SCOPE 44 - Introduction of Genetically Modified Organisms into the Environment

In response to public concern, Congressional interest and encouragement from the business community, on 26 June 1986 the Executive Branch of the US Government published the final part of the `Coordinated framework for the regulation of biotechnology' in the Federal Register (FR 51, No. 123, pp. 23302-93). This achievement resulted from more than two years of work by a large number of people representing more than 18 federal agencies and executive offices. The goal in developing the `Coordinated framework' was to explain to the American Public that, for questions involving the products of `biotechnology' (more specifically, organisms derived from recombinant-DNA technology), human health and the health of the environment were of paramount concern and were adequately protected. The policy guidelines are based on widely accepted scientific principles and provide a stringent, yet rational, basis for regulation.

The process of development of the Administration's policy began in April of 1984 within a Cabinet Council Working Group. The Working Group was formed in response to public and Congressional concern over the increasing rate of research on organisms destined for introduction into the environment. At the time the process began there was general acceptance of the model of regulation of non-living products; however, there was considerable concern about the impact of new organisms introduced into the environment. The US Environmental Protection Agency (EPA) had begun to take a serious look at the regulatory problems and was working on the development of a policy. It was clear that several agencies had a stake in the process and therefore interagency coordination was essential.

In a December 1984 Federal Register Notice, the Working Group published a proposed coordinated framework which was open for a three month public comment period. Each affected agency attempted to define what it saw as the regulatory challenges of the technology and how the agency might respond. EPA's most critical element was a definition of a `new' organism, the key to regulation under the Toxic Substance Control Act (TSCA). The definition proposed in 1984 was `process' based. A microorganism would be considered `new' if significant human intervention had been used to develop it. Microorganisms developed by recombinant DNA were presumed to be new because they involved significant human intervention.

The December 1984 Notice also included a statement from the US Department of Agriculture (USDA) regarding what constituted a `regulated article' under USDA statutes. The Working Group proposed a strong central `Biotechnology Science Board' to oversee (and second guess) all of the Government's regulatory activity.

Those proposals are now history. In response to the December 1984 Notice the Working Group received hundreds of public comments about all aspects of the policy. While each agency was responsible for dealing with its own policy statement the Working Group served as a central policy coordinating forum. The Working Group eventually voted to eliminate the Biotechnology Science Board and to establish the Biotechnology Science Coordinating Committee (the BSCC) in its place. The BSCC consists of the Commissioner of the Food and Drug Administration, the Director of the National Institutes of Health, the Assistant Secretary of Agriculture for Marketing and Inspection Services, the Assistant Secretary of Agriculture for Science and Education, the Assistant Administrator of EPA for Pesticides and Toxic Substances, the Assistant Administrator of EPA for Research and Development, and the Assistant Director of the National Science Foundation for Biological, Behavioral, and Social Sciences.

The Committee operates as a scientific coordinating committee among the agencies, within the context of its charter and a Memorandum of Understanding signed by each of the members, and is not a committee focusing on regulatory oversight. It is important to recognize two factors about the BSCC. First, its responsibility is to focus on scientific and not policy questions, and, second, it is to act as the vehicle to coordinate agency interaction and help establish a rational basis for establishing lead agency responsibility in those areas where possible overlap of jurisdiction exists.

A central question in the discussion of regulatory oversight and review of the products derived from recombinant DNA revolves around what products constitute a potential hazard, based on a sound analysis of their unique genetic makeup. To that end each of the regulatory agencies, their advisory committees, and the BSCC focused on the definitions of what should be the conditons that trigger a regulatory review. The result was to refine the process-based definition from `human intervention' to include organisms that would not be 'naturally occurring' or are `pathogens.' It was felt that microorganisms resulting from the combination of genetic material among source organisms from different genera should be considered `new.' They were new because of the degree of human intervention required, the significant likelihood of creating new combinations of traits, and the greater uncertainty regarding potential risks of such organisms. Thus, an intergeneric organism would be a `new' organism. Other organisms in the same taxonomic genus created by genetic engineering would not be considered new organisms. However, even these would be regulated if they were pathogenic, under the related definition of pathogen that EPA was developing.

The issue of definitions eventually came before the BSCC as the members represented the particular agencies developing them. The BSCC felt that uniformity across agencies, to the extent possible and appropriate, would strengthen and simplify the regulatory structure. Uniformity would also tend to discourage `agency shopping' by the regulated community seeking to find a sympathetic regulatory agency.

At the time of publication of the 26 June 1986 Notice, it was thought that the appropriate regulatory balance necessary to deal with a new and rapidly developing industry had generally been achieved and, furthermore, that the principles established in this policy would be suitable as a model in other countries.

The 'Coordinated framework' is a broad and complex policy that explains the application of existing statutes to the regulation of recombinant DNA and outlines the approach to interagency coordination, which is so vital to this field.

Government regulation is not organized around technological processes, but rather the government tends to be structured around products, developed by various technologies for specific intended purposes. Therefore, one critical element in a coordinated regulatory framework is the common definition of the nature of the products subject to particular types of regulatory oversight.

The principal focus of the policy is environmental release of new organisms. There has been general acceptance of the regulation of non-living products of biotechnology and, in fact, the 1986 policy reiterates that the past regulatory practices will be maintained. The new policy explained the application of certain statutes over genetically modified organisms, and in some cases even imposes an abbreviated review over unmodified organisms when applied to environmental uses. There is a clear policy established requiring review of genetically engineered microorganisms prior to release into the environment with some organisms subject to an abbreviated review. In the unlikely event of a problem arising in this period of time EPA could use its authority under section 7 of TSCA to immediately limit or prohibit the manufacture, processing, distribution, or use of the product. In addition to the EPA activity, USDA will review all genetically engineered plant pests and animal pathogens.

The 'Coordinated framework' as a document and a policy is only the  beginning. Much work remains ahead in implementation. A major activity is informational and educational. The Biotechnology Science Coordinating Committee and the involved agencies have sought to provide information to the public, and agency officials have frequently testified before Congressional committees.

While it is not possible to predict precisely what impact biotechnology will have on the future of the world economy, most observers feel it will be substantial. Recent predictions state that the current situation in the United States of relatively few sales will change to several billion dollars in the 1990s and as much as 40 billion by the year 2000. The product mix by that time is expected to be pharmaceuticals, agricultural chemicals and pesticides, growth-promoting hormones for animals and plants, and a line of very high value added industrial chemicals. Many observers predict that the use of specially engineered microorganisms to degrade pollutants and chemicals and biological waste-treatment processes are also highly probably products for the relatively near future.

It appears, to the concern of many observers, that two non-scientific issues may play a dominant role in the future of biotechnology development and implementation in the United States. First, the regulatory climate could, if not rational, present industry with an insurmountable problem for the eventual introduction of products being developed now, leading to a future withdrawal of activities in these areas. Second, concerns within the financial community about the long-term stability of companies doing business in environmentally regulated fields will lead to decreased company values and lack of capital for the continued development and testing necessary to overcome the regulatory barriers of safety and effectiveness.

Everyone associated with the regulatory questions related to the issues of biotechnology have a major responsibility to balance the various opposing forces facing this technology. We cannot accept the notion that all biotechnology-derived products are too dangerous to introduce into the environment, yet we must acknowledge the legitimate concerns of the public and work to establish those principles that govern the safe environmental use of these products and allow the underlying research to proceed. In such a fast-moving technological environment it is necessary to regularly review the appropriateness of the scientific basis of existing regulation and to make any required adjustments in either the technology of regulation or the statutory basis for regulation. The interagency committees that worked on the current policy consider the existing regulations to cover the current and near-term biotechnology industry. As the technology changes we must continue to monitor those changes and work together to keep our regulatory `coordinated framework' modern and effective.

From a scientific viewpoint there are a number of questions that must be addressed as we view the appropriateness of various environmental applications of genetically modified organisms. These questions center on the uniqueness of the organisms and the properties that they possess that might pose an environmental hazard. The following questions are the most significant:

1. Is it inherently dangerous to use recombinant-DNA techniques to move genes between unrelated organisms?

2. Are recombinant-DNA engineered organisms like nonnative organisms? 

3. Will the use of recombinant-DNA techniques accidentally create new plant pests?

4. Can recombinant-DNA accidentally convert a nonpathogen to a pathogen?

5. Can introduced genes spread in a microbial or plant population?

6. Will recombinant-DNA engineered microorganisms alter soil microbial communities?

This set of questions can be easily addressed within the context of present knowledge based on past work in a number of fields. We cannot ignore the work of the last century, especially in the agricultural areas where the breeding of new plants and development of new microbes has been the mainstay of agricultural research. If one carefully examines the above questions and develops answers based on scientific evidence the conclusion is that the potential hazards posed by recombinant-DNA technology may be identified with little difficulty and may be managed easily at the early research stage. The conclusion that may be reached from this analysis is that the role of the regulatory bodies is to examine the evidence provided by the producers and determine the veracity of the data. More importantly, however, the proper analysis leads one to conclude that the potential hazards may be much easier to identify than is frequently stated and that over time broader categories of exclusions should be developed.