and serve as clearinghouses for information on biotechnology.¹⁶⁹

At this stage in the development of biotechnology, considerable analysis by federal agencies and private industry should be directed toward determining whether or not there is a need for regulatory controls. If the technology represents environmentally significant risks, then new legislation to strengthen and coordinate existing authority and new programs to apply that authority to biotechnology [13 ELR 10380] will likely be needed. Development of expertise in the agencies is critical. It may be most appropriate to establish a lead agency to coordinate efforts to assess risks and the need for regulation. EPA appears best suited for such a role, since it is an environmental regulatory agency while other agencies have different primary purposes. But other agencies, for example, NIH and USDA, may have more expertise in certain areas and should play an active role. And the role of the Federal Interagency Advisory Committee on Recombinant DNA Research could be expanded to consider nonrecombinant genetic engineering techniques, and to develop a regulatory system applicable to privately funded research as well.

Given the undertainties about the environmental effects of biotechnology, a cautious approach to regulation seems most appropriate. Careful risk assessment, control of releases, and monitoring of impacts can help ensure that biotechnology produces no tragic environmental surprises.¹⁷⁰ And as with the NIH guidelines, if in the light of experience, it appears that regulation was overly restrictive, rules may be relaxed.¹⁷¹

1. Wash. Post, Sept. 16, 1983, at A1, col. 1.

2. Wash. Post, Sept. 20, 1983, at A1, col. 1.

3. 122 SCI. NEWS 389 (1982).

4. Wash. Post, Apr. 30, 1983, at A1, col. 1.

5. Recombinant DNA technology involves the transfer of genetic material from one organism into another that is then capable of reproduction in its new "recombined" form. Other genetic engineering methods include plasmid transfer, cell fusion, and in vitro fertilization. See OFFICE OF TECHNOLOGY ASSESSMENT, U.S. CONGRESS, IMPACTS OF APPLIED GENETICS: MICROORGANISMS, PLANTS, AND ANIMALS (1981) [hereinafter cited as OTA REPORT].

6. See OTA REPORT, supra note 5, and notes 1-4. See also, Symposium, Recombinant DNA Activities: International and Comparative Legal Ramifications, 12 U. TOL. L. REV. 803-958 (1981).

7. See OTA REPORT, supra note 5. See also 219 SCI. 609-746 (1983) Biotechnology issue); Demain & Solomon, Industrial Microbiology, SCI. AM., Sept. 1981, at 66 (Industrial Microbiology issue).

8. See OTA REPORT, supra note 5, at 7-17. See also H. Price, Remarks at ALI-ABA Conference, Industrial Applications of Genetic Engineering: The Legal and Regulatory Regime (Feb. 17, 1983); Russell, The Marketing of Genetic Science: The Tree of Knowledge Grows on Wall Street, AMICUS J., Summer 1983, at 4.

9. See Hearing on the Environmental Implications of Genetic Engineering Before the Subcomms. on Science, Research, and Technology and Investigations and Oversight of the House Comm. on Science and Technology, 98th Cong. 1st Sess. 98-78 (June 22, 1983) [hereinafter cited as Biotechnology Hearing]. See also ENV'T, July/Aug. 1982 (Biotechnology issue).

10. See generally Symposium, Biotechnology and the Law: Recombinant DNA and the Control of Scientific Research, 51 S. CAL. L. REV. 969 (1978); WATSON & TOOZE, THE DNA STORY (W.H. Freeman & Co. 1981) [hereinafter cited as THE DNA STORY]; KRIMSKY, GENETIC ALCHEMY (MIT Press 1982).

11. The current version of the guidelines are found at 48 Fed. Reg. 24556 (June 1, 1983). See infra text accompanying notes 41-63 for further discussion of the guidelines.

12. See, e.g., D. Stetten, Jr., "Valedictory By the Chairman of the NIH Recombinant DNA Molecule Program Advisory Committee," Remarks presented at the Apr. 28, 1978 meeting of the NIH Recombinant DNA Molecule Program Advisory Committee. Dr. Stetten suggested that the "encyclopedic guidelines" be replaced by a simple statement such as "the conditions of containment appropriate for any recombinant DNA experiment are those which are dictated by the most virulent or dangerous organism entering into that experiment" rather than the fact that recombinant DNA may be present. Document 12.6 in THE DNA STORY, supra note 10.

13. For further discussion, see infra text accompanying notes 20-33, and OTA REPORT, supra note 5.

14. See generally Biotechnology Hearing, supra note 9 (statement of Frances E. Sharples, Oak Ridge National Laboratory).

15. Foundation on Economic Trends v. Heckler, No. 83-2714, ELR PEND. LIT. 65799 (D.D.C., complaint filed Sept. 14, 1983). See also Fox & Norman, Agricultural Genetics Goes to Court, 221 SCI. 1355 (1983).

16. 447 U.S. 303 (1980).

17. See Krimsky, Social Responsibility in an Age of Synthetic Biology, ENV'T, July/Aug. 1982, at 2, 10. See also Biotechnology Hearing, supra note 9 (statement of Frances E. Sharples, Oak Ridge National Laboratory).

18. See generally 219 SCI. 609-746 (1983) (Biotechnology issue); Rogers, Gene Splicing Leaves the Lab, NEWSWEEK, Aug. 15, 1983, at 63; Hilts, The Test Tube Babies of Agriculture, Wash. Post., Apr. 30, 1983, at A1, col. 1; Giant Mice Grow From Rat Hormone Gene Transplant, 122 SCI. NEWS 389 (1982); OTA REPORT, supra note 5.

19. 15 U.S.C. §§ 2601-2629, ELR STAT. 41335. See EPA Asserts Authority to Regulate Bioengineering Byproducts Under TSCA, INSIDE E.P.A., July 1, 1983, at 1; OFFICE OF TOXIC SUBSTANCES, U.S. ENVIRONMENTAL PROTECTION AGENCY, TSCA PRIORITIES AND PROGRESS, (July 1983); Hilts, EPA Will Take Over Regulation of the Gene-Engineering Industry, Wash. Post, Aug. 9, 1983, at A5, col. 1. See also infra text accompanying notes 86-101 for a discussion of the applicability of TSCA to biotechnology.

20. See, e.g., OTA REPORT, supra note 5; Miller, Lingg & Bulla, Bacterial, Viral, and Fungal Insecticides, 219 SCI. 715 (1983) (Biotechnology issue); Vournakis & Elander, Genetic Manipulation of Antibiotic-Producing Microorganisms, 219 SCI. 703 (1983) (Biotechnology issue); Klibanov, Immobilized Enzymes and Cells as Practical Catalysts, 219 SCI. 722 (1983) (Biotechnology issue); Bacteria That Eat PCBs, CHEM. WEEK, Mar. 16, 1983, at 35.

21. See, e.g., Ream & Gordon, Crown Gall Disease and Prospects for Genetic Manipulation of Plants, 218 SCI. 854 (1982); Barton & Brill, Prospects in Plant Genetic Engineering, 219 SCI 671 (1983) (Biotechnology issue).

22. See, e.g., Mighty Mice — Gene Transfer Creates Giants, TIME, Dec. 27, 1982, at 79; Marx, Gene Transfer Into the Drosophila Germ Line, 218 SCI. 364 (1982).

23. See, e.g., the testing requirements for microbiological pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act discussed infra note 110.

24. S. REP. NO. 1313, 93d Cong., 2d Sess. (1974), accompanying the Federal Noxious Weed Act of 1974 (discussed infra at notes 138-150 and accompanying text) noted, for example, that weeds "compete with desirable economic plants for water, light, mineral nutrients, and other plant growth requirements, and reduce yields."

25. See Biotechnology Hearing, supra note 9 (statement of Frances E. Sharples, Oak Ridge National Laboratory). Congressman Albert Gore, Jr. stated:

Severe ecological damage has often resulted when new organisms are introduced into an environment to which they are not native. Today, through genetic enegineering, scientists are creating innumerable exotic organisms that will eventually be released into the environment. While there are certainly benefits to be reaped from this technology, I am concerned that we have a proper understanding of all potential environmental ramifications before a genetically novel organism is released, rather than having to learn about them after the damage has occurred.

Press release of the Committee on Science and Technology, U.S. House of Representatives, June 17, 1983 (emphasis in original).

26. 48 Fed. Reg. 9436 (1983). Notice of an RAC meeting to consider a request by Drs. Panopoulos and Lindow to release genetically recombined bacteria, 48 Fed. Reg. 9441 (1983); release approved, 48 Fed. Reg. 24552 (1983). See also 48 Fed. Reg. 37198 for a notice of an RAC meeting to consider requests to field test another recombinant microorganism and a genetically engineered plant.

27. See Biotechnology Hearing, supra note 9 (statement of Steven E. Lindow, Department of Plant Pathology, University of California, Berkeley).

28. Rogers, Gene Splicing Leaves the Lab, NEWSWEEK, Aug. 15, 1983, at 63.

29. Id.

30. See, for example, S. REP. NO. 1313, supra note 24, "Most pest weeds presently in the United States and causing losses were originally of foreign origin." See also SHARPLES, SPREAD OF ORGANISMS WITH NOVEL GENOTYPES: THOUGHTS FROM AN ECOLOGICAL PERSPECTIVE (Oak Ridge National Laboratory 1982).

31. See Biotechnology Hearing, supra note 9 (statement of Don R. Clay, Acting Assistant Administrator, Office of Pesticides and Toxic Substances, EPA). This uncertainty also extends to bioengineered plants and animals.

32. See, e.g., Demain, Industrial Microbiology, 214 SCI. 987 (1981); Demain & Solomon, Industrial Microbiology, SCI. AM., Sept. 1981 at 66.

33. Quote of Ronald Cape, Chairman of Cetus Corporation, in Powledge, Surveillance of Genetic Engineering: Will Restraints Continue to Loosen?, 1 BIOTECHNOLOGY 322, 328 (June 1983).

34. 42 U.S.C. §§ 4321-4361, ELR STAT. 41009.

35. 7 U.S.C. §§ 135-135k, 136-136y, ELR STAT. 42301.

36. 33 U.S.C. §§ 1251-1376, ELR STAT. 42101.

37. 42 U.S.C. §§ 6901-6987, ELR STAT. 41901. RCRA and a number of other federal statutes may apply to environmental pollution caused by biotechnology, but not necessarily to the deliberate releases of organisms. For example, RCRA applies only to wastes and therefore should be considered by the food processing industry and the pharmaceutical industry that may produce living waste from the large-scale containment methods. In addition, the Clean Air Act regulates the discharge of hazardous air pollutants, including biological materials, 42 U.S.C. § 7412(a)(1), ELR STAT. 42219. The Hazardous Materials Transportation Act regulates the interstate transportation of dangerous materials, including etiologic agents that "may pose an unreasonable risk to health and safety or property." 49 U.S.C. § 1803. Finally, the Marine Protection, Research, and Sanctuaries Act prohibits ocean dumping of any material which would "unreasonably degrade or endanger human health, welfare, or amenities, or the marine environment, ecological systems, or economic potentialities" without a permit. 33 U.S.C. § 1412(a), ELR STAT. 41863. This article will also not address the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., or the Occupational Safety and Health Act, 29 U.S.C. §§ 651-678.

38. 7 U.S.C. §§ 150aa-150jj.

39. 7 U.S.C. §§ 2801-2813.

40. 42 U.S.C. §§ 9601-9657, ELR STAT. 41951.

41. Initially published in 1976, 41 Fed. Reg. 27902; the Current version is found at 48 Fed. Reg. 24556 (1983).

42. The Secretary of Health and Human Services shall conduct research in the Service, and shall encourage scientific institutions and scientists to conduct research, 42 U.S.C. § 241(a), through grants-in-aid, id. § 241(a)(3), and other grants and contracts, id. § 241(b)(1).

43. Guidelines, § IV-C-1, 48 Fed. Reg. 24561 (1983).

44. Guidelines, § IV-C-2, 48 Fed. Reg. 24562 (1983). Members of the RAC are chosen to provide a collective expertise in scientific fields "relevant to recombinant DNA technology and bilogical safety …. At least 20 percent of the members shall be persons knowledgeable in applicable law, standards of professional conduct and practice, public attitudes, the environment, public health, occupational health, or related fields." Additionally, representatives from other federal agencies, such as the Department of Agriculture, serve a nonvoting members of the RAC. Id. Major actions require the publication of the RAC meeting agenda in the Federal Register at least 30 days prior to the meeting, and the Director of NIH may similarly publish proposed decisions for 30 days of public comment before action is taken. § IV-C-1-b-(1), 48 Fed. Reg. 24561 (1983).

45. The guidelines estabish good laboratory practices and prescribe physical and biological containment level to reduce the probability of human infection or environmental release of organisms containing recombinant DNA. Biological containment refers to the design of organisms that are unlikely to survive outside the laboratory or become infectious if released because of nutritional requirements or sensitivity to environmental conditions. The guidelines, as originally promulgated at 41 Fed. Reg. 27902 (1976), prohibited the deliberate release of such organisms. The guidelines have been revised in 1978, 1982, and 1983 — each time the guidelines were relaxed as the potential risk associated with certain experiments was found to have been overestimated.

46. Guidelines, § I-C, 48 Fed. Reg. 24557 (1983).

47. Guidelines, app. J, 48 Fed. Reg. 24577 (1983).

48. The guidelines do provide for the voluntary compliance of privately funded institutions, § VI, 48 Fed. Reg. 24563 (1983). Protection for proprietary data of such institutions is also considered by the guidelines, § VI-E, 48 Fed. Reg. 24564 (1983).

49. Guidelines, § I-B(i), 48 Fed. Reg. 24557 (1983).

50. The oil-degrading organism invented by Dr. Chakrabarty, and patented in 1981, was created by the insertion of intact plasmids (circular pieces of DNA that code for proteins that impart additional capabilities to a bacterium, such as antibiotic resistance or, in this case, an enhanced ability to degrade hydrocarbons). U.S. Patent No. 4,259,444, issued Mar. 31, 1981. See Diamond v. Chakrabarty, 447 U.S. 303 (1980).

51. Guidelines, § III-B-4(a), 48 Fed. Reg. 24558 (1983). The recombinant DNA "may be transferred … and propagated under conditions of physical containment comparable to P1 and appropriate to the organism under study." The P1 level, app. G-II-A, 48 Fed. Reg. 24569 (1983), is the least restrictive of four designated levels of containment. No special laboratory design is required, app. G-II-A-3, 48 Fed. Reg. 24570 (1983); nor is special containment equipment required, id, app. G-II-A-2. In such situations, the principal investigator makes the judgment on containment "as part of his responsibility to 'make the initial determination on the required levels of physical and biological containment ….'" Section V n.2. This "judgment is to be reviewed and approved by the institutional Biosafety Committee as part of its responsibility to make an independent assessment of the containment levels …." Id. Advice may be also requested from the NIH Office of Recombinant DNA Activities, and in turn from the RAC.Id.

52. The appropriate containment level "will be determined by the" institutional biosafety committee. Guidelines, § III-B-4-a, 48 Fed. Reg. 24558 (1983).

53. Guidelines, § III-A-2, 48 Fed. Reg. 24558 (1983).

54. Guidelines, apps. L-I & L-II, 48 Fed. Reg. 24580 (1983).

55. Guidelines, id. at app. L-II-A.

56. Guidelines, id. at app. L-II-B. This requirements may not prevent the environmental harm resulting from the over-development of a given modified strain of an organism that manifests harm not through the direct expression of gene products that are toxic, but rather, for example, through overutilization of scarce resources in a particular ecosystem.

57. Guidelines, id. at app. L-II-C. The vector consists, for example, of DNA from plants of the same or closely related species, app. L-II-C(ii), or from plant pathogens from which disease-causing sequences have been deleted, app. L-II-C(iv).

58. Guidelines, id. at app. L-II-D. These conditions are to be determined as "appropriate for the plant under study and the geographical location." Provision should also be made "for using good cultural and pest control practices, for physical isolation from plants of the same species outside of the experimental plot …. Review … should include an appraisal by scientists knowledgeable of the crop, its production practices and the local geographical conditions." Id.

59. Id.

60. Guidelines, § IV-C-1-b, 48 Fed. Reg. 24562 (1983).

61. See supra note 26.

62. Foundation on Economic Trends v. Heckler, No. 83-2714, ELR PEND. LIT. 65799 (D.D.C., complaint filed Sept. 14, 1983, amended Sept. 18, 1983).

63. Guidelines, app. J, 48 Fed. Reg. 24577 (1983).

64. See Scientists' Institute for Public Information, Inc. v. Atomic Energy Commission, 481 F.2d 1079, 3 ELR 20525 (D.C. Cir. 1973); CALDWELL, SCIENCE AND THE NATIONAL ENVIRONMENTAL POLICY ACT: REDIRECTING POLICY THROUGH PROCEDURAL REFORM (University of Alabama Press 1982).

65. See, e.g., Environmental Defense Fund, Inc. v. Corps of Engineers, 325 F. Supp. 728, 759, 1 ELR 20130, 20141 (E.D. Ark. 1970), aff'd, 470 F.2d 289, 2 ELR 20740 (8th Cir. 1972).

66. See, e.g., Trout Unlimited v. Morton, 509 F.2d 1276, 5 ELR 20151 (9th Cir. 1974) (need not discuss remote and highly speculative consequences).

67. See, e.g., Committee for Nuclear Responsibility, Inc. v. Seaborg, 1 ELR 20469 (D.C. Cir. 1971).

68. See PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIORAL RESEARCH, SPLICING LIFE: THE SOCIAL AND ETHICAL ISSUES OF GENETIC ENGINEERING WITH HUMAN BEINGS, app. C, Federal Government Involvement in Genetic Engineering, at 97 (1982).

69. See Guidelines, § III-A-2, 48 Fed. Reg. 24558 (1983). Some release experiments have been funded by USDA.

70. Some private companies have been made subject to the NIH guidelines through state or local laws, e.g., Cambridge, Massachusetts. Therefore, they must seek approvals from NIH and would come under NEPA. In addition, they may be subject to state environmental policy statutes modelled after NEPA. See KRIMSKY, BAECK, & BOLDUC, MUNICIPAL AND STATE RECOMBINANT DNA LAWS: HISTORY AND ASSESSMENT (Tufts University 1982).

71. NATIONAL INSTITUTES OF HEALTH, ENVIRONMENTAL IMPACT STATEMENT ON NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES OF JUNE 23, 1976 (two parts) (Oct. 1977).

72. NEPA § 102(2)(C), 42 U.S.C. § 4332(2)(C), ELR STAT. 41010.

73. 40 C.F.R. § 1508.18, ELR REG. 46033. If the deliberate release requires a permit or other approval from a federal agency, an EIS may be required. For example, EPA must prepare an EIS before issuing national pollutant discharge elimination system permits under the FWPCA. See infra text accompanying notes 112-122 for a discussion of the applicability of the FWPCA. However, the requirements of some statutes are considered the "functional equivalent" of NEPA and actions under them do not require an EIS. See, e.g. Twitty v. North Carolina, 527 F. Supp. 778, 12 ELR 20336 (E.D.N.C. 1981), aff'd, 13 ELR 20788 (4th Cir. 1982) (EIS not required for PCB disposal since TSCA is functional equivalent of NEPA); Environmental Defense Fund, Inc. v. Blum, 8 ELR 20749 (D.D.C. 1978) (EIS not required for FIFRA exemption).

74. 40 C.F.R. § 1508.27, ELR REG. 46034. As established in the regulations, to clarify conflicting case law, the word "major" reinforces but does not have a meaning independent of the term "significantly." 40 C.F.R. § 1508.27, ELR REG. 46034.

75. See Biotechnology Hearing, supra note 9, (statement of Dr. Ralph W. F. Hardy, at 12, 13).

76. See Foundation on Economic Trends v. Heckler, No. 83-2714, ELR PEND. LIT. 65799 (D.D.C., complaint filed Sept. 14, 1983 amended Sept. 18, 1983). Plaintiffs seek to enjoin experiments involving the deliberate release of recombinant DNA organisms approved by NIH under the guidelines, arguing thar the approvals and the NIH guidelines violate NEPA, the Administrative Procedure Act, and federal common law of nuisance. They also unsuccessfully sought a temporary restaining order under the Federal Advisory Committee Act to compel the RAC to open to the public a September 19, 1983 meeting in which the RAC considered two proposals for deliberate releases by private companies voluntarily complying with the guidelines. 48 Fed. Reg. 37198 (1983).

77. Environmental Defense Fund, Inc. v. Corps of Engineers, 325 F. Supp. 728, 759, 1 ELR 20130, 20141 (E.D. Ark. 1970), aff'd, 470 F.2d 289, 2 ELR 20740 (8th Cir. 1972) (emphasis in original).

78. Scientists' Institute for Public Information, Inc. v. Atomic Energy Commission, 481 F.2d at 1092, 3 ELR at 20531-32.

79. See, e.g., Committee for Nuclear Responsibility, Inc. v. Seaborg, 1 ELR 20469 (D.C. Cir. 1971); Environmental Defense Fund, Inc. v. Hoffman, 421 F. Supp. 1083, 7 ELR 20152 (E.D. Ark. 1976); Bucks County Board of Commissioners v. Interstate Energy Co., 403 F. Supp. 805, 6 ELR 20406 (E.D. Pa. 1975); Cape Henry Bird Club v. Laird, 359 F. Supp. 404, 3 ELR 20571 (E.D. Va. 1973), aff'd, 484 F.2d 453, 3 ELR 20786 (4th Cir. 1973).

80. 40 C.F.R. § 1502.22, ELR REG. 46023. See Comment, CEQ's "Worst Case Analysis" Rule for EISs: Reasonable Speculation or Crystal Ball Inquiry?, 13 ELR 10069 (1983), for an analysis of the rule. The Council on Environmental Quality has recently proposed a guidance memorandum for federal agencies implementing the rule, 48 Fed. Reg. 36486 (1983).

81. See Biotechnology Hearing, supra note 9. See also Comment, Innocuous Inoculum or Perilous Parasite? Encouraging Genetic Research Through Patent Grants: A Call for Regulation and Debate, 18 SAN DIEGO L. REV. 263, 284 (1981).

82. See Save Our Ecosystems v. Watt, 13 ELR 20529 (D. Or. Mar. 21, 1983) (EIS for herbicide spraying in forest required a worst-case analysis); Southern Oregon Citizens Against Toxic Sprays v. Watt, 13 ELR 20174 (D. Or. Sept. 9, 1982) (worst-case analysis required for substitution of 2,4-D for Silvex as herbicide spray in forest).

83. Commentators point to several flaws. First, the EIS was prepared after the guidelines were issued; NEPA requires preparation of EISs on proposals, not completed actions. Second, the EIS analyzed the environmental impact of the guidelines, rather than the environmental impact of NIH-funded recombinant DNA research. Third, the EIS failed to analyze the impact of NIH's failure to regulate the private sector. And finally, the EIS has been criticized for substantive flaws. See Chalker & Catz, A Case Analysis of NEPA Implementation: NIH and DNA Recombinant Research, 1978 DUKE L.J. 57.

Dr. Donald S. Fredrickson, Director of NIH, was informed in the spring of 1976 that NIH could be charged with violating NEPA if the guidelines were released before issuing an EIS. He recognized that the "tortoise-like march from draft to final EIS could take years" and therefore

delaying the issuance of the Guidelines pending completion of the EIS process was never an alternative. The voluntary agreements made at Asilomar were losing their hold on the scientists, confusion was mounting, and dissidents in various communities threatened to obtain either local regulation or prohibition of the research if Federal standards were not quickly forthcoming. It was obvious that the public interest would be better served — and the opportunity of scientists to continue experiments, better protected — with guidelines than without them, even if an EIS were not published until after their issuance.

Fredrickson, "A History of the Recombinant DNA Guidelines in the United States" in Proceedings of a Conference on Recombinant DNA held at Wye College, Kent 1979 (document 12.17 in THE DNA STORY, supra note 10).

In 1977, environmental groups filed suit, alleging that NIH violated NEPA by funding recombinant DNA research without first considering environmental factors in an EIS, and by releasing the guidelines before a draft EIS had been published for public comment. See Friends of the Earth v. Califano, No. 77-2225, ELR PEND. LIT. 65464 (S.D.N.Y., complaint filed May 9, 1977).

84. see sura note 76.

85. In Mack v. Califano, 447 F. Supp. 668, 8 ELR 20347 (D.D.C. 1978), plaintiff sought to enjoin an NIH experiment involving the implantation of genetic material of polyoma, a virus known to cause cancer, into enfeebled strains of E. coli, a human bacteria. The court ruled that the experiment met the requirements of the NIH guidelines and that the EIS for the guidelines constituted a "hard look" at the environmental impacts of recombinant DNA research and was adequate under NEPA.

86. See, e.g., EPA Asserts Authority to Regulate Bioengineering By-products Under TSCA, INSIDE E.P.A., July 1, 1983, at 1; Biotechnology Hearing, supra note 9 (statement of Don R. Clay, Acting Assistant Administrator, Office of Pesticide and Toxic Substances, EPA); Karny, Regulation of Genetic Engineering: Less concern About Frankensteins but Time for Action on Commercial Production, 12 U. TOL. L. REV. 815 (1981); McGarity & Bayer, Federal Regulation of Emerging Genetic Technologies, 36 VAND. L. REV. 461 (1983).

87. TSCA § 4(a)(1)(A)(i), 15 U.S.C. § 2603(a)(1)(A)(i), ELR STAT. 41336.

88. TSCA § 4(a)(1)(A)(ii), 15 U.S.C. § 2603(a)(1)(A)(ii), ELR STAT. 41336.

89. TSCA § 4(a)(1)(B), 15 U.S.C. § 2603(a)(1)(B), ELR STAT. 41336.

90. 15 U.S.C. § 2604, ELR STAT. 41338.

91. TSCA § 5(a), 15 U.S.C. § 2604(a), ELR STAT. 41338.

92. TSCA § 5(b), 15 U.S.C. § 2604(b), ELR STAT. 41339.

93. TSCA § 5(e), 15 U.S.C. § 2604(e), ELR STAT. 41339.

94. See von Marschall, OEDC Efforts to Harmonize New Chemicals Testing: Variations on a Theme, 12 ELR 15038 (1982).

95. TSCA § 3(2)(A), 15 U.S.C. § 2602(2)(A), ELR STAT. 41336.

96. TSCA § 3(8), 15 U.S.C. § 2602(8), ELR STAT. 41336.

97. S. REP. No. 698, 94th Cong., 2d Sess., reprinted in TSCA, LEGISLATIVE HISTORY OF THE TOXIC SUBSTANCES CONTROL ACT 253 (1976) (emphasis in original).

98. Biotechnology Hearing, supra note 9, (statement of Don R. Clay, Acting Assistant Administrator, Office of Pesticide and Toxic Substances, EPA).

99. Id.

100. In Diamond v. Chakrabarty, 447 U.S. 330 (1980), the Supreme Court considered whether a genetically engineered bacterium was a "manufacture" or "composition of matter" within the meaning of the patent statute, 35 U.S.C. § 101. The ultimate holding adds to the question raised under TSCA: The Court held that the microbe was patentable subject matter as a "nonnaturally occurring manufacture or composition of matter" given the intent of Congress in enacting the patent statute to "include anything under the sun that is made by man."

101. TSCA § 3(2)(B), 15 U.S.C. § 2602(2)(B), ELR STAT. 41336.

102. 7 U.S.C. § 136a, ELR STAT. 42304.

103. 7 U.S.C. § 136u, ELR STAT. 42318. EPA considers the wild-type ice-nucleating bacteria to be "pests," and therefore the modified bacteria recently approved by NIH for release are pesticides, see supra note 27 and accompanying text. To enable EPA to regulate such experimental uses, it may change its experimental land use exemption from 10 acres or less to zero acres. See 40 C.F.R. § 172.3(a)(1).

104. 46 Fed. Reg. 18323 (1981).

105. Regulation of "Biorational Pesticides": Policy Statement and Notice of Availability of Background Document, 44 Fed. Reg. 28093 (1979).

106. 40 C.F.R. § 162.5.

107. 47 Fed. Reg. 53203 (1982) (proposed new provision, 40 C.F.R. § 158.65(b)).

108. 40 C.F.R. § 162.5(4). In its proposed rule to create these exempted categories, EPA noted that although the exempted organisms could be considered to be pesticides under FIFRA, they might directly or indirectly be pests of nontarget organisms and, therefore, could be regulated under the statutory authority of these other agencies. 46 Fed. Reg. 18322 (1981). In the proposed rule, EPA noted that as a practical matter, only a few organisms would be affected by the exemption, i.e., parasitic control and predaceous arthropods used to control populations of their insect hosts and prey. Id. at 18324. EPA concluded that the exempted organisms were adequately regulated and monitored by the other agencies. However, if future events showed that the exempted agents were not being adequately regulated by the other agencies, those organisms would be called to the attention of the appropriate agency or added to 40 C.F.R. § 162.5-1 as a nonexempted organism. 46 Fed. Reg. 18323 (1981). Biorational pesticides are defined to include biochemical compounds, such as pheromones, and microbiological pest control agents. Proposed rule, 47 Fed. Reg. 53192 (1982). This rule indicates that biorational pesticides are inherently different from conventional pesticides in that they have a "unique non-toxic mode of action, low use volume, target species specificity and natural occurrence." Id. Furthermore, "based on these characteristics, the Agency expects that many biorational pesticides pose lower potential risk than conventional pesticides." Id.

109. The rule notes that each variety or subspecies of microorganism used as a pesticide must be tested. 47 Fed. Reg. 53203 (1982) (proposed new provision, 40 C.F.R. § 158.65(b)).

110. The proposed rule contains several tables that set forth the biorational pesticide data requirements. Product analysis data include the product identity and its manufacturing process (for both biochemical and microbial agents, and residue data for biochemicals but not for microbes unless they show evidence of survival, replication or infectivity, or cause toxic or pathological effects (in tests that include subchronic oral, dermal, and inhalation exposures of animals, teratogenicity, and cellular immune response testing). It includes tests that must be performed to evaluate the effects of biorational pesticides on non-target organisms, and requires testing for effects upon avian, freshwater fish, and aquatic invertebrate species. Environmental testing by additional protocols is required when toxic effects are noted in these test animals. Proposed C.F.R. § 158.165, tables (a)-(g), 47 Fed. Reg. 53214 (1982).

111. The Acting Administrator for Pesticide and Toxic Substances further testified that "more extensive data or information may be necessary to evaluate genetically engineered pesticides." Biotechnology Hearing, supra note 9 (statement of Don R. Clay). Additionally, the "[d]ata requirement for genetically-engineered microbial … agents would be determined on a case-by-case basis" except where requirements had already been specified. 47 Fed. Reg. 53203 (1982). New regulations from EPA for genetically engineered microbiological products are expected in the next few months.

112. FWPCA § 101(a), 33 U.S.C. § 1251(a), ELR STAT. 42105.

113. FWPCA §§ 301, 402, 33 U.S.C. §§ 1311, 1342, ELR STAT. 42123, 42140.

114. FWPCA § 502(6), 33 U.S.C. § 1362(6), ELR STAT. 42146.

115. Id.

116. FWPCA § 502(14), 33 U.S.C. § 1362(14), ELR STAT. 42146.

117. FWPCA § 402, 33 U.S.C. § 1342, ELR STAT. 42141.

118. FWPCA § 401, 33 U.S.C. § 1341, ELR STAT. 42140.

119. FWPCA § 403, 33 U.S.C. § 1343, ELR STAT. 42142.

120. See, e.g., New York Water Quality Standards Class SC Waters, New York Division of Water Resources Regulations, ch. X, art. 2, pt. 701.

121. FWPCA § 403(c)(1)(B), 33 U.S.C. § 1343(c)(1)(B), ELR STAT. 42142.

122. See, e.g., effluent limitations for the research subcategory, pharmaceutical chemical category, which address biological and chemical oxygen demand, solvents, and tar still bottoms, 40 C.F.R. § 439.52; and those for the hospital category, which address only biological oxygen demand, suspended solids, and pH, 40 C.F.R. § 460.10.

123. Federal Plant Pest Act, 7 U.S.C. § 150aa-150jj. In addition, several animal quarantine and related laws authorize USDA to prevent dissemination of communicable diseases of animals. See Biotechnology Hearing, supra note 9 (testimony of Edgar L. Kendrick, Acting Deputy Assistant Secretary for Science and Education, USDA).

124. S. REP. No. 189, 85th Cong., 1st Sess (1957), reprinted in 1957 U.S. CODE CONG. & AD. NEWS 1184.

125. Under 7 C.F.R. § 330.108, the Deputy Administrator of the Plant Protection and Quarantine Program, Animal and Plant Health Inspection Service, has been delegated the actual regulation under the Act.

126. 7 U.S.C. § 150aa(c) (emphasis added).

127. See infra notes 144 & 150 and accompanying text. The Deputy Administrator also may establish requirements for any class of products that are pests, such as genetically engineered bacteria. 7 C.F.R. § 352.3(c).

128. 7 U.S.C. § 150ee. The implementing regulations (issued under the Plant Pest Act and the Plant Quanantine Act, 7 U.S.C. § 151) state that the "unregulated movement of means of conveyance, their stores, baggage, mail, plants, plant products, garbage, earth, stone and quarry products, and other products and articles" may disseminate plant pests. 7 C.F.R. § 330.102. Thus, shipping packages containing genetically engineered organisms may be inspected by the Department. This inspection authority also applies to foreign arrivals. 7 C.F.R. § 330.105(a).

129. 7 C.F.R. § 330.204. The term "move" is also defined broadly to mean "ship, deposit for transmission in the mail, otherwise offer for shipment, offer for entry, import, receive for transportation, carry, or otherwise transport, or move, or allow to be moved, by mail or otherwise." 7 U.S.C. § 150aa(g).

130. 7 C.F.R. § 330.204(2).

131. 7 U.S.C. § 150ff.

132. 7 U.S.C. § 150dd(b)(1). This section incorporates language found in the Federal Noxious Weed Act, see infra text accompanying note 141, such that the Secretary may take remedial actions when "the existence of a plant pest new to or not theretofore known to be widely prevalent or distributed within and throughout the United States would constitute a threat to crops, other plant life, and plant products of the Nation…."

133. 7 U.S.C. § 150dd(c).

134. Id. at § 150dd(e).

135. Id. at § 150dd(b)(2).

136. 7 C.F.R. § 330.202.

137. Id. at § 330.108.

138. 7 U.S.C. §§ 2801-2813.

139. S. REP. NO. 1313, 93d Cong., 2d Sess. (1974), reprinted in 1974 U.S. CODE CONG. & AD. NEWS 7663, noted that federal and state seed acts as well as the Federal Plant Pest Act and other federal acts were "too narrow in coverage to reach all plants of foreign origin that are of concern to United States agriculture."

140. 7 U.S.C. § 2801.

141. Id. at § 2802(c) (emphasis added). Although the statute was directed to organisms of "foreign" origin, the language in the statute referring to plants "new to or not widely prevalent in the United States" may also encompass the products of biotechnology.

142. Id. at § 2803(a). However, any such regulations are applicable only to noxious weeds identified by publication and after a hearing if requested by any interested person. Id. at § 2809. At the present time, seven types of aquatic, six types of parasitic and 13 types of terrestrial weeds are regulated. 7 C.F.R. § 360.

143. 7 U.S.C. § 2805. The Secretary may take emergency action, such as seizure, to prevent dissemination. Id. at § 2805(a).

144. Id. at § 2809.

145. Id. at § 2806.

146. Id. at § 2804.

147. Id. at § 2805(a). The Secretary is authorized to "seize, quarantine, treat, destroy, or otherwise dispose of, in such manner as he deems appropriate, any product or article …." Id.

148. Id. at § 2805(b). Costs are recoverable, however, if "the owner establishes that such destruction or disposal was not authorized …." Id. at § 2805(d).

149. Id. at § 2808.

150. A narrow reading of the phrase "can injure" would limit the application of the Act. See supra note 127 and accompanying text.

151. Exec. Order No. 11987, 42 Fed. Reg. 26949 (1977), ELR REG. 45025.

152. The Lacey Act, 18 U.S.C. § 42, forbids the importation into the United States of specified species of wild mammals, wild birds, fish (including mollusks and crustacea), amphibians, reptiles, or the offspring or eggs of any of the foregoing which the Secretary of the Interior identifies by regulation to be injurious to human beings, to the interests of agriculture, horticulture, forestry, or to wildlife or the wildlife resources of the United States. Id. at § 42(a)(1). In addition, the shipment between "the continental United States, the District of Columbia, Hawaii, the Commonwealth of Puerto Rico, or any possession of the United States" may also be prohibited. Id. at § 42(a)(1). This section explicitly does not authorize action with respect to the importation of plant pests as defined by the Federal Plant Pest Act, Id. at § 42(a)(1); nor does this Act restrict importations by federal agencies for their own use, Id. at § 42(a)(3). The Lacey Act Amendments of 1981, 16 U.S.C. §§ 3371-3378, set forth penalties for the import, export, transport, etc. of plants and fish and wildlife in violation of U.S. laws, treaties, or regulations or in violation of Indian tribal law.

153. Exec. Order No. 11987, § 1(c).

154. Id. at § 1(b).

155. Species are typically defined in terms of structural, morphological and genetic similarity, and the ability for species members to interbreed and produce fertile offspring.

156. Exec. Order No. 11987, § 2(a). Executive agencies shall also encourage "States, local governments, and private citizens" to act similarly.

157. Id. at § 2(d).

158. Id.

159. CERCLA § 104, 42 U.S.C. § 9604, ELR STAT. 41945.

160. 26 U.S.C. §§ 4611-4682, ELR STAT. 41957.

161. CERCLA § 107(f), 42 U.S.C. § 9607(f), ELR STAT. 41948.

162. CERCLA § 104(a)(1), 42 U.S.C. § 9604(a)(1), ELR STAT. 41945.

163. CERCLA § 101(22), 42 U.S.C. § 9601(22), ELR STAT. 41943.

164. CERCLA § 104(a)(1), 42 U.S.C. § 9604(a)(1), ELR STAT. 41945.

165. CERCLA §§ 101(14), 102, 42 U.S.C. §§ 9601(14), 9602, ELR STAT. 41943, 41944. "Hazardous substance" includes those "elements and compounds designated under § 311(b)(2)(A) of the FWPCA, which present an "imminent and substantial danger" to public health; hazardous wastes listed under § 3001 of the Solid Waste Disposal Act, based on criteria that take into account toxicity, persistence, degradability, and potential for accumulation in tissue; toxic pollutants listed under § 307(a) of the FWPCA; hazardous pollutants listed under § 112 of the Clean Air Act; and "imminently hazardous chemical substances or mixtures" regulated under TSCA.

166. CERCLA § 104(a)(2), 42 U.S.C. § 9604(a)(2), ELR STAT. 41945.

167. CERCLA § 107, 42 U.S.C. § 9607, ELR STAT. 41947.

168. In the absence of federal regulation, tort law may play a significant role. See, e.g., Biotechnology Hearing, supra note 9 (statement of Geoffrey Karney) (discussing potential tort liability relating to deliberate releases).

169. See generally Biotechnology Hearing, supra note 9 (statement of Don R. Clay).

170. Exciting as the advances which may be realized through biotechnology may be, we must also be cognizant of some potential safety and environmental quality concerns which could result from the application of these developing technologies. In order to assure that any potential hazards do not become reality, we recommend a controlled, stepwise, progressive program of development … before finally entering limited field evaluations which can be closely supervised. Through such a programmed cautionary approach, we can maximize the scientific impacts while minimizing any untoward consequences for the environment. This stepwise approach is consistent with the NIH guidelines which were initially quite cautious and were revised to be consistent with experience.

Biotechnology Hearing, supra note 9 (statement of Ralph W.F. Hardy, at 11). See generally Seminar Series: Biotechnology and nology and the Environment, sponsored by the American Association for the Advancement of Science and EPA (1983) (proceedings to be published).

171. Regulators must be mindful of overly restricting biotechnological development. According to Congressman Gore, "Our society has much to gain from the uses of biotechnology and we must be careful not to unduly inhibit its development." Quote from CHEM. WEEK, July 6, 1983, at 36.

13 ELR 10366 | Environmental Law Reporter | copyright © 1983 | All rights reserved