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9-Misc: Lawsuit questions algae imports into Hawai'i



                                 PART I
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TITLE:  Lawsuit questions algae imports
SOURCE: Pacific Business News, USA
        http://www.bizjournals.com/pacific/stories/2005/09/12/daily11.html
DATE:   12 Sep 2005

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Lawsuit questions algae imports

A hui of local environmental groups is suing the Hawaii Board of
Agriculture and local biotech company Mera Pharmaceuticals to force a
hearing on the importation of genetically modified algae into the state.

Mera, formerly known as Aquasearch, has received approval from the Board
of Agriculture to import and mass-produce seven strains of genetically
modified algae to its facility at the Natural Energy Laboratory of Hawaii
Authority in Kona on the Big Island as part of an agreement with a
mainland pharmaceutical company. Mera normally produces nutritional
supplements made from algae.

The hui of 16 environmental groups, called Na Maka O Hawaii Nei, is
seeking to force a contested case hearing before the Board of Agriculture
to evaluate the algae importation. The suit was filed in 1st Circuit
Court Friday. The case hearing would force Mera and Na Maka O Hawaii Nei
to present information for their arguments for and against importation of
the algae.

Na Maka O Hawaii Nei previously asked the board for the hearing in July
but its request was denied in August on the grounds that the hui is a
third party. The board ruled that a contested case hearing can be called
for only when an applicant is denied permission to import.

A representative from Mera did not immediately return PBN's call for
comment. Hawaii Department of Agriculture spokeswoman Janelle Saneishi
said she could not comment because the department has not yet received
the complaint.


                                 PART II
------------------------------- GENET-news -------------------------------

TITLE:  Biotech firms strain against state ag rules
SOURCE: Pacific Business News, USA, by Clynton Namuo
        http://pacific.bizjournals.com/pacific/stories/2005/08/15/story3.html
DATE:   15 Aug 2005

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Biotech firms strain against state ag rules

Red tape is strangling Hawaii's biotechnology industry and keeping it
from expanding, researchers and businesspeople say.

Stringent regulations, prolonged approval times for importation and
persistent opposition from community activists are quickly giving Hawaii
a reputation as a bad place to do biotechnology research or business,
industry executives say.

"We're entering a new time. Biotechnology is no doubt complicated," said
Lisa Gibson, president of the Hawaii Life Sciences Council. "We've got
rules that are from another era. They were designed for mainstream
agriculture."

But those who favor keeping the rules tight are concerned about the
introduction of potentially dangerous species into Hawaii's unique
ecosystem, and they point to the destructive incursions of invasive
plants as proof their concerns are legitimate.

By its nature, biotechnology research and development requires the
importation of microorganisms for laboratory studies. Importation
requires state Department of Agriculture approval, which can sometimes
take a year.

"This is a big hurdle that industry and researchers have to overcome,"
said Kevin Kelly, University of Hawaii managing director for the
Experimental Program to Stimulate Competitive Research. "When you're
trying to be competitive, you don't have 90 days or six months to wait
around."

Mainland biotech hubs, such as San Diego and Boston, face no such
importation restrictions.

In Hawaii, the Department of Agriculture regulates microorganism
importation through a series of lists classifying each type as low,
medium or high risk.

Low-risk microorganisms are easily brought in and out of the state.
Medium-risk microorganisms must receive department approval and high-risk
microorganisms must receive full approval from the state Board of
Agriculture following public hearings.

Developing a list of microorganisms scientists are allowed to bring in
has created problems for researchers working with newly identified
microorganisms. Bob Bidigare, director of the Center for Marine Microbial
Ecology & Diversity at the University of Hawaii, is doing research on
Coconut Island in Kaneohe Bay in which he analyzes samples of mud and
seawater to see if there are any beneficial microorganisms present.

He routinely sends samples to San Diego for analysis, but runs into
problems bringing the microorganisms back into the state.

Because the organisms are newly identified and not on any Department of
Agriculture list, they must go through full department approval before
being allowed back into the state, despite coming from Kaneohe Bay in the
first place.

"There have been so many times where I've been frustrated," he said.

In contrast, Mainland companies face only federal restrictions, which ban
work on certain dangerous pathogens but do not restrict importation.

Yet there are those in the research community who say that because
Hawaii's environment is unlike any on earth, importation restrictions
help to protect against the threat of invasive species.

William Walsh, an aquatic biologist with the state Department of Land and
Natural Resources, said scientists have made mistakes in the past and
will continue to do so in the future. He said careful study of
microorganisms prior to importation is the best way to minimize risk.

"I think given the fact that we are the endangered [species] capital of
the world ... we have to be a little bit more cautious," he said.

Walsh, who works in the Division of Aquatic Resources, said that in the
1970s scientists introduced a type of algae called Gorilla Ogo to Waikiki
Beach and Kaneohe Bay. The seaweed was supposed to be used for scientific
research but ended up growing out of control.

Today, it is a nuisance that is suffocating many coral reefs along Oahu's
south shore.

But Gerry Cysewski, president and CEO of Cyanotech Corp., which produces
nutrition supplements from microalgae, said the state's added layer of
bureaucracy is unnecessary.

"There's really no scientific rationale for having this restrictive
attitude toward importation of microorganisms," he said. "Pathogenic
organisms are very restricted by the federal government. The interesting
thing is that the microorganisms somehow get thought of as germs.
Microorganisms are ubiquitous in nature. The vast majority of
microorganisms are harmless, and indeed some of them are beneficial."

Questions over the growth of biotech in Hawaii are coming on the heels of
Kamehameha Schools' plans to develop a biotech center in Kakaako and the
completion of the new UH medical school. The new biotech park is expected
to create 1,500 to 2,000 jobs, according to Alex McGehee, executive vice
president of Enterprise Honolulu.

Even as prime real estate is poised to open for biotech companies, the
climate to do such business remains gloomy, advocates say.

Research and business dollars are put in jeopardy by seemingly endless
regulations, said Hubert Olipares, biosafety officer with UH
Environmental Health and Safety.

Cysewski said large-scale biotech research in Hawaii simply isn't
practical because of state importation rules.

"For a company to become commercial, they have to complete a lot of
research," he said. "Typically, research would involve the screening of a
lot of microorganisms. To start screening a multitude of organisms for a
new product, we certainly could not do that, whereas a company on the
Mainland could do that much more efficiently."

State officials agree that their process for importation needs reform,
but they say the industry must present a plan for change before anything
can be done.

Many of the microorganisms listed as moderate and high risk can be
downgraded to low risk, vastly expediting the importation process, said
Amy Takahashi, microorganism specialist with the Agriculture Department.

She said half of the microorganisms on the lists, representing thousands
of organisms, can be downgraded and made easier to import if only
industry representatives would step up and present a plan.

"We need to get input from the research community," she said.

Public input also is a concern for anyone doing biotech research in Hawaii.

Mera Pharmaceuticals, whose production facility is in Kona and which
planned on importing numerous strains of algae for large-scale growth,
was delayed first by the Department of Agriculture and most recently by a
hui of local community groups that sued to stop importation of the algae
until more research is done.

But Neil Reimer, plant quarantine branch chief at the Ag Department, said
public input is necessary, no matter how long it takes.

"The community input is important, but at the same time it does slow
things down," said Reimer, who is in charge of microorganism importation.
"Communities should have some input as to what's being brought into their
environment."

Biotech research necessitates the testing and analysis of large numbers
of microorganisms, but that is nearly impossible in Hawaii because those
microorganisms simply can't be brought here, Bidigare said. He said state
regulations are archaic and need to be changed.

"All organisms aren't created equal," he said. "They're treating every
organism like it's ebola. Finding cures for disease is a numbers game.
The more numbers you have, the greater probabilities there are you're
going to find a hit."




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