It's Time for a New Biotechnology Law

In a letter dated July 1, 2011, Secretary of Agriculture Tom Vilsack recently notified Scotts Miracle-Gro, a lawn-care company based in Ohio, that it could develop and use a genetically modified (GM) grass without review and approval by the Department of Agriculture (DOA). The grass was engineered so that Roundup, a Monsanto weed-killer, and related pesticides would not hurt it, and lawns with the grass could be kept free of weeds by spraying. The position taken in the Secretary's letter, reportedly also taken by DOA in a case involving importation of petunias from New Zealand, reverses the Department's long-standing position that it has the authority to regulate use of any GM plant.

The DOA reversal is legally sound, but a better response to companies like Scotts Miracle-Gro is not to duck regulation, but to adopt new federal legislation prescribing an effective, comprehensive, and transparent process that assures GM organisms will not harm human health or the environment. We need such legislation to ensure that the use of GM organisms is safe. But, we also need legislation to ensure that GM organisms will be available to address the ever growing challenges for a healthy planet. These organisms offer huge potential for good, yet they suffer from public stigma, and the skepticism and confusion driving that distrust will only grow if government steps back from their scrutiny.

First, consider the applications for GM organisms. The extremes of drought, flooding, and other weather will increase with climate change. Flood-tolerant GM rice varieties have been developed and can survive underwater where others die. Dry spells can inhibit plant growth, and a range of GM crops, including peas and corn, are being engineered for continued, fast growth with less water. Tomatoes have been engineered to resist frost and grow in salty, inhospitable soils. ‘Golden rice’ has been engineered to produce iron and beta-carotene for Vitamin A, improving diets in developing nations where vitamins are scarce. A vaccine for hepatitis B has been engineered into bananas. Tomatoes and other vegetables have been modified to stay fresh longer on the shelf. Algae have been modified to produce ethanol. Bacteria have been modified to digest cancer-causing hazardous waste. Mosquitoes have been modified to resist malaria. The GM ‘Enviropig’ poops less phosphorus, making less water pollution. GM corn and other crops produce a pesticide that would otherwise be less discriminately sprayed. GM goats produce milk with a drug that prevents blood-clotting in humans. GM bacteria make insulin. Jellyfish genes can be put into other species and make them glow - a key marker for research. These are just a fraction of the GM organisms in use or development, and the list is growing exponentially with rapid advances in technology for DNA sequencing and re-construction. Some find it scary, which is part of the reason for their opposition. But the genetic plasticity of life is facing us as never before, and is a powerful tool for the well-being of our species.

GM organisms pose risks, but these can be managed. Food safety is the most contentious issue, although the least risky of the debated concerns-- unless the genes inserted produce chemicals harmful to people, the GM plant or animal will be digested just like other food. Food safety agencies, such as the Food and Drug Administration (FDA) in the United States, effectively review proposed new foods for safety all the time. If the GM organism produces a pesticide, like BT corn, then a particularly close review is needed,. However, determining whether eating the corn is safe is basically the same as determining whether eating sprayed corn is safe.

The most substantial concern about GM organisms, especially pesticide-resistant or pesticide-producing plants, is that they will escape from controlled environments and spread, or hybridize with related varieties. Organic farmers fear that GM plants will appear in their produce and harm their brand and earnings. Ecologists have expressed concern that GM organisms will be introduced into the environment, spread, and cause harm, similar to invasive species that are not genetically modified. Hybridization already been reported for GM bentgrass - used as lawn cover - and has also been reported for corn in Mexico. A similar concern has been aimed at fast-growing GM salmon, where FDA market approval is being sought. What if the salmon escape and multiply? Will they out-compete and replace unmodified populations? The developers of these salmon have answers, and assert that only sterile females will be sold. Despite these assurances, particular caution is warranted. If the set protocols are not followed, and a fertile pair was to enter the wild and reproduce successfully, how would you get them - all of them - back in the cage?

These risks are real, but not a reason to stop modifying crops or fish. We just need to be very careful, which requires an open, comprehensive, balanced, well-informed, and firmly cautious process for deciding whether a GM organism should be made or used. Unfortunately, we do not have a process like that in the United States.

The foundation of U.S. policy for GM organisms is the Coordinated Framework for Regulation of Biotechnology, promulgated by the Office of Science and Technology Policy on June 26,1986 (51 Federal Register 23302), and generally referred to as the "Coordinated Framework." The Coordinated Framework relies on a mosaic of existing laws and three principal implementing agencies: the DOA, FDA, and the Environmental Protection Agency (EPA). In general terms, under the Coordinated Framework, the FDA handles food safety and potential harm to animals, DOA handles potential harm to plants, and EPA handles GM organisms, including microbes that produce pesticides or may produce toxic substances. The premise of the Coordinated Framework is that these laws and agencies can adequately address risks to human health and the environment posed by any GM organism.

One, key problem with this premise is that the legal authority the DOA relies on - the Plant Pest Act - is limited to regulation of "plant pests," and the statutory definition of that term does not include "plants" themselves unless they are one of a few kinds that harm other plants and are considered "parasitic." DOA originally worked around this problem by noting that GM crops were genetically modified using viruses or bacteria and by asserting that these viruses and bacteria were themselves plant pests. DOA then concluded that the new GM crop was itself a plant pest under the Plant Pest Act because it was an amalgam of the crop plant and the virus or bacteria used to modify its genes. One may ask whether or not these microbes are in fact plant pests, but a larger legal problem arose with development of new technologies for genetic modification. One technique, for example, is to shoot gold pellets coated with DNA into the embryos of corn or other crops. No one would argue that a plant pest was involved. Nevertheless, the DOA maintained from 1986 until the recent determinations on grass and petunias that any GM plant might pose a "plant pest risk" and therefore is subject to DOA review. The GM grass referenced in Secretary Vilsack's letter was developed by Scotts Miracle-Gro without using viruses or bacteria. In that letter, DOA has recognized that its long-standing view of the law's reach was flawed and that the Coordinated Framework is not comprehensive. New authority is needed from Congress.

The framework for a new biotechnology law has been sitting quietly on the shelf for a decade. In the last year of the Clinton administration, the Department of the Interior (DOI) prompted a White House review of GM organisms by the Council on Environmental Quality (CEQ) and Office of Science and Technology Policy (OSTP). DOI's concern was the potential impact of GM organisms on the environment - the same issues that Interior and other agencies were addressing with invasive species. DOI noted legal and policy deficiencies of the Coordinated Framework, and developed framework principles for new legislation (Proposed Legislation). This was reviewed closely and well received by some agencies in the closing days of the Clinton administration. Yet it was opposed by DOA and FDA, which asserted that the Coordinated Framework was both comprehensive and effective. Time ran out, and the discussion did not move forward in the Bush administration.

The Proposed Legislation is based on five principles. First, all types of organisms should be subject to review and regulation. No taxonomic category of GM modified organism is inherently free of risk. Second, regulation should cover possession or transportation for any purpose, including research and personal use. The litany of invasive species causing great damage includes many not connected to commercial activity, and the same could happen with GM organisms. Third, review and approval of GM organisms should consider the full range of effects they may have on the environment. In reviewing transgenic salmon, for example, the FDA is directed by statute to review safety with "reference to the health of man or animal." Plants, microbes, and ecological functions are important too. Fourth, the review of environmental effects should be open to public scrutiny and comment. The current FDA review is not fully public. The final principle is that federal wildlife conservation agencies should review and approve proposed activities concerning GM organisms when the potential exists for these to escape into the environment and cause harm to other wildlife. These are the agencies with the knowledge, experience and mission to prevent ecological harm, and their review and concurrence provides assurance that harm will not occur.

The Proposed Legislation would assign to EPA the lead responsibility for administering the new act. The EPA Administrator would decide whether or not to allow activities involving GM organisms, and could authorize an activity only if she determined, based on the best scientific data available, that the activity would not cause appreciable environmental or economic harm, or harm to human health. The Proposed Legislation includes procedures for public notice and comment, as well as a minimum of four standards to be considered that relate to the likelihood of an organism escaping from a controlled environment, reproducing, and causing harm. The Proposed Legislation would also require EPA to consult with federal agencies with expertise and mission in three key areas of concern and secure their concurrence before approving activities. These are: protection of fish, wildlife, or plants (Secretary of the Interior, or Secretary of Commerce in the case of marine species); impacts on agriculture (Secretary of Agriculture), and effects on human health (Secretary of Health and Human Services, presumably delegated to the FDA).

In the wake of Secretary Vilsack's correct reading of the law, now would be a good time for the Obama administration to take the Interior Department's legislative proposal off the shelf and move it forward so that the United States, for the first time, will have a comprehensive, coordinated, and effective framework for regulating genetically modified organisms. A new law will significantly improve the nation's ability to prevent harm from the release of GM organisms. But equally as important, a new law will facilitate the development and use of GM organisms by moving their review from the shadows of an arcane and incomplete legal process and into the light, where their overall great, prospective benefit to humankind can be appreciated.

A more detailed discussion of the Proposed Legislation is provided in W.Y. Brown. Promise and Peril. Environmental Forum: Vol. 18, No. 5. Environmental Law Institute. September/October 2001.