Most everyone agrees that there must be risk management for new technologies like GE crops. ORB is interested in forming a conduit between public perception and the regulatory controls that are, and are not, currently in place.
US federal regulation | state regulation (oregon) | international regulation | public sector regulation
Around the world, approximately 1.6 billion acres have been planted with first-generation GE crops. These crops contain input traits – like herbicide resistance or toxicity to pests – designed to benefit farmers.
Now researchers are developing second-generation GE crops with output traits designed to benefit consumers and food manufacturers. These crops will have improved shelf life, be more nutritious, and be less allergenic than their non-engineered parents.
Other second-generation GE crops will contain pharmaceuticals or vaccines, and exhibit drought or salt tolerance.
GE Bananas are probably the best candidate to deliver a bite-sized vaccine for hepatitis B to millions of people in developing countries.
Both the US National Academy of Sciences and the European Union have formally stated that GE foods pose no unique health or safety risks, and are at least as safe as conventional plants and foods. Yet even as the release of second-generation crops dawns, the sun threatens to set on consumer's attitudes towards GMOs.
Crops modified by molecular and cellular methods should pose risks no different from those modified by classical genetic methods for similar traits. -National Academy of Sciences, National Research Council (1989)
The use of more precise technology and the greater regulatory scrutiny (over biotech foods) probably make them even safer than conventional plants and foods. -European Commission Round Table on GMO safety research (2001)
There are three types of law: legislative, regulatory, and case law. Here in the US, there is no GMO legislation of any kind - we rely entirely on regulation and court decisions (e.g. the patent rights case Monsanto vs. Schmeiser).
A coordinated framework regulates biotechnology products in the US. The central rationale for this is that the focus should be on the product rather than the process.
Back in 1986 when the framework was published, the US already had existing health and safety laws that could provide immediate regulatory protection. There did not appear to be a good alternative, statutory approach since the broad spectrum of products obtained with genetic engineering cuts across many product uses regulated by different existing agencies.
Therefore, the regulation of genetically engineered crops in the US is overseen by the USDA (APHIS), the FDA, and the EPA. (For more information, visit the Cornell's GEO-PIE website.)
The United States Regulatory Agencies Unified Biotechnology website gives information on the regulatory oversight of agricultural biotech products. This site has a searchable database with information on genetically engineered crops that meet requirements for food, feed, or planting use.
The Information Systems for Biotechnology (ISB) at Virginia tech is an excellent resource for regulation and risk assessment information concerning agricultural biotechnology. The site features a monthly newsletter and maintains a searchable database of US and international GMO field tests and commercialization and deregulation of GMOs.
The Pew Initiative on Food and Biotechnology has released a report called Issues in the Regulation of Genetically Engineered Plants and Animals that examines the ability of the US regulatory review process to manage future products of agricultural biotechnology.
Put forward in 2002, Ballot Measure 27 would have required the mandatory labeling for all foods with genetically engineered ingredients sold in Oregon. The measure was defeated in the 5 November 2002 general election with 371,851 votes in favor and 886,806 votes against.
Proponents of the measure argued that GMO labeling is a consumer right, and claimed that genetically engineered foods pose health and safety risks.
Opponents argued that Oregon's agricultural community would be burdened by excessive costs if the measure were to pass, and that fully segregating GMO foods from non-GMO foods would be impractical. In addition, opponents claimed that there is no evidence that GMO foods posed a danger to human health.
Put forward in 2005, the Oregon Genetically Engineered Pharmaceutical and Industrial Crop Act was intended to prohibit the growing, raising or cultivating of certain genetically engineered plants (for biopharming) from August 1, 2005 to July 31, 2009.
Pharmacrops are grown by splicing human or animal genes onto plants such as corn or tobacco. The genetic engineered plants then produce proteins that can be used to make pharmaceuticals quickly and inexpensively.
The governor and the 2005 Senate charged the Oregon Departments of Agriculture and Human Services with convening a Biopharming Ad Hoc Committee. This committee, which included ORB director Steven Strauss, developed a consensus policy recommendation to the governor regarding biopharmaceuticals produced in human food or animal feed crops.
The committee concluded that a case-by-case regulatory approach, rather than a wholesale prescriptive or prohibitory approach, is warranted because of the enormous diversity in safety and benefits from different biopharm products. The committee did not endorse or reject all forms of biopharming.
The Biopharm Bill was signed into law by Governor Ted Kulongoski on 23 April 2007. The bill had previously passed the Senate 29-1 and the House 55-0.
The purpose of this bill is to increase state involvement in the permitting and monitoring of biopharm crops in Oregon.
The law requires 2 steps - negotiating a memorandum of understanding (MOU) with the USDA and then writing specific Oregon rules.
As authorized by ORS 561.738 and 561.740, a rulemaking hearing to establish a review system for federal permit applications to grow biopharmaceutical crops in Oregon (under the Biopharm Bill) will take place in October 2008.
Between 2004-2008, 99 notifications and permits for transgenic plants were submitted for review to the Oregon Department of Agriculture. Of these, 10 were either denied or withdrawn.
The successful applications included field trials for canola, corn, creeping bentgrass, Kentucky bluegrass, poplar trees, soybeans, sugarbeets, and sweetgum, as well as agrobacterium.
The traits incorporated into these crops include resistance to insects, bacteria, nematodes, fungi, and herbicide sprays; agronomic properties for yield and stand improvement; heat tolerance; and other expressions.
None of these crops or applications is currently produced in commercial quantities, and those that are grown require review and approval by the FDA, EPA, and USDA.
The European Commission has published a list of 26 genetically modified (GM) products that have been released legally in the EU market.
Regulation of GMOs in the European Union (2005). View questions and answers about European regulations.
Trade tolerance monitoring in Spain: A biotechnology coexistence update (2005). Produced by the US Department of Agriculture's Foreign Agricultural Service in response to a decree by the Spanish government governing the coexistence of genetically modified (GM) and non-GM crops.
GMO safety: Genetic engineering, plants, and the environment, supported by Germany's Federal Ministry of Education and Research.
Food and Agriculture Organization (FAO) of the United Nations
International Service for the Acquisition of Agri-biotech Applications (ISAAAA)
The Cartagena Protocol on Biosafety is an international agreement on biosafety as a supplement to the Convention on Biological Diversity. These pages contain information on the ratification of the Protocol, meeting details and supporting documents, and highlights.
The Convention on Biological Diversity (above) is dedicated to promoting sustainable development. Conceived as a practical tool for translating the principles of Agenda 21 (a comprehensive plan of action to be taken globally, nationally and locally by organizations of the United Nations System, Governments, and Major Groups in every area in which humans impact the environment) into reality. The Convention recognizes that sustainability is about not only plants, animals and microorganisms and their ecosystems; it is about people and our need for secure access to food medicine, fresh air and water, shelter, and a clean and healthy environment in which to live.
Biosafety Clearinghouse (BCH) Portal. The Biosafety Clearinghouse (BCH) is an information exchange mechanism established by the Cartagena Protocol on Biosafety to help agencies implement its provisions and to facilitate the sharing of information on, and experience with, living modified organisms (LMOs).
Harmony or havoc: can the WTO, Biosafety Protocol, and Codex Alimentarius work together? (Science and Development Network, 2005.)
Elements of Precaution: Recommendations for the regulation of food biotechnology in Canada. Panel Report on the Future of Food Biotechnology prepared by the Royal Society of Canada, 2001.
Biotechnology in India. Nature created a special collection of articles on science in India in 2005, covering India's biotechnology sector. The articles touch on the bureaucracy that hinders research in India, the gap between research and teaching, conflicts between funding agencies, and the need to increase innovation to sustain the growth of India's biotechnology sector.
Pubic Research Initiative - a foundation with the objective of involving the public research sector in regulatory and international agreements relevant to biotechnology. For more information on the initiative, view the FAQs page.
Poorer nations turn to publicly developed GM crops. Nature Biotechnology. 2005.
The Cartegena Protocol and the future of agbiotech. Nature Biotechnology. 2005.
Public research scientists want a say in GM negotiations. Science and Development Network. 2005.
Impacts of biotech regulation on small business and university research: Possible barriers and potential solutions. A discussion sponsored by the Pew Initiative on Food and Biotechnology and USDA-APHIS. 2005.
Experience from the humanitarian golden rice project: Extreme precautionary regulation prevents the use of green biotechnology in public projects. By Ingo Potrykus. 2004.
Private research and public goods: Implications of biotechnology for biodiversity. UN-FAO. 2004.
Regulating transgenic crops sensibly: lessons from plant breeding, biotechnology, and genomics. Nature Biotechnology. 2005.
Full report on the second meeting of the parties (MOP2) of the Cartagena Protocol. 2005
