Hawai'i relaxes rules on biological research

By Beverly Creamer
Advertiser Education Writer

New state regulations that took effect last week relax the use of potentially hazardous biological materials in scientific research, in part because the Sept. 11 attacks added a sense of urgency to Hawai'i's defense against bioterrorism.

"We don't want to hamper importation when it has to do with rapid diagnosis of these agents," said Amy Takahashi, microorganism specialist with the Department of Agriculture, which developed the new rules. "Because of Sept. 11, we're looking at how we can facilitate the importation, but with state oversight."

Hawai'i has long been a tough regulator of scientific research, largely because of the state's unique geography and environment. That has frustrated scientists who say advanced research work has been driven out by the state's extra layer of regulations, which often duplicate federal security measures.

"Our infectious disease research community is probably cut in half," said Jim Douglas, a University of Hawai'i professor of microbiology. "We've had people leave the university. They go elsewhere where they don't have these extra restrictions."

The exodus has been fueled by budget reductions at the university in the last few years and the lack of a type of laboratory known as Biosafety Level Three, needed for the most hazardous agents. A laboratory renovated for this level of work at Leahi Hospital, paid for by the National Institutes of Health, has taken five years to complete and been waiting for final certification since March.

Takahashi said state regulations governing the importation of everything from E. coli to tuberculosis bacteria to organisms that could attack crops were instituted for good reason. The rules govern thousands of microorganisms, including disease pathogens and agents that could be employed in bioterrorism.

"We feel there is sufficient federal oversight by the CDC (Centers for Disease Control) for the human pathogens," said Takahashi. "But with other types of microorganisms, federal oversight might not be sufficient. They tend to look at the organism based not on Hawai'i needs, but nationwide. We want to have direct oversight on these imports because we want to protect our industry here."

State permits are still required for the list of "select human pathogens" (including anthrax) if those seeking to import are not part of a laboratory authorized by the CDC to study the organism.

But there is no longer a list of prohibited agents, such as TB bacteria and E. coli. And there is now a list of unrestricted organisms that do not require a permit to bring into the state.

Even with the looser regulations, many levels of oversight remain — both state and federal — that would prevent dangerous agents from becoming a threat.

"We can be closed down as an institution if we don't have the right rules in place," said Martin Rayner, interim director of the Pacific Biomedical Research Center, an arm of the university.

Douglas is one of the researchers who has chafed for years under layers of what he considers outmoded state bureaucracy. He says the Department of Agriculture should not be setting standards for human pathogens that have nothing to do with plant materials or crops.

Douglas has been trying without success to import weakened anthrax — the type used in animal vaccines — for a course he teaches in the microbiology of pathogens. It would be part of the course work for training medical technologists, specialists who eventually will be employed in hospital laboratories to identify infectious agents.

"I'm trying to get it, but there's nervousness about it," Douglas said. "We teach medical technologists in the state, so I thought we should offer some special instruction in how to identify some of the bacteria that are associated with bioterrorism, so if something ever happens here there would be people who could deal with it.

"Right now, if there is a big outbreak, the labs that could handle it would be overwhelmed."

Douglas emphasizes that even when biological materials have gained the permitting necessary to be imported for study, they are "attenuated" — meaning they have been weakened by removal of certain pieces of the chemical structure.

"Most attenuated strains are vaccines or potential vaccines, so they're safe for people to use," he said.

For instance, he has worked extensively with the tuberculosis bacteria, hoping to find out which strains are becoming drug-resistant and how best to fight back.

With the rules relaxed, Douglas hopes to find the appropriate weakened anthrax for his course in the spring, believing it is crucial for his students to gain experience with such an agent.

Says Rayner: "If we say we're never going to study anything potentially dangerous, we might as well give up."

Reach Beverly Creamer at bcreamer@honoluluadvertiser.com or 525-8013.