Misguided Fear of Biotech Should Not Translate to Regulatory Hurdles

Jim's Corner

A recent editorial in the New York Times lays bare how demonization of biotechnology hinders innovations that can “save lives and protect the environment.” Opponents of genetic engineering stoke consumer distrust of biotechnology, against all evidence of the industry’s safety record, only to drive up regulatory costs for biotech companies, argue the authors, Pamela C. Ronald, a professor of plant pathology at the University of California, Davis, and co-author of Tomorrow’s Table, and James E. McWilliams, a history professor at Texas State University and author of Just Food.

A recent example of just such a campaign came in the case of Monsanto v Geertson Seed Farms, in which the Supreme court ruled that the 9th District Court had abused its discretion by prohibiting USDA from determining how best to regulate the planting of genetically engineered alfalfa. Soon after the ruling, Andrew Kimbrell, executive director of the Center for Food Safety, wrote in an article on Huffington Post that “the Court opinion supported the Center’s argument that gene flow is a serious environmental and economic threat” and “genetic contamination from GMOs can still be considered harm under the law.” While the Supreme Court recognized that organic farmers have standing to make the claim that gene flow from biotech crops can harm their businesses – and to seek relief in the courts – it also clearly supported USDA’s authority to regulate and deregulate planting of biotech crops. The results of the case require the USDA to document and assess more fully the potential environmental impact of the plantings it allows, but still permits groups to then challenge those decisions in court.

Other emerging biotechnology applications are clearly chilled by the tactics being used by opponents. In a recent article, New York Times reporter Andrew Pollack reports, “Some algae researchers worry they will be engulfed by the same backlash aimed at biotech foods.” At the July meeting of the President’s Commission for the Study of Bioethical Issues, Dr. Allison A. Snow of Ohio State University raised unfounded concerns about a hypothetical release of genetically engineered algae, including algal blooms and consequent fish die-off. Natural algal blooms and fish die-offs already occur on an annual basis, and genetically engineered algae would not present a greater risk of causing them. BIO will submit comments on the recent meeting and will continue engagement with the commission.

President Obama asked the Bioethics Commission to study the implications of synthetic biology, following the May announcement by the J. Craig Venter Institute that researchers had created the world’s first self-replicating synthetic cell. The Venter Institute itself has been proactive in exploring the ethics of synthetic biology and options for the industry and government to cooperatively and appropriately regulate it. Use of biotechnology in research and commercial settings for any of the sectors – health, agriculture, and industrial biotech – is regulated under the Coordinated Regulatory Framework, by the EPA, the USDA, the FDA and/or the NIH. Amy Patterson of the NIH, another participant in the commission meeting, noted that over the biotech industry’s 35-year existence, regulatory oversight easily has kept pace with scientific developments.

Federal and state agencies effectively evaluate the safety and potential impact on human health, agricultural production and the environment of all new biotechnology products. As an industry, we should strive to remind the public that these products are being used safely and provide substantial value.

The value of the biotechnology applications that activists are seeking to delay is measurable and considerable. Biotechnology can help farmers more economically grow a nutritious source of feed for animals in a more environmentally sustainable way. Algae is a promising source of low carbon transportation fuels that can reduce greenhouse gas emissions compared to gasoline. Synthetic biology has already enabled a cost-effective treatment for malaria, the production of synthetic rubber for tires from biomass instead of petroleum, and an efficient one-step process for turning renewable resources into diesel fuel.

Rather than through legal proceedings or through the misguided stoking of fears, the risks inherent in any biotech endeavor are most appropriately addressed through corporate and scientific responsibility and steps to reduce human error. Member companies of the Biotechnology Industry Organization make a proactive commitment to the responsible use of technology, such as in the Excellence Through Stewardship program, and agree to abide by a common Bioethics Statement of Principles. BIO’s conferences feature speakers, panels and seminars that address the ethical considerations of the work. For instance, Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, addressed ethical considerations in relation to synthetic biology at BIO’s World Congress in 2009.

While biotechnology may continue to push the boundaries of science to produce innovative and useful benefits, there is no reason to fear this scientific inquiry. On the contrary, in light of the industry’s safety record and the 35-year history of the use of the science, there is no need to impose undue or misguided regulation on the industry or its products.

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