POSTED: 7 AUGUST 2005 - 8:30pm HST

More on pharm-algae lawsuit

freshwater micro-organismslike these may be engineered into productsfor pharmaceutical corporations

Groups sue over algae import permit
A coalition wants an environmental review

By Stewart Yerton 3 August 2005 in The Honolulu Star-Bulletin

The Hawaii Board of Agriculture violated state law by permitting a biotechnology company to import genetically modified algae into a taxpayer-funded facility on the Big Island without proper environmental reviews, a coalition of community and environmental activists alleged yesterday in a lawsuit.

The suit, filed in state Circuit Court in Kona, claims that the Board of Agriculture violated the Hawaii Environmental Policy Act when it granted a permit in June allowing Mera Pharmaceuticals to import several strains of "biopharmaceutical" algae to a state facility in Kailua-Kona.

The plaintiffs are the groups Ohana Pale Ke Ao, Kohanaiki Ohana, GMO Free Hawaii and the Sierra Club's Hawaii chapter. They are represented by the Honolulu office of Earthjustice, a nonprofit environmental law firm.

The suit claims the state board granted the permit without conducting an environmental assessment as required for activities on state or county land. Without that basic review, it is impossible to tell whether the board should be required to perform a more involved -- and potentially more costly -- environmental impact study, said Isaac Moriwake, a lawyer for Earthjustice.

The suit asks the court to bar Mera from importing the algae until the Board of Agriculture has complied with state environmental laws. A spokeswoman for the Hawaii Department of Agriculture declined to comment yesterday, saying the agency had just received the complaint.

The suit was filed just more than a month after the Board of Agriculture granted Mera a permit to import several strains of fast-growing, genetically modified microalgae to its facility, located on the Big Island at a state-owned business incubator. The company is working with Rincon Pharmaceuticals of San Diego to conduct tests on "biopharmaceutical" algae, which has been genetically altered to produce experimental drugs intended to treat a variety of illnesses. The permit also allows Mera to grow the algae in outdoor containers located at the facility.

The board's granting of the permit followed objections from numerous citizens who questioned the algae's potential to spread outside the facility, pollute nearby areas and cross-breed with native algae unique to Hawaii.
The suit calls the nearby Kohanaiki area "a center for traditional Hawaiian activity," containing ancient places of worship, altars, petroglyphs and brackish ponds used for shrimp gathering. Kohanaiki was the focus of a landmark 1995 Hawaii Supreme Court decision upholding the right of native Hawaiians to have access to private land for traditional practices.

"Hawaii's land use laws have been of utmost importance to the organization," said Karen Eoff, president of Kohanaiki Ohana. "In this case, it just seems obvious that the need for environmental review is imperative."

"Hawaii state law requires that the state do its homework before rushing in and approving something like this," said Nancy Redfeather, spokeswoman for the Ohana Pale Ke Ao. "There are too many unknowns that weren't answered at the hearings."


Citizens Sue For Review Of Biopharm Algae
Hawai`i Lawsuit Seeks Further Study of Consequences of Genetically Modified Microorganisms

by Jeffrey Mikulina, Director Sierra Club, Hawai'i August 2, 2005
Phone: 808.538.6616

Kailua-Kona, HI -- Today, citizen groups `Ohana Pale Ke Ao, Kohanaiki `Ohana, GMO Free Hawai`i, and Sierra Club, Hawai`i Chapter, represented by Earthjustice, filed a lawsuit in the Circuit Court of the State of Hawai`i, against the Board of Agriculture, State of Hawai`i, challenging the approval of a permit to allow the production of potentially dangerous genetically modified microorganisms on the Big Island.

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.”