Letter in Support of Massachusetts Bill to Regulate Biolabs

Eugene B. Benson, Esq, Alternatives for Community & Environment, June 26, 2007

Senator Susan C. Fargo
Representative Peter J. Koutoujian
Co-Chairs, Joint Committee on Public Health
State House
Boston, MA 02133

Re: House Bill 2097, An Act Promoting Research and Protecting Public Safety and the Environment

Dear Senator Fargo and Representative Koutoujian:

I attended most of the Committee hearing on June 13 during which testimony was given on HB 2097 and heard opponents of the legislation make many statements that were wrong and misleading. The purpose of this letter is to correct what I consider the most serious of those misstatements. This letter also responds to questions that you asked during the hearing.

There seem to be five categories of objections to the legislation: 1) the legislation is not needed because high containment biological research laboratories are adequately regulated; 2) the legislation is duplicative; 3) laboratories have excellent health and safety records; 4) the legislation will not improve health and safety in labs; 5) the legislation will hinder research and economics. As I discuss below, each of those objections is wrong.

There Is No Comprehensive Federal Or State Biological Research Laboratory Health And Safety Law. The Current System Of Self-Policing Federal Guidelines Is Broken.

Opponents of laboratory health and safety legislation claim that research laboratories are adequately regulated. The fact is that there is no comprehensive federal or state laboratory safety law or regulatory program to ensure that high containment biological research laboratories in Massachusetts operate safely. Instead, under federal guidelines, laboratories police themselves through Institutional Biosafety Committees (IBCs) whose members they appoint.

On October 4, 2004, the Sunshine Project published, Mandate for Failure, the State of Institutional Biosafety Committees in an Age of Biological Weapons Research, based on an eight-month survey of the operation of 390 IBCs. The report’s introduction notes that:

Historically, IBCs have the responsibility, at the institutional level, to protect human health and the environment from the risks of biotechnology research.

The US does not have a comprehensive laboratory safety law, thus, the IBCs operate under non-binding guidelines managed by the US National Institutes of Health.

The Sunshine Project report summary and recommendations include the following:

Even before the release of this report, NIH took modest steps to try to encourage IBCs to comply with the NIH guidelines. NIH’s Office of Biotechnology Activities (NIH OBA) issued suggestions in the form of “question and answer” and “guidance” documents. These efforts did not work, in large measure because NIH has no legal authority over IBCs. In the end, IBCs comprise a voluntary system that has failed at its present task.

While there are exceptions, the notion that research laboratories generally maintain effective, accountable local committees that exercise responsibility over laboratory biosafety is herein demonstrated to be false.

Guidelines and suggestions are not working. The root of the problem lies in the fact that the United States does not have comprehensive laboratory safety law. The system does not even have comprehensive reporting requirements for accidental releases ...

The IBC system ... will only be made effective by making it a matter of law. A regulated system should establish real, enforceable consequences for noncompliance and a level playing field by making binding regulations equally apply to all institutions conducting biological weapons and biotechnology research.

The Sunshine Project report was widely noted in scientific and academic circles. An April 29, 2005, article in the Chronicle of Higher Education on the report and the ensuing controversy about whether a federal biosafety law is necessary includes the following:

The NIH’s Mr. Shipp acknowledges that the relationship between the NIH and institutional biosafety committees is largely based on trust. The agency does not collect IBC minutes to confirm that they are reviewing research, and it does not require biosafety committees to certify that they are in compliance, as it does with institutional review boards.

Institutional review boards, which are responsible for ensuring human subjects protection in research, are governed by federal law. (Unlike IBCs, which are not.)

Elisa D. Harris, a senior research scholar at the Center for International and Security Studies at the University of Maryland at College Park, said it is time to replace the guidelines with a comprehensive laboratory-safety law that would cover all research institutions.

At least one IBC chairman agrees. Philip Chandler, of the biosafety committee at the Medical College of Georgia, said the guidelines have given colleges too much “poetic license,” and replacing them with a law would “remove the inconsistencies.”

“People who like to flout guidelines can't flout rules,” he said.

It is also important to note that the IBC guidelines do not apply to all research in BSL3 and 4 laboratories. The federal IBC guidelines are limited to research involving recombinant DNA (rDNA) molecules. They do not apply to other research. Much research not involving rDNA occurs in BSL 3 and 4 laboratories. For example, for many years Boston has had a regulation prohibiting rDNA use in BSL4 labs and thus Boston University (BU), which is building a large BSL2/3/4 laboratory facility in Boston, has promised that rDNA research will not occur in its BSL4 laboratories. Consequently, the IBC guidelines would not apply to all the work that would be performed in the BSL4 portion of the facility, the portion reserved for the most dangerous research.

The Legislation Does Not Duplicate Existing Law

Opponents of the legislation claim that the legislation duplicates existing law. They are wrong. First, as noted above, there is no comprehensive federal law or regulation for health and safety practices in BSL3 and 4 laboratories. Instead there is a set of guidelines that are limited to self-policing, are not enforced, and do not have the force of law. Second, as noted above, the guidelines do not apply to research that does not involve rDNA. Third, the guidelines do not apply to research that is not federally funded.

Further, the legislation contains some key provisions not found in the federal guidelines. The most important would require DPH approval of the most dangerous research. That provision is adopted from the recommendations of a blue ribbon panel appointed by the federal government to assess the issue of dangerous biological research experiments. The panel recommended a review process that has not been incorporated into the federal guidelines. The law also would require a review of siting of BSL4 laboratories, a procedure required for many types of potentially dangerous facilities but lacking from even the guidelines.

Biological research facilities often claim that the three elements of containment in BSL2/3/4 laboratories are laboratory practice and technique, safety equipment, and facility design. While we question the claim that there are only three elements to lab safety, federal laws and regulations do not cover the three elements. Instead, there are federal regulations on transport and registration that do not concern any of the elements of health and safety in laboratories, guidance that is not enforced and that does not have the force of law, and some suggestions, the sum total not amounting to a comprehensive federal laboratory safety law. HB 2097 is a comprehensive health and safety law for all the elements of health and safety in biological research laboratories. It fills in the blanks where there are no federal laboratory safety laws or regulations and where the state must step in to protect the public health and safety and environment.

There Is A History Of Accidents And Releases At High Containment Biological Research Laboratories.

Opponents of the laboratory safety law claim that BSL3 and 4 laboratories are safe. They also claim that there has never been a release from a BSL4 laboratory in North America and thus the law is unnecessary. They cannot make that claim for all BSL4 labs because there have been releases from BSL4 labs - labs that are as modern and self-contained as will be BU’s BSL4 lab. Further, proponents of the legislation testified at the Committee hearing that there have been accidents at high containment laboratories and of releases that have occurred.

Enclosed is a copy of Mistakes Happen: Accidents and Security Breaches at Biocontainment Facilities, written by The Council for Responsible Genetics and updated in May 2007. It is a compilation of accidental and intentional releases, staff exposures and infections, and security breaches at biocontainment laboratories that have been reported or are otherwise known (as discussed below, some accidents, exposures, infections, and security breaches are not reported).

The opponents of the lab safety law provided no documentation for their safety claim, but we know from reviewing their environmental filings that they rely on an October 15, 2003, report compiled by Dr. Karl Johnson for the National Institutes of Health (NIH). NIH commissioned the report in an attempt to quell community concerns that BSL4 labs are inherently risky. Regrettably, Dr. Johnson’s research for his report is anecdotal, rather than fact based. It relies only on interviews with staff at the facilities. It is not a detailed review of all laboratory exposure events at the three US BSL4 laboratories, and should not be relied upon to make claims about the safety of BSL3 or 4 laboratories.

An especially erroneous statement based on Dr. Johnson’s report is in the federal Supplemental Draft Environmental Impact Statement for the BU lab where it claims that, “With the longest running experience with a BSL-4 (33 years) Ft. Detrick Maryland has an outstanding safety record ... Previous documents exposures at Fort Detrick in their original lab facilities mention one laboratory-acquired infection between 1959-1969 and no clinical or other infections in the more recently constructed USAMRIID facility.”

That statement, unfortunately, is incorrect. USAMRIID has an extensive history of both exposures and laboratory-acquired infections over the last two decades. According to a study by USAMRIID researchers, published in the Journal of Occupational and Environmental Medicine in August 2004, 234 employees at USAMRIID were evaluated for exposure to 289 biological agents classified as “bioterrorist agents,” resulting in five confirmed clinical infections between 1989 and 2002. The recorded infections were from exposures to glanders, Q fever, vaccinia, chikungunya, and Venezuelan equine encephalitis. There were also numerous exposures to anthrax, plague, Western and Eastern equine encephalitis, orthopoxviruses, yellow fever virus, and Rift Valley fever virus which did not lead to infections, but for which postexposure antibiotic prophylaxis was administered (when available). For some of these diseases, of course, there is no available treatment.

The report, (Rusnak, et al. 2002) thoroughly reviewed all exposure records and paints a significantly different picture of the safety record at USAMRIID than Dr. Johnson’s report, which implies that accidents are extraordinarily rare. In contrast data show that there was an average of 16.7 persons evaluated per year for accidental exposures to bioterrorism agents. The authors of the study conclude:

In summary, we reviewed available medical and safety records at USAMRIID from 1989 to 2002 and reported on 234 evaluations of potential exposures and illnesses to bacterial, rickettsial, and viral disease agents. During this period, there were five confirmed infections. The large number of exposure incidents reported in this time period serves as a reminder that work in a laboratory of this type is inherently hazardous.

The authors also concluded:

Therefore, it is imperative for laboratories that elect to work with highly hazardous agents to be fully cognizant of the risk of occupationally acquired illnesses and institute policies and proactive employee health procedures to evaluate potential exposures.

Dr. Johnson released an August 28, 2004, update to his October 15, 2003, report. In it he describes numerous accidental infections in BSL 3 and 4 laboratories, including those leading to deaths of persons outside the laboratory, which he did not include in his 2003 report. Some of those infections took place before Dr. Johnson wrote his 2003 report, justifying concerns that all incidents of laboratory infections are not known. In his 2004 report, Dr. Johnson wrote that,

Subsequent to the October 15, 2003, report ... there have been three reported laboratory-acquired infections with BSL4 viruses, one fatal ebola infection in 2004 and two Marburg infections, 1988 and 1990 ... These experiences demonstrate that working with certain viruses carries significant risk to workers, and further indicates that facility, equipment, and adherence to sound protocols for worker safety are all important to minimizing infections.”

A recent study of the anthrax releases at Fort Detrick supports the need for a comprehensive laboratory safety law. An October 14, 2004, USA Today article (Anthrax Slip-Ups Raise Fears About Planned Biolabs) reported on the US Army report on the anthrax releases from the Fort Detrick BSL3/4 laboratory. Three strains of anthrax escaped the supposedly secure BSL3 laboratory, which is designed to enable scientists to safely work with deadly microbes. That type of research is likely to occur in laboratories in Massachusetts. The report and statements of experts in the article serve to show that the opponents of the lab safety legislation understate the likelihood of exposures outside the containment area of the lab. Highlights of the article include:

Researchers expressed relief that no one was hurt or killed in the episode, but Stephanie Loranger of the Federation of American Scientists asks, “Fort Detrick is one of the premier biodefense labs, and if they have problems, what does it mean for all the others?”

“The good news is nobody got the disease (ie, anthrax),” says Alan Zelicoff, a biodefense expert who is now a consultant at ARES Corp., a risk analysis firm. “The bad news is that nobody got the disease because just about everybody near the BL-3 suite had been vaccinated.”

“The message here from a scientific and policy standpoint is profound,” Zelicoff says. “Facilities that are medical and microbiological may not be suitably equipped for dealing with aerosolized versions of the organisms that they otherwise deal with in great safety. These facilities probably ought not be located in a heavily populated area. How do you contain smoke?”

In addition, a December 15, 2000, NIH memorandum acknowledged the risk of releases from BSL4 laboratories. In pertinent part, the memorandum reads that a reason to build a BSL4 laboratory in rural Hamilton, Montana, “well removed from major population centers,” is that “the location of the laboratory reduces the possibility that an accidental release of a biosafety level-4 organism would lead to a major public health disaster.”

It is also important to recognize, as noted during testimony at the Committee hearing, that the increasing number of BSL3/4 labs and work with select agents means that more experiments will be done by those with little experience working with select agents or in high containment laboratories, thus increasing the risks of accidents.

Further, for the first time, universities will run large BSL4 labs, raising more health and safety concerns. Robert Lamb, Professor of Biochemistry, Molecular Biology, and Cell Biology, University of Chicago, is reported in The Scientist as saying that it is a bad idea to locate any high-level lab on a university campus, because they typically won’t invest as much money as federally operated labs at places like the Centers for Disease Control and Prevention do in running them. “Universities are always cutting corners afterwards to save money, because they’re always broke. It’s complex and it’s cumbersome, and you need a huge support staff.” (The Scientist, March 5, 2004.) In addition, academic laboratories, staffed by graduate and post-doctoral students who are there temporarily, are always under-experienced compared to other laboratories.

Opponents of laboratory safety laws not surprisingly fail to note that there is no comprehensive reporting of laboratory accidents and infections. As noted by the Council for Responsible Genetics when it released, Mistakes Happen: Accidents and Security Breaches at Biocontainment Facilities,

Many advocates claim that accidents rarely, if ever occur at Biosafety Level 3 and 4 facilities. In fact, the frequency of such incidents is widely disputed, given a lack of comprehensive federal reporting guidelines for laboratory exposures/infections, breaches of security, or environmental releases from microbiological and biomedical laboratories.

The laboratory acquired infections website, maintained by research scientists, (http://www.laboratory-acquired-infections.info) reaches a similar conclusion:

With the advent of bioterrorism, and the emergence of various infectious diseases (from HIV, to E. coli O157:H7 and SARS), public consciousness and the level of research activity on human pathogens are at an all time high. It is therefore logical that the frequency of laboratory-acquired infections has risen in proportion. No one really knows for sure because data are lacking. The CDC does not routinely reports laboratory-acquired infections, because they are not considered outbreaks. This suits research institutions, who prefer to avoid the negative publicity of accidents in their laboratories, and federal agencies, who prefer to look the other way. The CDC does not automatically investigate lab accidents and when it does, its recommendations are not shared widely and indeed may not even be dispersed to other labs in the same institution. Too often, laboratory accidents are either entirely covered up or sanitized for public consumption. The victims of this indifference and of the cover ups are the researchers, who pay with their health, their careers, and sometimes their lives.

The establishment of a mechanism of surveillance of laboratory-acquired infections, with systematic reporting, systematic investigating, efficient dispersion of recommendations and institutional accountability is long overdue. Continued federal indifference allows continued recklessness and negligence in laboratories with potential disastrous consequences for researchers and the public they come in contact with.

Despite the failure to report, there continue to be revelations of laboratory errors leading to infections. For example, in April 2005 the Sunshine Project reported that a leaky aerosol chamber was responsible for three laboratory-acquired infections in a Seattle BSL3 laboratory in 2004, and that such chambers are used in many high containment laboratories across the country, including those doing biodefense work. The Sunshine Project concluded that,

This case underscores how the ‘precise and neat’ public image of BSL-3 and BSL-4 facilities that is promoted by NIAID and labs is frequently at odds with messy and risky realities. ... In this case the institutions involved apparently didn’t even inform their peers about the problems. Public Safety and an informed debate about the biodefense program require the government to mandate public disclosure of all significant lab accidents. This may be more cold water on overheated biodefense safety claims; but we frankly wonder how many more serious problems have been kept out of the public eye.

The most recent known example of laboratory-acquired infections and failure to report was revealed today, June 26, 2007, by the Sunshine Project after a lengthy freedom of information act battle to obtain documents. According to the Sunshine Project, “Three Texas A&M University biodefense researchers were infected with the biological weapons agent Q Fever in 2006. The infections were confirmed in April of that year, but Texas A&M officials did not report them to the Centers for Disease Control (CDC), as required by law. Instead, Texas A&M officials covered the infections up until now, illegally failing to disclose them despite freedom of information requests dating back to October 2006.” There is no indication that the federal government has taken any enforcement action for the violations.

Opponents of laboratory safety laws also fail to mention modern high containment biological laboratories outside the United States where there have been recent releases. As reported in the Washington Post on May 29, 2004, and acknowledged by the World Health Organization and the Centers for Disease Control (CDC), SARS outbreaks in Asia have been caused by releases from high containment biological laboratories,

Scientists still do not fully understand exactly where or how SARS emerged 18 months ago. But it is now clear that the most threatening source of the deadly virus today may be places they know intimately - their own laboratories.
Together the three SARS outbreaks have highlighted the unique hazards to public health that arise from accidental laboratory releases of germs that no longer exist - or barely exist - in the wild.

The CDC wrote in Health Information for International Travel 2005-2006,

From July 2003 through September 2004, 17 laboratory-confirmed SARS cases were reported. Six persons were infected through laboratory exposures: one in Singapore, one in Taiwan, and four in China. One of these six cases initiated a chain of transmission that ultimately resulted in seven additional cases and one death. All the laboratory-acquired infections resulted from lapses in appropriate biosafety procedures.

The Legislation Would Reduce The Risk Of Accidents And Releases.

Chairman Koutoujian asked how the legislation would prevent a repeat of incidents such as the tularemia infections at Boston University in 2004. In 2004, due to laboratory errors, three researchers were infected with tularemia, two in May and one in September. Two of the three researchers (one infected in May and one infected in September) required hospitalization, yet BU claimed that it did not realize the researchers were infected with tularemia until November of that year. BU then failed to report the infections to the Boston Public Health Commission until much later. It also submitted environmental reports claiming that there had never been a laboratory acquired infection in any of its laboratories, even after it knew that the researchers had been infected.

Legislation cannot guarantee that a laboratory accident or infection will not occur, but it can greatly lessen the risk and require better follow-up and remedial action. HB 2097 would lessen the risk in a number of important ways, including by requiring:

  • A laboratory training plan approved by DPH
  • Medical surveillance that would have identified the first laboratory acquired infection and thus prevented the later infections
  • Reports on risk and assessment and annual IBC reports to DPH
  • Whistleblower protections
  • On-site inspections to review conditions, safety equipment, and the general working environment, and to speak with researchers
  • Two IBC members who are not appointed by nor beholden to the facility

The legislation mandates a mechanism for surveillance of laboratory-acquired infections with systematic reporting, systematic investigating, and institutional accountability. None of that is present in the IBC guidelines.

Further, the legislation would require an extra level of scrutiny - DPH approval of health and safety protocols - for the most dangerous research. That would not have made a difference in the tularemia incident but would make a difference with more dangerous research.

The law makes IBC guidelines into enforceable state law, provides for state oversight, and adds health and safety provisions that are missing from the IBC guidelines, such as whistleblower protections. It also provides the deterrence of real penalties. It is a vast improvement over the current condition.

The Legislation will not hinder research or economics.

A biotech executive testified at the hearing that his company sometimes does BSL3 research and the legislation would prevent that. His understanding of the legislation is incorrect. There is nothing in the legislation that prevents BSL3 research or that would prevent him from operating a BSL3 laboratory. Rather, the law sets health and safety standards, based on federal guidelines, for such research.

An industry representative testified, without any supporting information or documentation, that the legislation might deter a company from locating in Massachusetts. There is no support for such assertion. To the contrary, Cambridge remains the hotbed of biotech in Massachusetts even though it is the only municipality with a health and safety regulatory program for laboratories. Further, very few biotech companies perform BSL3 or 4 research (to our knowledge there is one commercial BSL3 laboratory in Massachusetts and no BSL4 laboratory). Most research in BSL3 and 4 laboratories is federally funded in non-profit institutions because the work does not have obvious commercial value.

Further, there is nothing in the federal funding requirements that would limit federal funds to areas that do not regulate laboratories. Such funding regularly flows to research done in Cambridge, which has laboratory regulations.

Conclusion

I appreciate the time and attention that the Committee will be spending on this matter. The public health and environmental risks from high containment biological laboratories are serious. Research in such labs will include the study, and sometimes the weaponization, of the most lethal pathogens known. Although authorities insist that such research is conducted under the strictest security, mistakes are inevitable and occur.

High containment labs will use sophisticated technologies and procedures to decrease the risk of an accidental or intentional release of pathogens and to prevent a release resulting from a terrorist attack, but as we have seen in many other instances, accidents occur, sophisticated technologies are imperfect and fail, and some people have nefarious motives. Releases could occur by many means, including a breach of the containment system, laboratory acquired infections of workers, or escape of infected research animals or insects. The consequences could be deadly if there were a release of even a small amount of pathogens from a BSL3 or 4 laboratory into a nearby neighborhood.

Such labs would be potential targets for terrorists, who might view the labs as a source of bioweapons materials or a facility to destroy. An attack on, or infiltration of, a lab could result in the release of pathogens or the escape of infected laboratory animals. An attack on a lab that did not release pathogens would likely cause damage in the nearby community.

With the increase in the number of BSL 3 and 4 laboratories in the Commonwealth, and the additional research on select agents that will be undertaken, the time is ripe to pass comprehensive health and safety legislation for high containment biological research laboratories. The Commonwealth needs to step into the void. I believe that to do less would be to jeopardize the public health and environment.

HB 2097 meets the need very well. Its provisions are not created from whole cloth. Its health and safety requirements are common sense and generally accepted as good practice by laboratories. They set a realistic floor for what we should expect of BSL3 and 4 labs. Requiring DPH to adopt regulations provides the necessary flexibility to adapt the program to changing conditions over time. Allowing municipalities to adopt more stringent requirements, and to administer the program where their requirements are at least as protective as the legislative requirements, recognizes that Boston and Cambridge regulate rDNA research, including prohibiting rDNA in BSL4, and that municipalities may have special requirements and need flexibility.

I may be contacted at 617-442-3343 x226 and gene@ace-ej.org for more information and would be happy to assist the Committee in its review of the legislation.

Thank you.

Sincerely,

Eugene B. Benson
Legal Counsel and Program Director

Mistakes Happen

Accidents & Security Breaches at Biocontainment Facilities
Enclosure with Eugene Benson’s Letter

An interesting example occurred at the hearing on HB 2097 when a speaker criticized the legislation for requiring each IBC to contain at least two residents of the municipality where the facility is located who are independent of the facility, as if that were a new burdensome requirement. The NIH guidelines call for each IBC to include at least two persons who are not affiliated with the facility (other than being on the IBC) and who represent the interests of the surrounding community with respect to health and protection of the environment. NIH Guidelines § IV-B-2-a-(1). To ensure that occurs, the legislation authorizes DPH and the local board of health to make those appointments but allows the facility to reject the appointments for good cause.

There are few federal requirements. OSHA regulations apply to some injuries to workers, but it is a reactive, not a proactive process, coming in after an accident occurs. Most importantly, OSHA does not require a comprehensive laboratory health and safety program; nor does it require practices or procedures to ensure that select agents are not accidentally or intentionally released from a laboratory. OSHA also has limited reporting requirements. For example, BU was not required to report to OSHA that three of its researchers accidentally became infected with tularemia in one of its labs in 2004 because OSHA rules require reporting only if the three researchers had become infected in the same incident or if a worker died. There is a federal regulation requiring special packaging when select agents are shipped, but the legislation does not have requirements for transport and thus does not duplicate the federal regulation. Federal regulations also require registration of select agents with the Centers for Disease Control (CDC) or the US Department of Agriculture, depending on the select agent, but not with a state. The CDC and USDA will not share the registration information with a state.

Boston and Cambridge have regulations for laboratories, but HB2097 is more comprehensive than the Boston and Cambridge regulations. It establishes a uniform state standard, which is important for municipalities that do not have the resources or expertise of Boston or Cambridge to regulate BSL 3 and 4 labs. It provides a process to allow a municipality with regulations at least as protective as the state program to receive DPH approval to operate the municipal program in place of the state program so that there will be no duplicate state and municipal program.

The report may be downloaded from the Council for Responsible Genetics website: www.gene-watch.org.

For example, in 2003 the Mayor and City Council of Davis, California, wrote to NIH urging it not to fund the application of the University of California, Davis, for a BSL4 laboratory, citing safety concerns. NIH did not fund the UC Davis application. Residents of Hamilton, Montana, where NIH is building its own BSL4 lab, protested the decision to place the laboratory in their community and filed litigation to stop the project. The litigation was settled and NIH is building the laboratory.

As discussed on the next page, underreporting is likely because there are incentives not to report and no effective federal oversight.

BU documents show that its BSL3/4 lab will house experiments in which researchers aerosolize deadly viruses and other biological toxins.

There are also questions about the quality of oversight and training in university laboratories. For example, Boston University had designated Dr. Peter Rice to direct research training in the BU BSL4 lab. It was in Dr. Rice’s BU lab in 2004 that three researchers became infected with tularemia, and it took months for BU to diagnose the infections as tularemia even though two of the three researchers were hospitalized. The revelations about the infections resulted in Dr. Rice’s departure from BU.

The Washington Post called the SARS incidents “reminiscent” of a notorious smallpox release in England in August 1978. In that earlier incident, the head of microbiology at a medical school was rushing to finish his experiments before the deadline to turn in or destroy his stocks of smallpox. The World Health Organization judged the lab’s containment unsatisfactory but did not have the power to close the lab. The smallpox virus became aerosolized in the lab and traveled through duct work to another part of the building, where it infected and killed one person, who transmitted it to family members before dying.

It is important to note that the tularemia infections occurred in a BSL2 lab and thus would not be subject to the legislation because the legislation regulates only BSL3 and 4 laboratories. The legislation would make a positive difference in BSL3 and 4 laboratories. Also, some of the practices and procedures required for facilities with BSL 3 and 4 labs, such as composition and practices of the IBC, would filter down to the BSL2 labs in those facilities.