Mapping Public Policy for Genetic Technologies

Chapter 12. Agriculture

This chapter was prepared by Barbara Foster, senior policy specialist in NCSL's Environment, Energy and Transportation Program, and Brenda Trolin, former program director of NCSL's Employment and Insurance Issues Program.

Information Contained in this Chapter

Federal Regulation of Plant Biotechnology

Development of New Plant Varieties

U.S. Food and Drug Administration

U.S. Department of Agriculture

U.S. Environmental Protection Agency

Oversight by Multiple Agencies

Federal Regulation and Labeling

APHIS

FIFRA

TSCA

Labeling of Foods Obtained Using Biotechnology

State Seed Laws

Integrated Pest Management (IPM)

Intellectual Property Rights, Grower Agreements and Seed Laws

Pros and Cons of Agricultural Engineering

Conclusion

Agriculture in the United States has quietly evolved into a premier high technology industry. Biotechnology has created a worldwide agricultural system with tremendous capabilities. Inherent in such technological breakthroughs is the need to develop new public policies that adequately address the emerging issues.

Federal Regulation of Plant Biotechnology

Development of New Plant Varieties

Much confusion clouds issues related to the development of new plant varieties through biotechnology. Some consumers incorrectly believe that in the United States, the federal government scrutinizes and directs every step of the development of these new plant varieties. Others believe—also incorrectly—that there is no federal oversight of this process.

In fact, the U.S. government regulates the field testing—the growing of crops—of plant varieties developed through biotechnology. In addition, the federal government has provided guidelines to plant researchers to assist them in the development of these plants and to address safety questions.

Researchers must prepare comprehensive data to support the safety and wholesomeness of new crop varieties developed through biotechnology. This process often requires many years of laboratory and field testing before a product is brought to market.

U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is the primary agency responsible for ensuring the safety of food and feed products. In May 1992, FDA published in the Federal Register a policy statement regarding its role in the regulation of new plant varieties. This document stated that the characteristics of a food, not the method used to produce the food, form the basis of FDA’s role in ensuring the safety of foods from new plant varieties.

This chapter was prepared by Barbara Foster, senior policy specialist in NCSL’s Environment, Energy and Transportation Program, and Brenda Trolin, former program director of NCSL’s Employment and Insurance Issues Program.

Thus, FDA’s role in the regulation of food is driven by the food product, not the process by which it is produced. This position is not new. In fact, it is based on years of agency experience.

Consistent with FDA’s "product, not process" position, foods developed through plant biotechnology are judged to determine equivalence to foods developed through traditional plant breeding. "Equivalent" in this context means that there is no meaningful change in nutritional value or composition of the food and that the new variety is as safe as the existing varieties already in commerce.

Included in FDA’s May 1992 Federal Register statement, are guidelines to assist plant varieties to ensure this equivalence. These guidelines, or "decision trees," pose safety questions and make recommendations as to when a manufacturer may need to consult with FDA on questions ranging from natural plant toxicants to nutrient content to possible allergenicity.

For example, if a company develops a virus-protected squash, FDA recommends that the developer verify that the composition of the squash—including its nutrient content—is substantially unchanged, and that no known allergens are introduced into the squash.

FDA’s role in the development of crops through plant biotechnology is one of consultant in all stages of crop development through plant biotechnology. In most instances, FDA approval of new plant varieties—as with traditionally bred plant varieties—is not required because the plants are equivalent to those already in commerce. Based on the questions and issues posed by the FDA decision trees, the plant developer seeks agency consultation as indicated.

FDA approval is required if the plant developer does not satisfy the questions posed in the decision trees. For example, if the new plant contains a known allergen that it previously did not contain, FDA requires product approval before it reaches consumers. Or if the new plant contains a food additive not "generally recognized as safe" (GRAS), then FDA approval of the plant is required.

U.S. Department of Agriculture

The U.S. Department of Agriculture (USDA) regulates agricultural products and research—including the development of new plant varieties—primarily through its Animal and Plant Health Inspection Service (APHIS).

To ensure that new plant varieties pose no threat to production agriculture or to the environment during cultivation, APHIS regulates the research development by requiring permits for the field testing, shipping and delivery of any seed or plants modified through biotechnology.

For example, if a company wishes to develop a plant that is tolerant to a specific herbicide, APHIS must review the research design and results and grant the right to grow the plant in a test plot.

During this review process, APHIS considers possible concerns posed by a new plant variety. Outcrossing, or the unintentional breeding of a domestic crop with a related species, is one such consideration. If there is a high potential for a new plant variety to outcross with a weedy relative and transfer of a new trait to that relative could pose a risk, APHIS may not allow a test plot and further development of such a plant. To guard against environmental risks, most plant developers avoid adding traits that could increase the competitiveness or other undesirable properties of weedy relatives.

As APHIS and the developers of new plant varieties gain more experience with certain crops, they have expedited the regulatory review process by implementing a process called notification. Notification status for field-testing is granted for crops that already have been studied and tested extensively and do not demonstrate environmental risks. In most cases, developers of new plant varieties of these crops simply must notify APHIS of their intent to conduct field testing, provided that the testing plan meets performance standards specified for that crop. A lengthy review of additional research data is not necessary, as long as the changes in the plant fall within descriptions set forth and approved by APHIS.

APHIS oversight of a new plant variety remains in force until the developer requests and is granted a determination by the agency that its oversight no longer is needed. Such determinations of nonregulated status have been granted for a half-dozen new plant varieties, including delayed-ripening tomatoes and virus-protected squash.

U.S. Environmental Protection Agency

The U.S. Environmental Protection Agency (EPA) regulates any pesticide that may be present in food and sets tolerance levels to provide a high margin of safety for consumers. Regarding new plant varieties, EPA oversees the development of plants that are able to protect themselves against insects or disease. For example, the B.t. protein produced in corn plants (for protection from the European corn borer) must be approved by EPA.

EPA also regulates the use of all herbicides. As part of this responsibility, EPA regulates the use of a herbicide on a new plant variety that is tolerant to that specific herbicide.

Oversight by Multiple Agencies

Most products of plant biotechnology have regulatory oversight by at least two, and often three, federal agencies. For example, a potato developed to contain a higher-solids content will be regulated by USDA for field testing safety. In addition, the potato developer must complete a consultation process with FDA. However, if a potato is developed with an insect protection, EPA will be involved in the regulatory process, along with USDA and FDA.

Federal Regulation and Labeling

The United States has several agencies that are responsible for regulation of food. The U.S. Food and Drug Administration is the primary agency regulating food safety. The U.S. Department of Agriculture, which oversees agricultural research and products, and the Environmental Protection Agency, which regulates substances released in the environment, also may play a role in regulating the development of food biotechnology products.

Food and Drug Administration Policy and the law. Foods developed through biotechnology will be subject to the same regulatory requirements the FDA uses to guard the safety of all foods in the marketplace. In May 1992, the agency issued specific guidelines for plant-based genetically-modified foods. These guidelines state:

Genetically-modified food products will be regulated in the same way as foods produced by other means.
These products will be judged on their individual safety, allergenicity, toxicity, etc., rather than the methods or techniques used to produce them.
The FDA will evaluate the safety of new ingredients added to foods through biotechnology the same way it now evaluates a new food additive such as a preservative or food color added to a cake mix or soft drink.

Under guidelines set forth in the federal Food, Drug and Cosmetic Act, the FDA has authority over genetically modified food products, drugs for humans and animals, and medical diagnostic devices. Already, the agency has approved for commercial sale products made through genetic modification, including several drugs, vaccines and medical diagnostic devices, and one food processing enzyme used to make cheese.

Safety assessment. The FDA and U.S. food laws place the burden of proving the safety of all new food products on manufacturers. FDA has issued special guidelines to help companies determine whether products developed through biotechnology need premarket government approval. Before a new biotechnology food product can be introduced, the food company must address a number of questions. They include:

Has the concentration of naturally occurring toxicants or allergens in the product changed?
Have the levels of important nutrients changed?
Could any alterations affect the product’s digestibility?
Have accepted, established scientific procedures been followed in the product’s development?
What are the environmental effects of the product’s growth and production?
Does the genetically-modified plant have a history of safe use in food?
Has the maker introduced into the product any substances that do not have a history of safe use in food?

If any substances are not generally recognized as safe, they must be approved as food additives before the product can be sold.

However, the FDA can ban a product from commercial sale at any time if it determines there is a "reasonable possibility" that a material added to a product makes the product unsafe for public consumption. If such a question arises after a product is on the market, the FDA can remove it from stores until the questions are answered.

Premarket approval. The FDA will not always require a company to receive special approval before introducing a new food product or a genetically-modified product on the market. Premarket review and approval will be necessary only under certain conditions. They include:

If the product has been genetically modified to contain a substance known to cause allergic reactions.
If the product contains material from a source not currently in the food supply.
If introducing or removing a substance causes the product’s nutritional value to change.

In such instances, the FDA could approve the product, but require it to carry a special label describing its content and characteristic, and health or safety information relevant to consumption of the food product. (See figure 12-1 below).

Figure 12-1.
Product Labeling

Product labeling has presented the area of greatest concern in connection with food biotechnology, but mainly as a result of misperception of FDA’s policy. The FDA policy guidelines state that foods produced through biotechnology will be subject to the same labeling laws as all other foods and food ingredients. Labeling would be required for biotech products in some instances—but not because the products were made using biotech.

Peanuts are a common allergen. If a gene from peanuts were inserted into potatoes or corn, where people would not expect to find peanut allergens, then the vegetables would have to be labeled to alert sensitive consumers. Potential food allergy is an example of a health or safety risk that would mandate a product label.

A researcher may improve the flavor of a fruit that traditionally contains a certain level of Vitamin C. If the new variety is changed in a way that results in either higher or lower amounts of Vitamin C, then that information would have to be disclosed. Nutritional content is an example that relates to the product’s usual composition or identity. Any substantial changes to this expected composition will mandate a product label.

If genetic engineering or any other breeding technique changed the composition of a peach so that it is no longer the same peach, then it would have to be called something different. It would have to have a different varietal name or, if the difference is substantial, it may not even be called a peach any longer. The proper identity of a food product is information that must be provided in all cases.

FDA invited public comment on the labeling policy because the agency understands the public holds diverse opinions about what information should appear on product labels. The request for comments focused on what criteria should be used to invoke labeling, as well as an assessment of the practical effect of labeling requirements. At this time, the FDA continues to analyze the data and comments it received, and plans to host a public hearing on labeling issues. The public comments will help the FDA evaluate the labeling requirements and ensure a sound policy.

APHIs

U.S. Department of Agriculture. The U.S. Department of Agriculture has several roles in agricultural biotechnology. The USDA has broad statutory power to regulate agricultural research and agricultural products, and its guidelines control everything from genetically-modified plants to animal vaccines. The USDA’s Office of Agricultural Biotechnology (OAB) coordinates all the department’s biotechnology activities, but 11 of its various agencies participate in some aspect of its work.

Perhaps the single most important of these agencies is the Animal and Plant Health Inspection Service (APHIS), which manages and enforces all USDA biotechnology-related regulations. APHIS also reviews and approves field research projects involving the genetic modification of plants via a plant pest. Potential projects include:

Plants with new traits for improved disease resistance.
Bacteria with a new gene that helps plants absorb nitrogen fertilizer.
An animal vaccine made with genetically-modified bacteria.

In March 1993, after a 60-day public comment period, APHIS announced an amendment to its rules that excludes six crops with a history of safe genetic modification from the prior approval requirement. The amendment allows genetically-modified corn, cotton, potato, soybean, tobacco, and tomato plants to undergo field tests with 30 days advance notification to APHIS.

Field test permits granted for these crops between 1987 and March 1993 accounted for 85 percent of total APHIS test permits. Considering the extensive data obtained from these field tests, APHIS determined that the tests of these crops do not result in any substance persisting in the environment or the introduction and dissemination of a plant pest. The amendment provides continued oversight, yet allows the agency to focus resources on applications for tests without such a proven record.

When an application is filed, the agency reviews the genetic background of the material to be tested and the plans for the test. If APHIS approves, it then:

Establishes the rules under which the test must be conducted.
Grants the necessary permits if the genetically-modified material is to be transported interstate.
Gives final approval for the test.

Cooperation. In some instances, the EPA or U.S. Food and Drug Administration might also be included in the approval process.

If the material to be tested is a pesticide, then the EPA is brought in under the guidelines of Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). If it is a genetically modified microorganism not otherwise regulated by another agency, EPA is brought in under the Toxic Substances Control Act (TSCA).
If the genetic modification adds something new to a food product, the FDA is included.

Environmental Protection Agency. The Environmental Protection Agency has jurisdiction over new chemical substances being considered for introduction into the U.S. market. The government defines all genetically-modified microbes—including bacteria, fungi, viruses and protozoa—as new chemical substances, so they come under EPA’s authority.

The EPA administers two laws that apply to biotechnology:
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and
The Toxic Substances Control Act (TSCA).

FIFRA

FIFRA is the law that regulates the registration, manufacture and use of all pesticides. Under this law, EPA must review and approve applications for genetically-modified pesticides or crop plants that contain pesticidal properties before any field tests can be conducted.

Examples of plants that would fall under this regulation are insect-resistant potatoes or viral-resistant cantaloupe.

This requirement is more stringent than for traditional chemical pesticides, which can be field-tested on a small scale (less than 10 acres) without prior EPA approval.

Before the EPA approves a field test, it must issue an experimental use permit (EUP). To obtain a permit, the recipient—usually a company or university—must supply the EPA with documentation describing in detail:

The genetic makeup of both the host and donor organisms.
The genetic modification that took place on those organisms.
The stability of the newly modified material.
The proposed field test’s design and monitoring.
All available health and environmental information on the host and donor organisms.
Results of tests performed in the laboratory and growth chambers.

After studying the proposed test’s potential exposure and possible hazards, the EPA has three options. It may:

Deny the request.
Approve it unconditionally.
Approve it with conditions, such as that certain practices must be carried out or that certain restrictions be required to minimize environmental exposure and the potential for any adverse effects.

TSCA

Regulation of genetically-modified chemical products is equally strenuous under the Toxic Substances Control Act. EPA must review and approve every new chemical product that falls under TSCA jurisdiction before the product may be manufactured for commercial use. This pre-manufacture notification process is required even if the product is to remain in a laboratory, fermenting vat or other type of closed system.

Labeling of Foods Obtained Using Biotechnology

No discussion of biotechnology and its application in agriculture generates more interest and apparent divergence of opinion than the topic of labeling. Proponents for labeling argue that all biotechnology products should be labeled to facilitate the "Consumer Right to Know." By carefully examining the purpose for labeling and the position taken by the Food and Drug Administration, legislation can be responsive to constituent questions and needs without creating unnecessary obstacles for these new developments.

Food biotechnology can be used to increase the quality and quantity of food through development of new plant varieties, food additives and food processing aids. These benefits are developed through the use of techniques that represent a continuum from plant breeding to the use of recombining DNA.

To deal with the multitude of different techniques and resulting data, a flexible system of safety evaluations guided by decision trees has been described (IFBC 1990) that was later referenced by several organizations, including the U.S. Food and Drug Administration (Federal Register, 1997) and the Organization for Economic Cooperation and Development (OECD).

The central purposes of food labeling are to inform and educate consumers to enable them to wisely choose food and improve their health. The issue thus becomes not whether a particular technique was employed in the production of a food but, rather, whether nutritional or compositional issues arise in light of that technology, which through labeling, should be brought to the attention of the consumer.

The FDA’s labeling policy requires that any issue related to safety must be labeled. Known allergens must be labeled. The policy also requires that when properties of a food or its preparation have been altered, this information be presented to the consumer.

Labeling issues are complex. Not only does the system of state and federal laws and regulation mesh to protect and inform the consumer, but also they protect interstate commerce. As the U.S. economy grows more global, one of the country’s primary export engines is the agricultural sector. Labeling issues are, indeed, global in nature and actions taken at the state level can have repercussions in the global marketplace.

For this reason, the concept of substantial equivalence is not only discussed in federal regulations, but is being discussed and implemented in the international arena as well. The concept is that if a food is nutritionally and compositionally equivalent to that of its traditional counterpart and its intended use is the same (within the normal range for that counterpart), then the food is judged to be substantially equivalent. Special labeling is not required for such food. Voluntary labeling that is truthful, not misleading, and that is verifiable could be appropriate. Substantial equivalence also encompasses the following concepts.

The concept of substantial equivalence does not mean that foods or ingredients are "identical." If a food or food ingredient is compositionally and nutritionally equivalent to the traditional counterpart within historical variation limits, it may, at least scientifically, be considered equivalent.
If the foodstuff is compositionally equivalent to the counterpart but has "well-defined differences," the differences must be subjected to well known nutritional and safety analysis. If there are no implications to the consumer from this perspective, the food may be deemed equivalent.
If a whole food is judged to be substantially equivalent the fractions of it also would be substantially equivalent. The minute presence of a new protein which, in and of itself, poses not allergenic or other safety risk and which has no meaningful impact on the overall protein content or amino acid profile, would not, as a matter of sound science, change the "characteristic" of the food or alter its equivalency.

Most companies that are developing improved crops and foods believe that the consumer has the right to truthful, nonmisleading information about the composition, nutrition, safety and quality of the foods they buy. Information generally is available to consumers in the food supply chain.

This type of middle ground, with provisions for voluntary labeling, allows information to be given to the consumer.

State Seed Laws

State seed laws have not been reviewed for some time. Reviews of seed laws may be necessary to accommodate new developments in seed technology. Issues to consider include the following.

Protect farmers from mislabeled or illegal products. What happens when a farmer receives seed from a conditioner that is mislabeled as Roundup Ready® herbicide, the crop will be destroyed. How does the state prevent farmer liability exposure to this risk?

Protect seed conditioners by standardizing record-keeping systems. What happens when a conditioner is asked to perform or is accused of violating seed or patent laws or regulations? How can the conditioner minimize the possibility of liability?

Improve industry communication and stewardship. How can the state contact and communicate with seed conditioners? How can the state ensure proper identity of all seed according to label and the law?

Ensure profitable technology access for all farmers. New seed technologies have, to date, remained available to all farmers. However, what happens if a few farmers abuse the technology and obstruct the ability to bring new products that offer even more?

Integrated Pest Management (IPM)

Agricultural biotechnology is being used to provide alternatives and different ways to control pests. Because of these applications biotechnology’s role in integrated pest management frequently is considered as IPM moves from being defined to being used in production agriculture.

IPM is a practice where pest management is but one component in the overall crop production system. The control of pests is viewed as a component of the overall cropping system rather than an end to itself.

The philosophy of IPM programs is based on the principle of giving growers the widest array of options available to control pests in precisely the right amounts at precisely the appropriate times. The program’s ultimate goal is to assure production of abundant, high-quality food and fiber in an environmentally and economically sound manner. IPM programs take the view that inappropriate application of a pest control strategy is as much a failure as is failing to control pests when an obvious control need existed. Both prevent growers from achieving the twin goals to provide cost efficient production of abundant, quality food while protecting the environment.

Sometimes IPM is confused with organic production or is used interchangeably with the concept of sustainable agriculture. The rules of organic agriculture vary from state to state. The USDA is preparing rules for organic production domestically, while the Codex Alimentarius is preparing rules for use in trade internationally.

Organic production rules tend to adopt methods of practice that consumers and producers regard as Organic. IPM clearly can be a component of organic production, but not all IPM approaches would be organic production methods.

More closely related is the concept of sustainable agriculture. The federal farm bill defines sustainable agriculture as:

… an integrated system of plant and animal production practices having a site specific application that will, over the long term: satisfy human food and fiber needs; enhance environmental quality and the natural resource base upon which the agricultural economy depends; make the most efficient use of non-renewable resources and on-farm resources and integrate, where appropriate, natural biological cycles and controls; sustain economic viability of farm operation; and enhance the quality of life.

The philosophy behind IPM, if implemented appropriately, can contribute to the goal of Sustainable Agriculture.

Recently, the USDA, FDA, and EPA developed a national initiative on IPM, seeking its use on 75 percent of U.S. crops by the year 2000. For the purposes of the initiative IPM is defined as:

the judicious use and integration of various pest control tactics in the context of the associated environment of the pests in ways that complement and facilitate the biological and other natural controls of pests to meet economic, public health, and environmental goals.

To achieve these, goals many acknowledge that research and development are a key to provide innovative solutions. In fact, the federal goals include competitive grants for research in IPM. Research on narrow spectrum, minimal risk pesticides; improved plant genetics and plant breeding; and transgenic plants that optimize pathogens to control pests will contribute to achieving these goals.

Biotechnology should be an integral component of IPM approaches because of the benefits the technology provides. These benefits include the enhanced use of biologicals, expanded host ranges, supplying protection to hosts that might not ordinarily be protected in that way, different delivery systems, and more specific pest targeting at earlier stages. Currently, approvals of plant pesticides by the EPA involve the use of best available management plans to ensure protection of the pesticidal trait and protect the environment.

State legislatures can serve the public interest by participating in the federal program at the state and regional levels. By encouraging innovative research and applying new technology, both the producers and consumers of the state benefit.

Intellectual Property Rights, Grower Agreements and Seed Laws

This is an evolving policy area. Legislative oversight is needed to ensure that intellectual property rights are protected to guarantee that beneficial new crop varieties are available to American farmers.

Many of the benefits that biotechnology brings to agriculture are through improving seeds. By placing new traits into seeds, farmers have access to new technology that helps them produce abundant, safe food in economical and sustainable ways.

Agricultural biotechnology developments are more like the development of new pharmaceuticals than like the agricultural developments of the past. It can take a decade and hundreds of millions of dollars to bring new bioengineered variety to the marketplace. This level of investment and that type of research and development produce benefits and policy issues alike.

Protecting intellectual property rights (IPR) is in the best interest of the entire agricultural industry, from growers and retailers and, ultimately, to the consumer. Without IPR, development investment will decline and agriculture’s ability to feed a rapidly growing world will be severely affected.

The ability of companies to share in the value created by biotechnology will affect their level of investment. Continued access to the technology requires states to update seed laws to protect access and prevent theft of technology that has been properly licensed to growers. Liability protection also must be given to growers, seed conditioners and others in the seed sale chain to protect their access to the technology and to protect honest brokers from fraud and abuse.

Pros and Cons of Agricultural Engineering

Agricultural biotechnology affects the economy, the environment, and the health and safety of the human population as well as animals and plants. The practical and theoretical difficulties center on identifying the long-term, desirable results from the possible but unidentified undesirable consequences.

The proponents of using genetic engineering to enhance agricultural, plant and animal products argue that they are only shortening the time frame in which nature and man have done exactly the same thing through multiple growing seasons. But now instead of waiting for a desirable spontaneous mutation, man can manipulate. Instead of spending years breeding countless generations of cows to achieve the best milk producer or generations of bulls to get the best breeders, man can manipulate. And genetic manipulation of plants can produce changes that might seldom occur or never be noticed in nature in the useful and foreseeable future. Proponents also point out that:

Genetic engineering carries the potential for increasing food supplies and food nutritional quality in a world where large numbers of people still starve to death.
By modifying plants to increase the presence of natural pesticides or the resistance to herbicides, the use of toxic and polluting pesticides and herbicides can be decreased.
Nitrogen fixing enzymes can decrease the need for water polluting fertilizers and perhaps assist in modifying undesirable climate change.
Plant resistance to different kinds of stress, such as drought, can be altered, thereby improving crop production and decreasing the effects of uncontrollable variables such as weather.
By exploiting the attribute of some bacteria to digest pollutants, bioremediation can be accelerated to clean up contaminated and unusable sites.
The medicinal properties of plants such taxol (a cancer fighting drug that originated in the Pacific yew) can be replicated and enhanced in the laboratory.

The arguments against the use of genetic engineering focus on the unknown and the possible risks.

Might the augmentation of natural pesticides have the potential for increasing the natural evolution of insect pests, which have shown themselves to be very adaptable or will the use of this technology extend their usefulness? (Note: Because all insects adapt or develop resistance, EPA controls the acreage of B+ planted. EPA addresses this during the approval process.)
Might a change or increase in natural plant pesticides have an adverse effect on other species for which the plants provide a benefit in terms of diet or habitat? (Note: Under the Plant Pesticide Act, EPA is required to look at the effect of non-target organisms.)
Might an insect resistant plant be so successful that other varieties will die out and essentially all the farmers’ products rely on one plant variety? Will genetic engineering decrease biodiversity and unknown plants like the Pacific yew become extinct because they have no apparent economic value? (Note: Arguably, more productivity on current acres versus bringing into production new acreage to meet population demands preserves biodiversity.)
Might there be unknown symbiotic relationships that could be eliminated or changed by the introduction or rearrangement of genes? It may be that x is necessary to get y and if x is changed, then y, a desirable attribute, will suffer?
Might a new attribute be introduced inadvertently and be toxic to some people with allergies?
If a crop such as rice is grown that provides a human protein to treat cystic fibrosis or to make drugs, could the changes in this crop have any detrimental effects if they appear in the normal food chain?
Can any of these genetic changes escape and create an adverse effect if they are in mass production and crossbred with other agricultural or uncultivated products?

The arguments about science and the pros and cons of acceptable risk have a long history. Some people opposed inoculations and vaccinations not because they were risky or unsuccessful but because they interfered with nature or God's will. Medical techniques of the past that appealed to what appeared to be common sense may be abhorred today. The issues narrow to the question of what should science do once it is known what it can do. How do we know what science can do without experimenting? Who has the power to draw the line to determine what is unacceptable? How does the tension between the will of the majority and the protection of minority rights play itself out in a test tube? Religious, ethical and cultural values all play a part in how the questions are addressed and how they are answered. Perhaps science will discover that some people have genes that causes them to dislike change and that others have one that cause them to perceive any change as progress and progress, as good.

Conclusion

It is critical that federal and state officials be informed, knowledgeable, and included as working partners in all phases of the ongoing biotechnology regulatory policy process. It is essential that state agencies be active partners, sharing oversight responsibilities to the state’s agricultural community and the consuming public at large.

As new advances are made in plant and animal production, it is critical to ensure that private and public issues are adequately reviewed. This would include such concerns as use of biologicals for pest control and food production, and assurances that adequate information is available to ensure that new products do not create new or unexpected management concerns.

State-federal biotechnology working groups could be formed to address areas of biotechnology policy, regulation and commerce. State and federal agencies, agribusiness and consumers should work cooperatively to assure that adequate information is available to ensure that new bioengineered production tools and consumer products reach the market in a timely manner.

To Table 12-1. Agriculture Legislation Introduced in 1997

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