This conference focused on issues such as plants as new sources of medicinals; bioremediation, phytosensing, and ecorestoration; gene-to-product development; and regulation, consumer acceptance, and risk management.
The products and processes addressed here are almost all at the research stage, whereas there is up to 15 years’ experience with commercial products in the enzyme and crop areas. Economic and environmental benefits of the products discussed could be large, e.g. plants engineered to produce low-cost medicinals with ease of scale-up stated as a unique advantage compared to traditional methods of manufacturing pharmaceuticals, plants that remediate soils in situ instead of wholesale excavation and landfill placement, and trees modified for lower lignin content so as to decrease processing costs while increasing pulp yields with less environmental impact. However, all have major not-yet-well-defined regulatory hurdles to navigate. This report provides cutting-edge information on a cross-section of these novel products and processes and includes open dialog on regulatory and related issues. It emerged that some academic scientists believe that biotechnology products are over-regulated, because regulation is based on process not trait.
All, including those from industry and the Biotechnology Industry Organization, support the necessity for regulation. The bottom line is cautious optimism for commercial use of these products; at this time there are few green lights, many yellow and some red.
The 2000 federal government interagency review of regulatory oversight of biotechnology products revealed that ensuring confinement could become a regulatory requirement for approval of some transgenic organisms. In 2001, the USDA asked the National Academies to review and evaluate biological methods and report on their application in confining transgenic crop plants, shellfish, trees, grasses, fish, microbes, insects and other organisms. Considerations of bioconfinement, when and why to consider it, bioconfinement of plants, animals, microorganisms, and biological and operational considerations for bioconfinement.
Literature contains many suggestions that plant genomes are highly variable. One early indication was the discovery that maize inbreds differ in the number of rDNA copies. Until the advent of genetic engineering technology had not crossed the species barrier in terms of gene transfer between kingdoms. However, DNA from unrelated species is transferred and incorporated into plant genomes mainly through viruses The integration of viral sequences may be widespread in the plant kingdom, having occurred for a long period of time. Similarly, genes from the bacterium, Agrobacterium rhizogenes, have been found in the genome of some tobacco species while DNA from unrelated higher plants has been found to be transferred between their mitochondria, and, from there, to their nuclei.
Hoban, Thomas; Nolan, Canice; Bennett, Allan (NABC, 2005)
Panelists expressed highly critical opinions of industry, government and universities regarding agricultural biotechnology and its products, especially those from cloned animals and PMPs from food crops, identified the major problem in European acceptance of GM foods as the consumer not the regulators; food processors aren’t going to source when risk is commonly associated with GM, and described the Public Intellectual Property Resource for Agriculture (PIPRA) that hopes to provide bundles of proprietary technologies to allow the benefits of biotechnology to accrue to a broader base of crops and consumers and developing-country farmers.
The Biotechnology Industry Organization (BIO), has introduced a training program laying out principles for confining plants that make pharmaceuticals and industrial products. Workshops dealing with compliance aspects affecting GM crops will be offered in conjunction with professional society meetings and conferences. Industry, university and federal research agency participation is expected help ensure that all abide by the federal requirements and understand the legal implications involved in conducting field trials with GM crops.
The past 10 years have been extremely successful for the biotechnology industry. Products that are herbicide-tolerant or produce their own insecticide to control specific pests. These varieties have been widely adopted by farmers in the United States and in seventeen other countries because they have provided benefits to farmers and the environment by increasing yields and reducing the use of insecticides. Despite this success, the introduction of new GM products has slowed considerably. Whereas most governments and many distinguished scientists have found that these crops are safe, some people continue to be concerned over perceived risks to human and/or environmental health. The controversy over genetic engineering will only increase with the next generation of products.
Hood, Elizabeth E.; Woodard, Susan L. (NABC, 2005)
Bovine trypsin can be synthesized in transgenic maize, nut lack of public acceptance is the major barrier to producing pharmaceutical or industrial products in plants. Response to this public distrust has driven current regulations to be quite restrictive. The scientific community and the regulatory agencies are striving to gather substantive safety data to support regulations that are based on scientific principles and will protect the public as well as allow this new industry to develop.
Hinchee, Maud; Pearson, Les; Parks, Dawn (NABC, 2005)
Forest genetics is only now reaching the stage at which genetically superior trees are being planted. Biotechnology is being applied to this new germplasm base. ArborGen’s mission is to develop and commercialize technologies, products and services that will ensure sustainability of the world’s forests.
There are regulatory and liability hurdles standing in the way of launching a new transgenic product. Despite past successes, and the knowledge gained from failures and near misses, the road to future commercial success in agricultural biotechnology remains fraught with difficulties. US agricultural biotechnology operations will need to maintain perfect divisions between its “green,” “white” and “red” sectors—food and feed, plant-pharmaceutical, and industrial applications.
Goldner, William; Day, Alex; Conway, Roger (NABC, 2005)
There is a new initiative to assist in the navigation of regulatory requirements for specialty or minor crops: the Specialty Crops Regulatory Initiative. It should assist public-sector and small private companies in meeting regulatory requirements. Obstacles in bringing products to market are a challenge and bridging communication between scientists and business people for effective is a vital step. Programs assist commercialization of industrial biotechnology products. They include the Federal Biobased Products Preferred Procurement Program, which provides government markets especially for early-stage products, and the USDA/CCC Bioenergy Program, which has catalyzed investment in the biodiesel industry.
USDA/APHIS has regulated transgenic organisms since 1987, and in 2002 established Biotechnology Regulatory Services (BRS) to place a renewed emphasis and priority on biotechnology. APHIS has authorized more than 10,000 permits and notifications for the introduction of GM organisms and deregulated over sixty products for use, establishing itself as an international leader in the safe regulation of transgenic products.