Hawaii residents sue for environmental
review of biopharm algae

KAILUA-KONA, Hawaii, August 3, 2005 (ENS): Before genetically engineered algae is grown to produce pharmaceuticals on the island of Hawaii, an environmental assessment should be conducted, say four citizen groups who filed a lawsuit Tuesday asking a state court to order the assessment.

The lawsuit filed against the state Board of Agriculture challenges the agency's approval of a permit to allow the production of genetically modified microorganisms on the Big Island.

The groups 'Ohana Pale Ke Ao and Kohanaiki 'Ohana, as well as GMO Free Hawaii, and the Sierra Club, Hawaii Chapter, represented by Earthjustice, are claiming that the microorganisms are potentially dangerous.

The state permit allows biotech company Mera Pharmaceutical, based in Kailua-Kona, to import and produce in a state operated research facility here seven novel strains of biopharmaceutical algae genetically modified to produce unapproved experimental drugs.

"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 lawsuit seeks to compel the Board of Agriculture (BOA) to comply with the Hawaii Environmental Policy Act by assessing 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 review process is complete.

The genetically engineered strain 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 genetically engineered algae for human consumption by, nor are their effects on humans and the environment known.

The algae used in the experiments, Chlamydomonas, is a common microorganism that exists in water, soil, and on 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 Hawaii, which experts say are unique to these islands. The groups contend that 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 (NELHA), a state owned technology park on the Kailua-Kona coast. Such large-scale, outdoor production compounds the risks of escape and contamination of the surrounding environment, the plaintiff groups contend.

"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," Karen Eoff, president of Kohanaiki 'Ohana. "It is imperative that environmental review be done."

"Algae have been the building blocks of life on Earth for three 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."

Mera's chief business is the production of nutraceuticals from microbial aquatic plants and the publicly traded company already produces one at Kona.

AstaFactor, Mera's first commercial nutraceutical, is derived from Haematococcus microalgae. It is a concentrated source of natural astaxanthin, found in fish and seafood species, "an effective anti-inflammatory and a powerful antioxidant," the company says.

Recognized for their potential medical and nutritional value, microbial aquatic plants can produce valuable products, says Mera, but the plants have been ignored because they have been impossible to grow at commercial scale until the company developed and patented closed-system photobioreactors.

The microalgae are grown in photobioreactors where conditions such as temperature, light and nutrient levels are controlled by computer. These allows the production of a large number of species at scale reliably, efficiently and at high quality, the company says.

"After maximizing growth in the closed photo-bioreactors, the algae are transferred to environmentally controlled ponds," the company explains on its website.

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 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 nearby. Established in 1978 for the preservation, protection and interpretation of traditional native Hawaiian activities and culture, the 1,160 acre Kaloko-Honokohau National Historical Park is the site of an ancient Hawaiian settlement. Resources include fishponds, house site platforms, petroglyphs, a stone slide, and a religious site.

"These Chlamydomonas 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 genetically engineered organism into Hawaii. The federal agencies usually responsible for regulating biotech organisms - the U.S. Department of Agriculture, the U.S. Environmental Protection Agency, and the U.S. Food and Drug Administration - have all disclaimed jurisdiction over the biopharm algae.

Chlamydomonas is on the state Department of Agriculture's list of restricted organisms under its quarantine laws. Further, the agency's staff have determined that the biopharm algae posed an "above moderate risk," which means that the Board of Agriculture must approve the project.

The Department of Agriculture made this determination based on the lack of federal oversight, the agency's lack of experience with genetically engineered 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 the requirement of environmental review under the Hawaii Environmental Policy Act (HEPA). The Board of Agriculture, with public participation, must evaluate the impacts of a project and its alternatives in an environmental assessment. If the assessment indicates that the project may have a significant effect on the environment, a more extensive environmental impact statement must be conducted.

At several hearings on the Mera proposal, the Board of Agriculture received 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 Board of Agriculture approved the application without mentioning the Hawaii Environmental Policy Act.

"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."

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