the public administrator engages biotechnology—a case of multiple roles

13
Policy Studies Review, Winter 1989 VOl. 8, NO. 2, pp. 455-467 THE PUBLIC ADMINISTRATOR ENGAGES Wayne Matthews and Morris Bosin BIOTECHNOLOGY-A CASE OF MULTIPLE ROLES The major purpose of this article is to examine possible roles available to the public administrator in addressing the emergence of biotechnology as a powerful shaping force in our society. To set the stage for this examina- tion, it might be useful to look in on a scenario that could be happening at any one of several federal agencies in Washington, D.C. John "X" is a division director in a prominent federal regulatory agency. His division is one of several staffs that is responsible for reviewing new product applications from industry. He arrives at work one morning to find a "special attention" package on his desk. It is an application from a large drug firm for approval to market a new product. However, this product is different because it has been developed via a biotechnology process--geneti- cally engineered microorganisms have been employed in the manufacture of the drug. John immediately informs his supervisor, his contacts in the Division of Regulatory Affairs, and the General Counsel in order to alert the "system" and to begin spreading the burden of simply "knowing." John and the firm's scientific and regulatory staff have been in contact on several occasions prior to the formal submission of this application. They have conferred informally concerning the approvability of the product. Through prior discussions the firm has now become somewhat more familiar with agency mechanisms and procedures with which they must conform to be considered as having an approvable product. At the same time, John and his staff have grown somewhat more confident (but not completely assured) that the company has undertaken appropriate studies and testing to assure safety and efficacy of the product. The company may even feel sufficiently confident to pave the way for their new product by initiating external pressures to ensure that it will be approved--including generating media publicity about the life-enhancing or prolonging qualities of the product. Scientists themselves, in order to establish research preeminence in a particular area, may release early, promising findings in medical journals--and subsequently the popular press may give advanced findings further publicity to the general public. As such pressure is exerted, John "X" will be in the position of attempting to balance the external interests for approval against the need for his own agency scientists to conduct a comprehensive assessment of the overall risk that these new biotechnology products represent to the general public. Specific questions to be answered in his risk assessment process include: * How close is the genetically engineered product in chemical make- up to the traditional version? * Will any viable genetic material be inadvertently transferred to humans, and have unanticipated negative consequences? 455

Upload: wayne-matthews

Post on 27-Sep-2016

212 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

Policy Studies Review, Winter 1989 VOl. 8, NO. 2, pp. 455-467

THE PUBLIC ADMINISTRATOR ENGAGES

Wayne Matthews and Morris Bosin BIOTECHNOLOGY-A CASE OF MULTIPLE ROLES

The major purpose of this article is to examine possible roles available to the public administrator in addressing the emergence of biotechnology as a powerful shaping force in our society. To set the stage for this examina- tion, it might be useful to look in on a scenario that could be happening a t any one of several federal agencies in Washington, D.C.

John "X" is a division director in a prominent federal regulatory agency. His division is one of several staffs that is responsible for reviewing new product applications from industry. He arrives a t work one morning to find a "special attention" package on his desk. It is an application from a large drug firm for approval to market a new product. However, this product is different because it has been developed via a biotechnology process--geneti- cally engineered microorganisms have been employed in the manufacture of the drug. John immediately informs his supervisor, his contacts in the Division of Regulatory Affairs, and the General Counsel in order to alert the "system" and to begin spreading the burden of simply "knowing."

John and the firm's scientific and regulatory staff have been in contact on several occasions prior to the formal submission of this application. They have conferred informally concerning t h e approvability o f t h e product. Through prior discussions the firm has now become somewhat more familiar with agency mechanisms and procedures with which they must conform to be considered as having an approvable product. At the same time, John and his staff have grown somewhat more confident (but not completely assured) that the company has undertaken appropriate studies and testing to assure safety and efficacy of the product.

The company may even feel sufficiently confident to pave the way for their new product by initiating external pressures to ensure that it will be approved--including generating media publicity about the life-enhancing or prolonging qualities of the product. Scientists themselves, in order t o establish research preeminence in a particular area, may release early, promising findings in medical journals--and subsequently the popular press may give advanced findings further publicity to the general public.

As such pressure is exerted, John "X" will be in the position of attempting to balance the external interests for approval against the need for his own agency scientists to conduct a comprehensive assessment of the overall risk that these new biotechnology products represent to the general public. Specific questions to be answered in his risk assessment process include:

* How close is the genetically engineered product in chemical make- up to the traditional version?

* Will any viable genetic material be inadvertently transferred to humans, and have unanticipated negative consequences?

455

Page 2: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

456 Policy Studies Review, Winter 1989, 8:2

* What laboratory controls are in effect to ensure that modified or- ganisms of any type are not accidentally released into the outside environment?

John believes that the tendency of the current administration is to approve these products. If this happens i t will be accompanied by positive publicity for several groups. These include

* the regulatory agency that was sufficiently far-sighted to foster in- dustry innovation and yet still managed to safeguard the health and safety of the public;

the industry that provided the innovative machinery and capital to make the dream a reality; and

*

* a prescient Congress and administration who had the vision to provide a flexible legislative and implementation framework which enabled the public and private sector to work together as partners, not adver- saries.

The above case demonstrates one of the most perplexing dilemmas facing today’s public administrators. How do they address emerging new tech- nologies in our environment, technologies that hold great promise for improving quality of life, but whose potential adverse consequences must be understood and managed by the public sector? This article will examine the public administrator’s role from two distinctly different perspectives, the functional, and the interpretive. The functionalist perspective is char- acterized by a belief t ha t organizations, environments, products, and processes are concrete, objective entities. These entities can be dealt with, a t times through an instrumental logic and a t others via political maneuver- ing both inside and outside of the “organization.” But in both instances the administrator is attempting to cope with an objectively defined social world. The vast majority of management, public administration, and organization theory literature is written from a functionalist orientation.

From the interpretive perspective all meanings are socially constructed. They are given life, elevated, and supported by people. Meanings ascend in importance and influence a s they are more widely shared. Thus, to an interpretivist it is crucial to study meanings underlying action--meaning from the social actor’s point of view and the process by which meaning is created. So, for example, from the interpretive perspective, rather than an administrator attempting to determine the most effective program strategy to address biotechnology developments (functionalist stance), the notion of effectiveness itself becomes problematic, and needs t o be investigated (Bur- re11 & Morgan, 1980). In order to understand the difference between functionalist and interpretive slants, the paper will proceed as follows:

1. The challenge (problem and opportunity) of biotechnology will be out-

2. Our introductor scenario will be re-examined, first from a functionalist

lined along with an overview of current regulatory efforts.

perspective, anzsecond from an interpretive point of view.

Page 3: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

Matthews/Bosin: The Public Administrator. . . 457

3. A rationale is offered to explain how the interpretive view of the public administrator's job can help to improve his or her response to the challenge of biotechnology.

BIOTECHNOLOGY - THE CHALLENGE

Biotechnology attempts to use biological systems (or parts of organisms) for practical purposes (Becker, 1985; Cheremisnoff & Ouelletts, 1985; Wat- son, Tooze, & Kurts, 1983; Whelan & Black, 1982). The techniques of biotechnology are being applied to many organisms, including viruses, fungi, bacteria, algae, and higher plants and animals. There is little doubt that biotechnology has captured the fascination and concern of scientists, entrepreneurs, and the general public. Jus t how rapidly this has occurred is illustrated by the following passage:

On the floor of the New York Stock Exchange one morning in 1980, when the announcement was made that Genentech, a new biotech- nology firm, had gone public, their stock rose from $36 to $89 in twenty minutes--a Wall Street Record. One popular newspaper termed i t "love a t first sight." The next year, more than 80 biotech- nology firms were established, and Cetus Corporation set a Wall Street record for the largest amount of money raised in an initial offering--$115 million. (Washington Post, 1985)

The economic potential of biotechnology is awesome. More than $1.4 billion is being invested each year in biotechnology research. Studies predict that sales of biotechnology products by the turn of the century could total $10 billion to $15 billion. These figures are based on the projected productivity of more than 200 biotechnology companies and a host of phar- maceutical, chemical, and farm product manufacturers that are seeking t o license a new generation of vaccines, drugs, pesticides, plants, and other products using biotechnology. Zilinskas (1980) and Grobstein (1983) have characterized biotechnology as Janus-like, with both beneficial and poten- tially negative affects on humanity. Most acknowledge however that the field will play a major part in the nature of human existence (Markle & Robins, 1985).

The current regulatory strategy being applied to biotechnology might be described as one of cautious but increasing optimism concerning the safety of these developments. Most federal agencies believe that the safety and environmental effects of biotechnology can be adequately addressed through such existing statutes as the Pure Food, Drugs, and Cosmetics Act, and the Toxic Substances Control Act. Nevertheless, it is likely that careful thought and debate will ensue about if and when certain statutes and regulations are applicable (Biotechnology Regulation, 1984; Coordinated Framework for Regulation of Biotechnology Hearing 1986). In 1976, NIH issued guidelines for research involving rDNA molecules. The guidelines apply to institutions and individuals receiving support from NIH for such research. Additional guidelines were published in 1986 (Guidelines for Research Involving Recombinant DNA Molecules, NIH).

A report on genetic engineering prepared by the Office of Technology Assessment (OTA) observes t h a t two t rends have developed a s the guidelines have evolved. First, requirements that specify conditions under

Page 4: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

458 Policy Studies Review, Winter 1989, 8 2

which rDNA experiments may be conducted have been progressively lowered. Second, centralized federal oversight has been substantially reduced by easing requirements for registration and review of experiments for which containment levels are specified in the guidelines. The momen- tum of product development and approval is not likely to slow down ap- preciably. The Food and Drug Administration (FDA) for example, has already reviewed and approved human insulin, human growth hormone, and alpha interferon made through genetic engineering, a s well as several diagnostic products derived from monoclonal antibodies.

As these new technologies continue to emerge, public administrators will ponder over the appropriate stance to take. Some light can be shed on alternatives available to the federal manager by analyzing the job from both the functionalist and interpretive perspective.

NEW PRODUCT APPROVAL - A FUNCTIONALIST PERSPECTIVE

Functionalist literature from several disciplines including, management, public administration, and organization theory, have depicted the role of t h e organizational manager a s multi-dimensional. Graham Allison’s models of rational actor, organizational process, and bureaucratic politics, can be used as a representative functionalist explanation of what transpires in the biotechnology product approval process (1971). In Allison’s rational actor model, the presumption is that given sufficient time and information, administrators can discover logical solutions to even the most complex problems. In the organizational process model, the administrator’s key concern is continuing to deliver what the organization characteristically produces. The administrator is constrained by existing organizational routines and current physical capabilities. Ranges of effective choices open to leaders are limited by such capabilities. In the bureaucratic politics model, the basic units of analysis are results that occur--not as a matter of conscious choice by an administrator--but through compromise, conflict, and confusion. lnterested parties are diverse, and have unequal influence.

I t is apparent from our introductory scenario that all three frames of reference have been employed. Industry’s increased understanding and appreciation of the agency’s mechanisms and procedures that must be complied with in submitting product applications is explainable from an organizational process frame of reference. John “X“, operating from an organizational process model, will be inclined to view the adequacy of federal regulation from the perspective of how his organization has tradi- tionally regulated products in the pre-biotechnology era. The traditional view is that health and safety regulations should be promulgated on the basis of products that are produced and consumed, and not on the basis of the process that is utilized to create the product--whether that process involves the use of genetic engineering or more traditional approaches (Miller, 1987).

Allison’s bureaucratic politics model explains why the firm’s increasing level of confidence (as increasing familiarity is gained with agency require- ments) may motivate i t to initiate pre-approval publicity via the mass media. If company managers sense that the current administration is highly motivated to foster industry innovation, then that prevailing intent will be played upon. John “X’s concern about how fast he should move

Page 5: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

Matthews/Bosin: The Public Administrator. . . 459

ahead with product approval may also be viewed from a bureaucratic politics model. How will a compromise be reached among the competing values of espoused by public interest groups, industry, and the federal government?

John might make the following assumptions under the bureaucratic politics model: Which of these groups are the most well mobilized? The Agricultural lobby? The Environmental Defense Fund? OMB? For ex- ample, how long can a regulation stop the use of rDNA-altered bacteria or rDNA strawberries to raise the temperature a t which frost forms on them, so tha t t he industry can save previously destroyed crops? When will in- dustry s tar t to object to the regulatory delay? How quickly can the product be approved without incurring the wrath of public interest groups? (Time, 1987).

Many (but not all) of the questions posed as part of the risk assessment process spring from Allison's rational actor model. How similar is the chemical makeup of the genetically engineered product to the product produced via traditional methods? How sure are we tha t viable genetic material is not inadvertently passed to humans consuming or using a geneti- cally engineered product? (Covello & Fiksel, 1985). How good are laboratory controls? (Andow 1986; Bovallius, Roffey, & Henniger, 1980; Madsen & Alexander, 1982).

A functionalist explanation of John "X"'s product approval activities leaves him in a somewhat splintered state. He wants to assess and manage the risk associated with these new products (rational actor). He is inclined to follow the l ines of least organizational resistance (organizational process) but he knows that in the last analysis the outcomes produced in the product approval arena are largely outside of his control because of the tug of competing interests (bureaucratic politics).

NEW PRODUCT APPROVAL - AN INTERPRETIVE PERSPECTIVE

Interpretivists would view the product approval process in a distinctly different light. Namely, as a process of socially constructed meaning. Central to t he interpretive view of public administration is the concept of enactment. Enactment has been termed as "acting with a predisposition" (Daft & Weick, 1984; Smircich & Stubbart, 1985). To enact is to experience, and in the process of experiencing, one essentially shapes the reality around one. Generally, one then reacts to that enactment as if it were independent of its creator. The process of enacting tends to eliminate alternative ways of acting. Through an enactment, an individual creates a strand of meaning out of a relatively ambiguous world. Meanings and understandings are constantly emerging through interactions, being shared, eventually taken for granted by the actors in a situation, and then used as a basis for planning subsequent actions. From a n in te rpre t ive perspective, public ad- ministrators such as John "X" not only enact to create patterns of meaning from essentially ambiguous data, they also rally and marshal1 support for certain categories of meaning above all others for the purpose of achieving some desiredpersonal end state.

The biotechnology product approval process can now be viewed as a series of enactments. In the introductory scenario there are shared enact-

Page 6: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

460 Policy Studies Review, Winter 1989, 8:2

ments and understandings of reality taking place at different levels. Three discernible levels of shared reality are

1. an agency-industry enactment

2. an agency-public enactment

3 . a congressional-presidential-public enactment

Agency-Industry Enactment

At the agency-industry level both parties engage in a process through which meanings are negotiated with respect to biotechnology products. Industry and government scientists attempt to understand each other's intents. Data submitted by industry to support product applications need to make sense to reviewers like John "X". As the biotechnology paradigms between industry and government are mutually constructed, shared under- standings regarding data, testing procedures, and so forth become increas- ingly easy to achieve. Confidence levels between the two parties also grow, and each party develops expectations of the other. Each party's action reinforces actions of the other party. In a situation where government is regulating industry activity, a mutual defining process occurs (Schutz, 1970). The type and extent of federal oversight is shaped by the kind of industry activity occurring, and the range of permissible activity, in turn, is influenced by the nature of federal oversight. An acceptable "approvable biotechnology product" evolves. This tends to eliminate the surprise factor when industry applications are submitted to reviewing agencies.

To a functionalist the importance of this negotiation process lies in the fact that both company and agency are moving closer to some ultimate objective t r u t h about t he safety and efficacy of biotechnology-based products. However, from an interpretive view the significance of the negotiation rests in (1) its ability to create mutually agreed upon meaning regardless of any perceived external validity of those meanings and (2) the power residing in those meanings to shape future actions or the part of both government and industry.

Conflicts in understanding can arise to the extent that information from either party is withheld, revealed suddenly, or if one party attempts to circumvent the other by establishing a different meaning with a third party such as the press. Sudden revelations of information can occur on both industry and government sides. I t occurs on the industry side if a firm submits a formal application for a new product without engaging in prior informal communication. Conversely, shared understanding can be weakened if the regulatory agency issues a new rule concerning biotechnol- ogy-based products in the absence of prior consulting with industry.

Agency-Public Enactment

A second level of enactment occurs as the federal regulatory agency attempts to engage the public in a set of shared meanings concerning biotechnology. The principle actors within this second enactment frame are agency administrators, the mass media, public interest groups, and the

Page 7: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

Matthews/Bosin: The Public Administrator. . . 46 1

general public. The enactment a t this level is geared toward raising public confidence in the safety of genetically-engineered products.

Establishment of shared meanings between federal agencies and the public entails t he management of public perceptions. Virtually every biotechnology conference that has been held within the past three years has devoted special attention to the issue of public perceptions regarding biotechnology. To what extent does the public believe that a genuine danger exists with respect to genetic engineering? What can be done to quell the public fears? The objective that federal agencies appear to have adopted at this level of enactment is to have the general public conclude tha t biotechnology-based products are, in fact, as safe as products produced via conventional means.

Several strategies are being employed in this regard. First, there has been an attempt on the part of federal agencies to demystify biotechnology by claiming that biotechnology is not really a new phenomenon. Beer, for example, has been fermented by using living organisms for thousands of years, and USDA has been engaged in animal and plant crossbreeding for a t least fifty years. Second, agencies such as USDA, EPA, NIH, FDA, and the National Academy of Sciences have issued pronouncements that it is adequate, for the most part, to regulate products produced via biotechnol- ogy through existing regulatory mechanisms. New legislative or regulatory machinery is not required. The safety of products for consumption can be guaranteed by monitoring the end product or end use rather than the process utilized to create the product. A third strategy to allay fears is the establishment of a unified framework of regulation to assure the public that the new technology is being monitored and controlled. This framework, established in 1985, outlines regulatory responsibilities of each federal agency having purview over biotechnology developments. In addition, some over-arching, coordinating mechanisms were established for the purpose of facilitating communication and appropriate review of new biotechnology products across agency lines.

Despite these strategies, some public administrators still struggle, privately, over the appropriate regulatory stance to take. Products of biotechnology are evolving so rapidly that verification of product and process safety and efficacy, through rigorous studies and testing proce- dures, is becoming increasingly difficult to determine. For instance, many scientists and administrators are concerned about release into the environ- ment of genetically altered and viable organisms or other entities. Where, wonder some administrators and program managers, are there gaps in the regulation, and how big are those gaps? Concern has also been expressed by public interest groups such as the Environmental Defense Fund. How- ever, the latter’s attempts to block genetic experimentation and environ- mental release through litigation have been only partially successful and to the extent that they have not proved effective, the enactment of biotech- nology as a ”safe science” has remained intact.

Page 8: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

462 Policy Studies Review, Winter 1989, 8:2

Presidential-Congressional-Public Enactment

Despite possible continuing concern about having a shared under- standing of biotechnology risk between regulator and regulated, a third level of enactment is also underway. At this level, the current administra- tion is encouraging public acceptance of biotechnology within a broader context of accepted beliefs. One of these concerns the underlying merit of privatization--that it is generally desirable to encourage rather than stifle industry innovation in order to improve the quality of life for society as a whole. Par t of this enactment is the belief that the president, his cabinet members, and Congress are actively keeping apprised of state-of-the art technologies. They are not detached, passive entities but are, in fact, managing technologies at the societal level, because these advances will have a significant impact on our life styles for years to come. This presen- tation of t he government to the people occupies the time and energies of many planning, public affairs, and policy staffs in Washington, D.C.

HOW CAN AN INTERPRETIVE APPROACH ASSIST THE PUBLIC AD- MINISTRATOR IN ADDRESSING BIOTECHNOLOGY?

Authors such as Kaufman (1969), Medeiros and Schmitt (1977), and Allison (1971)--arguing from a functionalist perspective--have presented the role of the administrator as one of mediating among values of efficien- cy/rationality, bureaucratic process, and politics. However, from an inter- pretive perspective, as we have seen, the mediation role of the public administrator drastically changes focus. I t becomes one of coordinating among different levels of enactment, or meaning, all of which may be in operation simultaneously. These meaning creation activities should be coordinated if enactments are to be coherent.

Table 1 illustrates the contrast in functionalist and interpretive accounts of our introductory scenario. Although this article has been written from the perspective of the interpretive researcher, that same frame of reference can be adopted by the public administrator. If this occurs, i t is likely to affect him in two ways: (1) what he or she is aware of; and (2) how he or she acts.

The Enacting Administrator--Increased Awareness

The administrator who is aware that he or she is in an enacting role, tries to suspend attitudes about the everyday world of regulation that are or- dinarily taken for granted. As such the administrator is likely to focus on some rather overarching questions concerning alternative conceptual ap- proaches in regulating biotechnology. To do this, certain traditional frames of reference and conceptual categories may have t o be a t least mentally dismantled. This entails purposely blurring the line between what tradi- t iona l a d m i n i s t r a t o r s may have previously conceived a s d is t inc t dichotomies. These include the notions of private vs. public sector; product vs. process; and risk assessment vs. risk management. Several illustrations are provided below which indicate tha t current governmental efforts are, in fact, sympathetic with an interpretive approach to managing the biotech-

Page 9: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

Matthews/Bosin: The Public Administrator. . . 463

Table 1 Biotechnology Product Review and Approval

Functional Model

Organizational Process

Prior to formal submission of a new product application, John ’X’ and company scientists learn the rules, procedures, activities, and ex- pectations of each others’ organizations.

Rational Actor

Agency scientists and regulators attempt to assess the degree of risk associated with new biotechnology products and determine accept- able risk-benefit ratios.

Bureaucratic Politics

Company officials may feel sufficiently confi- dent in their prospects for product approval to bring influences to bear on the situation, i.e., releases to the press, an informal call to OMB, etc. Scientists may also attempt to establish credit for new discoveries by publicizing early research results. Regulatory agency ad- ministrators may attempt to alleviate unneces- sary pub l i c fears concern ing new genetically-engineered products. They ac- complish this by managing public perceptions through education of the media, themselves.

Higher level government officials attempt to reinforce public confidence in the entire public- private sector partnership by emphasizing the positive aspects of biotechnology risk manage- ment on the part of federal regulators.

Interpretive Model

Enactment Level 1

John ’X’ and company scientists socially con- struct a shared meaning of biotechnology product safety/efficacy. This occurs through research results, tests of safety, and interpreta- tion of those tests. Interpretation of results is strongly influenced by the mutual learning taking place. During this learning process the agency reviewers develop expectations of what industry Is capable of accomplishing. A jointly constructed meaning of approvability may eventually be enacted. Shared meaning may be disrupted if results are shared with the press and the public before agency reviewers are comfortable or if the agency issues formal rules without prior negotiation.

Enactment Level 2

Regulatory agency administrators may attempt to enact a meaning of biotechnology safety and efficacy that the public will accept and which will result in a higher level of confidence in the agency, the industry, and in the safety of con- suming products developed through biotech- nology.

Enactment Level 3

A meaning is created and supported by ail relevant actors that citizens can enjoy the benefits of biotechnology while having their health and safety interests safeguarded by competent government and business leader- ship.

nology effort. The public-private sector dichotomy is already being blurred in the development of biotechnology in several ways. Examples include

* indirect subsidization of industry through federal research grants and agreements with universities who subsequently contract with firms for product research and development;

* efforts by the U.S. Department of Commerce to promote U.S. biotech- nology; and

federal regulation and permission to conduct field trials and to market rDNA produced products.

*

Page 10: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

464 Policy Studies Review, Winter 1989, 8:2

A traditional tenet of regulatory policy in several federal agencies, such as FDA and USDA, is to manage health risks on the basis of final products and not on the process that is involved in the creation of the product. The enac t ing adminis t ra tor , however, may not be a s wed a s o the r ad- ministrators are to the traditional distinction between product and process when i t comes to regulating biotechnology. He or she may reason that i t is not possible to understand fully what constitutes a genetically-engineered product entering the marketplace unless the process of gene mapping, sequencing, and manipulation is also understood. He or she realizes that understanding the process of genetic modification may be a firmer basis on which to assess safety and efficacy than checking for product composition or attributes.

Enacting public administrators are finding that the line is also blurring between risk assessment and risk management. Traditionally, risk assess- ment has been defined as making an objective determination of how much risk is involved in using a product or procedure. Risk management, on the other hand, entails making value judgments about how much risk is accept- able for given levels of benefit. Enacting administrators realize, however, that risk assessments in themselves involve making key value judgments.

Many biotechnology products produced by recombinant DNA procedures must be tested to determine whether the product contains any viable genetic material that might be harmful for humans. These products are tested in animals to determine their safety. Judgments must be made during risk assessment that involve both fact and value because human toxicological data is lacking. Values are involved in deciding how much credence one places on the tests, and what tests to employ. Beyond having the capability to loosen previously sedimented categories of meaning, the enacting administrator is introspective. What is my own orientation toward biotechnology? Is it an opportunity to enhance my personal scien- tific reputation? To gain additional research or regulatory turf’? To realize a financial windfall for my organization? How do these orientations affect my own strategy decision regarding how I assess risk, manage risk, or choose to manage public perceptions? The enacting administrator is par- ticularly sensitive to socially constructed meanings. From his or her perspective, biotechnology is a term that has been socially, not scientifical- ly, defined. How we choose to define biotechnology and what activities we select for inclusion in this category have substantial impacts. Some of these include direction and level of funding available for research, whether an activity is applicable under certain legislative or regulatory statutes, and whether a private sector research activity is eligible for patent protection.

The Enacting Administrator-Actions Taken

The enacting public administrator, as any other administrator, is called upon to arrive at decisions regarding the regulation of biotechnology. Fur- ther, he or she must make those decisions with the added realization that he or she (and others) are standing on a slippery slope of social construc- tions (Berger & Luckmann, 1967). The level of risk associated with biotech- nology, the blending of biotechnological process and product, the public perception of biotechnology, and even the definitions of biotechnology it- self, all are temporary constructs. Nevertheless, some definitive actions--

Page 11: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

Matthews/Bosin: The Public Administrator. . . 465

beyond simply possessing a greater awareness--are possible in order to improve the quality of decisions.

Distinguish Between Acting "As if" and Being "For Real"

The administrator attempts to distinguish those instances where h e or she is knowingly acting in a staged situation with respect to biotechnology. For instance, he or she may act as if he or she is a rational scientist dedicated to understanding the basic mechanisms of an organism's reaction to toxic levels. This pretending or taking the view of the others enables the administrator to consider a question involving biotechnology from one point of view--the rational. In a similar fashion other views may be taken. Yet, i t is critical to the effective administration of biotechnology development tha t the public administrator adopt a being for real stance, i.e., one where he or she is genuinely trying to understand the administrative complexity of the situation. There may be certain instances where an administrator needs to demonstrate a role to others for a motive; and there are other instances where he or she becomes so involved that he or she becomes the role; i.e., where his or her self-identity and his or her role playing are indistinguishable. If administrators can be a par t of t h e process of deliberating about a broader biotechnology while maintaining a "reflective aloofness," they will be in a better position to judge the various options and precautions that need to be taken in developing biotechnology.

Institutionalize Opposing Perspectives

Enacting administrators should not surround themselves with staff people who tend to see the biotechnology environment in the same way they do. People with opposing viewpoints should be employed to bring into consideration a range of questions that need to be assessed to assure that the fullest impact of a decision is being considered.

Recognize the Ongoing Nature of Decision-Making

Enacting administrators should recognize that the more visible decisions in the biotechnology arena are staged and scripted, e.g., the announced decisions to approve an experiment using genetically-modified ice- minus bacteria. But such a publicly-announced decision reflects a more subtle and ongoing deliberation that inevitably can only lead to the staged decision. The enacting administrator recognizes such events as shapers of meaning tha t influence the public's acceptance of the new technology. From this view, he or she may see a need to be involved in the publicity and the regulation of publicity that surrounds these events.

SUMMARY

When viewed from the epistemological perspective of the authors, public administrators who are currently attempting to address the biotechnology issue enact the realities associated with that issue. That is, they construct a framework of meaning surrounding biotechnology out of an ambiguous backdrop of data , events, disciplines, and people. What constitutes

Page 12: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

466 Policy Studies Review, Winter 7989, 8:2

"biotechnology," "acceptable risk," "legitimate risk assessment procedures," and the like, is developed through a process of social negotiation and gradual build up of shared understanding. Biotechnology and its associated concepts are not objectively determined. A case can be made that public administrators who buy into the interpretive epistemology themselves ( that all meanings are socially constructed) are more effective managers. This is because they have a unique perspective on the notion of "perspec- tive" itself. They have a facility to move into, and perhaps more important- ly, out of reference frames, e.g., rational, bureaucratic, political, more easily than their non-interpretive counterparts. They understand the deeper meanings associated with biotechnology and they understand who the people and institutions are within the "organization" who help to shape those meanings. With this enhanced understanding, interpretive ad- ministrators are capable of shaping the direction of meanings associated with biotechnology--and they do.

REFERENCES

Allison, G. (1971). Essence of decision--explaining the Cuban missile crises. Cambridge, MA: Harvard University.

Andow, D.A. Fate of microorganisms in the environment. Environmental Management, 10,470-487.

Uecker, Y. (Ed.). (1985). Recombinant D N A research and viruses: Cloning and expression of viral genes. Boston: Martinus Nijhoff Publishing.

Ijerger, P.L., & Luckmann, T. (1967). T h e social construction of reality. Garden City, NY: Dsubleday.

Biotechnology regulation. (1984, December 11). Hearing before the Subcom- mittee on Oversight and Investigations of the Committee on Energy and Commerce House of Representatives.

Bovallius, A.B.R., & Henniger, E. (1980). Long range air transmission of bacteria. Applied and Enuironmental Microbiology, 35, 1231-1232.

Cheremisnoff, P., & Ouellette, R.P. (Eds.). (1985). Biotechnology: Applica- t ions and research. Lancaster, PA: Technomic Publishing Company.

Coordinated framework for regulation of biotechnology. (1986, July 23). Hearings before the Subcommittee on Investigations and Oversight and the Subcommittee on Natural Resources, Agriculture Research and En- vironment of the Committee on Science and Technology House of Repre- sentatives.

Daft, C., & Weick, K.E. (1984). Toward a model of organizations as inter- pretation systems. Academy of Management Review, 2,284-285.

Grobstein, C. (1983). Who is Janus? Politics and the Li fe Sciences, 2, 55-59. Kaufman, H. (1969). Administrative decentralization and political power.

Public Adminis trat ion Review, 29(1), 11-18. Kohler, G., & Milstein, C. (1975). Continuous cultures of fused cells secret-

ing antibody of predefined specificity. Nature, 256, 495-497. Madsen, E.L., & Alexander, M. (1982). Transport of rhizobium and pseudo-

monas through soil. Soil Science Society ofAmerica Journal , 46,557-560. Markle, G.E., & Robins, S.S. (1984). Biotechnology and the social reconstruc-

t i o n of molecular biology. Paper presented at t h e meet ing of t h e American Association for the Advancement of Science.

Page 13: THE PUBLIC ADMINISTRATOR ENGAGES BIOTECHNOLOGY—A CASE OF MULTIPLE ROLES

Matthews/Bosin: The Public Administrator. . . 467

Medeiros, J.A., & Schmitt, D. (1977). Public bureaucracy: Values and

Schutz, A. (1967). The phenomenology of the social world. Evanston, IL:

Smircich, L., & Stubbart, C. (1985). Strategic management in an enacted

Tubers, berries and bugs: Scientists release man-made microbes into the

Watson, J.D., Tooze, J., & Kurtz, D.T. (1983). Recombinant DNA: A short

Whelan, W.J., & Black, S. (1982). From genetic experimentation to biotech-

perspectives. North Scituate, MA: Duxbury Press.

Northwestern University Press.

world. Academy of Management Review, 4 , 724-736.

environment. (1987). Time.

course. New York: Scientific American Books.

nology--the critical transition. New York: John Wiley and Sons.