WASHINGTON, D.C.—Some of the latest advances and trends in biotechnology—synthetic biology, genetic manipulation of viruses and bacteria and an increasing focus on vaccines and biologics, to name a few—have prompted federal officials to request information and public comment on exposure to infectious agents in healthcare settings, including biotech labs.
According to the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA), the 21st-century biotech industry is governed by 20th-century rules that do not clearly prescribe procedures for the safe handling of infectious agents. This, OSHA says, has resulted in some widely publicized cases of unsafe lab workplaces and biolab accidents.
Last September, for example, a University of Chicago scientist died after being infected by the focus of his research, the bacterium that causes plague. More recently, a former molecular biologist at Pfizer filed a lawsuit alleging that lax lab safety standards exposed her to an engineered form of the lentivirus, leading to paralysis and other injuries. Last month, a jury awarded the employee $1.37 million in damages, claiming Pfizer fired her for raising questions about laboratory safety. Pfizer denied any connection between its lab practices and the employee's claims.
Stating that the agency is "interested in strategies currently being deployed in healthcare and related work settings to mitigate the risk of work-acquired infectious diseases," OSHA in early May issued a sweeping request for information on occupational risks from infectious agents and suggestions for how to reduce them. The public comment request could be a first step toward possible new regulations. Although it is focused mainly on hospital and other healthcare workers, any rules are expected to also cover the estimated 232,000 employees who work in the U.S. biotechnology field.
"All workplaces must be safe workplaces," said Dr. David Michaels, OSHA's assistant secretary of labor, in a statement. "We know that workers in healthcare and related facilities may be exposed to infectious agents, and they deserve to be protected. Preventing infectious disease among workers also will reduce exposure to their family members and to patients."
Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. But four decades and many scientific innovations later, "we have inadequate standards for workers exposed to infectious materials," Michaels stated.
"Worker safety cannot be sacrificed on the altar of innovation," he said.
In particular, OSHA pointed to three specific areas of concern: biowarfare threats; synthetic biology; and the pharmaceutical industry's shifting focus onto vaccine and biologic drug development. Michaels also noted there are very few good statistics on biohazard accidents.
OSHA's solicitation for public comment may indicate that the agency is willing to put sharper teeth into the act. Specifically, OSHA is collecting information and data on the facilities and the tasks potentially exposing workers to risk; successful employee infection control programs; control methodologies being utilized (including engineering, work practice and administrative controls and personal protective equipment); medical surveillance programs; and training.
To submit comments or for more information, visit the Federal Register notice at https://s.dol.gov/38. OSHA asks that comments be submitted by Aug. 4.
At the same time, lawmakers in Washington, D.C., are also keen on updating the 40-year old act. The Protecting America's Workers Act of 2010 (HR 2067), backed by more than 100 sponsors, would bring OSHA into the 21st century by strengthening inspections, increasing penalties against employers who violate the law and establishing accountability to make workplaces safe. Criminal violations of the OSHA law would be made felonies, instead of the anemic misdemeanors they are under current law. Workers reporting workplace hazards would be protected from discrimination and retaliation.
