Nebulous new rules rouse fear and loathing in laboratories

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Transcript of Nebulous new rules rouse fear and loathing in laboratories

NATURE MEDICINE • VOLUME 9 • NUMBER 3 • MARCH 2003 247

NEWS

Two months ago, Texas Tech researcherTed Reid was planning to collaborate withThomas Butler, his colleague and head ofinfectious diseases. The researchersplanned to design antibiotics against theplague bacterium, Yersenia pestis.

Then, in January, Butler, 61, was arrestedfor misleading federal officials about miss-ing plague samples. He has since been re-leased after posting bail at $100,000, but isrequired to wear an electronic bracelet andis under house arrest. He faces up to fiveyears in jail and a fine of $250,000.

Reid says the episode opened his eyesto the risks a biodefense researcher nowfaces and has decided he wants nothingto do with the field.

“It’s just appalling what’s happening.We’re under siege here, everyone’s a sus-pect,” he says. “The whole thing is justout of control.”

In December 2002, the Department ofHealth and Human Services—via theCenters for Disease Control andPrevention (CDC)—and the USDepartment of Agriculture publishednew policies that require nearly 1,200 in-stitutions to follow stricter rules for thepossession, use and transfer of select bio-logical agents.

After his arrest, Butler signed a statementsaying he “accidentally destroyed” the bac-teria and neglected to fill out the properforms. Because there was no threat to thepublic, he said, he provided an inaccurateexplanation and did not re-alize it would require an ex-tensive investigation.

“I think what we’re talk-ing about here is a personlike me, an absent-mindedprofessor,” says Reid. “Whatwe’re all concerned about isthe response—30 agents in-vade his house in the middleof the night, interrogatehim…haul him off inchains. It’s appalling.”

Butler’s arrest made a bigimpression on several scien-tists, who described law enforcement officials’ treat-ment of him as “unreason-able,” “ridiculous” and“totally outrageous.” The in-cident seems to havebrought home the pointthat scientists who onceworked in relative obscurity

must now prepare tolive on the wrong endof a government mi-croscope.

The new rules re-quire all relevant per-sonnel to be clearedby elaborate back-ground checks, whichcould take severalmonths. All sensitiveareas must be locked,and unauthorized per-sonnel, includingother lab members,must be escorted.

“The days of thegraduate student com-ing in late at night,alone, to finish an ex-periment are over,” says Ron Atlas, presi-dent of the American Society ofMicrobiology.

But with the threat of bioterrorismlooming large, some change is necessary,points out Steve Ostroff, director of theCDC’s select agent program. The govern-ment must take measures to remove a “cer-tain amount of laxity” that existed in labs,Ostroff says. “Much of what’s in the rulesmakes good sense.”

A public comment period on the finalinterim rules ended 7 February. Althoughno one expects the rules to change signifi-cantly, many hope the government will

clarify exactly what it expects.One open question is how to

report destroying part, but notall, of a live culture. Another isthe possibility, for example,that a miscalibrated pipettemight each time remove fivemicroliters more than it is sup-posed to, adding up over a pe-riod to a larger volume. Aswritten, the rules do not addresssuch ambiguities.

The new regulations alsohold formidable challenges forbiosafety officials unaccus-tomed to elements such ascyber-security. “Everybody istrying to find out what it allmeans—there’s a general out-line without too manyspecifics,” says Lou AnnBurnett, Vanderbilt University’sbiosafety manager. Lackinghelp from the agencies,

biosafety officers are turning to each otherfor help, she says—a case of the blind lead-ing the blind.

Ostroff says he sees the system of peerverification as a good thing, adding thatthe guidelines are deliberately vague toavoid a ‘one-size-fits-all’ paradigm.Although the agencies published detailedguidelines on what state-of-the-art secu-rity could look like, he says, officials can-not offer any advice until the final rulesare published.

Most scientists agree in principle that itmakes sense to keep track of samples,maintain records and dispose of the selectagents carefully. But while part of thegrumbling is a natural pushback, someworry the myriad restrictions may driveaway the best researchers, at a time whenthe administration is pouring more moneythan ever into biodefense research.

In the end, some scientists questionhow much the new rules can really pro-tect the US from terrorists. “If you weregrowing [Clostridium botulinum], andsomeone took a vial out, could you tell?”asks Cara Schengrund, who works withthe botulinum neurotoxin. Or, she adds,if someone offered a meagerly-paid tech-nician a million dollars, “how would youknow that?”

Most important, says Texas Tech’s Reid,locking laboratory doors is antithetical tothe academic tradition of free exchange.“Universities need an open, free workplacethat allows people to interact,” he says.“You start acting like a government secu-rity lab, and it’s over.”

Apoorva Mandavilli, New York

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A plague on his house:Thomas Butler is nowunder house arrest

Nebulous new rules rouse fear and loathing in laboratories

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