Who should regulate?

38 BioEssays Vol. 8, No. 1 -January 1988

Who Should Regulate? Judith Freeman

As we stand on the threshold of a new era of agricultural technology and accomplishment, brought on by ad- vances in genetic engineering, it is timely that we consider the evolving role of an active and informed populace in the regulatory process. Governmental regulation of technology has long been a complex and difficult process that must integrate the frequent ambiguity of statutory intent, the assumed objec- tivity of scientific expertise and data, and the natural subjectivity of risk/ benefit or cost/benefit analyses. Today, however, more than ever before, regulatory agencies must also balance the viewpoints of special interests, such as industry, public advocacy groups, and professional associations. The issue of public participation in the regulatory process and the influence of public opinion on that process are growing in importance - particularly in light of intense media attention focussed on, such activities as the uses of pesticides and planned releases of genetically engineered organisms. The public is and should be involved in regulatory over- sight, but concomitant with that involvement is the responsibility on the part of the public to educate itself so that its involvement is one of understanding and rationality, rather than of perception and emotionality.

For example, public interest is likely to be intense when first a company or university researcher desires to release genetically engineering organisms into the environment ; such experimentation was delayed at least three years in California because of the public interest in the ‘ice-minus’ bacterium. As a scientist involved in regulatory pro- cedures, I recognize the need for public involvement in such matters. However, I am equally concerned about delays in the development of important genetically engineered products as I am interested in regulating against those products which may pose unreasonable risk to human health and the environment. On the one hand, the vicissitudes of traditional agricultural products have demonstrated that government regulation without public input is not

appropriate and that the absence of public involvement only enlarges the chasm of credibility between the regulatory agency and the public, while on the other regulation based primarily- on public perception is a random process tantamount to no regulation at all.

A few years ago, Washington’s Department of Agriculture initiated an eradication program against a small population of gypsy moths which had been detected near the University of Washington in Seattle. Initial field pro- posals for methods of control (aerial applications of a conventional insecticide) were met with loud public protest. A series of neighborhood public information meetings were held, during which confrontation was ofpn the order of the day. Eventually the department embarked upon an eradication program (involving the aerial application of the biological insecticide) which met with the approval of the adhoc neighborhood committees that had formed, and also with that of most of the community in general. In one sense, this scenario is an example of the system working effec- tively : a regulatory agency interacting with concerned and informed citizens to achieve a mutually acceptable decision on pest control (despite the possible original intention of the department to regulate without public input). A number of lay people became very knowledgeable about the gypsy moth in a short period of time, and thus were able to have an effect on a regulatory decision. The other side of this story, however, was the government regulators’ frustration in responding to those individuals or groups who may not have been well informed but who harboured strong convictions about the eradication effort. A great deal of my time during an entire year was spent in interacting with these people, attempt- ing to assuage their concerns by increasing their understanding of this particular issue. I cannot be sure how successful I was. At one point, I received a 35-page letter from a concerned citizen protesting the gypsy moth eradication project and the control materials, and

extolling the virtues of ‘ integrated pest management’ (IPM) as a solution to the gypsy moth problem. It became ap- parent that the writer was a ‘one-book’ expert on the subject of IPM; con- ceptual and factual errors were ram- pant. IPM is not a box of specific dimensions into which one stuffs the program of the moment; rather it is a dynamic process of many facets which is tremendously important to modern pest control. However, by definition, IPM is not particularly applicable when the goal is eradication. To have addressed sufficiently the many mis- conceptions and errors in this single letter would have necessitated the pro- duction of a substantial treatise. Lack- ing the resources for such a response, I was forced to respond, in effect, that his concerns were appreciated, but nothing in his letter gave sufficient cause to alter the intended eradication program. Thus, another disgruntled citizen concluded that government is insensitive and unwilling to listen - widening the chasm further.

Anyone working in the regulatory arena can probably relate similar stories. Departments of agriculture have met with increasing opposition to many programs designed to protect, preserve or enhance agriculture but which also have other, more direct impacts on the general public. Depart- ments of agriculture have traditionally not confronted the general public often, and, therefore, have not needed to devote much time to developing sensi- tivity to the public’s diversity of opin- ions, beliefs, fears, and concerns. Mean- while, the general public has become increasingly aware of and concerned about a multitude of agricultural and other industry practices. Pesticide and other chemical usage, nuclear power, food preservation by irradiation, and most recently, genetic engineering, have all become issues of concern. Moreover, in this new area, the regulatory climate appears murky : governmental credibility is constantly called into question; instant ‘experts’ abound ; true experts are considered untrustworthy because of their inability to prognosticate

BioEssuys Vol. 8, No. 1 -January 1988 39

SCIENCE AND SOCIETY

unequivocally. The federal regulatory processes

central to this discussion are those designed to preserve and protect the environment and human health, and the agricultural industry. Checks and balances are present in the form of outside science advisory panels, state and local regulatory agencies, special interest ‘watchdog ’ groups, Congress, etc., as well as in the actual processes required for law- or rule-making. This system is not perfect and mistakes are made, but it is a workable system of ‘ successive approximations ’ which makes frequent adjustments. The regulatory trend preferred by some, however, is ‘ regulation by public perception’, illustrated in the following case study.

Daminozide (Alar) is a plant growth regulator that has been registered since 1968 for use on a variety of orchard crops, as well as on peanuts, tomatoes, and some ornamental plants. The major use (75 Yo) of daminozide is on apples, functioning to improve fruit quality (color, size, firmness), extend storage life, and to prevent preharvest fruit drop. Based on carcinogenicity studies done during the 1970s and on EPA’s review by the U.S. Environmental Pro- tection Agency (EPA) of the daminozide database, EPA issued a ‘notice of intention to cancel’ daminozide in August 1985. Under the Federal Insec- ticide, Fungicide and Rodenticide Act (FIFRA), such cancellation actions must be submitted to the Science Ad- visory Panel for peer review before final cancellation actions are taken. The panel concluded that the available data were insufficient to perform a quanti- tative risk assessment for daminozide, based on discrepancies and errors in the carcinogenicity tests performed and reservations about the soundness of EPA’s dietary risk assessment. The panel found that none of the present studies were considered suitable to warrant banning daminozide. EPA’s subsequent action included the impo- sition of extensive data requirements on the manufacturer of daminozide and delay of the final decision on food uses of daminozide until sufficient data were available. Required studies included chronic feeding/oncogenicity studies in the rat and mouse with UDMH (a breakdown product of daminozide). Interim sacrifices were to be made at 8 and 12 months for the mice and 12 months for the rats, with appropriate interim reports; the final report is due July 1989. The final report on the chronic feeding/oncogenicity study

with daminozide itself in mice and rats is due August, 1988. Interim results of these new EPA-sanctioned tests have so far not indicated carcinogenicity ; additional interim results are expected at the time of writing.

EPA has also taken measures to reduce the human exposure to daminozide in several ways: by amending the label to indicate lower application rates for apples and to include a use advisory recommending that daminozide-treated apples not be used for sauce; and by reducing the daminozide tolerance on apples from 30 to 20 ppm (in practice, actual residues tend to be less than 4 ppm). Finally, EPA concluded that the public health will be protected during the time period (anticipated to extend to 1990) necessary to generate and review the additional data that will address the agency’s long- term concerns about daminozide residues in food.

Daminozide - and the apple industry - are currently victims of ‘extra-regulatory ’ regulation. The current official status of daminozide is that it is registered and legal for use on apples at the application rates indicated on the label. The unofficial status of daminozide is that if a grower uses it, he does so at the peril of not being able to market his apples. The underlying regulatory impetus is, in effect, public perception and the effect of that perception on the market-place. (This despite the fact that public concern about apples and daminozide is low.) Several large national grocery chains have announced publicly that they will not buy daminozide- treated apples, and some stores have posted signs near apple displays indi- cating that the apples are daminozide- free. These reactions seem to be the result of the negative publicity daminozide has been receiving, as well as of the campaign launched by Ralph Nader’s consumer group, Public Citizen, to ban the use of the material by querying supermarket chains whether or not they sell daminozide-treated apple products. Nader has also filled a lawsuit against the EPA, challenging the agency’s decision denying a 1 July, 1986 petition requesting establishment of a zero tolerance for daminozide on apples and other agricultural commodities.

Meanwhile, the power of public perception takes its toll. Tree Top Inc. of Washington state announced to its 3500 grower-members that it would not accept any apples for processing that were treated with daminozide during the 1986 season; they repeated the policy for the 1987 season. The Washington State Apple Commission

has again advised against the use of daminozide during the 1987 season, as they did in 1986. The public perception of these actions might be that these two powerful forces in the Washington State apple industry concur with the view of the consumer advocacy groups trying to ban the material that daminozide poses an unacceptable health risk. However, the reality is that money dictates a ‘defensive’ position. The financial risk of bringing daminozide- treated applies to market is too great in light of the perception that there is a health risk associated with daminozide, in spite of the facts. The facts are that the EPA and its extramural Science Advisory Panel have determined that there are insufficient data to support the presumption of risk. More.over the EPA has announced that there is no health risk associated with maintaining usage of daminozide on apples not destined for sauce (at the lowered tolerance of 20 ppm) during the 2-3 years required to obtained additional data on the material.

Who really is regulating daminozide? Not EPA, since if they were, the material would be in regular and acceptable use. It is actually public perception, based on public information that is now regulating daminozide. Is that necessarily bad? Not necessarily, because the infallible agency that makes no mistakes or misjudgments does not exist; public ‘watchdogs’ provide an important check on regulatory activities. However, the key is the reliability of the information that the public is provided and embraces. Regulation by public perception can be an unpredictable - at times seemingly random - proposition based on the illogic of emotion, isolated facts and half-truths. However, regulation by public understanding is a felicitous concept, based on the logic of comprehension of an unbiased col- lection of facts and reasonable as- sumptions. In the case of daminozide, consumer groups have seized on the results of carcinogenicity tests which have been determined by experts (both inside and outside the government) to be poorly run tests yielding flawed data, and are treating these results as fact. Is the general public being sufficiently informed and protected? Is the EPA regulating in a manner consistent with their mandate to protect human health and the environment?

If the citizenry is to be well informed and protected, they should possess more knowledge than the results of the questionable carcinogenicity tests; for example, the campaign to eliminate

40 BioEssays Vol. 8, No. 1 -January 1988

SCIENCE AND SOCIETY

daminozide-treated apples from grocery chains should include education of the public to demand (or accept) apples with less color, smaller size, occasional watercore and mealiness. Along with campaigning against pesticide usage in general, consumer groups should educate the public to accept a worm in an occasional apple, a blemish here or there. If the public did not demand insect-free, blemish-free fruit, there would be no incentive for the grower to spend the money to apply the materials that result in ‘perfect’ fruit. Regulation involving public understanding requires that the public know enough to make risk/benefit decisions and to understand the trade-offs involved.

If, however, it is the regulatory process that is faulty, then that process ought to be addressed broadly through legislative channels, rather than piece- meal, product by product. It is desirable that there should be more involvement in the regulatory process of an informed public, particularly in light of the recent U.S. Office of Technology Assessment survey that indicates the public does not have great confidence in government’s ability to regulate environmental applications of science and technology. Inter- estingly, however, this poll found at the same time that the public does recognize and accept government’s regulatory role-at least in terms of regulating

release of genetically engineered organisms into the environment. Thirty-seven percent of the public believes that the government should regulate this ac- tivity. Although the public feels more trust and confidence in the ability of academia to assess risk than in the ability of governmental agencies to do so, only 29% believes that this regulatory decision should be made by the scientific community. It is relevant to this discussion that only 5 % of those polled believe that voters, taxpayers, or community-based groups should make the decision. It is also significant that although the highest percentage of those polled believe that the government should regulate, that does leave a substantial percentage of the public ostensibly disenfranchised by the current regulatory process (the 63 % who believe that some group other than governmental agencies should regulate releases of genetically engineered organisms).

Regulation primarily by public perception is inappropriate but prevalent. It is regulation by and for small seg- ments of the general public (for example, the 6% who are fearful of daminozide-treated apples, or the 5 % who want the general public to make certain regulatory decisions) who use ‘facts’ at their discretion and who are subject to none of the checks and

balances which affect governmental regulation. The status quo of the regulatory process is imperfect, but repar- able and amenable to change. The governmental regulatory process already includes the scientific community in its decision-making process, and inclusion of the general public as well is becoming more acceptable to regulators and more widespread. But just as it is incumbent upon government regulators to involve the general public in their process, it behooves the public to assume the responsibility of becoming better informed while de- manding inclusion. The world is shrink- ing; everyone is now essentially in everyone else’s backyard. As we move into the age of genetic engineering and all it can offer - medically, agricult- urally, industrially - the world becomes one big backyard. We all share it, we all must be responsible for it, and together we must make rational, informed decisions on what to do in it.

(This article represents the views of the author and should not be construed as necessarily representative of the views of the agency for which she works.)

Department of Agriculture, State of Washington, 406 General Administration Bldg., AX-41, Olympia, WA 98504, USA.

Mitogens and Int-I and lnt-2: Oncogenic Proteins,

Morphogens? Antony W. Burgess

Cancers initiated by the mouse mammary tumour virus (MMTV) are associated with two sites of integration- int-1 and int-2.’~~ In C,H mice, half of the MMTV induced tumours have the proviral sequences integrated within 15 kb of the int-1 locus and in the other half, MMTV is integrated within 30 kb of the int-2 locus. These insertional events lead to the activation of the int- 1 or int-2 loci. Thus MMTV insertion can induce 1-10 copies of int-1 mRNA per mammary tumour cell, in contrast

to normal mammary tissue cells where it has not been possible to detect int-1 mRNA.S Similarly, int-2 mRNA is detected in the tumours which have the MMTV proviral sequences close to int- 2 but this mRNA is essentially un- detectable in normal mammary

The cDNA’s for both int-13 and int- 25 have been cloned and sequenced. Furthermore, the int-Z gene has been used to construct a murine retrovirus capable of expressing the int-1 proteim6 A Y2 viral construct containing the int-

1 gene (known to be capable of pro- ducing the 37 kDa int-1 polypeptide) induces a transformed phenotype in an established mouse mammary epithelial cell line. This same virus has no app- arent effect on several fibroblast cell lines.6 Although the int-1 protein product appears to be modified by pro- teolytic cleavage and appears to enter a secretory pathway, neither the bio- chemical or physiological functions of the protein have been unravelled.

Even though neither int-1 and int-2

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Who should regulate?