Of Cuffs and Custodians

Anne MacNamara The sight of Texas researcher Thomas Butler led away in handcuffs, an image broadcast across America earlier this year, shows that US regulators are serious about stricter laboratory security.1 Colleagues describe Butler, chief of the infectious disease division in the Texas Tech University Department of Internal Medicine, as a talented scientist long devoted to defeating plague. But the September 2001 terrorist attacks transformed plague from a scourge of the Third World into a potential weapon of mass destruction in the eyes of regulators. A federal grand jury indicted Butler last month on 15 counts, including smuggling, lying to federal agents, illegally transporting biohazards, and tax fraud, according to the Avalanche Journal of Lubbock, Texas. None of the charges target terrorism or suggest that Butler infected anyone with plague; nor do they allege that he violated new select-agent regulations that took effect in February. Butler faces allegations fashioned from tax laws and rules about transporting biohazards. If convicted, the 61-year-old scientist could be jailed for 74 years and charged $3.6 million (US) in fines. Butler's predicament underlines the gravity of new security strictures. "That brought it home that you don't make idle statements [when] you're dealing with some dangerous stuff, and the security agencies take it seriously," says Robert Sanzotera, director of safety at the Texas Tech health center. Butler's attorney, Floyd Holder of Lubbock, did not return calls for comment. But he told the Associated Press that his client will plead innocent. "Since the reason for all these activities was to aid this nation in its effort to defend against bioterrorism, it seems cruel thanks," Holder told the news service.2 "I'm dis-appointed that the government felt they had to do this to one of the nation's top research scientists." Texas Tech biochemist Ted Reid, a professor of ophthalmology, predicts that the public health system will pay a price for the Butler prosecution. "It's incredibly scary," says Reid. "People have been doing business a certain way for quite a while, and what we're faced with is a situation where we will have to be very circumspect. With these things happening, people who are doing microbiology are risking a lot." Scientists and research administrators are already struggling to keep up with regulations that roll out in piecemeal fashion.3 An "interim final rule" that went into effect in February is not the last word on the subject. "At the end of 2003 there will be yet another version of the final rule," says Steven Ostroff, who is heading up the drive to get the rules implemented at the Centers for Disease Control and Prevention (CDC) in Atlanta. Interim or no, however, should those rules be broken, someone--probably a top-level university executive--could incur sizeable fines and possible jail time. That potential has executives and scientists contemplating worst-case scenarios. MAINTENANCE MYSTERY A hypothetical scenario making the rounds goes something like this: Research Institute A (RIA) has registered itself, its responsible officials, its principal investigators, scientists, and other laboratory staffers to work with select agents. Everyone has signed up with the US Department of Justice; they have submitted to fingerprinting at the campus police station and to screening by the FBI, in accord with the new regulations. The hypothetical researchers set to work on a new anthrax vaccine, using pathogens obtained from a licensed vendor, which has also been registered and cleared. The material was shipped through channels that regulators have found suitable for handling stuff that bioterrorists would like to get their hands on, all in keeping with the regulations. The university has spent plenty on closed ventilation systems, secure containers, and top-of-the-line locked refrigerators. No one is sure whether the rules require these precautions, but RIA wants to stay on the safe side. At the end of the day, everything is shut down and locked up, a fact documented by the principal investigator and witnessed by another scientist. The scientists go home. Six hours later, a maintenance staffer unlocks the lab, empties the wastebasket and leaves. This is caught on videotape, since super-security-conscious RIA also has invested in top-of-the-line video monitors. And the maintenance staffer, who in the grainy footage of videotape, bears an unfortunate resemblance to Saddam's son, Uday Hussein, quits that night, never to be heard from again. The question is, under the new select-agent rules, did the university's security safeguards fail to block the maintenance staffer's access to the anthrax? The answer is, maybe. It depends how federal regulators will ultimately define access. But as Butler's arrest makes clear, breaking the rules can mean big trouble, even if no one gets hurt, the wastebasket remains empty, and the mystery maintenance worker departed to join the US Army. "How the heck are we going to deal with the janitor?" asks Susan Ehringhaus, former vice chancellor and long-time general counsel of the University of North Carolina, Chapel Hill. Now a senior administrator at the school and on research leave at the American Association of Medical Colleges, she stays in touch with other university lawyers. The janitor is on their minds, she says, along with myriad uncertainties that make compliance with new federal security rules something of a crapshoot. In the end, the janitor problem may be solvable. One possibility: security-cleared maintenance crews. Nevertheless, the problem illustrates the change in culture accompanying the new era of security-conscious science, one in which small details loom large and large issues such as open communication among labs look enormous. Select-agent rules list three potential classes of experiments too dangerous to perform without prior approval from regulators. Two are described; the third is left blank, to be filled in later, after regulators decide the rule has been broken. This is one of many provisions that worry scientists. "Even without the post-Sept. 11 impetus, there were warning clouds on the horizon that says the (select-agent) regulation could be expanded wherever the situation warrants," Ehringhaus says. "This represents sufficient uncertainty that the scientist who is planning the next year or two worth of research and proposals could be deterred. From a lawyer's standpoint, uncertainty itself can be a deterrent when the penalties are high." SELECT-AGENT SLIP-UPS Texas Tech is struggling along with other universities to comprehend and implement the new select-agent control rules. Sanzotera posits a hypothetical situation involving a secure vault storage space used to safeguard the select agents being used by several investigators, each of whom has access to the vault. "Do all principal investigators having access to the room have to be present for one to remove the material and log the event?" he asks. Underlying the intricacies is the cultural challenge the new rules present to research institutions, one that is present despite researchers' willingness to pitch in and help in the biodefense effort. "It is difficult because in an educational environment you have to almost beat them on the head with regulations to get them to pay attention, and you get the feeling you're interfering with their academic pursuits," Sanzotera says. The speed with which new rules were drafted--under congressional deadlines--complicates the cultural change for scientists. Federal agencies have taken heat from researchers who say science was shoved aside in a race to get regulations out fast. "They were asking for comments but making the rule effective almost the same day the comments were due," says Tony DeCrapeo of the Council on Governmental Relations. "People were asking, 'Why are we commenting? What's the point?'" In the months since the first version was released in late August 2002, however, CDC and the microbiology community have established new lines of communication. Ostroff says most questions focus on which strains of pathogen are covered by the rule and which are entitled to an exemption. The CDC's select-agent Web site lists a running tally of excluded pathogens, and it usually takes only a few weeks to get a ruling, says Stephen A. Morse, associate director for science at the CDC's Bioterrorism Preparedness and Response Program. New clarifications show up regularly on the "frequently asked questions" (FAQ) sections of the US Department of Agriculture's and CDC's Select Agent Web sites.4,5 A recent addition to the CDC's FAQ sheds light on the janitor question. Access, it says, means "the freedom or ability to obtain or make use of a select agent." If light bulbs need to be changed, wastebaskets need to be emptied or copiers need to be repaired in an area where select agents are stored, the research facility must provide an escort or a security container capable of keeping the maintenance worker's hand out of the select-agent jar. Peg Brickley (pegbrickley@hotmail.com) is a freelance writer in Philadelphia. References 1. US District Court, Northern Texas, USA v. Thomas C. Butler, Jan. 15, 2003. 2. Associated Press, "Texas Tech professor indicted in case of bubonic plague vials," April 10, 2003. 3. Title II of Public Law 107-188, the Public Health Security and Bioterrorism Preparedness Response Act of 2002 requires the CDC and USDA to implement rules. CDC's rules are at 42 CFR 73; USDA's are at 7 CFR 331 and 9 CFR 121. 4. Centers for Disease Control and Prevention, "Select Agent Program," available online at www.cdc.gov/od/sap 5. United States Department of Agriculture, Animal and Plant Health Inspection Service, "Agricultural Bioterrorism Protection Act of 2002: Biological Agents and Toxins; Possession," available online at www.aphis.usda.gov/vs/ncie/bta.html function sendData() { document.frm.pathName.value = location.pathname; result = false if (document.frm.score[0].checked) result = true; if (document.frm.score[1].checked) result = true; if (document.frm.score[2].checked) result = true; if (document.frm.score[3].checked) result = true; if (document.frm.score[4].checked) result = true; if (!result) alert("Please select") return result; } .myradio{background-color : #94bee5} Please indicate on a 1 - 5 scale how strongly you would recommend this article to your colleagues? Not recommended 1 2 3 4 5 Highly recommended Please register your vote

Of Cuffs and Custodians

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