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Date:

February 21, 2002

Subject:

National Academy of Science Report,

 

Today in AgBioView:

* USDA News Release on NAS Report
* BIO Statement on NAS Report on Transgenic Plants
* NAS Release
* USDA asked to improve scrutiny of altered crops
* Panel Urges U.S. to Tighten Approval of Gene-Altered Crops
* ICAR's Bt cotton report
* Lord Haskins criticises GM opposition
* LSN FINDS COMMON CAUSE WITH GREEN PARTY

http://www.usda.gov/news/releases/2002/02/0060.htm

USDA News Release on NAS Report

Contact: Jim Rogers (301) 734-8563

ìBiotechnology poses innumerable benefits for producers, consumers, and the environment worldwide. Under a regulatory framework administered by USDA, the Food and Drug Administration, and the Environmental Protection Agency, the Federal Government is working to ensure the safety of products developed through biotechnology.

ìToday, U.S. Department of Agriculture received the National Academy of Sciences (NAS) report Environmental Effects of Transgenic Plants. The report, which was commissioned in January 2000 by USDAís Animal and Plant Health Inspection Service (APHIS), reviews the scope and adequacy of the APHIS component of the Federal regulatory framework for biotechnology. As requested, the report evaluates the evolution of APHISí regulatory program, assesses the effectiveness of changes that APHIS has made to improve the program over the years, and makes recommendations for further refinements. USDA welcomes the input from NAS.

ìThe NAS report notes that new transgenic plants receive greater regulatory scrutiny than conventional plants. The NAS recommendations were provided ëas a means to help improve an already functioning system.í The report notes the constant evolution of the regulatory review processes and recognizes that USDA has improved oversight of this new and evolving technology since it was initiated. Additionally, the report reaffirms that plants produced through modern biotechnology pose no different risk than plants produced through more traditional methods.

ìIt is important to note that USDA has already addressed some specific issues raised in the report, which involve three processes: notification, permitting and petitioning for non-regulated status.

ìThe report affirmed the conceptual basis of APHISís streamlined ënotificationí process for field trials. APHIS is currently working to incorporate independent scientific input into the ënotificationí process. A wider base of scientific knowledge will allow APHIS to ensure that field testing of transgenic plants does not lead to unwanted environmental effects.

ìAPHIS regulates the movement, importation and field testing of biotech enhanced plants and microorganisms through ëpermitting.í As part of this process APHIS solicits comments from the public on formal environmental assessments of transgenic plants. APHIS is considering how best to further encourage public comment and receive broader scientific input during the permitting phase.

ìAPHIS is currently assessing options for monitoring already commercialized transgenic plant products. The agency can already bring the organisms back under regulation if a plant pest risk is discovered. However, the agency is considering whether it may be appropriate in some instances for research agencies to gather additional environmental information through non-regulatory means.

ìAPHIS will thoroughly review the report and study its recommendations. We believe that this study will be an important tool in the future regulation of biotechnology.î
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BIO Statement on NAS Report on Transgenic Plants

Contact: Lisa Dry, (202) 962-9231
Biotechnology Industry Organization (BIO)
February 21, 2002

Dr. Michael J. Phillips, executive director for food and agriculture of the Biotechnology Industry Organization (BIO) issued the following statement in response to todayís National Academy of Sciencesí report titled "Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation."

WASHINGTON (February 21, 2001) "Todayís report, commissioned by the United States Department of Agriculture (USDA), confirms the effectiveness of a comprehensive regulatory system that has been in place for more than a decade, and which has reviewed and granted more than 30,000 field permits without a single incidence of injury to human health or the environment.

"USDA is to be commended for requesting a scientific review of their system -- a system that works -- to see what enhancements, if any, might be needed. The suggestions offered by the panel may be viewed as tweaking a regulatory system that is held as the gold standard around the world.

"As the biotechnology industry matures, the agencies and regulations will be elaborated upon and modified as we learn more through experience; this is the normal course of science.

"BIO supports the overall tone and tenor of the NAS document; we might not be 100 percent in agreement on some wording and recommendations, but the report is not an indictment of the existing system; instead, it is a validation of a very good regulatory system with an excellent track record. It is a system that is flexible enough to incorporate many of the reportís recommendations, which will make it even better."

The Biotechnology Industry Organization (BIO) represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.
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Date: Feb. 21, 2002
Contacts: Bill Kearney, Media Relations Officer
Andrea Durham, Media Relations Assistant
(202) 334-2138; e-mail

FOR IMMEDIATE RELEASE

Regulation of Transgenic Plants Should Be Reinforced;
Field Monitoring for Environmental Effects Is Needed

WASHINGTON -- The U.S. Department of Agriculture should more rigorously review the potential environmental effects of new transgenic plants before approving them for commercial use, says a new report from the National Academies' National Research Council. The committee that wrote the report also said the public should be more involved in the review process and that ecological testing and monitoring should continue after transgenic plants have entered the marketplace.

Appropriate environmental risk analysis and public acceptance of transgenic plants depend on a federal regulatory system and culture that communicates to society the seriousness with which potential environmental risks are being addressed, the report emphasizes.

"USDA has substantially improved its regulation of transgenic plants, but the process could be improved further by soliciting greater public input, enhancing scientific peer review, and more clearly presenting the data and methods behind regulatory decisions," said committee chair Fred Gould, William Neal Reynolds Professor of Entomology, North Carolina State University, Raleigh. "Our report provides a detailed road map for the federal government to follow as it reinforces its assessment of environmental risks."

While the committee called for an enhanced regulatory process for transgenic plants, it also noted that the current level of regulation for such plants is higher than for other agricultural products and practices. This is the case despite the fact that the committee did not find any strict distinctions between the types of environmental risks posed by plants genetically engineered through modern molecular techniques and those modified by conventional breeding practices. There is typically no formal assessment of potential environmental effects of newly introduced crop varieties produced by conventional breeding. There is no immediate need to regulate conventionally bred crops, but their potential environmental effects should be re-evaluated.

The Animal and Plant Health Inspection Service (APHIS) -- the arm of USDA responsible for regulating transgenic plants -- reviews about 1,000 applications each year from biotechnology companies wishing to field-test new transgenic plants or petitioning to have a plant deregulated altogether. Field-testing of most transgenic plants is approved through the "notification" process, whereby applicants notify APHIS that a plant meets general guidelines for not causing unwanted environmental effects. If the agency agrees, the plant can be grown while the company conducts further field-testing to rule out adverse environmental effects. But there is no public or independent scientific input in this process, and no limit to the acreage that can be planted.

There also is a need to re-examine which transgenic plants should be tested and allowed to grow commercially through notification, the committee said. It discovered one case, for example, where it appears that a variety of corn that produces a protein with insecticidal properties, known as avidin, was grown commercially under the notification process.

At the same time, however, the committee called notification an important step in effectively streamlining the field-testing review process. In fact, given what APHIS has learned about certain plant traits, it should be able to quickly screen many of the current generation of transgenic plants for potential environmental risks. More detailed investigations should be conducted only when preliminary testing indicates a possible risk.

Most biotech companies commercialize transgenic plants by petitioning for non-regulated status -- in essence requesting APHIS to determine that there is no environmental risk associated with a specific transgenic plant. As part of this process, APHIS always conducts a formal environmental assessment that it publishes in the Federal Register, providing the public with a 60-day comment period. But the committee found that almost no one comments. It said that before making precedent-setting decisions regarding field-testing or deregulation, APHIS should solicit broad external scientific and public review well beyond the use of the Federal Register, and that the agency should convene a scientific advisory group before any changes in regulatory policy are made.

Some transgenic plants are engineered to produce a pesticide, which could potentially harm or kill non-target organisms or allow pests to develop immunity to the pesticide. However, the committee found that APHIS's treatment of these two issues in its environmental assessments is generally superficial. The agency should either increase the rigor of its analysis of pest resistance and impacts on non-target species, or completely defer to the U.S. Environmental Protection Agency, which also assesses these risks.

Because APHIS considers deregulation final, it does not conduct post-commercialization monitoring for environmental effects. The committee said that without systematic monitoring, however, there is no way to ensure that environmental damage has not occurred. It recommended that such monitoring take place to validate the pre-commercialization environmental testing and to spot unanticipated or long-term environmental impacts. Large-scale planting might cause environmental effects or impact non-target organisms in ways that could go undetected in the pre-commercialization testing phase. Validation testing can be carried out through existing USDA programs, but field-monitoring will require the development of an interactive program involving government agencies and academic scientists. Additional funding will be needed in both instances.

The study was sponsored by the U.S. Department of Agriculture. The National Research Council is the principal operating arm of the National Academy of Sciences and the National Academy of Engineering. It is a private, nonprofit institution that provides science and technology advice under a congressional charter. A committee roster follows.

The report Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation is available on the Internet at http://www.nap.edu. Copies are available for purchase from the National Academy Press; tel. (202) 334-3313 or 1-800-624-6242. The cost of the report is $49.95 (prepaid) plus shipping charges of $4.50 for the first copy and $.95 for each additional copy. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

NATIONAL RESEARCH COUNCIL
Division on Earth and Life Studies
Board on Agriculture and Natural Resources
Board on Life Sciences
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USDA asked to improve scrutiny of altered crops

The San Francisco Chronicle
FEBRUARY 22, 2002
By Tom Abate

A scientific panel has urged the U.S. Department of Agriculture to tighten its premarket review of genetically engineered crops and to monitor them after planting for possible environmental effects.

But the 320-page report, issued yesterday by a committee of the National Academy of Sciences, also said genetic engineering, as a tool, poses no greater environmental risk than traditional crop breeding, which can also introduce traits that can jump from the farm into the wild with unforeseen consequences.

Fred Gould, an entomologist at North Carolina State University and chair of the NAS committee, said the report was intended to close "small loopholes" in the rules under which the USDA reviews about 1,000 new biotech crops each year. The panel urged the USDA to tighten rules governing field tests of new crops. Currently, if a company declares that it doesn't expect any environmental effects, and the USDA agrees, the firm can conduct the tests.

"But there is no public or independent scientific review in this process, and no limit to the acreage that can be planted," the committee said.

The NAS report also criticized the USDA for failing to monitor "the tens of millions of hectares of transgenic crops" that have been commercially planted in recent years.

"There has been no environmental monitoring of these transgenic crops, so any effects that might have occurred could not have been detected," the report said.

The committee said the USDA keeps too much information about new crops secret to protect the competitive interests of biotech companies and urged the agency to share more data with the public.

"People don't know the ins and outs of genetic engineering, but they remember the Ford Pinto," said Deborah Letourneau, an environmental studies professor at the University of California at Santa Cruz and member of the NAS panel. "Credibility is really important, and companies and regulatory agencies need to build it."

Critics said the report demonstrated the inadequacy of USDA regulations. "It's not a difficult bar to meet to get USDA approval for a genetically engineered crop," said Jane Rissler, with the Union of Concerned Scientists.

But Michael Phillips, with the Biotechnology Industry Organization, said the NAS report exposed a double standard because the USDA doesn't regulate new crops bred through conventional means, even though the NAS committee found that such plants can have environmental consequences.

Although the NAS panel did not call for the regulation of conventional crops, the report said future studies should consider whether crops bearing certain traits -- such as pesticide or herbicide resistance -- pose such environmental risks that they should be subject to review regardless of whether they are created in the greenhouse or the lab.

The USDA, which requested the NAS report in response to criticism of its procedures, said it will review the findings before deciding what to do next.
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Panel Urges U.S. to Tighten Approval of Gene-Altered Crops

The New York Times
February 22, 2002
By ANDREW C. REVKIN

The government should more carefully, and publicly, review the environmental impact of genetically altered plants before approving them and, to detect unforeseen problems, should monitor fields even after such crops are being grown commercially, a panel of biologists and agricultural scientists concluded yesterday.

The panel, convened by the National Academy of Sciences, said the Department of Agriculture had not missed any big environmental risks in its review of genetically modified plants, a step required before the plants can be either field-tested or grown for marketing. The scientists also emphasized that their findings were intended to "improve an already functioning system," and noted that "the standards being set for transgenic crops are much higher than for their conventional counterparts."

But, they said, biotechnology companies are rapidly developing new plants containing either combinations of genes, or individual genes that induce the plant to produce industrial chemicals, fuels and other materials. These efforts, the panel said, will require much more rigorous testing and review than the government currently undertakes.

Other crop types, produced by nongenetic means, can pose environmental risks as well, the panel said. But it said the public had demanded, and should be granted, an extra level of precaution when organisms are genetically engineered.

The panel's report, a summary of which was described yesterday in The Wall Street Journal, was requested by the Agriculture Department and took two years to produce. It concluded that the testing and assessment of genetically altered plants should be made "significantly more transparent and rigorous," with reviews by independent panels of experts, with more involvement of the public and with less secrecy.

It noted that companies seeking permission to commercialize genetically altered plants in the United States were allowed to keep much more data confidential than in other countries.

Officials of the Animal and Plant Health Inspection Service, an Agriculture Department agency that issues permits for genetically modified crops, said the study validated their current program while pointing to areas to improve. Bobby R. Acord, administrator of the inspection service, said the agency was already "considering how best to further encourage public comment and receive broader scientific input."

Companies producing bioengineered crops echoed the agricultural officials, pointing to the report's qualified endorsement of the existing regulatory system. "They make a number of suggestions for enhancing that process, but they make it very clear that a rigorous assessment is being done," said Dr. Eric Sachs, a geneticist who is director of scientific affairs for Monsanto.

Environmental groups said the report could help produce what they described as much-needed improvements in the review process.

"It has been a cakewalk for the industry in terms of getting products approved," said Dr. Margaret Mellon, a molecular biologist and biotechnology expert at the Union of Concerned Scientists.

"The real question raised by this report," Dr. Mellon added, "is whether a rickety system that hasn't been very rigorous but probably has served well enough to date is adequate enough to take us into the future." The answer delivered by the panel, she said, is that the system is not up to the task.

The report noted, for example, that although the Environmental Protection Agency required monitoring of approved crops that have genes for pest-killing toxins, neither that agency nor any other is responsible for monitoring crops with other genetic traits.

The committee also said agricultural officials currently approved most proposed plant varieties for field tests, with no limit on acreage, on the basis of a company's written statements. Much more review is needed, it said, along with involvement by independent scientists and the public.
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From: "Deepali Nimbalkar"
Subject: ICAR's Bt cotton report
Date: Fri, 22 Feb 2002 16:39:07 +0530

So finally a positive report on trials of genetically modified Bt cotton in India has been submitted. About time too! Hopefully the GEAC should not cause further delays. No doubt that further opposition from the environmental terrorists is to be expected, but I think the report is a step in the right direction.

In addition to yield enhancement the reduction in fertilizer doses would definetely cut costs and help in improving the farmers income. India has lagged behind in the cotton production due to this delay but this should come as a welcome step for everyone. The indegenously developed varieties would also be welcome. I think not just cotton but transgenics in other crops (foodgrains/cashcrops) would help improve the status of the average farmer in developing and under developed countries. They could go a long way in solving the hunger problem for the ever increasing population of the world. For the environmental sceptics, they should be shown the report (Agbioview- 20th Feb 2002) where GM plants have been proved as beneficial for the environment by allowing other grasses and weeds to grow and thus helping in prevention of soil erosion. This would be especially beneficial to a country like India which increasingly faces the threat of desertification i! n its western parts.

I work in the field of Environmental Sciences and in my opinion we have a much greater threat to the environment from the toxic effluents released by the industrial units which are reducing our life span and deteriorating the quality of our life as compared to the transgenics which could actually help improve the quality of life for a large number of people.Rational thinking by these environmental terrorists is the need of the hour.

Deepali Nimbalkar
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http://news.bbc.co.uk/hi/english/uk/wales/newsid_1834000/1834181.stm

Lord Haskins criticises GM opposition

BBC
21 February, 2002

One of the UK Government's chief advisors on farming has criticised the Welsh Assembly's opposition to genetically-modified (GM) crop trials in Wales. Lord Haskins, the Rural Recovery co-ordinator for England, likened attempts to stop GM crop trials to King Canute trying to stop the tide coming in.

We are only going to be shooting ourselves in the foot if we don't allow our farmers to test GM crops. He defended GM crops as an important component in future efforts to feed a growing world population.

"These GM trials are taking place and commercial GM activity is taking place in America, in South America, in Australia and in Asia," he said.

"We are only going to be shooting ourselves in the foot if we don't allow our farmers to test them."

Lord Haskins made the comments in a BBC Wales sponsored lecture to the Cardiff University Regeneration Institute on Wednesday night. It was the second in a series of public lectures sponsored by the BBC, in association with the Regeneration Institute.

In Wales, the assembly has opposed GM maize trials.

Lord Haskins was also scornful about the potential of organic farming, which the assembly also supports. However, he did back efforts to subsidise environmentally-friendly farming activity.

Scientific advances

During the lecture, Lord Haskins considered the ongoing food debate, in the light of the world's growing population.

He argued that man's ingenuity - which has resulted in a major increase in food production over the past two centuries - will solve the problem of having to double existing food production in the next 30 years.

He cited advances including progress in animal and plant-breeding science, as well as in the development of fertilisers, fungicides and herbicides.

Lord Haskins argued the future demand can be met in genetic modification raising food outputs to "spectacular heights".

He also felt that satellite technology would squeeze vital improvements from harvests and the elimination of inefficiencies in agricultural industries across the world.
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LSN FINDS COMMON CAUSE WITH GREEN PARTY

February 21, 2002
Life Sciences Network Media Release
www.lifesciencesnetwork.com

The Life Sciences Network today welcomed the support given by Green Party MPs Sue Kedgley and Sue Bradford to a petition calling for reductions in excessive and indiscriminate use of agrochemicals said Chairman, Dr William Rolleston. 'The Network's members fully support initiatives which will reduce impacts on the environment caused by improper use of pesticides and herbicides. The agrochemical industry spends a huge amount of time and money providing education and training for commercial applicators and major users. All agrochemical products are packaged with detailed instructions on safe use. 'Agrochemicals are a substantial contributor to the rural economy. 'The real step change in agrochemical usage will come when herbicide and pesticide resistant crops are introduced into New Zealand agriculture on a commercial basis so our growers can gain similar chemical reductions as their competitors overseas. 'US farmers have reduced pesticide and herbicide usage by hundreds of thousands of tons by using GM crops; with major benefits for the environment and for farm worker safety - both issues which the Green Party has been strongly in favour of,' concluded Dr Rolleston.