Enforcement of Regulations: Panel Discussion

EDWARD LEE ROGERS, Esq., Attorney at Law DAVID J. GLASS, Ph.D., Vice President, Government and Regulatory Affairs, Biotechnica Agriculture RICHARD D. GODOWN, President, Industrial Biotechnology Association MARGARET G. MELLON, Ph.D., J.D., Director, National Biotechnology Policy Center, National Wildlife Federation REBECCA J. GOLDBURG, Ph.D., J.D., Environmental Defense Fund

EDWARD LEE ROGERS: I am concerned about whether the Coordinated Framework for Regulation of Biotechnology¹ is adequate. I am not sure that it is efficacious to talk in terms of intergeneric organisms, or whether it is practical to use a pathogen/nonpathogen distinction as the basis for choosing the level of review. I also question whether the 90-day review period under the Toxic Substances Control Act (TSCA)² and the 60-day period under the Federal Plant Pest Act (FPPA)³ are adequate review timeframes for something as complex as a novel organism.

The philosophy of my client, Jeremy Rifkin, is that we have a new technology that is fraught with risk. He recognizes, and we acknowledge in our litigation, that in most instances biotechnology will not present much risk. But the fact remains that the scenario of a great catastrophe is still possible. If the regulators err in a particular review, serious consequences could ensue.

So, one of the difficult questions is, what threshold level of risk should trigger an intensive review by an agency? Should nonpathogens not be subject to an intensive review? What if the organism has abiotic implications?

Consider the "ice-minus" bacteria. Conceptually, this organism could have two possible effects. One is an impact on precipitation patterns, if the "ice-minus" mutant bacteria should replace its natural counterpart. "Ice-plus" bacteria apparently play a role in atmospheric precipitation patterns, because they are responsible for the formation of ice at certain temperatures.

The second possible effect is that there could be destruction of the plant of a type that would not occur if the "ice-minus" bacteria were not on its surfaces. If a plant supercools because the plant epiphyte on its leaves or blossoms is an "ice-minus" bacteria, then when the plant finally does freeze, intercellular damage could occur.

These are nonpathogenic ecological impacts, which only receive Tier 1 review under the Coordinated Framework. So, I think that the issue of pathogenicity is one thatneeds further scrutiny.

I am also concerned about gaps in the regulatory process. It is possible to have a noncommercial recombinant DNA research and development project in an institution that is not funded by the National Institutes of Health (NIH). Where would that research be regulated? If I understand the position of the U.S. Environmental Protection Agency (EPA), it may very well not be regulated at all.

DAVID J. GLASS: I will try to provide industry's viewpoint and some thoughts about these issues. Some of these are colored by my perceptions and may not represent widely held industry viewpoints.

From the start, industry's position has been to accept the fact that some amount of regulation, particularly for environmental uses of biotechnology, is necessary and probably inevitable. At this stage in the United States, it is generally true that any new technology will be subject to some level of regulation. Even if no hazards are particularly known or proven about the new technology, regulation is likely because of public concerns about the uncertainties of new technologies.

Speaking more specifically about biotechnology, any time one releases a microorganism or any organism into the environment, a number of potential effects should at least be examined or assessed. Any time a company plans to introduce a new organism, a risk assessment should be done.

In spite of the fact that industry acknowledges the need for regulation, government must be careful not to overregulate. Overregulating in the early stages of technology can hamper innovation by erecting too many barriers in the innovator's way. In the biotechnology area we are particularly concerned with the regulation of the small-scale field tests that occur in the early stages of research and development.

Industry recognizes the need for some risk assessment. This morning's presentations were a good indication of the types of risk assessment that are appropriate. In effect, government agencies are already performing these assessments as proposals such as my company's undergo evaluation.

Biotechnica Agriculture has gone through the review process already, has more applications pending, and is considering several field tests over the next couple of years. Therefore, we may take a more practical approach than those who look at the subject from a distance. Based on our experience, we believe that for small-scale field tests the system does work and is adequate to protect the environment and public health.

That is not to say that the Coordinated Framework could not use certain modifications, or that all areas are covered as well as they could be. But biotechnology companies want to introduce beneficial agricultural products in the near future, not in the year 2000. From that perspective, the regulation in place now at the federal level is sufficient to provide adequate review on an efficient enough basis to get products through the field testing stage and into the market.

Several future issues are of particular importance. Most of our discussions here today, and over the past four or five years, have focused on small-scale field testing. As we move toward larger-scale testing and field tests in the environment, [19 ELR 10507] other issues need to be addressed. Nobody can predict how the agencies will regulate larger-scale testing. We will probably end up groping our way together through this stage as companies reach that point in their research. As the Congressional Office of Technology Assessment (OTA) noted in its recent study,⁴ the one thing that is clear is that the data we gather from the small-scale tests will be helpful in evaluating the risks of large-scale tests.

Two other issues are important. The first is public acceptance of biotechnology, on which the future of the industry rests. Industry's ability to conduct field tests is contingent upon obtaining the support and acceptance of the local communities in which tests are proposed. Early efforts to fieldtest biotechnology products were unsuccessful because of poor public perception. More recent efforts by companies such as my own have shown that it is possible to garner community support if field test proposals are handled properly.

The second issue is the role of state governments. The public wants state governments involved in biotechnology. There is a role for state regulation, so long as it does not unnecessarily duplicate the federal regulatory process.

I have been involved in discussions like these for almost five years. The debates used to focus on whether it was safe to conduct field tests. About a year ago, when the first field tests were conducted, the tenor of the debate changed considerably.

There have now been five microorganism field tests in the U.S. alone, and a handful in other countries. The debate should be different now. We should not be debating whether the tests should be done, but rather how they can be conducted safely, how they can be monitored, and how we can gather the data we need in order to to move ahead.

We are moving ahead with small-scale field tests. The time for talk is gone. Small-scale field testing occurs at an early stage of product development, and many different product candidates may be evaluated in a single experiment. Industry is not asking for shortcuts, nor is it arguing that regulation is inappropriate. We are asking simply that regulation of small-scale field tests be made more routine.

RICHARD D. GODOWN: I will begin by referring to the OTA report, the release of which coincides beautifully with today's discussion. The report says, "The potential benefits of new biotechnologies have been widely reported. Thus, this report focuses primarily on questions raised by the critics."⁵ It is important to keep that perspective in mind because there is much in this report to make industry uncomfortable. The report discusses the implications of the possible, the probable, and the maybe.

I would not describe industry's position as one of wanting to rush headlong into biotechnology. Our position is precisely as David Glass has enunciated it: we think that some regulation is inevitable and desirable.

Industry discovered a long time ago that unless a third-party government instrumentality gives its imprimatur, after an arms-length review and analysis, products will not succeed with the public. For this reason, the biotechnology industry and the Industrial Biotechnology Association have never engaged in bashing the regulators. It is not productive.

My second-favorite quote in the OTA report is: "Adequate review of planned introductions is now possible. A review process that involves critical study of planned introductions by experts with relevant knowledge and experience offers confidence of being able to anticipate and prevent most potential problems."⁶

This is a significant concept. We are not experimenting randomly with organisms. Random approaches are hardly beneficial for industry, and certainly not for the public or the government. Rather, industry is proceeding on a scientifically based, step-by-step course of action. This approach is designed to lead us to the marketplace as quickly as possible, with safe, efficacious, successful products that do what we intend them to do.

The biotechnology industry needs to find its niche in the marketplace. The industry has already been successful in the financial sector; we have been able to convince the venture capitalists that biotechnology is a good idea. A number of companies have been able to attract investors willing to take a chance with the development of this new technology. But biotechnology's products will still have to succeed in the marketplace.

In many cases, biotechnology offers preferable alternatives to traditional technologies. Too stringent regulations could have a chilling effect on industry development. We favor appropriate regulation, not overregulation.

The questions that you and I want answered by the regulatory system about a product are: Is the biotechnology product safe? Is it environmentally neutral or friendly? In the case of pesticides, for instance, does the product work? Is it efficacious? Is it a plant pest?

The questions we want answered about the regulatory system are: Does it produce answers and decisions within a reasonable length of time? Is it overly restrictive, requiring more data and tests than are necessary under the circumstances? Is it too loose, giving false assurances which cause trouble later? Is a simple gene marker subject to the same kind of rigorous review as a recombinant product that contains a toxin?

Another question is whether the regulations are consistently applied. Are all applications treated equally? The EPA has proposed that Environmental Biotechnology Committees (EBCs) should review experiments on a regional or local basis. One would think that proposal would be welcomed by industry, but we are concerned about whether this approach would ensure equal treatment in various regions of the country. If not, then it would not be fair; companies would begin to shop for forums.

The most important question to ask about regulations is whether they are based on sound science. "Analysis paralysis" can result if regulations call for too much sifting and review and too much contemplation of what is conceivable rather than what is statistically probable. That is unacceptable.

On the whole, the existing regulations are properly attuned. We look forward to the time when, on the basis of experience and science, they can be diminished further. This will make the route from the greenhouse to the marketplace easier, benefiting us all.

MARGARET G. MELLON: The National Wildlife Federation is a mainstream environmental group that has [19 ELR 10508] recently become involved with biotechnology issues. We believe that the prospect of the widespread engineering of organisms affects our mission to protect and conserve the environment. Also,we are among the organizations with special concerns about wildlife; to us, animals' status is dependent on more than their use by humans.

We have many concerns about biotechnology; they can be grouped at three levels. First, we are concerned about the risks of unwanted effects from releasing particular organisms. For example, there are many cases within this country where foreign fish have driven native fish to extinction. We are concerned about the prospect of a technology that creates genetically novel fish and then releases them without any consideration of such ecological impacts.

Our second concern is the secondary or indirect effects of biotechnology. An herbicide-tolerant corn plant may itself pose no risk as a weed, but use of that crop may encourage the use of more herbicide than in the past. Similarly, pest-resistant plants will have secondary impacts on pest populations and on pesticide responses to those pests.

There also has been discussion about using biotechnology to create organisms resistant to pollution. Some researchers hope to produce fish that can live in acidified waters, or that can tolerate low oxygen concentrations. Along the same lines, biotechnology could be used to breed trees that are tolerant to sulfur dioxide and other air emissions.

NWF is concerned about the secondary impact of breeding pollution tolerance. What effect will that have on our commitment to protect the environment? Once we have populated the waters of the Northeast with acid-tolerant fish, what do we do if we develop the means to clean up the air, and bring the lakes back to their normal acidity?

Finally, we have tertiary concerns about biotechnology. My organization is made up of many people who hunt and fish. Many of our members have a close but not "romantic" view of the environment. Yet, when I talk with them about biotechnology, they voice real concerns about genetically engineering wildlife. What wildlife will be left if we have engineered all species within our control? What part of the environment will remain wild? Hunters and fishermen have an affection for the environment as it currently exists. In that sense, they are conservative, and they are disturbed by the notion of intrusions on wilderness, including genetic intrusions.

The Coordinated framework is wholly inadequate to address the concerns that organizations like ours have about biotechnology. To summarize, the Coordinated Framework deals fairly well with microorganisms and with a narrowly defined group of plants. It does not deal at all with vertebrate animals.

When the federal framework fails to apply to large groups of engineered organisms, it is irrelevant whether the regulatory system "works" or whether it requires too much data. To date, society and Congress have not acknowledged many of the problems presented by genetically engineered organisms.

I have numerous other, less fundamental complaints about the Coordinated Framework. I will focus on one, concerning university research, where I think the confusion and overlapping nature of the existing regulatory framework will be quite problematic. Right now, EPA regulates commercial research, the United States Department of Agriculture regulates agricultural research, NIH regulates some government-sponsored research, and the National Science Foundation other such research-four different regulatory bodies. Most of these bodies are currently considering using local, institutional, decentralized review to implement their authority. Eventually, this complex system of overlapping reviews will result in an untenable situation on the university campus.

REBECCA J. GOLDBURG: I would like to explain why I believe that the Coordinated Framework is a patchwork of preexisting statutes and provides suboptimal regulation. To do this, I will contrast two examples of potential releases of genetically engineered organisms. Using these examples, I will point out deficiencies in the Coordinated Framework.

One current application of recombinant DNA technology is development of plants that will produce flowers with new colors or other decorative traits. It is hard to argue that such plants pose a threat to the environment very different from conventional carnations or roses. The fact that these plants are made with modern genetic technology does not make them inherently dangerous. And since most domesticated plants do not survive well without human intervention, a new flower color is unlikely to give these plants the ecological advantages that make them weedy.

Next, consider a pesticidal microbe, where genetic technology is used to add a toxin gene to an otherwise innocuous microbe. Such organisms do pose environmental concerns above and beyond those that would be posed by the use of the parent organism. A pesticidal microbe potentially could harm organisms other than those it was intended to harm. Under the right circumstances, the spread of such a microbe or its toxin gene could be favored by natural selection.

These two examples provide a few lessons about biotechnology regulation. The most important lesson is that the recombinant DNA technology by which the organisms are made does not itself raise environmental concerns. Rather, the nature of the product is what should be considered. Product-based regulation is scientifically sensible.

Product-based regulation is also important because as the number of techniques used to genetically alter organisms continues to grow, we will need to consider much more than recombinant DNA technology. Therefore, only regulating organisms made with recombinant DNA is already inadequate regulation. Despite this, USDA's regulations under the Federal Plant Pest Act⁷ and the NIH Guidelines⁸ only pertain to organisms modified by recombinant DNA techniques. These regulations are based on processes, not products.

You heard earlier that USDA considers its regulations to be product-based. But in fact, USDA's approach is process-based because it is keyed to situations where the vectors used for engineering plants happen to be plant pathogens. USDA can claim that all genetically engineered plants are currently potential plant pests, but the vector itself is entirely harmless in its use. So in effect, USDA is regulating the process of recombinant DNA.

EPA's regulations, on the other hand, are product-based. Thus different agencies are using different definitions of what needs to be regulated. Some of these definitions are not based on very sound science.

[19 ELR 10509]

We ought to ask ourselves why such inconsistencies exist. I believe that these and other unmentioned problems are the result of the Reagan administration's desire to avoid new biotechnology legislation. Under the Coordinated Framework policy statement, existing statutes are being twisted to do things they were not intended to do. The resulting mishmash, which takes about fifty pages of fine print in the Federal Register just to describe, is not very good regulatory policy. Ultimately, both researchers and environmentalists would be much better served by new legislation specifically addressing releases of genetically engineered organisms.

Which agency should administer such legislation? Two agencies, EPA and USDA, are currently regulating most releases of genetically engineered organisms. USDA has no mandate to protect the environment, and is responsible for promoting and regulating biotechnology at the same time. EPA has a mandate to protect the environment and no vested interest in the development of biotechnology. Therefore, it is the better agency to regulate releases of genetically engineered organisms.

I am not suggesting that we create a super biotechnology agency or a "Genetic Engineering Act of 1988". We do not need a mechanism to regulate all the products of biotechnology together. The concerns raised by drugs are simply not the same concerns generated by releases of engineered organisms. But in the area of releases, we do need to improve on the Coordinated Framework.

DISCUSSION

JAMES FAUSONE: The environmental groups seem to feel that we need more comprehensive legislation in this area. What is the reaction of the industry representatives?

GODOWN: It is true that reading the Federal Register is not a pleasant task, and that the Coordinated Framework requires hard work to produce the intended coordination. But this regulatory task has been accomplished under existing statutory authority — EPA, USDA, the FDA and the Department of Labor are all involved. Imagine the amount of time and the number of pages of proposed regulations in the Federal Register that would be involved if we started from scratch. We would then have to wait for decisional law on the new statute before industry would feel confident about going forward with biotechnology. I think that the environmental groups are proposing to throw out the baby with the bath water. This should be resisted.

ROGERS: Doesn't the question of whether we are throwing out the baby with the bath water depend on what sort of baby we had in mind? If we were to pass clarifying legislation for TSCA, wouldn't that resolve questions about whether regulations should be process-oriented or product-oriented? Are you barring the possibility of any legislative reform?

GODOWN: Legislative reform being what it is, I think the job can be done as it has been done so far-by drafting appropriate regulations. I am not taking the position that the existing regulations are perfect. I just believe that there is already a sufficient statutory basis to reach our goals by regulatory fine-tuning.

My concern about dipping into the legislative barrel is that we would come out with much more than an apple — we would get a tremendous Christmas tree. A new statute would have to reconcile every legislator's idea about what is wrong with biotechnology or what protection is needed. We would spend years resolving that battle.

The United States is now number one in the world in biotechnology. We can change that if we work hard enough at it.

PARTICIPANT: Dr. Goldburg, you said that regulating recombinant DNA is too narrow an approach, but that there should be an outer limit to regulating genetically engineered organisms. Where is that outer limit?

GOLDBURG: Defining the outer limit is difficult, but clearly, recombinant DNA is not it. One only has to think of new techniques like electroporation,¹ which makes it very easy to insert single genes into the genetic material without recombinant DNA techniques, to realize that regulation based solely on the use of recombinant DNA is outdated. EPA has already proven that one can regulate genetically engineered organisms with criteria that are product-based. EPA has chosen intergeneric organisms as its criterion; I think that classification is a reasonable first step.

PARTICIPANT: The Association of Biotechnology Companies is interested in the skill mixes between USDA and EPA as they relate to the ability to review biotechnology products. What are the checks and balances between the biologists at USDA and the chemists at EPA? If biotechnology regulation is consolidated in one agency, will it be necessary to change the skill mixes?

GOLDBURG: EPA has already put more biologists on staff to deal with biotechnology. Although there might have to be some changes in skill mixes to consolidate regulation, I hope that EPA would continue to draw on USDA's expertise. But EPA is not itself incapable of regulating bio-logical products. The agency is already doing so under TSCA.

PARTICIPANT: It seems that as more groups become involved in biotechnology, there will be more information in the regulatory system. So what advantages does consolidation offer over a system where the Coordinated Framework already gathers enough interesting information?

GOLDBURG: The Coordinated Framework sometimes gathers information twice, and allows duplicate reviews. Single agency regulation could still employ the right scientific expertise, not only by drawing on other agency scientists but also by routinely circulating information to university scientists. EPA sometimes has meetings of university experts who work with the particular organisms that the agency is considering. EPA should continue to do that in order to maximize the use of expertise. So, I do not see scientific expertise as being a limiting factor.

PARTICIPANT: What I am suggesting is that there are certain niches in which each regulatory agency is particularly skilled. If we try to pull out some niches where one agency is not particularly adept, and present them to another agency to implement, we will end up with a long learning curve. We have seen this happen in the Patent Office in this same area.

ROGERS: We have faced this problem in other areas of environmental regulation. In the early 1970s, USDA regulated pesticides. Many people, particularly those in the environmental movement, found this delegation unsatisfactory. Since USDA was also responsible for promoting agribusiness and therefore was pro-pesticide, critics alleged that the dangers of pesticides were not being adequately evaluated. As a result of that debate, EPA ended up with the Federal [19 ELR 10510] Insecticide, Fungicide, and Rodenticide Act (FIFRA)¹ and jurisdiction over pesticides.

The situation is analogous here. Again, USDA is a promotional agency, much like the old Atomic Energy Commission. This causes problems when we try to develop a purely regulatory context for biotechnology.

MELLON: We have seen that whichever agency takes responsibility for biotechnology, that agency will require more expertise. The existing skill mix is not at all adequate. We have never asked questions like the ones we are asking now about biotechnology products. Three or four years ago, there were few ecologists in the federal government, and they probably would have been working on other things.

An advantage to giving a single agency responsibility for biotechnology is that it facilitates compiling the information that we will be gathering as a result of small-scale field tests. We want the regulatory framework to answer questions about the dangers of biotechnology. Right now, we are seeing four or five releases a year. Five years from now, when we are faced with hundreds of releases involving many different strains of organisms, people will be turning to the federal government for assurances that the earlier releases were safe. If the data on earlier releases are scattered, it will not be as easy to answer questions and build on experience as we now envision.

MICHAEL LIDSKY: Lee Rogers indicated that the processing time for permits is 60 days. It is actually 60 days for permits for interstate movement or importation, when the organisms are shipped to a contained facility. For release into the environment, there is a 120-day review period. If we do not believe that we have enough information to make a good decision within that time period, we extend the review period.

Dr. Mellon, you made the point that we need to regulate more plants. It sounds as if you are suggesting that we need to regulate more plants just because they are genetically engineered. USDA's position is that we need to regulate plants if they are potentially harmful to agriculture, but not just because they are genetically engineered.

MELLON: I want to regulate plants if they are potentially harmful to the environment as a whole. USDA, on the other hand, wants to regulate plants if they are potentially harmful to agriculture. I am looking at a larger set of organisms than you are. But I agree that if your purpose is only to regulate plants that are potentially harmful to agriculture, then you probably have an adequate regulatory scheme.

LIDSKY: Another point I would like to make concerns the argument that USDA has a conflict of interest in regulating biotechnology. If the Agricultural Research Service wants to import an organism or do an experiment, they need a permit like everyone else. We have required them to obtain permits for as long as we have had the statutory authority to do so. Universities that are engaged in USDA-funded research must obtain permits as well. There are no special cases.

The Department of Health and Human Services has both research and regulatory responsibilities. Yet, no one questions the adequacy of the FDA's product review just because it is initially funded by NIH. So why do people question USDA? We operate in the same manner.

Lastly, Rebecca Goldburg made a point about singling out recombinant DNA research for regulation. When USDA issued its final rule, we amended the plant pest regulations in 7 CFR Section 320.200 to include processes of genetic engineering other than recombinant DNA techniques. While these regulations do not cover releases into the environment, we are considering making changes to address these concerns.

CHARLES L. ELKINS: This conference has encouraged me to try to make a distinction in my mind between deciding whether something is caught up in the regulatory net and deciding whether it needs an extensive review. We have heard a number of discussions here about possible loopholes in the regulatory net. If a scientist or company wants to create a particular organism there may be a question whether anyone has jurisdiction over it. In my view it is not legitimate to say: "One of the reasons we might not need to include this particular organism in the regulatory net is because there is no risk."

Determinations that something should not be caught up in the regulatory net because there is no risk can be undisciplined determinations not subject to peer review. It is hard to see how an entire class of organisms, no matter what their characteristics or use, can be risk-free.

Once an organism is judged to be within the regulatory net, there should be no expectation that the organism be subjected to onerous requirements. Instead, the expectation should be that a thoughtful assessment of risk be done in a disciplined manner subject to peer review in some fashion and that a risk-based decision be made.

EPA's proposed regulations, at least as now written, state that naturally occurring organisms at the research and development stage will not be examined further. This may be an extreme case of EPA inaction, but the agency is still accountable for this decision: people can challenge it in court. That is different from saying that we do not have jurisdiction and will not even review an organism.

Industry and government would be well served by a complete regulatory net without any holes. Then, industry could be accountable for products on the basis of the risk stemming from a particular organism or use. Otherwise, we leave it to industry or scientists to argue that the net does not apply to them but that we should not worry because there is no risk. That would not be a credible approach.

PARTICIPANT: I have noticed that several of the statutes in this regulatory framework exempt universities and research labs. For example, research labs were exempted recently from reporting releases. Based on Delaware's regulatory experience with research labs and universities, I am not so sure that this is advisable.

GLASS: Your comments raise the point that I was trying to make earlier. The statutes that we have discussed today all have different provisions. Nonetheless, they are all designed to regulate manufacturing and commercial activities. TSCA, in particular, does not apply to research and development activities; they have traditionally not been regulated in many scientific disciplines in this country.

Biotechnology regulation has brought many such activities under regulation for the first time, particularly on the commercial side but in some cases on the university side as well. For example, a university scientist developing a biological pesticide is subject to EPA review under FIFRA. A university researcher developing a chemical pesticide, however, would be free to field-test it as long as the test plot was under ten acres, because of a research exemption in the FIFRA regulations.

So, it is not that a research exemption has been carved out of the regulation in this area, but that for the first time some research has been dragged into regulation.

[19 ELR 10511]

GOLDBURG: Although many are under the impression that the NIH Guidelines cover most research activities, the fact is that they do not. The Guidelines apply to indoor research with recombinant DNA, and they primarily address the risk that recombinant DNA research poses to human health.

The Guidelines contain few provisions that address the issues associated with deliberate release. In fact, NIH is quite obviously trying to get out of the business of reviewing the deliberate release of engineered organisms during the research process. It does not feel comfortable with that role, since most of the NIH members are biomedical researchers. Their withdrawal from this field leaves a big gap.

Because the NIH Guidelines have been in place for so long and have worked fairly well for the activities to which they apply, people erroneously assume that they are in place to deal with this next phase of activity.

PARTICIPANT: To sum up, there is a consensus that there are holes in the regulatory scheme. The question is whether or not these holes can be filled by regulation alone, or whether it will take statutory revision to cover them. We are particularly concerned about regulation of vertebrate animals.

As several scientists have pointed out, once you have done recombinant DNA research, you have the technology. That is, once you develop novel organisms in the laboratory, they are the recombinant DNA technology. This phenomenon may account for why we are finding it necessary to regulate biotechnology research.

1. Office of Science and Technology Policy, Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 et seq. (June 26, 1986).

2. 15 U.S.C. §§ 2601-2654, ELR STAT. TSCA 001.

3. 7 U.S.C. §§ 147a, 150aa-jj.

4. U.S. CONGRESS, OFFICE OF TECHNOLOGY ASSESSMENT, NEW DEVELOPMENTS IN BIOTECHNOLOGY — FIELD-TESTING ENGINEERED ORGANISMS: GENETIC AND ECOLOGICAL ISSUES, OTA-BA-350 (1988) [hereinafter OTA REPORT].

5. OTA REPORT, at 3.

6. OTA REPORT, at 4.

7. Department of Agriculture, 7 CFR Parts 330 and 340, Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There is Reason To Believe Are Plant Pests, 52 Fed. Reg. 22,892 et seq. (June 16, 1987).

8. Department of Health and Human Services, Guidelines for Research Involving Recombinant DNA Molecules, 51 Fed. Reg. 16,958 et seq. (May 7, 1986).

1. Hart, Electroporation: Shocking Cells for Novel Plants, AGRICULTURAL BIOTECHNOLOGY NEWS, Nov./Dec. 1986.

1. 7 U.S.C. §§ 136-136y, ELR STAT. FIFRA 001.