* HARDY rice: less water, more food
* Centre to attract scientists to Africa
* 'Humanised' organ tests set
* GE legislation amended
* USDA FAS Attache Reports
* Ag Biotech Risk Analysis in the US Government
HARDY rice: less water, more food
- PhysOrg.com, September 10, 2007
An international team of scientists has produced a new type of rice that grows better and uses water more efficiently than other rice crops. Professor Andy Pereira at the Virginia Bioinformatics Institute (VBI) has been working with colleagues in India, Indonesia, Israel, Italy, Mexico and The Netherlands to identify, characterize and make use of a gene known as HARDY that improves key features of this important grain crop.
The research, which was recently published in the Proceedings of the National Academy of Sciences, shows that HARDY contributes to more efficient water use in rice, a primary source of food for more than half of the world's population.
Rice (Oryza sativa) is a water guzzler when compared to other crops. It typically uses up to three times more water than other food crops such as maize or wheat and consumes around 30 percent of the fresh water used for crops worldwide. In conditions where water is scarce, it is important to have crops that can efficiently generate biomass (plant tissue) using limited amounts of water. HARDY rice shows a significant increase in biomass under both drought and non-drought conditions. The researchers found that the biomass of HARDY rice increased by around 50 percent under conditions of water deprivation (drought) compared to the unmodified version of the same type of rice.
Dr. Andy Pereira, professor at VBI, stated: "This transdisciplinary research project involved the study of two plants. First we used a powerful gain-of-function screening technique to look at a large number of Arabidopsis plants that might have features favorable to water and drought resistance. We were able to identify the HARDY mutant due to its considerable reluctance to be pulled from the soil and its smaller, darker green leaves. Molecular and physiological characterization showed that the improved water usage efficiency was linked to the HARDY gene."
Dr. Aarati Karaba, who worked on the project as a graduate student jointly at the University of Agricultural Sciences in Bangalore, India, and at Plant Research International, Wageningen, The Netherlands, commented: "The next step was to introduce the HARDY gene into rice and examine the features arising from this transformation. In rice, HARDY seems to work in a slightly different way than Arabidopsis but it still leads to improved water-use efficiency and higher biomass. Further studies showed that HARDY significantly enhances the capacity of rice to photosynthesize while at the same time reducing water loss from the crop."
Dr. Andy Pereira, added: "DNA microarray analysis allowed us to look at gene expression patterns regulated by HARDY. We specifically focused on genes that have gene ontology (GO) terms, namely genes that have been assigned by the scientific community to specific biological processes or functions. Using this approach we were able to identify clusters of known genes regulated by HARDY whose levels changed under conditions of plant water deprivation. We also saw distinct changes of gene clusters linked to the metabolism of key proteins and carbohydrates, which probably explains some of the feature differences we have detected in Arabidopsis and rice."
The scientists have been able to track down these improvements in water-use efficiency to a specific type of molecule known as AP2/ERF-like transcription factor. Transcription factors are proteins that bind to DNA and control gene expression and the HARDY gene encodes a protein that belongs to a specific class of AP2/ERF-like transcription factors. Shital Dixit, Graduate student at Plant Research International, Wageningen, The Netherlands, commented: "At this point in time, we do not know the exact function of this transcription factor although we suspect that it impacts maturation processes linked to tissue desiccation. More work remains to be done to elucidate the precise function of this protein as well as the processes on which it has a major impact. What is clear is that HARDY rice offers the exciting prospect of improved water-use efficiency and drought resistance in rice and perhaps other grain or seed crops. This should contribute in a sustainable way to maintaining high crop yields under conditions of limited water availability."
Genetics centre to attract scientists to Africa
- Vivian Warby, BuaNews (South Africa), Sept. 10, 2007
Cape Town - The International Centre for Genetic Engineering and Biotechnology (ICGEB) will make an important contribution in efforts to reverse the "brain drain" on the African continent.
Speaking on Monday at the opening of the Cape Town component of the ICGEB, President Thabo Mbeki said the centre could turn the "brain drain" into a "brain gain" for Africa.
The laboratory at the Groote Schuur Hospital, is one of only three major international biotechnology laboratories, servicing a 74-country partnership.
It joins its sister components in Trieste, Italy and New Delhi, India, to form "one of the most powerful international facilities for high quality scientific research and training in the field of biosciences".
The President said the ICGEB is an eminent example of how humanity can put together limited individual resources within nation states to create a substantial international force for the good of all.
"As we all know, biotechnology can, and must, play a key role in addressing many of the challenges facing the African continent, in particular, and the developing world as a whole."
This branch of knowledge, he said, is making and will make a critical contribution in terms of addressing contemporary and future needs in such areas as health, food and energy security, especially in the wake of major global challenges that include climate change.
"Equally, we look to biotechnology to assist us in the developing world to enhance our capacity in the areas of indigenous knowledge systems and biodiversity, so that we can develop these areas into sustainable initiatives for the benefit of all our peoples and humanity as a whole," he said.
President Mbeki stated that one of the critical challenges facing the African continent was to ensure that it produced sufficient numbers of experts in the area of science and technology.
He said it was hoped that the youth would be inspired by the example set by eminent scientists such as the four South African Nobel Prize winners in biotechnology-related fields, who are:
* Sydney Brenner, for his work in eluding controlled cell-death during organ development, (2002); * Aaron Klug on macromolecular biology, (1982); * Allan Cormack for co-inventing the CT scan (1979) and * Max Theiller, for his work on yellow fever (1951).
"We are indeed very proud of these high achievers who, through their work, demonstrate the potential for science to turn the tide of poverty in Africa and help us to build a modern, knowledge driven-economy."
Mr Mbeki said that the Cape Town component of the ICGEB would hopefully support regional cooperation on biotechnology and strengthen other regional platforms.
The central role played by technology in economic development, he said, was being increasingly acknowledged internationally.
"There is no doubt that scientific knowledge and innovation could jump-start and sustain our continent's development process and ensure that we meet the Millennium Development Goals.
Being an ICGEB member, he said, offers us new opportunities to further our National Biotechnology Strategy through participation in advanced ICGEB collaborative research programmes and comprehensive training schemes.
"In addition, we have been able to participate in a high-level inter-governmental forum where policy issues related to bio-safety and technology transfer are discussed. - this would all contribute to keeping Africa in the mainstream of technological advances," he said.
The South African government, through the Department of Science and Technology, is contributing about 4 million Euros towards the start-up costs of the Cape Town component of the ICGEB over the next four years.
"I have it on good authority that these funds are only sufficient to establish three research groups, while the component aims to institute a minimum of seven research groups by 2010," said the President, calling on potential partners to assist and work with this component to ensure that it realises its objectives.
US set for 'humanised' organ tests
- Clive Cookson, The Financial Times (UK), Sept, 11 2007
A new international re-search effort is under way to create animal organs for transplantation into patients, Lord Winston, one of Britain's top fertility researchers, told the BA Festival of Science. But he said a key experiment was likely to take place in the US rather than the UK, as a result of government "bureaucracy".
Xenotransplantation - making up for the shortage of human donors by breeding pigs for their organs - was a lively research topic in the 1990s but never came into clinical use as a result of safety concerns. Lord Winston said his research group at Imperial College London was working with Atazoa, a spin-out company, to pursue a new route to transgenic pigs.
The researchers add genes to the animals' sperm and then breed from them in a conventional way, rather then working with embryos.
The idea is to block the production of surface proteins that normally trigger a catastrophic immune re-sponse when organs are transplanted between species. "Humanised" hearts and other organs could then be transplanted into humans without the fear of rejection.
The procedure has been successfully tested in mice, but when Lord Winston sought permission to use it to alter pigs' testes, the Home Office took more than a year to grant a licence.
The Department for Environment, Food and Rural Affairs (Defra) then stopped Atazoa using the genetically modified male pigs to sire young, ruling that breeding from transgenic farm animals would breach a European Union directive.
"We have had numerous problems, but one of the biggest has been the regulatory framework," Lord Winston said. "It took us 13 months to get a licence to simply inject the testes of six pigs. That, I think, is notacceptable.
"Then we were refused permission to mate the animals, so we have been unable to demonstrate we have got the appropriate gene target in the right place," he said. "That was extremely disappointing. Now we are are trying to do [the breeding] in Missouri."
Lord Winston, who is a Labour peer and television science presenter, has a long record of attacking UK regulation of research andmedicine.
The Human Fertilisation and Embryology Authority is his favourite target.
Amendment to genetic engineering legislation
Minimum separation of 150 and 300 metres for GM maize
- GMO Safety, August 8, 2007
After months of negotiations, the German minister for agriculture, Horst Seehofer, has agreed on new rules for the cultivation of genetically modified crops with his coalition partners from the CDU and SPD. The cabinet agreed to the amendments to the genetic engineering legislation today. As Seehofer told the press at the end of July, fields of GM and conventional maize must in future be separated by a distance of at least 150 metres. If organic maize is grown in the vicinity, the minimum distance will be double. Other controversial points, such as the liability provisions and the public site register remain largely unaltered. A relaxation of the "GM-free" labelling rules for food are to follow.
The principal item of the legislative package is the draft regulation on good farming practice for the cultivation of GM crops. The cultivation provisions contained in it are designed to ensure that contamination between genetically modified and conventional or organic crops is largely prevented. Special provisions for maize cultivation are contained in an annex to the legislation, while similar cultivation provisions for potatoes are due to follow in the autumn, according to Seehofer. Separation distances and careful handling to prevent contamination
The main point of disagreement between the coalition partners, CDU, CSU and SPD, was the minimum distance to be respected by GM maize farmers. They eventually agreed on two different distances: 150 metres from fields with conventional maize and 300 metres from organic maize fields.
If a neighbouring maize farmer agrees, the minimum distance can be reduced or scrapped. The minimum distance can also be reduced for official cultivation experiments, provided the male inflorescences (tassels) are removed or covered with bags before flowering so that no pollen can escape.
Farmers who plant GM crops will have to follow other rules in addition to those concerning separation distances:
* Duty to inform: A farmer who plans to sow genetically modified seed must inform neighbouring farms within 300 metres of the field in question. The neighbour then has a month to respond and to inform the GMO farmer of his own cultivation plans.
* Precautions: During sowing, storage and transport the farmer must ensure that GM seed and harvested produce are not mixed with conventional products. For instance, farmers must use closed containers and carefully clean any machines used before reusing them for conventional seed or produce.
* Controlling volunteer plants: A farmer who grows GM crops must monitor the field after harvest and during the following cropping season to check that no leftover seeds germinate on a GMO field that is planted with conventional crops the following year.
* Records: Farmers must keep records of GM crop cultivation and cultivation measures.
* Crop rotation: A GM maize field many not be used for conventional maize until at least two years after the GM maize harvest.
Liability and site register unchanged
In the coalition agreement the current government announced that it would be revising the Genetic Engineering Act and relaxing some of the restrictive provisions it contains on the use of genetically modified crops. But not much has been done at this level. In particular, the controversial liability provisions for the cultivation of GM plants have seen no change. Farmers who plant GM crops will continue to be jointly and severally liable for loss of income suffered by neighbouring conventional farmers as a result of GMO presence, even if the individual cannot be shown to be at fault.
What remains unclear is how a liability case is defined in detail. Trade associations had requested that the government give the GMO labelling threshold of 0.9 per cent as a clear guideline for liability. On the other hand, environmental associations are calling for compensation claims to be allowed even for lower levels of presence of GM plant material. According to Seehofer, however, a hearing of experts found that changing the liability law would not be wise or practicable.
The public register for GMO fields will continue to allow people to see the precise location of the fields online. Critics of this provision had pointed out that it is too easy for people intending to destroy fields to identify the fields with GM crops in the site register. Relaxation for experimental plantings
What is new, however, is a provision that primarily affects field research: If material from field trials with GM plants finds its way into conventional harvests, the harvest will no longer be deemed unsaleable. It must be ensured, however, that the harvest produce in question does not end up in food or feed. It could be used, for instance, in biogas plants. Consultations and additions after the summer recess
Das Kabinett hat dem Gesetzespaket am 8. August zugestimmt. Nach der Sommerpause können die Beratungen in Bundestag und Bundesrat beginnen.
The cabinet voted in favour of the legislative package on 8 August. After the summer recess the consultations can begin in the Bundestag and Bundesrat. In the autumn the minister for agriculture, Seehofer, also intends to introduce legislation to make it easier for producers of foods of animal origin such as meat and milk, in particular, to sell their produce under the label "GM free". The criteria for this are to be brought into line with the wording of the new European Regulation on organic production.
FAS Daily Attache Report Digest
- USDA Foreign Agricultural Service (FAS), Sept. 10, 2007
Agricultural Biotechnology Report
BOSNIA AND HERZEGOVINA, September 10, 2007 -- Bosnia and Herzegovina's (BiH) anti-biotech position is growing day by day, and now some imported U.S. food products are being tested for biotech content and are rejected. BiH lacks detailed regulations for the import and marketing of biotech foods, and since November 2004 the import of biotech products has been forbidden. Knowledge about biotechnology is poor even among scientists and agricultural officials. Agriculturists and non-government organizations that promote organic agriculture oppose biotech applications and encourage producers, consumers and regulators to reject biotech products.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291547
CZECH REPUBLIC, September 10, 2007 -- The Czech Republic, as a member of the EU, follows the EU's legislative framework for biotechnology. Act 78/2004, amended by 346/05, replaced the first Act on GMO 153/2000. The Ministry of Environment is the competent authority for handling biotech product notifications, and the Ministry of Agriculture is responsible for notifications of biotech food and feed. The Czech Republic ratified the Cartagena Protocol on Biosafety in October 2001. This year between 5,000 and 6,000 hectares of Bt corn (MON 810) is being grown in the Czech Republic, a four-fold increase since last year. The Czech Republic's coexistence rules require isolation distances and notifications to the Ministry of Agriculture and the Ministry of Environment. When voting on biotech approvals at various levels in the EU, the Czech Republic takes a case-by-case approach and bases its decision on scientific evidence.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291707
SWITZERLAND, September 10, 2007 -- Switzerland has an onerous and slow process for approving products of agricultural biotechnology for food and feed use. In addition, starting in November 2005, a five-year moratorium on approvals for planting of biotech crops or production of genetically modified animals was put into place. The restrictive regulatory environment, combined with strong anti-biotech public sentiment has dampened interest in the Swiss market for biotech products.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291710
CHINA, PEOPLES REPUBLIC OF, September 10, 2007 -- The Chinese government continues to place great importance on biotechnology in agriculture and has committed to investing US$500 million in research and development from 2006-2010. China is the world's sixth largest producer of biotech enhanced crops and it remains the largest market for U.S. biotech agricultural products. However, domestic political factors continue to prevent China from commercializing any biotech staple food crops, most significantly rice and corn. Persistent concerns about the biosafety regulations established six years ago add to the uncertainties over some aspects of the trade in biotech products. This document is an update of the 2005 report (CH5069) and includes the most recent approvals for domestic production and importation and current policy issues of concern relating to the regulatory process.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291718
MEXICO, September 10, 2007 -- Although Mexico does not maintain any significant barriers to the importation of biotechnology derived crops, or foods derived from biotechnology, the implementing regulations of the Biosafety Law have yet to be approved or published, thus leaving a number of gaps in Mexico's biotechnology policy framework. Official sources estimate that the implementing regulations will be in place within the next few months, thus clearing the way for research, investment, and commercialization of biotechnology derived agricultural products. These regulations will serve to supplement the Biosafety Law, passed in February of 2005, by establishing the respective responsibilities and jurisdictions of the Mexican ministries and agencies that monitor and/or enforce biotechnology related experiments, production, and commercialization.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291733
INDONESIA, September 10, 2007 -- Section Updated: II. Biotechnology Trade and Production; IV. Marketing Issues; V. Capacity Building and Outreach. There has been no progress to date on implementation of the GOI Regulation on Biosafety of Transgenic Products that was enacted in 2005.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291737
NICARAGUA, September 10, 2007 -- Nicaragua is implementing the provisions of the Cartagena Protocol. The GON requires a risk analysis for the import of biotechnology products. The risk analysis has not stopped trade between the United States and Nicaragua.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291747
UZBEKISTAN, REPUBLIC OF, September 10, 2007 -- Uzbekistan does not commercially produce any transgenic crops nor does it have any regulations in place affecting their import. There are no regulations concerning labeling of food or feed derived from transgenic crops.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291752
THAILAND, September 10, 2007 -- Thailand is edging closer to removing the 2001 ban on field testing for agricultural biotech products, and developing a national biosafety framework that would support the expansion of research and commercialization of biotechnology in Thailand. Until these milestones are reached, Thailand risks being at a competitive disadvantage from neighboring countries that have produced successful outcomes through their research in biotechnology.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291754
COSTA RICA, September 10, 2007 -- On July 17th, 2006, the Costa Rican Legislative Assembly ratified the Cartagena Protocol. The Protocol became law on November 27th, upon publication in the Official Diary. Other initiatives to regulate products of modern biotechnology, including processed products, have been put on hold pending internal agreement among government authorities.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291762
ITALY, September 10, 2007 -- Italy's recent 'yes' and 'abstention' votes to approve EU importation of specific new biotech events, after years of negative votes, represents the most important recent development on biotechnology in Italy. Field-testing of genetically-modified crops could restart, after a long ban, but is still opposed by the Minister of Environment.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291765
Annual Agricultural Biotechnology Report
BRAZIL, September 10, 2007 -- Updates were made regarding the approval process for biotech events in Brazil as a result of Law 11,460, from March 21, 2007. Despite the changes made in the structure of the National Technical Commission on Biosafety (CTNBio) to speed the approval of biotech events in Brazil, near all new approvals are subject to court injunctions filed by anti-biotech groups within and outside the government, and by unsupportive government prosecutors.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291792
RUSSIAN FEDERATION, September 10, 2007 -- Anti-biotechnology campaigns are increasing in Russia, largely due to upcoming elections. No significant improvements on national biotechnology policy are expected in the next year, and loopholes in existing policies will continue to restrict development of the biotech product market. Imports of biotech products are expected to continue, but not to increase, and cultivation of biotech crops will likely continue to be banned. New biotech labeling regulations in Moscow, Russia's largest urban market, conflict with federal regulations and are creating new barriers to trade in biotech products.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291797
SRI LANKA, September 10, 2007 -- Biotechnology in Sri Lanka is still in its infancy as biotechnology policy and regulations are still being developed. A national policy on biosafety was launched by the Ministry of Environment and Natural Resources in October 2005. Although GM labeling regulations were introduced in January 2007, these regulations have not been implemented, as the authorities do not have the resources and expertise for enforcement.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291816
Reaching Out to Thai Papaya Producers
THAILAND, September 10, 2007 -- During the week of July 16, FAS/Bangkok, in cooperation with the State Department and the Biotechnology Alliance Association conducted a series of seminars titled, "Crisis and Solution: The Problem of Papaya Ring Spot Virus in Papaya Exporting and Productions" throughout Thailand. More than 200 participants attended the three seminars, including private and commercial papaya producers, media reporters, consumers, papaya processors, and academics. As part of the seminars, FAS/Bangkok invited a Hawaiian biotech papaya producer, Ken Kamiya, to speak directly to Thai producers about the risks of not adopting biotech papaya when faced with PRSV.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291841
KENYA, September 10, 2007 -- The passage of the Biosafety Bill 2007 into law is at an advanced stage. Kenya has an approved National Biotechnology Policy.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291848
German Genetech Law - Coalition Compromise
GERMANY, September 10, 2007 -- The German genetech law is expected to be only marginally amended despite an almost two year intensive discussion process. The minimum distance for biotech corn to neighboring conventional corn will be set at 150 meters and at 300 meters for organic corn. Rules for 'without-genetech' labeling are expected to be eased.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291854
ECUADOR, September 10, 2007 -- Sections Updated: Section I, Food Laws, has been updated to reflect recent changes to Ecuador's Health Code, which prohibits imports, use and trade of foodstuffs containing genetically modified organisms. Although Ecuador's food import regulations are generally based on international standards, the country faces challenges in enforcing its food regulations.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291874
FRANCE, September 10, 2007 -- France is the EU's second largest producer of biotech corn, increasing its biotech corn acreage fourfold from 2006. Spain is the principal market. Potential downsides for French biotech researchers and farmers include: lack of consumer acceptance and anti-biotech activities negatively impacting domestic demand and increased government requirements without additional regulatory support.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291890
KOREA, REPUBLIC OF, September 10, 2007 -- Sections Updated: Section I, II, IV, V, VI, VII, IX and Appendix I, II Import requirements of U.S. origin rice have been added and labeling requirements for food products have been updated. An example of a nutrition label has been added. In April 2007, MAF introduced GMO labeling requirements for packaged animal feed. These new labeling requirements take effect on October 11, 2007. MAF has also extended mandatory GMO labeling for bulk crops to all biotech events that are approved by KFDA for human consumption.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291900
HONG KONG, September 10, 2007 -- Hong Kong appears on the brink of establishing mandatory labeling for biotech foods. Such a step could seriously undermine sales to this 9th largest market for U.S. grocery products, which amounted to about $610 million in 2006. U.S. products will be impacted because of the cost of labeling and retailers' fear of consumer reaction. The Hong Kong government released a set of guidelines on voluntary labeling for biotech foods last year and will be conducting a survey to evaluate the effectiveness of voluntary labeling. The trade said that there is virtually no positive labeling of biotech foods, given the voluntary nature of the guidelines. While the government has not announced its decision to implement a mandatory labeling scheme, industry sources have said they are certain the HKG is moving in this direction and will use the survey result to support their initiative. Meanwhile, the legislative drafting of the bill for the implementation of Cartagena Protocol has halted pending the Protocol's developments of detailed implementation requirements. Presently, Hong Kong does not have any specific regulation regarding biotech foods.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291946
PAKISTAN, September 10, 2007 -- Pakistan is progressing in Agricultural Biotechnology: bio safety guidelines and rules were enacted in April 2005 and a system to monitor and evaluate in-coming proposals has been established. There are no biotechnology-related trade barriers between U.S. and Pakistan.
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291983
GERMANY, September 10, 2007 -- There are signs of progress in the field of biotechnology in crop production in Germany. A noticeably increasing number of farmers is showing interest in planting Bt corn varieties. The planting area for Bt corn in 2007 is estimated at about 2500 ha versus 950 hectares in 2006. On the other side, NGOs and many politicians are fighting a desperate battle against the technology. Many politicians claim that research is ok but commercialization is not needed and not wanted. Amendments are being considered to the current German law governing field releases of biotech events and labeling of biotech foods
Read This Report http://www.fas.usda.gov/scripts/gd.asp?ID=146291984
Agricultural Biotechnology Risk Analysis Research in the Federal Government: Cross Agency Cooperation
- Agricultural Biotechnology Risk Analysis Research Task Group Biotechnology Research Working Group Subcommittee on Biotechnology Committee on Science National Science and Technology Council, Sept. 10, 2007
[full document is 27 pp.]
The AGRA task group has provided an important forum for members of Federal regulatory agencies, the Federal agencies that conduct and fund agricultural biotechnology research and the broader community to discuss those areas of research that are necessary to maintain the U.S. government's strong scientific basis for agricultural biotechnology risk analysis. It also provided an opportunity for Federal government agencies supporting other types of research to provide feedback on the risk assessment discussion and valuable access to research organizations not typically contacted by the regulatory agencies. Many of these topic areas are especially important for the supportive research discussed in this report.
The members of the AGRA task group examined the scientific foundation for the risk assessment undertaken by the Federal government and identified information areas that could be improved or made more complete. These particular areas of interest, while essential to risk assessment, are often overlooked by academic and Federal researchers intent on publishing ground-breaking innovations. These specific areas include baseline data on the composition of foods including animal products, monitoring for ecosystem effects, functional features used to identify weediness and invasiveness, and pollen biology in relation to plant outcrossing. These topic areas are broader and longer-term than those encompassed by most targeted research programs.
The role of Federally-funded research is critical because it deals with issues of long-term public benefit that cannot as easily be addressed by private, for-profit companies. Federal research that is funded independent of commercial interests can also provide the level of credibility and transparency necessary to achieve and maintain public trust and confidence in the regulatory system. This role, which includes directed research for the Federal regulatory agencies, must be focused and strengthened to maximize impact and maintain the efficacy of the Federal regulatory system.
For Federally-funded research to be most effective, sustained coordination is needed among Federal agencies. Since research related to the risk analysis of the products of agricultural biotechnology is being supported by several agencies, coordination ensures that all of the diverse research areas of need are covered and that the data are communicated to the regulatory agencies. The AGRA task group has demonstrated that collaboration between and coordination among
Federal agencies can be achieved through an interagency task group. The activities of the AGRA task group have already had an impact on Federally-funded research portfolios through coordinated agency input into program announcements. In addition, the AGRA-sponsored symposium bringing together representatives from Federal agencies with academic researchers was extremely valuable for fostering communication between these two communities.
Coordination of Federal agencies in this arena will continue through the Agricultural Biotechnology Working Group, which is co-chaired by OSTP and the National Economic Council and includes representatives from USDA APHIS, EPA, and FDA with regulatory responsibilities for agricultural biotechnology. Agency coordination through this working group will ensure that regulation keeps pace with changing technologies and that there continues to be a strong scientific basis for agricultural biotechnology regulation in the United States.
*by Andrew Apel, guest editor, andrewapel+at+wildblue.net