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STOP THE BU BIOTERRORISM LABState Legislation to Regulate Laboratories for Health and Safety House Bill 1397; House Docket 4249 AN ACT TO PROTECT THE PUBLIC HEALTH AND ENVIRONMENT FROM TOXIC BIOLOGICAL AGENTS Sponsored by State Representative Gloria L. Fox Here's a guide to understanding why the legislation is essential, who supports it, and what can be done to make it law. Getting a Copy of the Legislation Revised Legislation - September 2005 Testimony in Favor of the Legislation
Boston University will receive federal funding to construct a biological research laboratory that includes BioSafety Level 4 (BSL4) containment, the highest level of containment. BSL4 laboratories are used for the most dangerous toxic biological agents, those that cause fatal human disease by spreading through the air, or with an unknown cause of transmission, such as Ebola and other viral hemorrhagic fevers. Many of the toxic biological agents could be used in biowarfare and bioterrorism. An agent escaping containment would pose a severe threat to public health and the environment and could cause a public health crisis. Currently there are only three U.S. BSL4 laboratories operating; none are in Massachusetts. In addition, Tufts Veterinary School has proposed building a BSL3 laboratory in Grafton, which also would experiment on dangerous toxic biological agents. Massachusetts has no regulatory program for BSL4 or other high containment biological laboratories. The federal government has only self-enforcing guidelines that have been proven unsuccessful. Massachusetts has standards for other inherently dangerous facilities, such as a landfills and power plants, on where they might be located, how the location decision would be made, operations and maintenance requirements, and other appropriate standards to protect the public health and environment. But it has no such standards for high containment biological labs. BSL4 laboratories are inherently dangerous because they experiment with toxic biological agents that could cause a disease outbreak, deaths, and a public health crisis if released into the community. 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, infections of workers who leave the lab and infect others, escape of infected research animals or insects, or while the viruses were being transported to the lab. The consequences could be deadly if there were a release of even a small amount of pathogens from the lab 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 Massachusetts, and the additional research on select agents that will be undertaken, the time is ripe to pass comprehensive laboratory safety legislation for high containment biological research laboratories. The Commonwealth needs to step into the void. To do less would jeopardize the public health and environment. The LegislationThe legislation creates a comprehensive regulatory public health and safety program for high containment biological laboratories, based on existing state laws for hazardous and polluting facilities and federal guidance. Key points of the legislation are:
The legislation will close the many gaps that now exist. The detailed requirements for BSL4 labs as compared to the more general requirements for BSL2 and 3 labs reflect the increased risks inherent in BSL4 labs. Requiring DPH and DEP to adopt regulations provides the necessary flexibility to adapt the program to changing conditions over time. Allowing municipalities to adopt more stringent requirements recognizes that Boston and Cambridge regulate rDNA research, including prohibiting rDNA in BSL4, and that municipalities may have special requirements and need flexibility. Getting a Copy of the Bill - now House Docket 4249The legislation as originally filed is House Bill 1397. HB 1397 is an older version of the legislation. Representative Gloria Fox, the bill's sponsor, asked the Joint Committee on Environment, Natural Resources, and Agriculture, to which the bill is assigned, to substitute the revised version, House Docket 4249, for the older version. You can also download a fact sheet about the legislation. See below about the revised legislation! Revised legislation - September 2005 After the June 9, 2005, Committee Hearing, we began working with Representative Fox's office and others, including the Massaschusetts Public Health Association, to revise the legislation to include many of the comments and suggestions that were made on House Docket 4249. In September 2005, we completed the revision and Representative Fox gave the revised version to the Committee Co-Chairs. We would like the Committee to report the revised legislation out favorably. You can download the revised legislation. The revised legislation is an improvement over HD 4249 (which was an improvement over HB 1397) in a number of ways. It:
The revised legislation has the support of the Massachusetts Public Health Association and the Massachusetts Nurses Association. Representative Gloria Fox introduced the legislation in December 2004 and has made it one of her top legislative priorities. As of May 12, 2005, the legislation co-sponsors are: Senators Jarrett Barrios, Cynthia Creem, Robert Havern, Robert O'Leary, Pamela Resor, Susan Tucker, and Dianne Wilkerson; and Representatives Cory Atkins, Demetrius Atsalis, Ruth Balser, Christopher Fallon, Colleen Garry, Patricia Jehlen, Jay Kaufman, Kay Khan, Barbara L’Italien, Elizabeth Malia, J. James Marzilli, James Miceli, Shirley Owens-Hicks, Matthew Patrick, Anne Paulsen, Byron Rushing, Carl Sciortino, Frank Smizik, Ellen Story, Benjamin Swan, Timothy Toomey, Martha Walz, and Alice Wolf. Organizations that have Endorsed the Legislation A list of organizations that have endorsed the legislation is on the Boston Mobilization website. In addition to those organizations, both the Boston Public Health Commission (BPHC) and the Massachusetts Public Health Association (MPHA) testified at a June 9, 2005, legislative committee hearing that the state needs a comprehensive program to regulate high containment biological labs. Both the BPHC and MPHA told the committee that they have concerns about provisions in the current legislation, but support the need for such legislation. We are speaking with both of them about the legislation. NEWS: The MPHA has endorsed the Sept. 2005 revised legislation! The Joint Committee on Environment, Natural Resources, and Agriculture held a hearing on the legislation on June 9, 2005. This was the first hearing in two plus years of public hearings about the BU lab that was fair and not set up for BU's benefit. The Committee heard about seven hours of testimony from both supporters and opponents of the legislation. The Committee gave each side equal time to make its presentations and rebuttals. The Committee is the first government body that did not openly kowtow to BU. It seems to us that speakers made a good case for regulating high containment biological laboratories. Speakers spoke persuasively and directly about the need for the legislation -- some from personal experience working in biological research labs. As has been its practice, BU trotted out its same old tired set of misrepresentations and misleading statements about the lab. BU also made the preposterous claim that the federal government would not fund the lab if BU had to wait for the state to adopt regulations under the legislation. There is nothing in the legislation that would prevent the federal government from funding lab. The law requires DPH and DEP to adopt regulations on lab safety within six months and that there be a moratorium on the lab during those six months. Of course, it would take the federal government more than six months to rebid and award the lab funds to another entity, and then it would need to begin the NEPA process for that new location. The federal government has much time and money invested in BU and it is not about to pull the plug on the BU lab if the legislation requires a six month delay while the state adopts regulations. We think that the real reason that BU opposes the legislation is that it does not want to be regulated, it does not want there to be an independent look at where BSL4 labs should be located, and it does not want to have an independent laboratory oversight committee with real authority -- especially one that it does not appoint. We are cautiously optimistic that a majority of the Committee understands that a comprehensive health and safety law for high containment biological labs is essential. If that's so, it means that the Committee will likely revise the bill and then report it out favorably (revision of the bill is to be expected -- bills get revised, sometimes many times on the way to becoming law). Our next challenge may be to make sure that what the Committee reports out is strong and appropriate and something worthy of support. Testimony and Comments in Favor of the Legislation At the June 9, 2005, Committee hearing, many persons spoke persuasively about the need for the legislation. Here is written testimony that speakers shared with us:
That's only some of the testimony in favor of the legislation, but we don't have written copies of others. In addition to the many speakers who spoke in support of the legislation, both the Massachusetts Public Health Association (MPHA) and the Boston Public Health Commission testified at the Committee hearing that the state needs to regulate high containment biological laboratories, although each said it has concerns with provisions of the proposed legislation. Here is the MPHA's testimony. Write to the members (or at least the co-chairs) of the Joint Committee on Environment, Natural Resources, and Agriculture. Ask them to approve the revised legislation. Send a copy of your letter or email to Representative Gloria Fox. Tell your state senator and representative that you support the revised legislation and ask him/her to support the legislation. If he/she wants more information about the legislation and why it is necessary, we would be happy to meet with him/her to provide the information. (If he/she is a sponsor or cosponsor of the legislation, please thank him/her for supporting the legislation.) To learn who your state senator and representative is, click here. Download a letter that you can send to your state senator and representative. Write to us at stopbioterrorlab@ace-ej.org and let us know what your state senator and representative had to say about the legislation. If you belong to any groups, organizations, etc., ask them to endorse the legislation. Please let us know of any endorsements. If the group/organization wants more information about the legislation and why it is necessary, we would be happy to meet with the group/organization to provide more information. Join our email list for updates. Send a request to join to: stopbioterrorlab@ace-ej.org. Write to us at stopbioterrorlab@ace-ej.org if you want to volunteer to do more to help get the legislation passed. Sign an online petition. Do you want to know how the federal government oversees high containment biological laboratories? Download, Mandate for Failure. The State of Institutional Biosafety Committees in an Age of Biological Weapons Research, based on the Sunshine Project's review of the federal program. The report concludes that the federal government relies only guidance and suggestions, not laws or regulations! Labs oversee themselves through Institutional Biosafety Committees that they appoint -- and that even that limited program is broken. The report states that "... 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." Experts say that high containment laboratories may accidentally release toxic biological agents into the community when laboratory workers become infected in the lab, leave the lab not knowing they are infected, and infect others. Take a look at this warning from the World Health Organization:
In 2004, three BU researchers, in three separate incidents, became infected with tularemia, a bioweapons agent, in a BU lab. It took BU months to determine that the researchers were infected with tularemia, even though two of the three researchers were hospitalized with the illness. BU failed to inform the public of the infections and claims that it does not know how infectious tularemia got into its lab. Here are resources about the incidents:
Surprisingly, there is no comprehensive federal reporting requirement for laboratory-acquired infections. The legislation would correct that. It requires reporting to the state. Here's information about laboratory-acquired infections and the lack of reporting requirements:
BU's response to this is a smokescreen. It claims that it will appoint an External Scientific Advisory Committee of scientists who are independent of BU to advise and oversee health and safety at its bioterrorism lab. We analyzed BU's claim and that found that every member of the Committee has connections to BU and the lab. Not one of them is independent. And, the BU Committee would have no legal or regulatory power. The legislation would correct that. It would require each BSL4 lab to have a community oversight board with real power, with members appointed by the municipality and state and only one member appointed by the lab. You can download our analysis of BU's conflicted Committee. More information about the campaign to pass the legislation is on the Boston Mobilization website.
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