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POLICY & REGULATION: ‘Ill-defined, irrational and costly’ GM approval process must be reviewed, academic



                                  PART 1


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TITLE:   ?ILL-DEFINED, IRRATIONAL AND COSTLY? GM APPROVAL PROCESS MUST BE REVIEWED, ACADEMIC

SOURCE:  Food Navigator, USA

AUTHOR:  Elaine Watson

URL:     http://www.foodnavigator-usa.com/Regulation/Ill-defined-irrational-and-costly-GM-approval-process-must-be-reviewed-academic

DATE:    05.07.2011

SUMMARY: "The system for assessing new GM crops with nutritional and environmental benefits must be improved to reduce the time and expense of gaining approvals and enable smaller players to get a look in, according to one leading academic. This did not mean taking shortcuts on safety, merely modifying the process such that it took into account learnings from the extensive safety work already conducted on GM crops to avoid duplicating efforts, argued Dr Roger N. Beachy, who was speaking at a hearing held by the House Agriculture Subcommittee on Rural Development, Research, Biotechnology, and Foreign Agriculture last week."

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?ILL-DEFINED, IRRATIONAL AND COSTLY? GM APPROVAL PROCESS MUST BE REVIEWED, ACADEMIC

The system for assessing new GM crops with nutritional and environmental benefits must be improved to reduce the time and expense of gaining approvals and enable smaller players to get a look in, according to one leading academic.

This did not mean taking shortcuts on safety, merely modifying the process such that it took into account learnings from the extensive safety work already conducted on GM crops to avoid duplicating efforts, argued Dr Roger N. Beachy, who was speaking at a hearing held by the House Agriculture Subcommittee on Rural Development, Research, Biotechnology, and Foreign Agriculture last week.

As things stood, the cost ($5-25m) of gaining regulatory approvals for new biotech crops was such that only huge corporations could afford to participate, said Beachy, who is president emeritus at the Donald Danforth Plant Science Center in St. Louis and founding director of the National Institute for Food and Agriculture.

Meanwhile, many applicants had to wait up to a decade before getting the green light as they navigated through an ?ill-defined and/or unpredictable, sometimes irrational, and always costly? process,? said Beachy.

No new products from universities for a decade

He added: ?Researchers in universities and small companies have, since the mid-1980s made discoveries that are relevant to the less lucrative vegetable seed market [compared with the commodity crops big biotech firms focus on], and in cutting edge areas that have potential to revolutionize the biofuels and biomaterials industry.

?Yet, there have been no new products released to the market from universities for more than 10 years, in part because of the time and cost necessary to bring the new product forward.?

Regulators needed to ?discipline themselves to focus on what they need to know to ensure safety?, suggested Beachy, while the ?characteristics of the products that would trigger regulation and a relevant mechanism to trigger regulatory oversight should be redefined?.

Legal decisions ?not based on science?

Meanwhile, ?legal decisions not based on science? were also thwarting progress, claimed Charles Conner, chief executive of the National Council of Farmer Cooperatives in Washington, DC.

After ?extensive environmental, health and human safety reviews? USDA (the US Department of Agriculture) had determined that sugarbeet and alfalfa Roundup Ready products were safe for commercialization, said Conner.

However, these crops were subsequently (although ultimately unsuccessfully) challenged in court on ?procedural? National Environmental Policy Act issues, he said.

Although both crops were ultimately planted, the time and money expended to ?litigate these needless legal challenges has been debilitating to USDA?s efforts to review and approve new products?, claimed Connor.

Added Beachy: ?This is an exciting period of time in discovery and innovation. Unfortunately, it is not an exciting time for delivering new products of agriculture biotechnology to consumers or to those who would invest in the future of agriculture.?

The next generation of genetically engineered crops would play a key role in enabling farmers to meet growing demand for food and feed, while at the same time using less water, energy and fewer pesticides and herbicides, he said.



                                  PART 2

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TITLE:   RETHINKING REGULATIONS FOR BIOTECH CROPS

SOURCE:  Truth About Trade and Technology, USA

AUTHOR:  Ross Korves

URL:     http://www.truthabouttrade.org/news/editorials/trade-policy-analysis/18078-rethinking-regulations-for-biotech-crops

DATE:    07.07.2011

SUMMARY: "Dr. Beachy asked the subcommittee to consider the unintended consequences of overly stringent regulations of biotech crops. These include creating the perception that the technology is unsafe and causing many developing countries to be reluctant to adopt the technology. He noted, ?It (the regulatory process) has adapted poorly in response to the proven safety record and absence of adverse affect on the environment or on animal and human health of GE crops. It has not adapted to changes that have further enhanced the safety of the technologies; and it has not adapted to the needs of the market."

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RETHINKING REGULATIONS FOR BIOTECH CROPS

While the three billionth acre of biotech crops will be planted somewhere in the southern hemisphere in the next planting cycle and they move widely in international trade, regulation of biotech crops continues to be a public policy issue in the U.S. and other countries that grow and/or use them. In late June a subcommittee of the Agriculture Committee of the U.S. House of Representatives held a hearing to review the opportunities and benefits of biotechnology.

Roger Beachy, PhD, appointed by President Obama in 2009 to be the founding Director of the USDA National Institute of Food and Agriculture where he served until May of this year, testified as a scientist who was involved in the early stages of biotech research. He was a Professor in the Biology Department at Washington University in St. Louis, the Director of the Center for Plant Science and Biotechnology from 1978-1991 and worked with scientists from Monsanto to develop the first genetically modified food crop, a variety of tomato modified for resistance to a virus disease. His concern now is that inventions with a likelihood of success will ?continue to be delayed in reaching the marketplace because of regulatory processes that are ill-defined and/or unpredictable, sometimes irrational, and always costly.? The U.S. will increasingly be challenged by Brazil and China who are expected to provide half the new biotech varieties between now and 2015.

Dr. Beachy said that regulations were developed in the 1980s and finalized in 1986 as the Coordinated Framework for Regulation of Biotechnology under then existing authorities of USDA, EPA and FDA because the anticipated hazards were the same as with other types of agricultural innovation. The regulations were appropriate for the new technology, but have not been adapted to the experiences and new knowledge of the past 24 years. With sufficient time, money and patience, $5-25 million and up to ten years, some new technology can make it to the marketplace, but other useful products cannot get through the process to provide benefits to producers and consumers from investments in science and technology.

Four modifications to the regulatory process are suggested by Dr. Beachy. First, ?return to a firm commitment to base regulations on science? related to the safety of the product and not to the process by which it was developed. This will reduce the number of tests and the time and cost of regulations. Second, ?redefine the basis by which products of biotechnology are subjected to regulatory oversight.? The role of the Animal and Plant Health Inspection Service of USDA should be maintained, but the characteristics and mechanism of products that trigger regulation should be redefined.

Third, ?identify categorical exemptions that can streamline and reduce burdens for products/characteristics experience has shown to be safe.? Existing technologies and products would be reviewed to determine which technologies can have reduced oversight. Fourth, ?distinguish between real and perceived risks and focus on those that are real.? Congress needs to provide legislation to consider the opportunity costs of regulatory policies that discourage innovations that reduce risks of conventional agricultural practices. This could include how the National Environmental Policy Act (NEPA) of 1969 is applied to agriculture.

NEPA as it applies to agricultural biotechnology was explored in an article in the summer 2011 issue of Regulation magazine by Henry I. Miller, a physician, fellow at the Hoover Institution and founding director of the Office of Biotechnology at the Food and Drug Administration, and Gregory Conko, senior fellow at the Competitive Enterprise Institute. Under NEPA, agencies are required to consider the effects on the ?human environment? of ?major actions? they take. Actions with no significant impacts require only a brief Environmental Assessment, but significant impacts require an Environmental Impact Statement on every conceivable effect requiring hundreds of pages. Roundup Ready alfalfa and sugar beets were tied up in court over the initial USDA Environmental Assessments and court requirements to do Environmental Impact Statements.

Any changes in U.S. regulations for biotech crops will be closely watched by the rest of the world, particularly in developing countries where interest in biotech crops has increased, but regulatory structures remain undefined. Testifying at the subcommittee hearing was Dr. Calestous Juma, Professor of the Practice of International Development and Director of the Science, Technology and Globalization Project at Harvard University. He said the U.S. is a role model with ?its commitment to using a science‐led regulatory system for determining the approval of new products.? In addition to increasing agricultural productivity, biotechnology has the potential to create more nutritious crops like rice with additional amounts of vitamin A that could improve human health and increase productivity from healthier workers. African countries now have more interest in biotech crops than any time in the last 20 years. Dr. Juma concluded, ?The impact of their dedication will be limited
  unless they are able to benefit from prior knowledge and expertise accumulated in other countries. This is where the United States can serve as a role model in the use of biotechnology in agricultural transformation and science‐based approaches in regulation.? Kenya, Dr. Juma?s country of birth, has just approved importing biotech corn for food uses and the planting of biotech seed corn.

Dr. Beachy asked the subcommittee to consider the unintended consequences of overly stringent regulations of biotech crops. These include creating the perception that the technology is unsafe and causing many developing countries to be reluctant to adopt the technology. He noted, ?It (the regulatory process) has adapted poorly in response to the proven safety record and absence of adverse affect on the environment or on animal and human health of GE crops. It has not adapted to changes that have further enhanced the safety of the technologies; and it has not adapted to the needs of the market. The system needs attention, modification, and improvement if the U.S. and global agriculture communities and its consumers are to benefit from the investment in past and current science and technology that can impact agriculture and agriforestry.?



                                  PART 3

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TITLE:   HOUSE AGRICULTURE SUBCOMMITTEE LOOKS AT BIOTECH BENEFITS

SOURCE:  Western Farm Press, USA

AUTHOR:  

URL:     http://westernfarmpress.com/government/house-agriculture-subcommittee-looks-biotech-benefits

DATE:    23.06.2011

SUMMARY: "The House Agriculture Subcommittee on Rural Development, Biotech, Specialty Crops and Foreign Agriculture today held a hearing to review the opportunities and benefits of agricultural biotechnology. The academically focused hearing highlighted the benefits biotechnology provides agriculture, including improved yields and reduced impact on natural resources."

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HOUSE AGRICULTURE SUBCOMMITTEE LOOKS AT BIOTECH BENEFITS

 

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http://agriculture.house.gov/hearings/hearingDetails.aspx?NewsID=1400

Hearings, 112th Congress, Subcommittee on Rural Development, Biotech, and Foreign Ag: To review the opportunities and benefits of agricultural biotechnology

Witness Testimonies [for downloading]

The Honorable Charles F. Conner, President and Chief Executive Officer, National Council of Farmer Cooperatives, Washington, D.C.

Roger N. Beachy Ph.D, President Emeritus, Donald Danforth Plant Science Center, St. Louis, Missouri

Calestous Juma Ph.D, Professor of the Practice of International Development, Belfer Center for Science and International Affairs, John F. Kennedy School of Government, Harvard University, Cambridge, Massachusetts

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?Biotechnology developments have reduced pesticide use, improved conservation practices and afforded a more sustainable way for farmers to provide us with food, feed and fiber.?

The House Agriculture Subcommittee on Rural Development, Biotech, Specialty Crops and Foreign Agriculture today held a hearing to review the opportunities and benefits of agricultural biotechnology. The academically focused hearing highlighted the benefits biotechnology provides agriculture, including improved yields and reduced impact on natural resources.

The subcommittee received testimony from Chuck Connor, president and CEO of the National Council of Farmer Cooperatives; Dr. Roger Beachy, president emeritus, Donald Danforth Plant Center, St. Louis, Mo.; and Dr. Calestous Juma, professor of the Practice of International Development, Harvard University.

?Farmers have rapidly adopted the new technology and have enjoyed more convenient and flexible crop management, lower cost of production, higher productivity and/or net returns per acre and numerous environmental benefits,? Connor stated in his testimony. ?Biotechnology developments have reduced pesticide use, improved conservation practices and afforded a more sustainable way for farmers to provide us with food, feed and fiber.?

Each of the panelists stressed the need for a regulatory system based on sound science. Panelists also urged the subcommittee to consider how biotechnology can meet the future demands of a growing global population.

The subcommittee plans to hold a second hearing to examine the current regulatory system and the challenges imposed by litigation.