The regulation of genetically engineered plants: is Peter Rabbit safe in Mr. McGregor's transgenic vegetable patch?

AuthorEarp, David J.
  1. INTRODUCTION 1634 II. BACKGROUND 1635 III. THE STATUTORY BASIS FOR USDA REGULATION OF TRANSGENIC PLANTS 1640 A. The Development of a Federal Regulatory Policy 1640 B. USDA Regulation of Transgenic Plants 1641 IV. THE SCIENCE UNDERLYING THE CREATION OF TRANSGENIC PLANTS 1643 A. Traditional Plant Breeding 1643 B. Production of New Plant Varieties by Genetic Engineering 1645 C. Examples of Transgenic Plants Approved for Field Testing 1648 1. An Example from USDA's Old Permitting System: Virus Resistant Plants Containing Virus Coat Protein Genes 1649 2. An Example from the EPA Permitting System: Insect Resistant Plants Containing Bacterial Toxin Genes 1650 3. Tomato Plants Containing Antisense Fruit-Ripening Genes 1652 V. ENVIRONMENTAL CONSIDERATIONS REGARDING FIELD TESTING TRANSGENIC PLANTS 1653 VI. REGULATION AND DEREGULATION OF TRANSGENIC PLANTS 1655 A. Federal Policy 1655 B. Deregulation of the Flavr Savr[TM] 1658 C. APHIS's Proposed Rules under the Bush Administration 1661 D. APHIS's Final Rules under the Clinton Administration 1662 VII. AN ASSESSMENT OF THE CURRENT REGULATIONS 1665 VIII. CONCLUSION 1671 I. INTRODUCTION

    In a 1992 interpretive ruling, the United States Department of Agriculture announced that it would no longer regulate a genetically engineered tomato produced by the biotechnology company Calgene. This was the first genetically engineered crop plant approved for general, unregulated release into the environment. The Calgene tomato is now on sale in U.S. supermarkets under the brand name "MacGregor's"(1) In 1993, the USDA issued new rules for the regulation of field trials of genetically engineered plants, which generally streamline the regulatory process. As a result, biotechnology companies can now field test a range of genetically engineered plants without obtaining specific release permits. In addition, companies now can petition to have a particular transgenic plant completely exempted from USDA regulation. This comment reviews federal oversight of the release of genetically engineered plants into the environment and determines that the current regulations afford sufficient environmental protection, but that the law and regulations should be expanded to explicitly apply to all transgenic plants, and should contain monitoring requirements for large-scale releases.

  2. BACKGROUND

    Advances in molecular genetics facilitated the genesis of the modern biotechnology(2) industry in the 1980s and continue to expand our ability to modify the genetic characteristics of living organisms. Biotechnology is currently a $10 billion-a-year industry(3) and will likely be a $50 billion-a-year industry by the end of the 1990s.(4) Companies make biotechnological products for a wide range of applications, including healthcare, agriculture, and bioremediation.(5)

    Biotechnology depends, in large part, upon recombinant DNA (rDNA) technology.(6) In the early days of genetic engineering, assurances that genetically engineered microorganisms could not "escape" to the environment largely assuaged public fears regarding biotechnology's potential dangers.(7) Such assurances were effective because the organisms involved were primarily microorganisms confined to laboratory conditions in culture vessels.(8) In recent years, however, biotechnology has advanced to the point where biotechnologists routinely genetically engineer not only microorganisms but also plants and animals.(9) Moreover, many of these genetically altered organisms are specifically intended for release into the environment. A major goal of the agricultural biotechnology industry is to develop genetically engineered(10) crop plants with improved growth characteristics. This comment focuses on the environmental release of such genetically engineered crop plants.

    Biotechnologists can now transform(11) numerous plant species, including maize, wheat, cotton, rice, sugarbeet, and sunflower.(12) The traits introduced through genetic transformation include resistance to particular herbicides, resistance to viruses and insects, improved fruit ripening characteristics such as delayed spoilage, and improved nutritional value, which is achieved through modifying plant carbohydrate and oil composition.(13) Perhaps the best known product of agricultural biotechnology to date is the Flavr Savr[TM] tomato, produced by Calgene, Inc.(14) The Flavr Savr[TM], which is claimed to have improved shelf life and flavor,(15) is currently sold in supermarkets in northern California and Chicago under the brand name "MacGregor's."(16)

    Two federal agencies primarily regulate the release of transgenic plants into the environment: the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA).(17) After review by the USDA and the National Institutes of Health (NIH), the federal government granted the first permit for field testing a genetically engineered plant in 1986.(18) Since then, regulatory approval has been granted for hundreds of field tests of other genetically modified plants.(19) Such field tests generally involve small numbers of plants being grown in a controlled and contained area.(20) While some experts have expressed confidence in the environmental safety of such releases,(21) many have criticized the regulatory oversight of such releases.(22) For example, some commentators note with concern that Congress did not design the statutes authorizing the present regulatory scheme to oversee the genetically engineered products of modern biotechnology.(23) Others suggest that current regulatory policies may not sufficiently account for the possible ecological impacts of releasing genetically engineered organisms into the environment.(24) Despite such criticism, no environmental injury resulting from the field tests of genetically engineered plants has yet been reported.(25) As genetic engineering technology becomes more routine, the number of transgenic plants produced for field testing will almost certainly increase, and the burdens placed on the regulatory agencies will increase correspondingly.(26)

    After completing initial small-scale field trials, some biotechnology companies are now seeking to grow transgenic plants in larger scale productivity tests, where containment is more difficult. Most of these plants are produced with the hope of replacing existing crop plants, and thus companies ultimately intend their genetically engineered plants for unrestricted commercial release.(27) In 1992, after conducting field trial experiments with its transgenic tomato for a number of years under USDA's regulatory oversight, Calgene successfully petitioned the USDA to exempt the Flavr Savr[TM] from regulation for commercial scale-up.(28) The Flavr Savr[TM] is the first transgenic plant to reach the commercial production stage, but others are close behind.(29)

    In 1993, the USDA announced new rules that appear to streamline and relax regulation for certain classes of transgenic plants.(30) These rules replace a permitting procedure, which involved a detailed agency evaluation of each planned release, with a simple notification procedure.(31) EPA proposed a similar notification scheme for certain pesticides made from genetically engineered microorganisms.(32) The new USDA rules also allow an applicant to formally petition to exempt a transgenic plant from USDA regulation entirely.(33)

    The new USDA rules represent a subtle but significant shift in the regulation of transgenic plants in two respects. First, the notification-only requirement for certain releases shows that the USDA has reached a degree of comfort and familiarity with this technology that enables it to approve releases without detailed individual determinations. Second, the new rules anticipate the transition from the current small-scale, contained field trials of transgenic plants to general, unregulated releases for agricultural production. The possibility of widespread and unregulated cultivation of transgenic plants raises new issues regarding environmental interactions between those plants and existing ecosystems.(34)

    This comment analyzes the recent USDA regulations that govern the release of transgenic plants into the environment and assesses the effectiveness of these regulations in promoting both useful technology and environmental protection. This analysis begins in Part III with a review of the statutory basis for the USDA regulatory scheme. Part IV then reviews the science behind the creation of transgenic plants, and illustrates, with three examples, the USDA permitting procedure for field testing such plants. Part V looks at the environmental concerns engendered by the environmental release of transgenic plants. Part VI reviews the development of regulatory policy for biotechnology and analyzes the new USDA rules. Finally, Part VII considers the impact of the new USDA rules on environmental protection afforded by USDA regulatory oversight.

  3. THE STATUTORY BASIS FOR USDA REGULATION OF TRANSGENIC PLANTS

    1. The Development of a Federal Regulatory Policy

      Regulation of genetic engineering began in the 1970s with agreements between scientists to abstain from performing certain experiments in containment facilities available at the time.(35) As the technology evolved and its applications became more diverse, federal agencies assumed jurisdiction over the products of genetic engineering that fell within their traditional fields of regulation.(36) In 1985, the Biotechnology Science Coordinating Committee (BSCC) was established to coordinate the policies of the various agencies having authority to regulate biotechnology products.(37)

      In 1986, the Office of Science and Technology Policy (OSTP) published the "Coordinated Framework for the Regulation of Biotechnology."(38) In it, the OSTP concluded that biotechnology regulation required no new statutory authority, and that biotechnology's diverse products justified dividing regulatory oversight among several agencies.(39) Further, the...

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