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Critical Reviews in Food Science and Nutrition Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/bfsn20
Status of regulatory approval of biotechnology‐derived plants and animals Terry L. Medley J.D.
a
a
Director, Biotechnology, Biologics, and Environmental Protection , Animal and Plant Health Inspection Service, U.S. Department of Agriculture , 6505 Belcrest Road, Room 850, Federal Building, Hyattsville, MD, 20782 Published online: 29 Sep 2009.
To cite this article: Terry L. Medley J.D. (1992) Status of regulatory approval of biotechnology‐derived plants and animals, Critical Reviews in Food Science and Nutrition, 32:2, 151-155, DOI: 10.1080/10408399209527590 To link to this article: http://dx.doi.org/10.1080/10408399209527590
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
Critical Reviews in Food Science and Nutrition, 32(2):151-155 (1992)
Status of Regulatory Approval of Biotechnology-Derived Plants and Animals* Terry L. Medley, J.D. Director, Biotechnology, Biologics, and Environmental Protection, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, 6505 Belcrest Road, Room 850, Federal Building, Hyattsville, MD 20782
Downloaded by [ECU Libraries] at 12:44 26 April 2015
*New Food and Food Chemicals: Safety and Regulatory Considerations, sponsored by the Association of Government Toxicologists, Society of Toxicology, Food and Drug Administration, and Hosted by the National Academy of Sciences, May 1-2, 1990. ABSTRACT: Development of new technology brings with it decisions regarding regulation to ensure safety in technology transfer. Properly formulated and administrated, such regulations can act as a catalyst for the transfer of new technology, not a barrier. Such regulations must be based on sound scientific principles, and are intended to provide protection for the public, engender public acceptance, and foster communication with the various segments of society. To develop this new technology in a safe and orderly manner field testing of the products/ organisms of biotechnology, especially genetic engineering, has been permitted by the U.S. Department of Agriculture (USDA). USD A permits certify the environmental safety of field testing of plants and microorganisms developed through the use of material derived from plant pests. Permits are issued based upon analyses of the biology of the organism, the affected environment, and the precautions taken to ensure environmental protection. Licenses for the use of veterinary biologies, including recombinant vaccines, are also issued. KEY WORDS: biotechnology regulation, biotechnology products (environmental safety of), deliberate release (safety assurance/regulation of), genetic engineering, genetically modified organisms (safety assurance/regulation of).
I. INTRODUCTION "Investing in our Future" is one of five broad themes contained in "The Budget Message of the President," as a preface to the Fiscal Year 1991 Budget of the United States Government. In his message, President Bush states that, "With an eye toward future growth, and expansion of the human frontier, the budget's chief emphasis is an investment in the future. It proposes . . . record-high amounts for research and development . . . and it fulfills responsibilities to protect the environment . . . . " My remarks today will be confined to a discussion of how biotechnology regulations can be both a catalyst for technology transfer and pro-
vide improved "stewardship" for the protection of our environment. The U.S. Department of Agriculture (USDA), like other federal agencies, regulates the products of biotechnology on a case-by-case basis under its existing statutory authority. The USDA's broad historic authority to protect plant and animal health is applicable to the regulation of plants, microorganisms, and veterinary biological products developed through biotechnological processes. The USDA agency with a major responsibility for regulating these products is the Animal and Plant Health Inspection Service (APHIS). APHIS regulates the environmental release importation and interstate movement of certain genetically engineered plants and microorgan-
1040-8398/92/$.50 © 1992 by CRC Press, Inc.
151
isms through the use of a permit process. The approval process for veterinary biological products, on the other hand, involves the issuance of a license for a commercial product that will be sold for use in veterinary medicine.
Downloaded by [ECU Libraries] at 12:44 26 April 2015
II. LICENSES Under the authority of the Virus-Serum-Toxin Act of 1913, as amended, APHIS issues U.S. Veterinary Biological Product Licenses after satisfactory completion of all requirements to ensure purity, safety, potency, and efficacy. Veterinary biological products produced by recombinant DNA methods are evaluated on a case-by-case basis using the same stringent standards for licensing employed for conventionally produced biologies. A three-category classification scheme for hybridomas and recombinant-derived products based on biological characteristics and safety concerns was published in the Federal Register as a part of the final USDA policy statement on biotechnology in June 1986 (51 FR 23339, June 26, 1986). The first category includes inactivated recombinant DNA-derived vaccines, bacterins, bacterin-toxoids, virus subunits, or bacterial subunits. These nonviable or killed products pose no risk to the environment and present no new or unusual safety concerns. Monoclonal antibody (hybridoma) products used prophylactically, therapeutically, or as components of diagnostic kits are included in this category. The second category includes those products containing live microorganisms that have been modified by the addition or deletion of one or more genes. Precautions must be taken to ensure that the addition or deletion of specific genetic information does not impart increased virulence, pathogenicity, or survival advantages in these organisms that are greater than those found in natural or wild-type forms. Modifications must not impart undesirable new or increased adherence or invasion factors, colonization properties, or intrahost survival factors. . The genetic information to be added or deleted must consist of well-characterized DNA segments. Required licensing data may include
152
base pair analysis, sequence'information, restriction endonuclease sites, and phenotypic characterization of the altered organism. A comparison is also required between the genetically engineered organism and the wild-type form for factors affecting pathogenicity. The third category includes products using live vectors to carry recombinant-derived foreign genes that code for immunizing antigens and/or other immune stimulants. Live vectors may carry multiple recombinant-derived foreign genes because they can carry large quantities of new genetic information. To date, APHIS has issued 38 licenses for veterinary biological products manufactured from biotechnological processes, including bacterins (5), monoclonal antibodies for therapeutic or prophylactic use (2), diagnostic kits (26), and (5) live recombinant DNA-derived pseudorabies virus vaccines for use in swine.
III. THE PERMITTING PROCESS A. Procedures In the time remaining to me, I would like to review briefly procedures we have developed at APHIS to issue permits to field test certain genetically engineered plants and microorganisms and to ensure the safety of such tests to human health and the environment. I will focus on the 68 permits for release, although we also issue over 500 permits for importation and movement. APHIS published regulations that became final on July 16, 1987 under the authority of the Federal Plant Pest Act and the Plant Quarantine Act. In general, APHIS regulates an organism if it is included on the list of organisms considered to be plant pests. The organisms will be regulated if the organism itself is a plant pest, or if it contains nucleic acid sequences derived from a plant pest and these sequences have been introduced through the use of recombinant DNA technology. If a vector or vector agent is used and the vector is derived from a plant pathogen, the resulting modified organism to be field tested is reviewed. The regulations are an extension of current regulations (7 CFR Part 330).
Downloaded by [ECU Libraries] at 12:44 26 April 2015
Among the first generation of field tests, primarily the 21 tests that occurred in 1988, about half of the tests were for herbicide tolerance in tomato and tobacco. The remaining half were nearly all for insect and disease resistance, also in tomato and tobacco. In 1989, applications showed a much greater range of plants used for experimentation, including rice, corn, potato, soybeans, alfalfa, cotton, poplar, cucumber, and walnuts, and an extended range of characteristics to be tested, including slowed fruit ripening, heavy metal sequestration, and increased nutritional composition. In 1990, the applications have expanded to include modified pathogenic bacteria, an ever-increasing range of disease-resistant plant cultivars, and modifications of two of the three most agronomically significant crops in the U.S., rice and corn. Field tests proposed by industry are often now larger in scale and occur at multiple sites in multiple states. We are beginning to see a flow of sophisticated applications coming in from academic institutions, and, from what these researchers tell us, we expect a quantum jump in the number of proposed field tests from that community over the next year.
4.
5. 6.
7.
8.
pared by the reviewing scientist, and the EA is subject to peer review by the scientific staff. When the EA results in a finding of no significant impact (FONSI), the permit is issued and notice of the action and the availability of the EA and FONSI is published in the Federal Register. Currently, site inspections are conducted near the time of initiation of the field trial. The permit may contain special conditions that must be met, one of which involves the collection and submission of test data to APHIS. These data will be used to evaluate subsequent field applications of the same or similar organism. In addition to the copy containing confidential business information (CBI), the permit application must contain a copy with any CBI deleted. Confidential business information is protected from disclosure under the Freedom of Information Act (5 U.S.C. 552(B) (4)). Changes in the permit application may be submitted as amendments both before and after the permit is granted.
B. Application The permit application for release contains 14 points that must be addressed before the application is considered complete. This information includes a detailed description of the organism to be tested, who is responsible for conducting the test, where the organism is to be tested, and descriptions of how the organism will be prevented from dissemination into the environment during transport and during the field test. The review period of 120 d, which is required in the regulations, includes these features:
C. Environmental Analysis The EA is a key component in the permit review process. It is the public's assurance that APHIS has thoroughly considered the possible consequences of releasing the regulated article into the human environment. This analysis, documented in an EA, is made available to anyone who requests it, free of charge. The EA contains the following sections: 1.
1. 2.
3.
Notice of receipt of the application is published in the Federal Register. A copy of the application and the preliminary review are sent to the state in which the test will take place within 30 days after the application is received. The state agencies have 30 d to comment after receiving the application. An environmental assessment (EA) is pre-
2.
A summary describing the purpose of the EA, Departmental regulations, the conditions under which the permit is issued or denied, precautions against environmental risk, the background biology of the organisms tests, and the possible environmental consequences of the field test. A complete description of the environment that will be affected by the field test and the precautions developed for protecting that
153
3.
environment, including field plot design, field inspection and monitoring, test plot security, and disposal plans. The environmental consequences of the test are examined from all possible perspectives. Consideration is given to the biology of the recipient, donor, and vector, and to the potential for biological containment based on knowledge of this biology. Any possibility of risk to native flora and fauna is examined, as is any potential impact on human health.
Downloaded by [ECU Libraries] at 12:44 26 April 2015
D. Instruction Manual An instruction manual for completing the permit application is being prepared to educate and assist the applicant in the scientific community. The manual will provide, among other things, an up-to-date list of APHIS's staff who can answer questions about the permit process and a list of questions and answers to assist the applicant in determining whether the organism to be field tested is regulated. In 1989, the number of documented field trials with genetically engineered organisms approved by regulatory agencies of the U.S. greatly exceeded approvals by any other country. In the area of regulatory approval, as with scientific developments, the U.S. is recognized as the world leader. These significant accomplishments demonstrate the benefits to be derived from consulting the regulatory agencies responsible for protecting agriculture, human health, and the environment before releasing genetically engineered organisms into the environment. Development of new technology brings with it decisions regarding regulations for technology transfer. Properly drafted and administered regulations can be a catalyst, not a barrier, for technology transfer. Traditionally, development of regulations that neither overregulate or underregulate has been one of the most formidable tasks for the federal government. However, if the technological advances that are an outgrowth of a tremendous public and private investment by this nation are to be of the greatest benefit, the efforts to develop the appropriate effective regulatory
154
framework are more than justified and positive public perception is a necessity. It has been alleged by some that the regulations governing biotechnology, and especially those affecting field testing, will impede and slow development in biotechnology. However, since the development of the Coordinated Framework for Regulation of Biotechnology (51 Fed. Reg. 23302) (1986), and of specific regulations adapting existing laws to cover potential risks posed by genetically engineered organisms (CFR 340), the approval time for field tests has been reduced almost tenfold.. Specifically, it took almost 3 years to field test the "ice-minus" bacterium as opposed to an average of less than 100 d for field tests approved by APHIS in 1989. An important aspect of this review process is that notification of proposed field tests and evidence of reviews are made available for public scrutiny immediately. A necessary prerequisite for public acceptance is the opportunity for meaningful public participation.
IV. SUMMATION I would like to now leave you with the following points, based on the experience we have gained to date at USDA in regulating the products of biotechnology. 1.
2.
3. 4.
5.
The public must be assured that releases of genetically engineered organisms are being reviewed to prevent unknown or unintended effects. These reviews must be scientifically based to ensure public credibility and the industry's voluntary compliance. Evidence must be made immediately available that such reviews have taken place. Regulations should result in "informed decisions" that have taken into account and analyzed the various alternatives and are rational and appropriate. Procedures for effective ''public" participation are essential. Coordination and consistency is necessary among government agencies, and between governments.
REFERENCES 1. Animal and Plant Health Inspection Service, Plant Pests: Introduction of Genetically Engineered Organisms or Products; Final Rule, 52 FR 22882-22914, June 16, 1987.
Downloaded by [ECU Libraries] at 12:44 26 April 2015
2. National Academy of Sciences, Introduction of Recombinant DNA-Engineered Organisms into the Environment: Key Issues, Washington, D.C., National Academy Press, 1987.
3. Office of Science and Technology Policy, Coordinated Framework for Regulation of Biotechnology: Announcement of Policy and Notice for Public Comment, 51 FR 23302-23350, June 26, 1986. 4. Medley, T. L., Esq., Issues in assessing the environmental impact of veterinary biologies produced through biotechnology, Food Drug Cos. Law J., 821, 1988. 5. National Academy of Sciences, Field Testing Genetically Modified Organisms: Framework for Decisions, Washington, D.C., National Academy Press, 1989.
155
Critical Reviews in Food Science and Nutrition Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/bfsn20
Status of regulatory approval of biotechnology‐derived plants and animals Terry L. Medley J.D.
a
a
Director, Biotechnology, Biologics, and Environmental Protection , Animal and Plant Health Inspection Service, U.S. Department of Agriculture , 6505 Belcrest Road, Room 850, Federal Building, Hyattsville, MD, 20782 Published online: 29 Sep 2009.
To cite this article: Terry L. Medley J.D. (1992) Status of regulatory approval of biotechnology‐derived plants and animals, Critical Reviews in Food Science and Nutrition, 32:2, 151-155, DOI: 10.1080/10408399209527590 To link to this article: http://dx.doi.org/10.1080/10408399209527590
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
Critical Reviews in Food Science and Nutrition, 32(2):151-155 (1992)
Status of Regulatory Approval of Biotechnology-Derived Plants and Animals* Terry L. Medley, J.D. Director, Biotechnology, Biologics, and Environmental Protection, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, 6505 Belcrest Road, Room 850, Federal Building, Hyattsville, MD 20782
Downloaded by [ECU Libraries] at 12:44 26 April 2015
*New Food and Food Chemicals: Safety and Regulatory Considerations, sponsored by the Association of Government Toxicologists, Society of Toxicology, Food and Drug Administration, and Hosted by the National Academy of Sciences, May 1-2, 1990. ABSTRACT: Development of new technology brings with it decisions regarding regulation to ensure safety in technology transfer. Properly formulated and administrated, such regulations can act as a catalyst for the transfer of new technology, not a barrier. Such regulations must be based on sound scientific principles, and are intended to provide protection for the public, engender public acceptance, and foster communication with the various segments of society. To develop this new technology in a safe and orderly manner field testing of the products/ organisms of biotechnology, especially genetic engineering, has been permitted by the U.S. Department of Agriculture (USDA). USD A permits certify the environmental safety of field testing of plants and microorganisms developed through the use of material derived from plant pests. Permits are issued based upon analyses of the biology of the organism, the affected environment, and the precautions taken to ensure environmental protection. Licenses for the use of veterinary biologies, including recombinant vaccines, are also issued. KEY WORDS: biotechnology regulation, biotechnology products (environmental safety of), deliberate release (safety assurance/regulation of), genetic engineering, genetically modified organisms (safety assurance/regulation of).
I. INTRODUCTION "Investing in our Future" is one of five broad themes contained in "The Budget Message of the President," as a preface to the Fiscal Year 1991 Budget of the United States Government. In his message, President Bush states that, "With an eye toward future growth, and expansion of the human frontier, the budget's chief emphasis is an investment in the future. It proposes . . . record-high amounts for research and development . . . and it fulfills responsibilities to protect the environment . . . . " My remarks today will be confined to a discussion of how biotechnology regulations can be both a catalyst for technology transfer and pro-
vide improved "stewardship" for the protection of our environment. The U.S. Department of Agriculture (USDA), like other federal agencies, regulates the products of biotechnology on a case-by-case basis under its existing statutory authority. The USDA's broad historic authority to protect plant and animal health is applicable to the regulation of plants, microorganisms, and veterinary biological products developed through biotechnological processes. The USDA agency with a major responsibility for regulating these products is the Animal and Plant Health Inspection Service (APHIS). APHIS regulates the environmental release importation and interstate movement of certain genetically engineered plants and microorgan-
1040-8398/92/$.50 © 1992 by CRC Press, Inc.
151
isms through the use of a permit process. The approval process for veterinary biological products, on the other hand, involves the issuance of a license for a commercial product that will be sold for use in veterinary medicine.
Downloaded by [ECU Libraries] at 12:44 26 April 2015
II. LICENSES Under the authority of the Virus-Serum-Toxin Act of 1913, as amended, APHIS issues U.S. Veterinary Biological Product Licenses after satisfactory completion of all requirements to ensure purity, safety, potency, and efficacy. Veterinary biological products produced by recombinant DNA methods are evaluated on a case-by-case basis using the same stringent standards for licensing employed for conventionally produced biologies. A three-category classification scheme for hybridomas and recombinant-derived products based on biological characteristics and safety concerns was published in the Federal Register as a part of the final USDA policy statement on biotechnology in June 1986 (51 FR 23339, June 26, 1986). The first category includes inactivated recombinant DNA-derived vaccines, bacterins, bacterin-toxoids, virus subunits, or bacterial subunits. These nonviable or killed products pose no risk to the environment and present no new or unusual safety concerns. Monoclonal antibody (hybridoma) products used prophylactically, therapeutically, or as components of diagnostic kits are included in this category. The second category includes those products containing live microorganisms that have been modified by the addition or deletion of one or more genes. Precautions must be taken to ensure that the addition or deletion of specific genetic information does not impart increased virulence, pathogenicity, or survival advantages in these organisms that are greater than those found in natural or wild-type forms. Modifications must not impart undesirable new or increased adherence or invasion factors, colonization properties, or intrahost survival factors. . The genetic information to be added or deleted must consist of well-characterized DNA segments. Required licensing data may include
152
base pair analysis, sequence'information, restriction endonuclease sites, and phenotypic characterization of the altered organism. A comparison is also required between the genetically engineered organism and the wild-type form for factors affecting pathogenicity. The third category includes products using live vectors to carry recombinant-derived foreign genes that code for immunizing antigens and/or other immune stimulants. Live vectors may carry multiple recombinant-derived foreign genes because they can carry large quantities of new genetic information. To date, APHIS has issued 38 licenses for veterinary biological products manufactured from biotechnological processes, including bacterins (5), monoclonal antibodies for therapeutic or prophylactic use (2), diagnostic kits (26), and (5) live recombinant DNA-derived pseudorabies virus vaccines for use in swine.
III. THE PERMITTING PROCESS A. Procedures In the time remaining to me, I would like to review briefly procedures we have developed at APHIS to issue permits to field test certain genetically engineered plants and microorganisms and to ensure the safety of such tests to human health and the environment. I will focus on the 68 permits for release, although we also issue over 500 permits for importation and movement. APHIS published regulations that became final on July 16, 1987 under the authority of the Federal Plant Pest Act and the Plant Quarantine Act. In general, APHIS regulates an organism if it is included on the list of organisms considered to be plant pests. The organisms will be regulated if the organism itself is a plant pest, or if it contains nucleic acid sequences derived from a plant pest and these sequences have been introduced through the use of recombinant DNA technology. If a vector or vector agent is used and the vector is derived from a plant pathogen, the resulting modified organism to be field tested is reviewed. The regulations are an extension of current regulations (7 CFR Part 330).
Downloaded by [ECU Libraries] at 12:44 26 April 2015
Among the first generation of field tests, primarily the 21 tests that occurred in 1988, about half of the tests were for herbicide tolerance in tomato and tobacco. The remaining half were nearly all for insect and disease resistance, also in tomato and tobacco. In 1989, applications showed a much greater range of plants used for experimentation, including rice, corn, potato, soybeans, alfalfa, cotton, poplar, cucumber, and walnuts, and an extended range of characteristics to be tested, including slowed fruit ripening, heavy metal sequestration, and increased nutritional composition. In 1990, the applications have expanded to include modified pathogenic bacteria, an ever-increasing range of disease-resistant plant cultivars, and modifications of two of the three most agronomically significant crops in the U.S., rice and corn. Field tests proposed by industry are often now larger in scale and occur at multiple sites in multiple states. We are beginning to see a flow of sophisticated applications coming in from academic institutions, and, from what these researchers tell us, we expect a quantum jump in the number of proposed field tests from that community over the next year.
4.
5. 6.
7.
8.
pared by the reviewing scientist, and the EA is subject to peer review by the scientific staff. When the EA results in a finding of no significant impact (FONSI), the permit is issued and notice of the action and the availability of the EA and FONSI is published in the Federal Register. Currently, site inspections are conducted near the time of initiation of the field trial. The permit may contain special conditions that must be met, one of which involves the collection and submission of test data to APHIS. These data will be used to evaluate subsequent field applications of the same or similar organism. In addition to the copy containing confidential business information (CBI), the permit application must contain a copy with any CBI deleted. Confidential business information is protected from disclosure under the Freedom of Information Act (5 U.S.C. 552(B) (4)). Changes in the permit application may be submitted as amendments both before and after the permit is granted.
B. Application The permit application for release contains 14 points that must be addressed before the application is considered complete. This information includes a detailed description of the organism to be tested, who is responsible for conducting the test, where the organism is to be tested, and descriptions of how the organism will be prevented from dissemination into the environment during transport and during the field test. The review period of 120 d, which is required in the regulations, includes these features:
C. Environmental Analysis The EA is a key component in the permit review process. It is the public's assurance that APHIS has thoroughly considered the possible consequences of releasing the regulated article into the human environment. This analysis, documented in an EA, is made available to anyone who requests it, free of charge. The EA contains the following sections: 1.
1. 2.
3.
Notice of receipt of the application is published in the Federal Register. A copy of the application and the preliminary review are sent to the state in which the test will take place within 30 days after the application is received. The state agencies have 30 d to comment after receiving the application. An environmental assessment (EA) is pre-
2.
A summary describing the purpose of the EA, Departmental regulations, the conditions under which the permit is issued or denied, precautions against environmental risk, the background biology of the organisms tests, and the possible environmental consequences of the field test. A complete description of the environment that will be affected by the field test and the precautions developed for protecting that
153
3.
environment, including field plot design, field inspection and monitoring, test plot security, and disposal plans. The environmental consequences of the test are examined from all possible perspectives. Consideration is given to the biology of the recipient, donor, and vector, and to the potential for biological containment based on knowledge of this biology. Any possibility of risk to native flora and fauna is examined, as is any potential impact on human health.
Downloaded by [ECU Libraries] at 12:44 26 April 2015
D. Instruction Manual An instruction manual for completing the permit application is being prepared to educate and assist the applicant in the scientific community. The manual will provide, among other things, an up-to-date list of APHIS's staff who can answer questions about the permit process and a list of questions and answers to assist the applicant in determining whether the organism to be field tested is regulated. In 1989, the number of documented field trials with genetically engineered organisms approved by regulatory agencies of the U.S. greatly exceeded approvals by any other country. In the area of regulatory approval, as with scientific developments, the U.S. is recognized as the world leader. These significant accomplishments demonstrate the benefits to be derived from consulting the regulatory agencies responsible for protecting agriculture, human health, and the environment before releasing genetically engineered organisms into the environment. Development of new technology brings with it decisions regarding regulations for technology transfer. Properly drafted and administered regulations can be a catalyst, not a barrier, for technology transfer. Traditionally, development of regulations that neither overregulate or underregulate has been one of the most formidable tasks for the federal government. However, if the technological advances that are an outgrowth of a tremendous public and private investment by this nation are to be of the greatest benefit, the efforts to develop the appropriate effective regulatory
154
framework are more than justified and positive public perception is a necessity. It has been alleged by some that the regulations governing biotechnology, and especially those affecting field testing, will impede and slow development in biotechnology. However, since the development of the Coordinated Framework for Regulation of Biotechnology (51 Fed. Reg. 23302) (1986), and of specific regulations adapting existing laws to cover potential risks posed by genetically engineered organisms (CFR 340), the approval time for field tests has been reduced almost tenfold.. Specifically, it took almost 3 years to field test the "ice-minus" bacterium as opposed to an average of less than 100 d for field tests approved by APHIS in 1989. An important aspect of this review process is that notification of proposed field tests and evidence of reviews are made available for public scrutiny immediately. A necessary prerequisite for public acceptance is the opportunity for meaningful public participation.
IV. SUMMATION I would like to now leave you with the following points, based on the experience we have gained to date at USDA in regulating the products of biotechnology. 1.
2.
3. 4.
5.
The public must be assured that releases of genetically engineered organisms are being reviewed to prevent unknown or unintended effects. These reviews must be scientifically based to ensure public credibility and the industry's voluntary compliance. Evidence must be made immediately available that such reviews have taken place. Regulations should result in "informed decisions" that have taken into account and analyzed the various alternatives and are rational and appropriate. Procedures for effective ''public" participation are essential. Coordination and consistency is necessary among government agencies, and between governments.
REFERENCES 1. Animal and Plant Health Inspection Service, Plant Pests: Introduction of Genetically Engineered Organisms or Products; Final Rule, 52 FR 22882-22914, June 16, 1987.
Downloaded by [ECU Libraries] at 12:44 26 April 2015
2. National Academy of Sciences, Introduction of Recombinant DNA-Engineered Organisms into the Environment: Key Issues, Washington, D.C., National Academy Press, 1987.
3. Office of Science and Technology Policy, Coordinated Framework for Regulation of Biotechnology: Announcement of Policy and Notice for Public Comment, 51 FR 23302-23350, June 26, 1986. 4. Medley, T. L., Esq., Issues in assessing the environmental impact of veterinary biologies produced through biotechnology, Food Drug Cos. Law J., 821, 1988. 5. National Academy of Sciences, Field Testing Genetically Modified Organisms: Framework for Decisions, Washington, D.C., National Academy Press, 1989.
155
