APHIS Transgenic Arthropod Virtual Team Receives Vice Presidential Hammer Award 1oct97
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TRANSGENIC ARTHROPOD TEAM Hammer Award Recipients Team Leader ORREY P. YOUNG, PH.D. Members VED S. MALIK, PH.D. L. JOSEPH VORGETTS,
PH.D. KENNETH R. LAKIN,
PH.D. MICHAEL J. FIRKO,
PH.D RALPH D. STOAKS,
PH.D. DON C. VACEK, PH.D. GLEN GARRIS, PH.D. NORMAN C. LEPPLA,
PH.D. LAUREN JONES, B.S. |
On October 1, 1997, the APHIS Transgenic Arthropod Team was presented Vice President Al Gore’s “Hammer Award,” in recognition of its efforts to make government work better and cost less. From the APHIS press release...“APHIS’s virtual team developed the first system to authorize and regulate applicants requesting to introduce genetically engineered, or transgenic, arthropods and other invertebrates into the environment. To address the regulatory needs of the emerging transgenic arthropod industry, the team reinvented an existing system used to regulate transgenic plants and microorganisms. The new system emphasizes innovation, efficiency, transparency, and customer input and enables the staff to process permit applications in less than 120 days. For their work in establishing APHIS as the focus of federal transgenic arthropod regulatory activities and as a clearinghouse for information within the transgenic arthropod research community, the team is being recognized with a Hammer Award.”
The award ceremony for the Hammer Award was conducted as part of “A Biotechnology Celebration” at the Center for Agricultural Biotechnology on the campus of the University of Maryland in College Park, MD. Representing Vice-President Gore and presenting the award was Dr. Isi Siddiqui, Deputy Assistant Secretary of Agriculture. The celebration also included featured talks by Dr. Rita Colwell, President, University of Maryland Biotechnology Institute, and by Dr. Craig Reed, Associate Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture. Following a reception, Dr. Colwell conducted an open house of the Center for Agricultural Biotechnology at its new campus facility.
Presentation by Craig A Reed
Good morning. It is a great pleasure for me to be here to celebrate biotechnology and to recognize its prominent place in our future. There could be no more appropriate location for this event. Centers of learning and research such as this one will produce the innovations taking biotechnology into the next century. I salute Dr. Colwell for her vision and its state-of-the-art realization here at the University of Maryland.I am especially proud to recognize our Agency’s transgenic arthropod virtual team for earning Vice President Gore’s Hammer Award. The team’s work exemplifies the values and goals of a forward-thinking organization, which we value highly at USDA’s Animal and Plant Health Inspection Service. Congratulations on behalf of myself and all yo ur colleagues.
I’ve been asked to follow up Dr. Colwell’s review of emerging biotechnologies with a talk about APHIS’ regulatory role in their development. In recent remarks, Secretary of Agriculture Dan Glickman said, “We have a world population that in the next century is expected to grow at the rate of a New York City every month, a Mexico every year, perhaps even a China every decade. How do we feed all these people? We could continue ripping up fragile land and forests, and pump more pesticides into the ground. Or we could embrace the future—technology that allows us to dramatically increase yields ... using less water and less pesticides.”
I couldn’t agree more. Necessity is the mother of invention. And necessity is certainly the mother of biotechnology in regard to the productivity and environmental demands of the future. It holds the key to our success in the developing world markets and in feeding growing populations using environmentally and scientifically sound methods.
From my vantage point as APHIS associate administrator, I have seen the rapid development of new crop varieties and our regulatory process. Simply put, our Agency’s primary role is to oversee the introduction of genetically engineered plants and invertebrates to ensure that tests are conducted in ways that pose no significant impact on the environment or on agriculture.
This year marks a full decade that APHIS has been carrying out this mission. Ten years ago, we developed the USDA’s first biotechnology regulations. That first year, we issued 5 test permits—this year, we passed the 13,000 field-test site mark. While this industry has undergone unprecedented growth and change over the past 10 years, we remain committed to our Agency’s overriding mission of protecting U.S. agriculture. But, we also recognize that, if managed properly, the development and application of our regulations can actually serve another purpose—facilitating the safe transfer of technology. To successfully fulfill our role to protect and to facilitate the safe progress of biotechnology, we have had to shape our efforts strategically. We have considered—and sometimes even revisited—issues like, what should the scope of the regulations be?” And, “how flexible can we be?” By developing a strategic regulatory vision, we have been able to simultaneously ensure plant health and enable the efficient movement of biotech products from the lab to the greenhouse, and from the field to the marketplace.
The current system represents a commitment to regulatory innovation and flexibility—yet it is also rational and based on sound science. Our system evaluates genetically modified products on the basis of risk, determines the appropriate level of regulation needed to guard against any identified potential risks, and documents the actions we take. Our goal has been to develop regulations that neither over-regulate nor under-regulate.
In doing so, we focus on the characteristics of genetically engineered products themselves and on the uses to which they will be put—not simply on the fact that these products are produced through genetic engineering. Extensive scientific evaluations have not identified any safety problems unique to the methods used in biotechnology to develop new products. Our Agency has carefully studied this issue, and so have the Food and Drug Administration and the Environmental Protection Agency, which are responsible for reviewing these products for potential human health concerns and environmental risks. Each of these Federal Agencies agrees that, whether new products are produced by classical techniques or through biotechnology, the focus should be on the product, not the process.To further the strategic vision of our regulations, we have also committed to being responsive and flexible in our oversight. In fact, since 1987, we have significantly amended our regulations three times to keep pace with the accumulating knowledge in this field. The first major modifications were made in 1993, when we established a simplified application process—known as “notification”—for the field testing of six specific crops. Using the notification process, applicants certify that they have met our established eligibility criteria for a specific modification to a certain plant, as well as our performance standards for the confinement of the test organisms. With this change, applicants are no longer limited to using our original permit process, which requires extensive data, review, and approval before field tests can be initiated.
Under notification, the number of field trials increased greatly. In fact, more than 80 percent of all the field trials we oversee are conducted under the notification process. In 1993, we also established petition procedures to deregulate crops determined to be as safe to grow as those produced through classical means. This process, better known as commercialization, allows us to recognize the absolute agricultural safety of proven products.
Overall, derivatives of 48 different plant species have been field tested to date, including species as diverse as sugar cane, poplar trees, turfgrass, rice and sunflower—to name just a few. Derivatives of most major U.S. crops—including corn, soybeans, potatoes, tomatoes, cotton, and tobacco—have each had a large number of trials. We have deregulated a total of 27 products—including varieties of insect-resistant cotton, corn, and potato; virus-resistant squash and papaya; herbicide-tolerant corn and soybean; high-laureate canola; and delayed-softening tomato. As a result of these efforts, farmers planted 22 million acres of genetically altered crops during the recently completed planting season.
Having given you a look at where we’ve been, I’d now like to focus on an even more compelling subject: our future. How do we take our regulatory processes to the next level, meeting the needs of our customers while maintaining the integrity of the regulations themselves? To look into APHIS’ future as I envision it, we need look no further than the work of the biotechnology arthropod team we honor with a Hammer Award today.
I’ve discussed APHIS’ regulations for genetically altered plants, but, as you know, there are many more facets to biotechnology. For example, interest in genetically altered arthropods has increased greatly in the last 30 months. Our Biotechnology and Scientific Services team saw this trend coming and got to work early to shape our regulatory response.
I do not exaggerate when I say that insects rule the world. They have from the beginning of time adapted to their environment and will, no doubt, be here long after we are gone. No life form affects the planet more than insects. Agriculture itself would not be possible without the presence of insects, and yet they have the ability to do great harm to the environment, natural resources, our food supply, and to us. However, recent developments in biotechnology are helping turn potentially threatening insects into useful ones. For example, with genetic engineering, insects that decimate crops can be altered to destroy themselves—like the engineered cotton pink bollworm, which reduces its own population through a gene mutation that makes bollworms succumb to cold weather. Or they may be altered to be fatal to another harmful agricultural pest. On the flip side, some beneficial insects may be enhanced with a pesticide resistant gene that enables them to survive chemical treatments to eradicate other crop pests. As more and more researchers are discovering, the possibilities for genetic modification are seemingly limitless.
But, in a future of endless possibility, the need for strict regulatory control is critical, and APHIS is both well qualified and well prepared to provide that control. Our Biotechnology and Scientific Services team is a terrific example.
Anticipating the increasing importance of transgenic insects, they recognized that APHIS must be ready to guide the testing process for these organisms, and they went to work with a fresh philosophy--one with an eye on the future.
To develop guidelines for the way APHIS regulates genetically altered invertebrates, specifically arthropods, the team began by looking at established guidelines for engineered plants and microorganisms. To regulate this rapidly changing technology, they knew they needed the expertise of a wide range of scientific disciplines. Consequently, they put together a team of nine people from several APHIS divisions located in several States. Using e-mail as their principal mode of communications, the team was able to share a vast amount of knowledge and eliminate the expenses such efforts often accrue. To share their plans and scientific data with a global community of scientists and researchers, the team created a website on APHIS’ homepage devoted entirely to the regulation of transgenic arthropods. The site serves as a clearinghouse for the latest developments in this area, including information and comments from researchers, scientists and interested individuals. In an area where the knowledge base doubles every 36 months, the rapid exchange of information is crucial to any regulatory effort.
To ensure the timely implementation of the arthropod guidelines, permit applications are posted on the website within 7 days of their receipt, keeping the world abreast of all proposed field tests. To further speed the process, the team negotiated with appropriate agencies in several States to accept electronic letters of permit approval, cutting the time from application to authorization in half—from 120 days to 60.
As a result, one researcher at the University of Florida soon began testing a predatory mite that kills the crop-destroying spider mite, which may have enormous positive implications for fruit growers. Another researcher in New Jersey began controlled field testing of a transgenic nematode biocontrol agent that is resistant to summer soil temperatures. This kind of research will give farmers more integrated pest management options, a benefit to them and to the environment.
The accomplishments I have just outlined for you become even more significant when you learn that the arthropod working group never held a face-to-face meeting. They worked smarter, using the technology available to its fullest extent to maximize their efficiency. They sought advice, guidance, and data from the widest possible range of experts around the world. And they raised public awareness about their work.
By applying this model throughout the Agency we should be able to further strengthen our regulatory ability. As the science of biotechnology continues to expand, APHIS will work more and more in partnership with the scientific community, universities—especially with programs such as the one here at the University of Maryland—as well as with industry and with the public. Just as with the world of bioengineering, the possibilities for cooperative efforts are almost limitless.
Biotechnology is unquestionably the face of 21st century agriculture—in the United States and around the world. As biotechnology rapidly expands and becomes a larger part of the overall agricultural picture, APHIS will be there to ensure that all important new agricultural products are thoroughly tested and are safe before reaching the marketplace. As we make strides toward this future, I look forward to working together with you to meet the challenges we will face in the years ahead. Thank you.
soource: http://www.aphis.usda.gov/biotech/arthropod/tcurreed.html 25feb01
Presentation by Michael Dunn
President Clinton’s “New Covenant” alters the way the Federal Government does business and asks Government to expand opportunity, not bureaucracy. Part of the President’s initiative was the establishment of the National Performance Review—or “the Reinventing Government initiative”—to create a government that works better and costs less. The Hammer Awards celebrate employees’ success in achieving those goals.USDA has done much to forward these goals and is working to create a leaner, more responsive Department that is focused on expanding opportunity for U.S. agricultural producers. As part of this effort, we initiated an unprecedented restructuring program. By consolidating field offices and reducing administrative overhead, we have been able to cut costs while improving services.
APHIS’ new vision of empowering employees and putting customers first furthers the goal of a more responsive Government. The many Hammer Awards earned by APHIS employees attest to the Agency’s success.
Today’s Hammer Award winners are a team from APHIS’ Biotechnology and Scientific Services unit. These employees anticipated an industry need—in this case, the need for guidelines for the release of transgenic arthropods—and found a way to meet it without incurring additional Agency costs. Because this area of research is progressing rapidly, Government regulators need to keep abreast of new scientific developments in order to be responsive. Using e-mail and the World Wide Web, this team opened the permitting process for regulating transgenic arthropods, inviting Agency-wide participation and dialogue with prospective permit applicants, researchers, scientists, environmentalists, industry, and the public.
Expanding the use of the Internet even further, the team also negotiated agreements with individual States to accept electronic letters of permit approval. This strategy reduced the time, expense, and paperwork involved in permit approval, cutting the processing time in half.
APHIS’ work in the field of biotechnology is crucial to future agricultural success, and the innovative work of the Agency’s Biotechnology and Scientific Services team is helping shape that future. The regulatory process for the introduction of genetically altered plants and insects is essential to meeting increasing worldwide food demands while preserving the health of the environment.
source: http://www.aphis.usda.gov/biotech/arthropod/tcurdunn.html 25feb01
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