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INTRODUCTION
Why would Pfizer, the world’s largest drug company, so mistreat and silence one of their
top molecular biologists that a federal jury in Connecticut recently awarded her $1.37 million in
damages? The answer promises to tear open the curtain covering hazards confronting tens of
thousands of scientists and assistants in corporate, government and university labs. Becky
McClain’s lawsuit against Pfizer claimed that the company’s sloppiness exposed her to an
engineered form of the lentivirus, a virus related to one that could lead to immune deficiencies. It
documented the absence of any available risk assessments and exposed the cruel refusal to give
afflicted employees their own exposure records on the grounds that they are company trade
secrets. Pfizer denied connections between its lab practices and Ms. McClain’s reoccurring
paralysis and other illnesses. Becky McClain is not alone. As a revolution in genetic and other
biological sciences has greatly expanded the number of laboratories in the past twenty years,
workers in the biological industries have suffered from health and safety regulations that have
fallen well behind the times. David Michaels, the head of OSHA, has admitted that there are
“many gaps” in his agency’s standards. “New biological materials, nanomaterials, there are
many things where we don’t have adequate information” (NY Times interview).
The Council for Responsible Genetics is mobilizing an effort to ensure that worker health
and safety are once again protected in the United States by identifying hazards, educating the
public and policy makers and working towards the creation of enforceable and openly accessible
standards and practices for biological laboratories. The following report represents an important
step in this process as it lays out the current regulatory framework for commercial and academic
biotechnology laboratories in the United States, identifies specific gaps in these regulations and
offers some initial recommendations for improvements.
QUESTIONS EXPLORED
(1) What federal regulations currently govern worker safety in commercial and academic
biotechnology laboratories?
The main federal agencies overseeing safety in biological laboratories are OSHA and NIH.
OSHA’s regulations on chemical and blood borne pathogen hazards govern both academic and
commercial labs. The NIH issues two sets of guidelines describing safety practices for biological 4
laboratories. Along with the CDC, it issues a manual on Microbiological and Biomedical
Laboratories (BMBL). The Office of Biotechnology Activities (OBA) at the NIH also publishes a
set of safety requirements for experiments dealing with recombinant DNA (rDNA), entitled the
NIH Guidelines for Research Involving Recombinant DNA Molecules. While the guidelines on
rDNA are mandatory for institutions receiving NIH funds, largely universities and academic
laboratories, the BMBL is entirely advisory for all institutions.
(2) What gaps exist in these regulations?
While comprehensive and frequently updated, the NIH guidelines are largely advisory for many
institutions. Even the NIH guidelines on rDNA research, which are mandatory for academic
institutions, remain largely unenforced. This is primarily because the NIH is not an inspection or
enforcement agency. OSHA regulations on the other hand, while mandatory, do not address a
broad range of potential safety issues encountered in biological laboratories. OSHA has specific
regulations governing chemical substances and blood borne pathogens, which focus on HIV and
HBV. However, most of the potentially infectious agents studied and engineered in biolabs are
covered by neither of those two provisions in the OSHA regulations.
(3) How can oversight of laboratory safety be improved?
At minimum, OSHA should make both the BMBL and the NIH guidelines on rDNA research
mandatory for all laboratories. This reform, however, is still insufficient given the high level of
expertise required in order to assess and enforce compliance with NIH guidelines. Rather, safety
rules that are conducive to fast and easy inspections that can be conducted by regulators lacking
in specific expertise on biological and rDNA hazards should also be implemented. Therefore,
OSHA should also enact specific rules that govern safety generally, not unlike some of the
regulations research laboratories dealing with blood borne pathogens or chemical hazards must
comply with, including requirements for restricted access, air filters, personal protective
equipment, and food and drink prohibitions. However, because many biohazards are not only
blood borne but also perhaps airborne, provisions requiring the employer to assess specific
hazards and to protect against other routes of infection are also necessary.