The permit allows biotech company Mera Pharmaceutical to import and produce in a state facility in Kailua-Kona, Hawai'i Island seven novel strains of "biopharmaceutical" algae genetically modified to produce unapproved experimental drugs. The suit seeks to compel the BOA to comply with the Hawai'i Environmental Policy Act by reviewing the potential environmental impacts of the project. The suit also seeks to invalidate the BOA's approval and stop the project from proceeding until the mandated review process is complete.
"The law requires the State to fully examine the potential impacts of bringing these alien, drug-laden algae to our islands," said Earthjustice attorney Isaac Moriwake. "The government and public need to understand the potential impacts and available alternatives before this experiment begins."
The genetically engineered strains of algae have never been introduced anywhere outside the laboratory. The U.S. Food and Drug Administration has never approved a pharmaceutical substance produced by the GE algae for human consumption by, nor are their effects on humans and the environment known.
The alga used in the experiments, Chlamydomonas, is a common microorganism that exists in water, soil, even snowfields, can be transported in the air, and can survive a variety of harsh conditions in a dormant stage. Native strains of Chlamydomonas are known to exist in Hawai'i, which experts say are unique to these islands. This raises concerns of the biopharm algae not only spreading on its own, but also crossing with the native strains.
Mera Pharmaceutical seeks to manufacture large quantities of the biopharm algae for experimental purposes outdoors, in large plastic containers called "photobioreactors" at the Natural Energy Laboratory of Hawaii Authority, a state-owned technology park on the Kailua-Kona coast on the island of Hawai'i. Such large-scale, outdoor production compounds the risks of escape and contamination of the surrounding environment.
"Islands are fragile ecosystems. We've seen salvinia molesta on Lake Wilson, coqui frogs on the Big Island, and invasive algae along the shores of Maui and Waikiki. We do not want to see something like that happen on the Kona coastline. It is imperative that environmental review be done," said Karen Eoff, President of Kohanaiki ‘Ohana.
"Algae have been the building blocks of life on Earth for 3 billion years," said Jeff Mikulina, Director of the Sierra Club. "Surely we can spend a few extra months ensuring that genetically altering algae won't have unintended consequences."
The plaintiff groups are particularly concerned because the NELHA facility lies in a sensitive coastal environment that is cherished and regularly used by local residents, including Native Hawaiians. A popular camping ground, surfing spot, and beaches are located nearby, as well as numerous wetlands and brackish anchialine ponds which host native and endangered species and support legally protected Native Hawaiian cultural practices of gathering and access. A national park is also located in the vicinity.
"These algae are a foundation of life in all water and soils. The large-scale, outdoor production of their genetically modified forms practically rolls out the red carpet for their release into the environment," said Nancy Redfeather of 'Ohana Pale Ke Ao. "We need to exercise more prudence and precaution before introducing such drug-producing algae into our pristine Hawaiian ecosystems."
This case marks the first time ever the state has had to make the sole decision whether to allow the import of a GE organism into Hawai'i. The federal agencies usually responsible for regulating GE organisms -- the U.S. Department of Agriculture, Environmental Protection Agency, and the FDA -- have all disclaimed jurisdiction over the biopharm algae. Chlamydomonas, however, is on the state Department of Agriculture's "list of restricted organisms" under its quarantine laws. Further, DOA staff determined that the biopharm algae posed an "above moderate risk," which means that the BOA must approve the project. The DOA made this determination based on the lack of federal oversight, the DOA's lack of experience with GE Algae, concerns regarding large-scale production outdoors, and the "unknown effects on the environment if accidentally released."
Also, because the biopharm algae project will use state lands, it triggered HEPA's requirement of environmental review. This involves a process whereby the BOA, with the full participation of the public, must evaluate the impacts of a project and its alternatives in an "environmental assessment" and, if the EA indicates that the project "may" have a significant effect on the environment, a more extensive "environmental impact statement".
At several lengthy hearings on the proposal, the BOA received a flood of public testimony from concerned individuals throughout the state and even from the mainland, including local residents, Native Hawaiians, farmers, businesspeople, doctors, and scientists, who questioned the project and urged the Board to examine the potential impacts in a HEPA document. At the second meeting on June 26, 2005, the BOA approved the application without even mentioning HEPA.
"Shortcutting the legal process does nothing to ensure the protection of public health and the environment, or to foster public confidence in such projects," said Moriwake. "The state should just comply with the law by fully examining the potential impacts of this project in full public view."