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The Honolulu Advertiser
Posted on: Sunday, November 18, 2007

Paperwork on risky viruses mislaid

By Sean Hao
Advertiser Staff Writer

Hawaii news photo - The Honolulu Advertiser

UH has an import permit for the bird influenza virus strain H5N1, seen in gold, grown in MDCK cells, seen in green.

Advertiser library photo

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WHAT'S ALLOWED

The University of Hawai'i has 177 active restricted microorganism import permits, according to the state Department of Agriculture.

Here's a list of some of the microorganisms UH can import:

Avian flu - The main source of human infection by the H5N1 avian flu virus is close contact with dead or sick birds. Some 267 people worldwide have been infected by avian flu and 161 have died.

SARS - Severe Acute Respiratory Syndrome was the first severe and readily transmissible disease of the 21st century. Person-to-person transmission was stopped after nearly 800 deaths.

West Nile - The virus can infect humans, birds, mosquitoes, horses and some other mammals. In about 20 percent of human cases, it causes a flu-like illness. Fewer than 1 percent of patients die.

Dengue - Dengue is the most common mosquito-borne viral disease of humans in the world. Dengue fever is a severe, flu-like illness that seldom causes death.

Japanese B encephalitis - Japanese encephalitis is the leading cause of viral encephalitis in Asia with 30,000 to 50,000 cases reported annually. The disease is spread by mosquitoes infected with encephalitis.

Eastern equine encephalitis - Eastern equine encephalitis is a mosquito-borne viral disease found in the eastern half of the United States. Because of its high mortality rate EEE is regarded as one of the most serious mosquito-borne diseases in the United States.

Source: World Health Organization, Centers for Disease Control and Prevention

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Hawaii news photo - The Honolulu Advertiser

University of Hawai'i medical school staff employee Laarni Sumibcay prepares to enter a high-level security lab. The university has permits to import certain active restricted miccroorganisms for research.

ADVERTISER LIBRARY PHOTO | Jan. 23, 2007

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The state Department of Agriculture lost track of hundreds of viruses and microbes imported to Hawai'i for research purposes over a five-decade period because of a breakdown in the agency's paperwork system.

The bulk of the import applications were filed by University of Hawai'i researchers who failed to report on the inventory and location of viruses and other microbes imported under 356 state permits dating back nearly 50 years, the agriculture department said.

UH and other researchers typically are required to regularly report on the status of restricted microorganisms imported under state permits. However, this spring the state Department of Agriculture discovered that UH researchers were not submitting required paperwork on numerous imported bugs including dengue and West Nile viruses.

The reports allow public health officials to inventory and locate which viruses, bacteria and other risky microbes are present in Hawai'i laboratories at any particular time. However, UH's permit paperwork problems, which have since been resolved, did not result in added risk to Hawai'i residents, university and agriculture department officials said.

The paperwork problem was discovered by state officials in mid-March following an Advertiser request for data on microorganism imports. The discovery of major reporting failures prompted the state to prohibit UH from seeking new or renewed import permits for a five-month period starting March 30. That moratorium was lifted Aug. 27 after the university filed required paperwork for 356 import permits dating to the 1960s.

State and university officials shared the blame for the clerical problem, which in turn was attributed to outdated, manual permit filing systems and a lack of resources and familiarity with state regulations.

"The entire system was at fault on both sides," said agriculture department plant quarantine branch manager Carol Okada. "There are computers. We need to get off of this paper filing. And that's what we're doing now."

A new computerized permit system, new reporting requirements and increased inspections should ensure compliance in the future, she said. In addition, UH said it will better educate researchers on state regulations governing microorganism imports and add two new job positions to help monitor UH compliance in the future.

The discovery of the permit problems follows a recent ramp-up in virus imports as UH attempts to specialize in infectious disease detection and drug discovery. The university now has 177 microorganism import permits covering avian flu, dengue fever, West Nile virus, SARS and several encephalitis-causing viruses, the Department of Agriculture said. That increase in research activity has raised concerns about risks to the health of Hawai'i residents and the state's $12 billion tourism trade should an accidental release occur.

The microorganisms are part of an increase in biotechnology research efforts that promise public health benefits and the diversification of Hawai'i's tourism-based economy.

UH and other state officials contend there's little risk to the public of exposure to these viruses because access to the bugs is tightly controlled. However, the recent microorganism import reporting problems show that accountability over some of this research is lacking, said Maui physician Lorrin Pang, who has served as a World Health Organization consultant.

The permit paperwork problem could have impacted public safety, Pang said. For example, if there was a local case of anthrax poisoning, health officials would benefit from knowledge on whether anthrax was present at UH laboratories, he said.

"If you're going to bring anthrax in, I'd would like to know something about it because if we have reports of anthrax, I can say it's from you, or it's from naturally occurring stuff," Pang said. "You've got to have the paperwork. This is public safety."

The university said it is not currently conducting research on anthrax. However, UH has acknowledged importing several potential bioterrorism agents, including Japanese B, Eastern equine and Venezuelan equine encephalitis. There are no current plans to conduct research on those viruses, which are being kept to aid in disease detection, UH said.

The university's permit problems were traced to several issues including a lack of familiarization with state import regulations among researchers, said Jim Gaines, UH interim vice president for research. State reporting requirements are more stringent than federal rules. In other cases, researchers mistakenly thought the reports were not required because the microorganism permits were not used, Gaines said.

"Researchers that were new to the state were familiar with the federal regs but not familiar with the Hawai'i regs," he said. "That led to some confusion. We hope we have that cleared up now."

"We put a lot of effort in once this was brought to our attention."

In many cases, required paperwork was not filed because researchers that imported restricted microorganisms were no longer around.

"Some of the (permits) went back to the early '60s they were close to 50 years old and there were faculty members that were deceased (and) faculty members that were no longer with the university," Gaines said.

Computerized permitting systems installed this summer along with other new requirements are expected to ensure compliance with microorganism import reporting requirements in the future. However, data on hundreds of microorganism import permits dating back to the 1960s remain sketchy.

For example, the agriculture department is still unable to produce a list of restricted microorganisms that can be imported into Hawai'i under previously granted permits. The department also could not produce a complete list of microorganism permits that were found not in compliance with reporting requirements.

Permit data "is all (on) paper," the Department of Agriculture's Okada said. "It's all in these folders all over creation. Because it was done that way, there's no good way for us to do an audit of what was done and how much was not done."

Reach Sean Hao at shao@honoluluadvertiser.com.