State officials have been actively recruiting biotech businesses and investment since former Gov. Ben Cayetano endorsed the industry as a clean, high-tech way to save agriculture and diversify the economy. Plant scientists were among the first to cross the welcome mat, lured by Hawai'i's mild climate and the prospect of a year-round growing season. These Island qualities could shorten the lengthy research process required to develop the genetically engineered plants that some see as the solution to disease and world hunger.
Their creations-backed by private and public investments that topped $220 billion nationwide by the year 2003-have been hailed as 21st-century wonder crops, with the potential to boost harvests, produce cheap drugs and make farming less toxic. Known as transgenics, or genetically modified organisms (GMOs), these designer plants are the progeny and patented property of American universities, the federal government and such multinational corporations as Mon santo, ProdiGene, Novartis, Dow AgroSciences and Dupont/Pioneer Hi-Bred.
In this rarefied atmosphere of big players, big money, big promises and big dreams, the Aloha State has a big role. Dusty old plantation towns such as Kaua'i's Kekaha, O'ahu's Kunia and Moloka'i's Kaunakakai supply the farm labor and fertile, fallow fields that biotech researchers need to test their lab-invented plants in the real world of sun and soil. In the past 17 years, Hawai'i has hosted more than 4,500 open-field tests for experimental GMO plants, more than any place in the world. About 140 are currently under way throughout the state.
"These field trials are being conducted without adequate oversight or even knowledge of where it's being done," says Nancy Redfeather, a Kona coffee grower and member of HIGEAN, the Hawai'i Island Genetic Engineering Action Network. "I think it's really time for the people of Hawai'i to know what's going on."
Although an exact number is not available to the public, some of Hawai'i's outdoor trials have grown biopharmaceuticals-plants genetically engineered to produce medical supplies, drugs, vaccines and industrial chemicals. According to court documents, these tests involved experimental AIDS and hepatitis B vaccines, growth hormones, enzyme production from human genes, and aprotinin, a blood-clotting cow protein that is also an insect toxin. Island fields serve another industry purpose, too: growing seed for Mainland farmers from transgenic crops engineered to produce their own insecticides or resist herbicides.
For years, transgenic agriculture went largely unnoticed by most Islanders, save for those who tended the crops or noted its contribution to the state's $50 million seed corn industry, which expanded five-fold over the past decade and is now split about equally between GMOs and conventional hybrids. At most, they may have heard of Hawai'i's own contribution to the world of biotech: a papaya genetically engineered to resist the ringspot virus.
That era of obscurity appears to be ending-and perhaps not a moment too soon, in the view of Cha Smith, executive director of KAHEA, a coalition of environmental and Hawaiian cultural groups. "I'm horrified by this industry and the lack of critical thought about it. They're affecting life forms with no idea of the long-term impact. It's technology run amok, and I think it threatens the very core of Hawai'i."
Local residents are starting to question Hawai'i's role in transgenic agriculture, echoing concerns raised by scientists, politicians, food manufacturers, grocers, public health officials, trade organizations, organic farmers, conservationists and just plain folks all around the globe. What is being grown, and where? Will transgenics harm people, animals, the environment? Do the potential benefits outweigh the possible risks? Are existing regulations adequate, or properly enforced? Can GMOs be prevented from going places where they're not supposed to be?
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"These are huge concerns," Smith says. "I think they [state regulators] owe it to the people of Hawai'i and future generations to require a few more evaluations and reviews of this industry. If they're going to be here, let's at least have some accountability and monitoring."
GMO crops and their cultivation are largely regulated by the federal government, with virtually no accountability at the local level. As a result, it's not easy to know exactly what is going on here in Hawai'i. Even the process of trying to determine who has accurate information raises thorny new questions about credibility, responsibility, the reality of objective science and the true allegiance of government agencies charged with serving both industry and the people.
Muddying the waters still more are such powerful emotions as fear, mistrust, anger and greed; a full spectrum of political, economic and social ideologies; and highly charged ethical, moral and spiritual considerations. They combine to make GMOs one of the most challenging issues of our time, alongside stem cell research and cloning technology. And Hawai'i is smack in the middle of the fray, unable thus far to craft political solutions or even talk civilly about the subject.
SEARCHING FOR ANSWERS
Hawai'i's predicament-large-scale GMO experiments with little public discussion or oversight-caught the attention of the Pew Initiative on Food and Biotechnology, which advocates a carefully structured process designed to help communities peacefully resolve complex public-policy disputes.
"Pew saw Hawai'i as one of the states that was ripe for this kind of discussion," so it contributed seed money to get the ball rolling, says Bill Kaneko, director of the Hawai'i Institute for Public Affairs, a Honolulu-based nonprofit that strives to mediate this sort of contentious squabble as a neutral party. "The goal is for the project to provide a safe forum where the issue of GMOs can be discussed. That's what we'll be working on over the next 12 to 18 months."
Kaneko does not expect that all the disputes will be resolved in that time, given the complex, emotional nature of the debate and the "very painstaking process" required to even determine who should participate as stakeholders in the discussions. "But if the group can identify one or two key priority issues and focus on those, that's a win," he says. "Even if there is no consensus, the fact that the project can bring all these people to the table is an early victory."
Redfeather agrees, noting that the Pew process offered the first glimmer of hope that differing views would be heard and considered. "There was this agreement among all parties that activists have a voice, and we didn't have one before this."
Paul Achitoff, lead attorney in the Honolulu office of Earthjustice, is seeking his answers through the courts. Acting on behalf of a consortium of local and national environmental groups, he has sued the state and federal governments to secure legal discussions on issues of GMO secrecy, regulation and safety.
The government restricts access to public records related to GMOs, namely, the permit applications for transgenic field tests. Achitoff's lawsuits, filed in November 2003, are the first to challenge this policy, and to question whether the U.S. Department of Agriculture is adequately regulating the industry.
As the lead agency in a three- pronged system of federal jurisdiction over the biotech industry, the USDA regulates genetically engineered crops and administers the permit system for field tests. The Food and Drug Administration manages genetically modified organisms used in food and medicines, and the Environmental Protection Agency oversees "novel organisms"-entirely new life forms created by biotech researchers-as well as plants that contain pesticides, including some of the seed corn crops raised in the Islands.
Achitoff says his suit against the state is intended to force the Hawai'i Department of Agriculture to comply with the open records act and release specific details about the nature and location of experimental field trials. The state agency so far hasn't done so, insisting that it is merely enforcing directives imposed by the USDA, which has supported the industry stance that confidentiality is warranted to protect crops from vandals and trade secrets from competitors.
Some information is available through a Virginia Tech Web site (www.isb.vt.edu), which posts applications for field-trial permits and their status. It usually, but not always, discloses the reason for the test, the crop involved and whether it is a considered a biopharmaceutical. But while it names the state, it does not disclose the specific location and details about biopharmaceutical tests are rarely included. Achitoff says his clients believe people have a right to know where transgenics are being grown, especially biopharmaceuticals, since none have been approved for use by humans or animals. "The shroud of secrecy surrounding biopharming is unacceptable," Achitoff says.
That case has been stayed indefinitely pending federal court action on Achitoff's second lawsuit, which aims to make the USDA take a closer look at those risks by conducting an environmental impact statement (EIS) on its overall regulatory program for transgenic crops, as well as for each proposed field trial. Applicants for permits also would need to consult with the U.S. Fish and Wildlife Service to determine if their proposals would affect the state's 300 endangered plants and animals, which comprise more than a third of all protected species in the nation.
The USDA has not granted any new permits for biopharm testing since the lawsuit was filed, Achitoff says, and government attorneys have argued that all Hawai'i field trials using biopharmaceutical crops have been completed, so the case is moot.
Industry supporters say the lawsuit could inhibit biotech's future growth in Hawai'i if the state is perceived as anti-GMO. They maintain the existing three-tiered system provides sufficient governmental oversight, and there are no documented risks, anyway. "We need to collaborate and work together to avoid giving the impression that we are in any way opposed to biotech," says Lisa Gibson, spokeswoman for the Hawai'i Life Sciences Council, an industry advocacy group. "Because if we don't, we'll lose out, and these businesses pay living wages and do things to help and heal people."
That approach doesn't wash with Achitoff. "The industry is basically regulating itself and their attitude has consistently been there aren't any environmental risks. But clearly, risks do exist, and they're not always the obvious ones. There have been any number of instances that have shown the controls are not adequate to contain these crops in open fields." He noted that studies have shown GMO crops on the Mainland have interbred with wild plants and other commercial crops, and that monarch butterfly larvae are harmed by a pesticide used in one type of GMO corn.
Critics also contend the regulatory process is tainted because of what appears to be a cozy relationship between federal agencies and the industries they oversee. As evidence, they point to the USDA's practice of funding and conducting extensive biotech research, including the so-called "terminator technology" that prevents the second-year propagation of transgenic seed, ensuring that farmers must buy new seeds each season from private companies. Others have criticized what they characterize as the agency's rubber-stamp approach to field-trial permit applications. According to a report published by the U.S. Public Interest Research Group, the agency has rejected only 3.5 percent of the nearly 40,000 permit applications submitted, and those were due to incomplete applications and paperwork errors.
Achitoff says the Earthjustice litigation stems, in part, from a growing grassroots movement that is demanding more industry accountability and government oversight in the area of transgenic agriculture. If the court rules that an EIS is required for field trials, industry would be forced to reveal its rationale for present testing practices and explore alternatives, he says, and the public, now largely excluded from the permitting process, would have a say in how transgenic experiments are carried out in their communities.
The U.S. Food and Drug Administration has ruled that transgenic crops and foods containing GMOs are essentially the same as their conventional counterparts, and thus pose no danger to people or ecosystems. FDA administrators contend that fears about long-term health risks and inadvertent environmental contamination from the accidental release of GMOs are groundless and based in hysteria, not science. Scientists working with companies that produce transgenics, such as Pioneer Hi-Bred's Cindy Goldstein, also maintain that their research projects and commercial products are completely safe-aside from problems that occasionally arise when people unknowingly eat food modified with genes from plants or animals to which they are allergic-because nothing has turned up to indicate otherwise.
"There haven't been any reports of anyone getting ill or negative environmental impacts from GMOs]," says Goldstein, a plant physiologist and molecular biologist who handles biotech education and community outreach for plant breeder Pioneer Hi-Bred at its Waialua headquarters. "We're in our 10th year of planting biotech crops and we haven't seen any of these negative affects documented by studies."
William Walsh, a Kona-based biologist with the state Division of Aquatic Resources, suspects that's because "no one is looking," in part because most scientists are highly specialized and don't have the educational background needed to consider the big picture. "It's hard to find people with the breadth of knowledge to say with certainty what's really happening. I'm not an expert on this by any means, and there's really no one in the state who is."
Rapid advances in the biotech industry further complicate the safety issue, he says, because "there's often a considerable lag time before something is recognized as a problem. A lot of these developments are racing way ahead of government's ability to keep track of them."
WHO IS MINDING THE PHARM?
This may be the most troubling aspect of GMOs in the Islands. The state has no specific regulations relating to GMOs, Achitoff says, and "to my knowledge there is no meaningful federal oversight once the [field-trial] permit is granted. In theory, the [state] Department of Agriculture does some monitoring, but for all practical purposes, there is none. They don't have the expertise, resources or incentive to monitor it."
The Hawai'i DOA employs just one inspector, Carol Okada, to monitor all the active field trials in the state, which currently number about 140. Attempts were made to reach Okada for this article, and she reportedly did respond in writing to questions about the nature of her monitoring efforts and the adequacy of current staffing. But because of the Earthjustice lawsuit, her replies were submitted to the state attorney general's office. More than 10 weeks later, as this article was going to press, the agency still had not completed its review.
The EPA, meanwhile, operates on a complaint basis, which did result in fines being levied against two companies for permit violations on Kaua'i and Moloka'i associated with growing crops that contained pesticides. Still, biotech opponents question how well the EPA keeps track of the field trials, given that it maintains no staff or offices on Neighbor Islands, where most of the research occurs.
Dr. Lorrin Pang, a consultant to the World Health Organization, is concerned not only about monitoring, but what he considers a dearth of scientific information needed to conduct meaningful oversight. Pang also heads the Maui Branch of the state health department, although he is careful to specify that he is speaking not on behalf of the agency, but as a private citizen, when he discusses transgenics. He maintains that GMOs, especially the experimental ones grown in Hawai'i, have not been adequately studied to determine their effects on people and the environment and that makes open-air testing a risky business, particularly for biopharmaceuticals that contain vaccines and human genes.
"We don't know anything about them, because they're so novel," Pang says. "So we don't know how to control them, how they'll act in the environment or spread, the physiological effects, how to shut it down if something goes wrong."
The industry often uses food crops in biopharming experiments, which heightens the potential for adverse effects, says Pang, a position shared by the National Academy of Sciences and food manufacturers. Corn, the most common biopharm crop, produces pollen that is difficult to contain, which increases the likelihood of cross pollination with non-transgenic corn. "There's a big concern about pollen blowing in the wind, where everybody takes it in," he says, noting that it becomes impossible to determine individual exposure levels from such sources and engineered plants "have a lot of unintended variations."
Pang explains that each introduced gene is accompanied by a gene marker, which produces a protein and a promoter. "So you have four new things and they all are viable in the environment. There's inherent variation that has to be evaluated on a case-by-case basis."
Such evaluations are not being done, he says, even on transgenic crops approved for human consumption. "It would be nice to test them beforehand, but at least set up a post-marketing assessment," he says, citing a New England Journal of Medicine study that showed 50 percent of all new drugs show harm only in the post-marketing phase. "And these are drugs that have been tested for years before they're approved."
Allergic reactions are a primary concern, he says, because people eating unlabeled GMO products won't know exactly what they are ingesting. When it comes to biopharms, the potential for harm is even greater, according to documents filed in the Earthjustice lawsuits. David R. Schubert, an expert in molecular genetics and cell biology who heads the Salk Institute's Cellular Neurobiology Laboratory in San Diego, states in his declaration that "consumption or inhalation of the plant-produced pharmaceutical could trigger a number of dangerous immune system reactions. These include oral tolerance, allergic reactions and autoimmune disorders."
Pang, who is particularly worried about possible health impacts on workers in the GMO-crop fields, says he has expressed his concerns to state health department officials, but has seen no sign that the agency plans to expand its role in regulating or monitoring biotech activities. An agency spokeswoman confirmed his assessment, saying that federal agencies had jurisdiction over transgenic crops. "The Department of Health role in GMOs is small at best," she says. "Actually, there isn't much."
The local health department hasn't always been so quiet. In 1990, when field testing was in its infancy, Bob Grossman, former special assistant to the DOH director, was instrumental in creating an ad hoc committee to review and monitor biotech research. He also lobbied lawmakers to approve a bill that would have mandated an environmental assessment for every proposed field test. But the bill died, and when Grossman left the agency in 1994, the ad hoc committee died, too.
Since then, state agencies have generally deferred to the federal government in matters of monitoring and oversight. The Hawai'i Department of Agriculture does work with the USDA, through field-trial site inspector Okada's position, to ensure companies comply with the conditions in their field test permits. Otherwise, it gets involved only when biotech researchers and firms want to work with restricted species-plants and animals that pose some risk to human health, agriculture or the environment. The state Board of Agriculture (BOA), which includes representatives from the Department of Land and Natural Resources (DLNR) and the state health department, among others, makes the final call on those permits.
Some of the challenges facing state agencies involved in reviewing biotech proposals came to light in late May, when the BOA was considering a proposal from Mera Pharmaceuticals Inc. The firm wanted to import eight strands of algae that would be genetically engineered with synthetic human genes at its San Diego laboratory and then shipped to an outdoor production facility at the Big Island's Natural Energy Laboratory of Hawai'i. The project came before the board only because Mera wanted to use Chlamydomonas, a restricted species that is hardy and prolific, producing new generations every five hours. More than 70 people submitted testimony warning of the possibility of escape for an algal species that can survive in salt, fresh and brackish water, and even be absorbed into clouds, returning to earth with rainfall. Although two technical advisory committees had recommended approval, board members say they did not have enough expertise or information to make a decision. They voted to deny the company's request for procedural reasons, but left the door open for future consideration.
Mera returned on June 28, and this time its permit application was approved by a 6-2 vote of the board following four hours of public testimony, most of it in opposition. Board member Ted Liu, director of the state's Department of Economic Devel-opment, Business and Tourism, said he had carefully weighed all the interests at stake and determined that the project is important to the future of biotech in Hawai'i. "This was a very difficult issue, no question," Liu says. Other supporters, such as Cynanotech president Gerald Cysewski, whose company grows algae for the health-food industry at the same Big Island facility as Mera, said the proposal could boost the state's $27.7 million aquaculture industry.
The permit allows the company to import and grow seven strands of genetically engineered algae for one year for trial pharmaceutical production, and Mera officials said they would begin within 90 days. On July 8, however, a coalition of environmental groups, known as Na Maka O Hawai'i Nei, derailed those plans by filing a petition seeking a contested case hearing on the board's action.
If the board decides against such a hearing, petitioners said they will take the matter to the Hawai'i Supreme Court. Although the contested case process has been used extensively with land-development projects in Hawai'i, it has rarely been invoked with Department of Agriculture actions and has never before been sought to resolve disputes over biotech proposals. "It will break a lot of new ground," says Henry Curtis, director of Life of the Land, one of the groups that joined the petition.
Peter Young, who serves on the panel as director of the state DLNR, said in an interview following the May hearing that the decision shows how much thought and care is taken when reviewing proposals to bring new organisms into the state. "We don't operate in a vacuum," he says. "We consider information presented from a wide range of sources. I think the BOA makes good decisions." Young was not present at the second hearing.
Redfeather says the case highlights Hawai'i's extremely precarious position in the world of biotech and the tremendous influence exerted by economic interests. The industry is becoming increasingly technical and aggressive, she says, and government agencies do not have the scientific expertise, political will or funding to properly evaluate and monitor its proposals and experiments. She believes that public opposition, mounted hastily after a local newspaper broke the story, was all that prevented the project from moving forward in May.
State biologist Walsh concurs, noting that without the media coverage, the algae proposal "would have been under the radar, with no real scrutiny. That's not the best way to make these kinds of decisions. They've got to be done aboveboard and in a much more transparent process than there has been."
The Mera project seems to indicate that Hawai'i is headed in a new direction in its relationship with GMOs-one that includes more media attention, more questions and more aggressive tactics as both critics and supporters seek to advance their cases. But both sides are also open to broadening the debate.
Industry advocate Gibson said that a "transparent process based on the scientific method and research" is needed when discussing and evaluating proposals and issues that involves transgenics. "We need to create a forum for that to happen, because otherwise we lose out," she says. "Lots of smart people are excited about this, because the same science that is used in GMOs is what will be used to come up with a cure for cancer, for diabetes."
Gibson does not, however, advocate anything that would slow Hawai'i's growth in biotech or the life sciences. "This is our chance to grab our spot in the global economy," she says, noting that such an approach doesn't mean ignoring the possible risks or concerns and pursuing biotech at all costs. "Nobody wants to grow this industry so it hurts Hawai'i. We can come together and determine good science from bad science and chart our own future."
Redfeather and others believe that transgenic agriculture is too new and unproven to be given a place at the table. If they had their way, Hawai'i would never host another field trial or raise any transgenic crops. They want the state to slow down and adopt the precautionary principle, which advocates caution in the face of uncertainty. "When government doesn't step forward, I guess the public has to," she says.
But even if GMO opponents prevailed in their drive to stop transgenics cold, the biotech movement has already made significant inroads into the nation's pantries. Only a handful of transgenic crops have been approved for use and even fewer have enjoyed commercial success-predominantly soybean, corn and canola engineered to produce an insecticide or to withstand direct applications of Monsanto's herbicide, Roundup, as well as a growth hormone that stimulates milk production in cows. However, GMOs are now found in an estimated 60 percent to 70 percent of all products sold on supermarket shelves.
Still, there's plenty to be discussed, and the Islands are poised to take the lead in the emerging global debate over the future of transgenics.
Kaneko says Hawai'i's cutting-edge legal cases and Pew project are being closely watched by the National Conference of State Legislatures, among others, because lawmakers recognize that the political arena is not the best place to hash out highly technical matters further complicated by conflicting ideologies. "They're very interested in this issue, because other states with agriculture are going through it, too," he says. "In a very small way, if we're able to muddle through a process that brings people together, Hawai'i could become a model for the other 49 states."