Regulations
This is a list of five of the international and U.S. regulations and guidelines regarding safety in the biotech industry. There are many additional government, industry, academic and non-government documents on this topic.
ISO 35001 (International Standard on Biorisk Management)
Since 2001, biological risks—from terror attacks involving anthrax letters to outbreaks of new and re-emerging infectious diseases like SARS, Ebola, H5N1 avian influenza, MERS, and Zika—have been galvanizing a global construction boom of research labs meant for work on the deadliest pathogens. The history of lab accidents and lab-worker infections is disturbingly long.
The International Organization for Standardization, often called ISO, develops environmental, safety, and other standards for a wide-array of products and processes. In 2019, the organization released ISO 35001, a standard on biorisk management for laboratories that work with dangerous pathogens. Regulatory bodies, scientific journals, and diplomatic scientific engagement should use the ISO standard as a global floor for biosafety management.
WHO: Laboratory Biosafety Manual
In December 2020, the World Health Organization published the Fourth Edition of their "Laboratory Biosafety Manual."
"Laboratory biosafety and biosecurity activities are fundamental to protecting the laboratory workforce and the wider community against unintentional exposures or releases of pathogenic biological agents."
Emphasis is placed on the importance of a "safety culture" that incorporates risk assessment, good microbiological practice and procedure, appropriate training, and prompt reporting of incidents and accidents followed by appropriate investigation and corrective actions.
CDC: Biosafety in Microbiological and Biomedical Laboratories
In June 2020, the U.S. Centers for Disease Control (CDC) and National Institute of Health (NIH) published the 6th Edition of their book titled "Biosafety in Microbiological and Biomedical Laboratories (BMBL).
This 604-page book is an advisory document (not intended to be a regulatory document) recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective.
The core principle of this book is protocol-driven risk assessment. It is not possible for a single document to identify all of the possible combinations of risks and mitigations feasible in biomedical and clinical laboratories. The BMBL should be used as a tool in the assessment and proposed mitigation steps in biomedical and clinical laboratories.
Learn more about OSHA standards for laboratories. There are also 28 OSHA-approved State Plans, operating state-wide occupational safety and health programs. State Plans are required to have standards and enforcement programs that are at least as effective as OSHA's and may have different or more stringent requirements.
OSHA: OSHA Act of 1970, Revised in 1998 (includes biological hazards and blood-borne pathogens)
When the United States established the Occupational Safety and Health Administration (OSHA) and passed OSHA Act of 1970, working men and women believed they could go to work each day without concern for their mandated rights to a safe and healthy workplace environment. Although the OSHA Act of 1970 included Mandated Respiratory Protection, it excluded Biological Hazards & Blood-borne Pathogens.
In 1998, (almost three decades after the passing of the OSHA Act of 1970) OSHA released
the first revision to the Respiratory Protection Standard. This revision includes exposures to biological hazards and blood-borne pathogens, and it also includes an OSHA Respirator Medical Evaluation Questionnaire (Mandatory). However, most employees are not aware of this mandatory questionnaire, and their employers do not tell them.
Cartagena Protocol on Biosafety
The Cartagena Protocol for Biosafety is part of the Convention on Biological Diversity and was adopted on January 29, 2000, and was entered into force on September 11, 2003. Many national laws on biotechnology regulation are based on the Cartagena Protocol.
Under these laws, government approvals are generally needed for importation of Living Modified Organisms (LMOs) that cross international borders and for many industrial activities including "contained uses" or "environmental uses." LMOs include genetically modified plants, animals and microbes.
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