g o v e r n m e n t & policy
BIOTECH REGULATION UNDER ATTACK Public interest groups, some government officials are concerned that testing regime for transgenic organisms is inadequate Bette Hileman C&EN Washington
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ver the past two years, environ mental and consumer groups have shown increasing concern that the tests required for approval of genetically modified organisms might be inadequate to protect health and the environment. These groups are also concerned that biotech or ganisms are not being moni tored sufficiently after approval to measure what long-term cu mulative effects they may be having on wild plants and on ani mals and human health. Some government officials say the regulatory system for certain engineered organisms that are under rapid development is ill de fined or nonexistent. It is not clear which federal agency has ju risdiction over certain classes of organisms, such as plants that produce industrial chemicals, so premarket tests for them have not yet been formulated. Observers also claim that laws written for other purposes are being stretched to absurd lengths to cover certain transgenic products like en gineered salmon. To remedy this situation, critics favor a major revision of the federal frame work for biotechnology regulation or the passage of new legislation that would clearly delineate which agency has jurisdiction over the various classes of organisms. The proper agency would then lay out the general outlines of test ing that the modified organisms would undergo before approval. "It is time to rethink the roles of each agency and try to separate boosterism from critical sci ence," says Charles Benbrook, former director of the National Academy of Sci ences' Board on Agriculture and head of Benbrook Consulting Services, Sandpoint, Idaho, a firm that deals with agri 28
MAY 22, 2000 C&EN
cultural biotech and sustainable agricul ture issues. However, many government officials continue to insist that the regulatory framework for bioengineered organ isms is adequate to protect health and the environment. "We believe that our policies and processes in this area are well grounded in science and that we have an excellent track record in
crobial pesticides and crops engineered to resist insects under the Federal In secticide, Fungicide & Rodenticide Act (FIFRA) and other transgenic microbial products under the Toxic Substances Control Act. FDA, which decided in the late 1980s that most genetically engineered foods are not subject to regulation as food addi tives under the Food, Drug & Cosmetics Act (FDCA), established an advisory pro cess under which industries consult with the agency about any human health risks from transgenic foods. Until very recent ly, the consultations were voluntary. Now they are mandatory. The Department of Agriculture regu lates transgenic crops under the Plant Pest Act and engineered poultry and live stock under meat inspection laws. For crops, USDA issues permits certifying that the plant is not a pest. When a transgenic product does not obviously fit under one of these statutes, the agencies consult on an ad hoc basis and decide where it belongs. For c example, FDA is now in the pro Ε cess of approving a fast-growing Φ Γ ω transgenic salmon under the ani mal drug provisions of FDCA. η FDA's reviewing of environmental ο ο risk is a kind of "ludicrous stretch £1 a. ing of the law," says Anne R Ka puscinski, a professor in the de partment of fisheries and wildlife at the University of Minnesota. Because of the variety of stat utes used, the testing and infor mation requirements for various classes of organisms are vastly different. For example, plants that produce a pesticide, such as corn engi neered with the Bacillus thuringiensis gene (Bt corn), are subject to a fairly strict testing regime under FIFRA This means that the product developer must submit raw health and safety test data to EPA. These data are publicly available during a 30-day notice and comment peri od before the crop is approved. For herbicide-resistant plants, FDA is the primary regulator. It conducts consultations with the developer under FDCA in which the developer submits only summaries of tests to FDA, and no information is readily available to the public until after the consultation pro cess, says Laura M. Tarantino, deputy director of FDA's Office of Pre-Market Approval. FDA does not publish agencybacked conclusions on the safety of ge netically engineered food, she says. If a plant is not intended for human CO
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Levitt (above) and Rissler
applying our policy," says Joseph A. Levitt, director of the Food & Drug Ad ministration's Center for Food Safety & Applied Nutrition. "We believe that our oversight has been substantive, credi ble, and appropriate." Three agencies currently regulate genetically engineered products under several statutes designed to regulate pesticides, animal drugs, industrial chemicals, conventional crops, and meat. The framework was devised in the late 1980s and has not undergone fundamental reform since then. As a re sult, "agricultural biotechnology is still regulated by a patchwork of rules and programs with different requirements and underlying philosophies," says Jane Rissler, senior staff scientist with the Union of Concerned Scientists. The Environmental Protection Agen cy regulates genetically engineered mi
consumption and is not modified to con tain a pesticide, USDA is the primary agency involved in regulating it. It issues de facto commercial permits in the form of determinations that the plants are not pests and need no further regulation. At the same time, it does an environmental assessment of the plant under the Nation al Environmental Policy Act (ΝΕΡΑ). Some EPA officials say ΝΕΡΑ requires only that an assessment and disclosure of impacts be done. Thus, USDA could al low a technology that harms the environ ment to go forward if the technology also produces benefits. Transgenic trees, whose pollen can often drift hundreds of miles, will be regulated by USDA, and critics fear these will be subject to very little scrutiny under ΝΕΡΑ Although the regulatory framework sounds uncoordinated, the involvement of three agencies actually has a plus side, according to a government official who does not want to be identified. The interaction among the three agencies provides checks and balances, which are an advantage, she explains. One of the biggest mistakes made in
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sen says, the process of insertion of ge netic material involves a number of un predictable elements: the number of inserts of transgenic DNA, their precise position on a chromosome, and their functional and structural stability. The most important of these is the random or semirandom location of the genetic in sert, he says. The insertion site can affect expression of the inserted transgene it self as well as the expression of the genes in the recipient organism, he explains. "If the material inserts itself into the middle of an important gene, that gene would functionally be turned off," Han sen states. For example, "if the turnedoff gene happens to code for a regulato ry protein that prevents the expression of some [natural] toxin, the net result of the insertion would be to increase the level of that toxin." Another difference between transgen ic and conventional plants is that the transgenic plants on the market contain a promoter from the cauliflower mosaic vi rus that is inserted along with the desired transgene, Hansen says. This promoter responds to signals—from other genes
the regulation of transgenic organisms, critics say, was FDA's decision to con sider them "substantially equivalent" to conventional organisms. This conclu sion led to a very weak approval process with no mandatory testing require ments for effects on human health. Michael Hansen, research scientist at the Consumer Policy Institute, the re search arm of Consumers Union, ar gues that transgenic foods present unique risks and therefore should be re quired to achieve a standard of safety at least as strong as that for food additives. "Conventional plant breeding shuffles around aberrant versions [alleles] of the same genes, which basically are fixed in chromosomal locations as a result of evolution," he says. 'With genetic engi neering, one inserts genes on an essen tially random basis, using a gene 'gun' or other techniques, into a plant's chro mosomes," he explains. "Frequently, the genes come from living things with which the host organisms would never cross in nature," he notes. The identity of the transferred materi al may be completely known. But, Han
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