Impact of Public Perception on Regulatory Policy for Agricultural Biotechnology

Peggy G. Lemaux
Presentation given during the Scientific Session at the Nara International Symposium held in Nara, Japan
November, 1998


The new technologies for modifying agricultural crops through genetic engineering can result in the creation of new food and feed sources, new sources of products presently made with nonrenewable resources as well as novel products of value to consumers. Historically in the U.S. safety and efficacy of such products have been insured through an efficient and effective regulatory system that both protects the consumer and permits scientific advance. Extensive policy and infrastructure have developed in the U.S. to regulate the development and release of the products of biotechnology. As with any technology, however, there are benefits and risks to its use. There are those who see the value of these approaches as outweighing the risks; others view the risks, however, small, as unacceptable.

At least some of the unrest relating to the new foods derives from the fact that consumers do not understand the technology. It is fair to say that in the U.S. the majority of people do not understand even the basics of how food is grown or processed, let alone the classical genetic procedures by which they are developed. Without such an understanding, it is difficult to grasp how the foods of tomorrow will be produced and how they will be similar to or different from the foods of the past. Therefore assessing their safety can be an issue of concern to consumers because they are fearful of or misunderstand the technologies.

Risk Assessment - A Scientific Approach?

The potential for assessing risk in genetically engineered foods can be fairly accurately determined using current scientific information. This has formed the basis for certain aspects of regulatory policy, but public concerns, often inconsistent with the scientific measurement of risk, have also influenced regulatory policy. The basis for this concern depends on the familiarity, "friendliness" and voluntary nature of the risk (Meyers and Craigmill 1994). For example, compare the adverse consumer reactions in the U.S. to hamburgers contaminated with E. coli 0157:H7 or in Europe beef tainted with bovine spongiform encephalopathy (BSE) - situations where consumers were unaware of the risk - to the willing acceptance by many of picking and eating wild mushrooms or eating improperly prepared puffer fish.

These examples demonstrate that different situations and products can result in different perceptions of acceptable risk by consumers and these different perceptions can affect the development and application of regulatory policy. Biotechnology is an example where the public perception of risk varies widely within a national population and among countries. The differing perceptions and misconceptions can often lead to modifications in regulatory policy, which are inconsistent with the scientific measurement of risk. Some consumers believe that regulatory policy should strive for "zero risk", not realizing that developing policies consistent with this philosophy comes at an economic cost that might be inconsistent with the degree of risk and might not be necessary to insure public safety.

History of food Development

Since the time when humans moved from a nomadic lifestyle into one characterized by the exploitation of native plant and animal life, humans have modified and improved their foods. The classical breeding methods that were used have continued to the present and are now with increasing frequency augmented with other technologies, including the use of molecular techniques.

These newer techniques, although similar in biochemical mechanism to the classical methods, have some significant differences from the time-honored methods. First, the modern methods permit the genetic content of target organisms to be manipulated in a very precise manner, involving in many cases changing one gene amongst the over 100,000 genes present in the plant. In addition, the source of the gene can be any other living organism, whereas the older methods required that the two organisms exchanging genetic materials be closely related, usually members of the same genus or species.

Establishment of Regulatory Policy

Consumers in the U.S., Europe and Japan take for granted that the foods created by the classical methods, which they purchase although with few exceptions do not produce, are safe for themselves and their families. They involve very low risk of acute food-borne illness. However, safety and zero risk are not the same. What individuals define as "safe" is, for them, "acceptable risk" and cannot be determined scientifically. Individuals and societies can decide the level of risk they are willing to accept in their foods and what regulatory policies are necessary to insure the agreed-upon level of risk. It is important for scientists to realize that, while risk can be scientifically estimated, safety is a matter of public definition and is outside the realm of science.

How should public policy be determined when public perceptions of risk are at odds with scientific assessments? Which should be given priority? The answer lies somewhere between the two extremes. Public concerns must be taken seriously when they are widespread and persistent. This opinion must be tempered with the scientifically determined degree of risk. Policy that ignores scientific assessments will not serve the public good, but it cannot be the only guiding principle.

Factors Affecting Acceptance and Public Policy

If acceptance is to be considered in the establishment of public policy, it is necessary to understand that the public's view of new technologies is shaped by several factors.

The role of science and technology

In Japan and the U.S. it is generally accepted that science and technology play a role in improving people's lives. In the U.S. and Japan, the "heritage" is commonly to look for different and better ways of doing things and, in general, the American and Japanese populations have a positive view toward the role of science and technology in effecting this change. Citizens of some European countries seem to have a different attitude toward technological change and are more wary of its long-term consequences.

Involvement in public education efforts

In the early 1990's, members of U.S. and Australian public and private research organizations, including universities began pro-active efforts to educate the public about genetic engineering. The target audience included members of the media and public opinion leaders, who play a pivotal role in determining exactly what information people hear and read regarding an issue, in what way that information is presented and in what manner this information is used to shape public policy. If scientists and food professionals are reluctant or chose not to make themselves available to reporters and public officials or are not prepared to talk to them in an effective manner, media coverage and public policy can be skewed. Writers and public officials tend to be more educated when scientists are willing to share their views.

Trusted governmental and professional agencies need to be actively involved in information dissemination and education. For example, when recombinant bovine somatotropin (rBST) was introduced, the highly respected, former U.S. Surgeon General C. Everett Koop issued a statement that milk from rBST-injected cows was safe. In addition, several other governmental and public-sector agencies, e.g. American Medical Association, Food and Drug Administration and American Dietetic Association, released information in the popular press, peer-reviewed scientific journals as well as making a "hot line" available to answer questions on the safety of the product, thereby increasing the openness of information exchange (Christine Bruhn, personal communication). If this kind of engagement does not occur, an informational void can occur. It is the opinion of many that this occurred in Europe and the void was quickly filled by Green Peace (Hoban 1997). In a scientifically conducted survey of Japanese consumers in 1998, it was noted that they continue to trust independent, scientific experts with strong support for the Japanese Information Center, but support for the Ministry of Agriculture, Forestry and Fisheries and Ministry of Health and Welfare is declining (Thomas Hoban, personal communication)

Role of regulatory policy

Trust in a regulatory authority is also important to consumer acceptance. For many, although certainly not all, Americans hearing that the Food and Drug Administration has approved a food increases their confidence; they don't have the time to do independent investigations of food safety. The situation in Europe is quite different, especially in recent times. European citizens suffered a tremendous decrease in governmental trust during the BSE crisis, acknowledged by many as a classic example of ineffective risk communication (Nature 1997). The decisions made during the BSE controversy appeared to many to be based on political expediency rather than on public safety concerns. European governmental agencies are viewed as closely linked to the industries they regulate, a view which, if widely held, will be a major impediment in dealing with future food safety issues.

Development of Regulatory Policy

Genetically engineered rennin, used to make cheese, recombinant BST, used to increase milk output in cattle, and the FlavrSavr tomato, an enhanced fresh market tomato, were the first foods to enter the U.S. market that were developed by genetic engineering. Long before these and other products of genetic engineering reached commercialization, there was an extensive regulatory network devised to oversee experimentation and commercialization of the products. What are these agencies and what are their roles?

United States Department of Agriculture

The USDA is entrusted with regulating the transport, growth and propagation of plants through the Animal Plant Health Inspection Service (APHIS). The policy of this agency states that they do not view the products of biotechnology, Genetically Engineered Organisms (GEOs), as fundamentally different from those produced using traditional methods. Regulations of GEOs is covered by existing regulations, which were implemented for other technologies. The USDA realized, however, that the assessment of the products of the new technologies in some instances would require specific information that would lead to the introduction of some new requirements. This included the filing of extensive paperwork that provided great detail about the crop, the new genetic information introduced into it and, in the case of field testing, the precise manner in which the test would be conducted. The agency then reviewed the permit application and issued an environmental assessment, which outlined the environmental impact of the field test. If no significant impact was observed, the permit was issued. This process was time-consuming to complete and often required months for the permit to issue. The paperwork was burdensome and deterred many public sector scientists from pursuing field testing. In April of 1993, APHIS amended its policy to allow a notification alternative for the introduction of transgenic plants from six crops, corn, soybean, cotton, tomato, potato, and tobacco, provided the release was done in accordance with policy. These six plants were chosen because the largest number of field tests had been done with them and none had wild relatives in the U.S. In 1997 the notification alternative was amended to allow the alternative notification procedure to be used for the majority of crops in the U.S., as long as they were not noxious weeds or considered a weed in the area in which they would be released. In addition, certain plant virus sequences previously regulated were exempt because it was deemed that they did not pose a significant risk of creating a new virus. Certain other changes were enacted to ease the reporting burden.

Despite the burdensome nature of the permit process for field testing of transgenic plants, the numbers of field releases increased steadily, from 8 in 1987 to 1105 in 1998 (Figure 1). However, these early burdens likely skewed testing to certain economically important crops and limited the number of traits that were examined. This undue burden precluded certain experimentation that was needed to assess questions of environmental risk and consumer safety, creating in some minds, a regulatory dilemma. The shortened process has drastically reduced the time required to obtain a permit. The USDA felt comfortable with this shortened process because their earlier experiences gave them better predictive value with which to judge the possible impacts of a particular gene on a given crop species. This streamlining is beginning to lead to a wider variety of crops and traits being tested (Figure 2).

Organizations can request that an article be removed from the regulatory process, usually late in the stages of commercialization following extensive field testing and environmental monitoring. In order for this to happen APHIS issues a "determination" and an environmental assessment. To date 20 such determinations have been issued.

Environmental Protection Agency

The Environmental Protection Agency (EPA) has jurisdiction over new chemical substances being considered for introduction into the U.S. market. The government has defined all genetically modified microbes, including bacteria, fungi, viruses and protozoa, as new chemical substances, so they come under EPA's authority. This has caused this agency to be involved in the regulation of, for example, bioremediating and nitrogen-fixing microbes. The progress in bringing these organisms to market has been slow.

Recently the EPA has proposed a new Plant Pesticide Rule, which holds that this agency will regulate and designate all plants engineered with genes for pest resistance as pesticides. Large numbers of scientific and professional societies have found the policy scientifically indefensible and have openly opposed the proposed rule for several reasons (Council for Agricultural Science and Technology, 1998).