Apparently, as far as the general media is concerned, anyone with a big mouth and a web site can qualify as an instant expert on biolaboratory safety. At least that appears to be the case in Boston, Massachusetts, where a new BSL-4 biological research facility now under construction faces vehement opposition from a loose collection of regional activist groups regularly quoted as representing the safety concerns of the local neighborhood citizenry. Even cursory research, however, will clearly illustrate that who, and what, these groups actually represent is highly questionable.

You see, according to these groups, it seems that the Federal Government (i.e., “the Bush administration”) is conspiring with Boston University to promote biological warfare. They are doing this, the activists claim, by building a biological weapons manufacturing facility in the heart of the city of Boston. Other expressed concerns center around the fact that this location will put predominantly black and hispanic people at risk, not take into consideration the high percentage of AIDS cases in the community, or address the associated growth in new white-collar jobs leading to the “gentrification” of the neighborhood.

That’s right; even though these activist groups repeatedly and publicly refer to the BU facility as a bioweapons lab, they are still treated as credible and responsible by the media, as well as by many university and government officials. The truth that BU’s BSL-4 biolab is in fact part of the Congressionally approved and funded “Project BioShield” program, established in 2004 to protect all Americans from possible attack from deadly biological agents by developing and making available effective drugs and vaccines, is often given secondary or even tertiary mention.

Now, the highly touted, “independent” National Research Council (NRC) committee of experts has weighed in on the matter. Yet this committee may be more independent of common sense than anything else given its choice to lecture the National Institutes of Health (NIH) draft environmental impact study for its insensitivity to “environmental justice issues and how the biocontainment facility could affect an inner-city population in particular.”

Look, I certainly agree that the residents of any neighboring community and the public at large have every right and responsibility to be concerned about the potential risks posed to them by a BSL-4 facility. And they have the right to have these risks clearly identified and explained to them, as well as how these risks will be dealt with through advanced technology barrier systems, rigid procedures and protocols, redundancies and fail-safe systems, control and monitoring systems, watchdog agencies and emergency response plans. From this information, they, and their elected representatives, will be able to make an informed decision on whether there is an acceptable level of risk. And, in my opinion, when it comes to Level 4 pathogens, no level of risk is acceptable, regardless of the location of the facility.

The problem is that when self-serving, propagandist activist groups become the center of debate, the real questions of risk and safety become secondary to other political and ideological concerns. And it is also my opinion that when it comes to providing our nation’s population with defense against biological attack, there is also no level of acceptable risk. Safety must always come first.

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John Haystead,
Editor-in-Chief

IEST journeys to the past to move forward into the future of contamination control

By Roberta Burrows, IEST Deputy Executive Director; and Linda Fischer, IEST Technical Editor

Editor Frank Kramer, in the second issue of a new journal, wrote that the purpose of the publication was “to make facts available, and to turn light on the existence of a strong, coordinated body of men and women dedicated to the advancement of Environmental Engineering. It is a way to establish the highly respected science on the top-level plane.”

Fifty years later, the successor to that publication, the Journal of the IEST, is still addressing the science of environmental engineering, as well as that of contamination control. Published by the Institute of Environmental Sciences and Technology (IEST), the Journal will celebrate 50 years of continuous publication with special events and features throughout 2008.

Kramer was editor of the Journal of Environmental Engineering, published by the Society of Environmental Engineers (SEE) based in Los Angeles, CA. The 20-page first issue in October 1958 opened with a paper on a facility for horizontal vibration testing with electromagnetic exciters that discussed the “development and use of a small flat plate floating on an oil film during combined vibration and differential temperature test investigations.”

Another paper discussed a new precision centrifuge to test TITAN guidance system components, specifically an accelerometer that can “measure accelerations as minute as 0.000005 G.” The third paper detailed gauges and pumping equipment that would work in space and high vacuum. There was a report from a random vibration seminar and another from a symposium on acoustic testing.

In a year-end review of 1958 SEE activities in the February 1959 issue, chairman L.D. Carver noted the large number of members who had renewed memberships: “this has been even more encouraging in view of accelerated activity in this area by a competing environmental organization.” Perhaps that group was the Institute of Environmental Engineers (IEE), which had been the science section of the Environmental Equipment Institute until separating in 1956. In April 1959, the SEE and the IEE merged to become the Institute of Environmental Sciences (IES).

The Journal of Environmental Engineering was selected to be the official publication of the IES; the first issue under the IES banner was in June 1959. In October 1959, the journal was renamed the Journal of Environmental Sciences. From then, the publication underwent a series of name changes to reflect changes in the organization. From 1990 through 1994, the name was Journal of the IES, and from 1995

By George Miller

A government report has resorted to Cold War language and imagery: High-Containment Biosafety Laboratories: Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States. The term “proliferation” reeks of the arms race of a generation past, and has added oomph from its use in describing rapid growth and production in cell processes.

Beyond its title, the report invites Cold War comparisons in its out-of-our-hands explanation for why such facilities are difficult to count: “We found that the total number depended upon how you ask the question. Most often data were available on the number of facilities or sites that contained a BSL-3 or BSL-4 lab. The precise number of independent rooms within those facilities qualifying as BSL-3 or BSL-4 is not generally specified…. Experts also told us that counting the number of labs is problematic because the definition of the term ‘lab’ varies.”

The report, authored by Keith Rhodes, chief technologist in the U.S. Government Accountability Office, as testimony for hearings conducted in early October by the Congressional energy and commerce committee, is having its intended effect: “Do we really need 12 laboratories that operate at the very highest level of security? Is there a good reason for creating these labs, or have we simply begun an arms race against ourselves?” asked committee chair Rep. John Dingell (D-Mich.) in a statement after the hearing.

The hearings are a result of Congress approving large amounts of biotech research funding for terrorism and pandemic preparedness following the 9/11 and anthrax mailing attacks of 2001 and the SARS outbreak of 2003, and then in after-the-horse-escapes fashion realizing that some kind of oversight of the work is required.

In fact, oversight has existed for years. The National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), acknowledges its responsibility for the facilities that house the substantial amount of research that it funds. “Support for infrastructure…is essential if we are to fulfill our biodefense research agenda,” said Hugh Auchincloss, M.D., principal deputy director, in testimony. He cited recent advances—including leading-edge smallpox, anthrax, and Ebola virus vaccines—that required the use of such high-containment facilities.

Auchincloss said that NIAID works closely with each grant recipient to ensure that new labs are designed and constructed to the highest standards. NIAID staff architects and engineers work with contract construction quality management groups having additional expertise. “These teams make certain that the finished projects will meet the regulations of the Centers for Disease Control and Prevention (CDC) and the Department of Agriculture’s Animal and Plant Health Inspection Service for facilities that conduct research on select agents.”

Auchincloss added that NIH is committed to ensuring that the research conducted within the facilities is performed safely. “The most widely used guidance on the safe conduct of this research is the Biosafety in Microbiological and Biomedical Laboratories Manual (BMBL), which is now in its fifth edition and available online.”

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In 2002, NIAID determined that the BSL-3 or BSL-4 research space available was inadequate for its academic scientists conducting extramural research. Auchincloss said that the Institute estimated the new BSL-3 and BSL-4 facilities that would be required, and that Congress responded quickly with the necessary resources.

The National Institutes of Health is now implementing a construction program that will complete 14 new BSL-3 facilities and four new BSL-4 facilities within the next few years, said Auchincloss. “During this process, the NIH or its funded institutions have participated in literally hundreds of public forums on the nature and safety of the new facilities, and have submitted reports to Congress annually, along with periodic updates on our strategic plans. In addition, NIH leadership has discussed the infrastructure expansion with Congress on many occasions,” he said.

The public forums, reports, and discussions are all helping to raise issues that need to be addressed concerning germ containment and safety protocols in the post-Project Bioshield era.

Just ask the people who live adjacent to a BSL-4 facility being constructed at the Boston University Medical Campus. A neighborhood group has opposed the facility at most steps along the way [see “Transparency is Key to Neighborhood Acceptance of Biosafety Labs,” CleanRooms magazine, July 2007, p. 8] and is currently aligned with the Conservation Law Foundation in efforts to slow or halt facility construction.

The group maintains an issues-based web site that in early November carried a news article, “Mishandling of Germs on Rise at US Labs,” by Larry Margasak of the Associated Press, as its lead story. Margasak reviewed reports submitted to federal regulators and concluded that “American laboratories handling the world’s deadliest germs and toxins have experienced more than 100 accidents and missing shipments since 2003, and the number is increasing as more labs do the work.”

And if that weren’t enough to put the neighbors on high alert, a centerpiece of the GAO testimony provided detail of just how easily such mishandling can occur even by lab workers with the best intentions.

At Texas A&M University, according to the testimony, a lab worker was unknowingly infected with the Brucella bacterium after being enlisted to help operate an aerosolization chamber in a BSL-3 lab. The worker was the director of a BSL-2 lab and experienced in handling the infectious agent Mycobacterium tuberculosis. In testimony, Rhodes postulated that her M. tuberculosis experience might have provided a false sense of security:

“Typical routes of infection differ between M[.] tuberculosis and Brucella and normal procedure, including gowning and respiratory equipment, vary between the two agents. For example, the lab worker wore protective glasses, but they were not tight fitting. This was adequate when working with M[.] tuberculosis, but not with Brucella.”

The investigation concluded that the lab worker contracted Brucella through her eyes. More than six weeks passed before she fell ill, and only after symptoms persisted did she consult with an infectious disease specialist, leading her to recall the Brucella work. Although she got quite sick, she eventually resumed her normal activities while infected.

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“Such misdiagnosis is not uncommon with infectious diseases, as the initial symptoms often appear flu-like and brucellosis is not generally endemic in the population,” said Rhodes.

Figure 2. A CDC microbiologist inoculates a hen’s egg with avian influenza virus as part of a study to investigate newly emerging H5N1 viruses. The experiment was conducted inside a biological safety cabinet within a BSL-3 laboratory. Photo courtesy of CDC.Click here to enlarge image

He adds that there are risks in working alternately in BSL-2 and BSL-3 labs, with their different levels of procedures and practices. “The fear is that lab workers may develop a routine with BSL-2 procedures that might be difficult to consciously break when working with the more dangerous agents and activities requiring BSL-3 containment.”

Rhodes’s warning provides yet another red flag to the neighbors of the BU Medical Campus, many of whom still recall the 2004 incident at a BSL-2 facility there that resulted in the infection of three researchers with tularemia. The infections stemmed from a violation of safety procedures and most likely have done much to solidify neighbors’ resolve against the BSL-4 facility. As this issue went to press, both BU officials and neighbors were awaiting results of an environmental impact study by the National Research Council, commissioned by the State of Massachusetts, which is to include a worst-case scenario assessment. Results were due at the end of November.

Editor’s note: See CleanRooms’ January 2008 issue for a follow-up on the National Research Council’s findings and their anticipated impact on the management of biosafety facilities.

U.S. Department of Health and Human Services (HHS) Secretary Mike Leavitt recently announced a comprehensive initiative by the Food and Drug Administration (FDA) designed to proactively address the safety of the nation’s food supply.

Back in May, FDA was charged with developing the comprehensive plan to protect U.S. food supplies from both unintentional and deliberate contamination.

The Food Protection Plan proposes the use of science and a risk-based approach to ensure the safety of domestic and imported foods eaten by American consumers. “America’s food supply is among the safest in the world, and we enjoy unprecedented choice and convenience in filling the cupboard. Yet we face new challenges to meet both the changing demands of a global economy and consumers’ expectations,” Secretary Leavitt said. “This Food Protection Plan will implement a strategy of prevention, intervention, and response to build safety into every step of the food supply chain.”

According to FDA’s plan, the agency regulates some $417 billion worth of domestic food and $49 billion in imported food (2003 data) annually. The challenges of the current food industry—changing food production technology, human demographics (susceptible populations) and consumption (“convenience” food), business practices, new microbial threats, and communication issues—are all major hurdles that the plan is expected to address.

HHS Deputy Secretary Tevi Troy and FDA Commissioner Andrew von Eschenbach, M.D., presented the Food Protection Plan at a press conference in Washington, DC. “The Food Protection Plan calls for effective action before an outbreak occurs,” said Commissioner von Eschenbach.

Figure 1. HHS Deputy Secretary Tevi Troy, FDA Commissioner Andrew C. von Eschenbach, M.D., and FDA Assistant Commissioner for Food Protection David Acheson, M.D., announce FDA’s integrated strategy for protecting the food supply. Photo courtesy of FDA.Click here to enlarge image

The plan is premised on preventing harm before it can occur, intervening at key points in the food production system, and responding immediately when problems are identified. Within these three overarching areas of protection, the plan contains a number of action steps as well as a set of legislative proposals.

Figure 2. An investigator from FDA’s San Francisco District (left) is shown working with an investigator from the California Department of Health Services collecting soil samples as part of an investigation into an outbreak of E. coli O157:H7 in spinach. The contamination, which occurred during the fall of 2006 and sickened people in the United States and Canada, originated on farms in California. Photo by Black Star/Steve Yeater for FDA.Click here to enlarge image

The FDA says it will work with industry, state, local, and foreign governments to identify vulnerabilities and will look to industry to mitigate those vulnerabilities, using effective methods such as preventive controls.

The plan’s intervention element emphasizes focusing inspections and sampling based on risk at the manufacturer and processor level, for both domestic and imported products, that will help verify the preventive controls. This approach is complemented by targeted, risk-based inspections at the points where foreign food products enter the United States, including ports. According to the report, “Risk-based targeted inspections at the border will serve as a second layer of protection, rather than the principal one.”

The plan also calls for enhancing FDA’s information systems related to both domestic and imported foods to better respond to food safety threats and communicate during an emergency. The Food Protection Plan’s three core elements—prevention, intervention, and response—incorporate four principles for comprehensive food protection along the entire production chain:

• Focus on risks over a product’s life cycle from production to consumption.
• Target resources to achieve greatest risk reduction.
• Use interventions that address both food safety (unintentional contamination) and food defense (deliberate contamination).
• Use science and employ modern technology, including enhanced information technology systems.

Aspects of the plan that require additional legislative action include (but are not limited to) endowing FDA with the authority to require “practical defense measures” at vulnerable points in the supply chain to prevent deliberate contamination (e.g., requiring locks on tanker trucks that transport food); authorizing FDA to accredit qualified third parties to perform voluntary food inspections in order to provide more in-depth and potentially quicker review of imported goods; and implementing a new user fee requiring manufacturers and labs to pay the costs of re-inspections and follow-up services when the facilities fail to meet cGMPs or other FDA requirements.

The Food Protection Plan complements the Import Safety Action Plan recently delivered by Secretary Leavitt to President George W. Bush that recommends how the U.S. can improve the safety of all imported products. This year, $2 trillion worth of goods will be imported into the U.S., with predictions that amount will triple by 2015. Taken together, the two plans will improve efforts by the public and private sector to enhance the safety of a wide array of products used by American consumers.

For more information, visit http://www.fda.gov/oc/initiatives/advance/food/plan.html.