Biosafety

Biosafety as a branch of microbiology has an old and a more recent beginning. Some aspects of Biosafety were apparent very early in microbiological research conducted in the late 19th, early 20th centuries. Other aspects eluded recognition as is evidenced by the following information taken from the introduction of Biosafety in Microbiological and Biomedical Laboratories:

Microbiological laboratories are special, often unique work environments that may pose identifiable infectious disease risks to persons in or near them. Infections have been contracted in the laboratory throughout the history of microbiology. Published reports around the turn of the century described laboratory-associated cases of typhoid, cholera, glanders, brucellosis, and tetanus.¹ In 1941, Meyer and Eddie² published a survey of 74 laboratory-associated brucellosis infections that had occurred in the United States, and concluded that the "handling of cultures or specimens or the inhalation of dust containing Brucella organisms is eminently dangerous to laboratory workers." A number of cases were attributed to carelessness or poor technique in the handling of infectious materials.

In 1949, Sulkin and Pike³ published the first in a series of surveys of laboratory-associated infections. They summarized 222 viral infections, 21 of which were fatal. In at least a third of the cases, the probable source of infection was considered to be associated with the handling of infected animals and tissues. Known accidents were recorded in 27 (12%) of the reported cases...

This survey was updated in 1965,⁵ adding 641 new or previously unreported cases, and again in 1976,⁶ summarizing a cumulative total of 3,921 cases. Brucellosis, typhoid, tularemia, tuberculosis, hepatitis, and Venezuelan equine encephalitis were the most commonly reported infections. Fewer than 20% of all cases were associated with a known accident. Exposure to infectious aerosols was considered to be a plausible but unconfirmed source of infection for the more than 80% of the reported cases in which the infected person had "worked with the agent..." In his 1979 review,²⁰ Pike concluded that "the knowledge, the techniques, and the equipment to prevent most laboratory infections are available."

[The] fourth edition of the BMBL continues to specifically describe combinations of microbiological practices, laboratory facilities, and safety equipment, and to recommend their use in four categories or biosafety levels of laboratory operation with selected agents infectious to humans.

The development and publication of the first BMBL in 1984 was a milestone in placing a set of useful practices and procedures in the researcher’s hands, and the fourth edition continues to build on solid practice:

The descriptions of Biosafety Levels 1-4 parallel those in the NIH Guidelines for Research Involving Recombinant DNA, ^{22, 23} and are consistent with the general criteria originally used in assigning agents to Classes 1-4 in Classification of Etiologic Agents on the Basis of Hazard.²⁴ Four biosafety levels are also described for infectious disease activities utilizing small laboratory animals. Recommendations for biosafety levels for specific agents are made on the basis of the potential hazard of the agent and of the laboratory's function or activity.

Experience has demonstrated the prudence of the Biosafety Level 1-4 practices, procedures, and facilities described for manipulations of etiologic agents in laboratory settings and animal facilities. Although no national reporting system exists for reporting laboratory-associated infections, anecdotal information suggests that strict adherence to these guidelines does contribute to a healthier and safer work environment for laboratorians, their co-workers , and the surrounding community. To further reduce the potential for laboratory-associated infections, the guidelines presented here should be considered minimal guidance for containment. They must be customized for each individual laboratory and can be used in conjunction with other available scientific information.

The more recent beginning came with the development of the NIH Guidelines in response to the flurry of "gene splicing" activity performed in plasmids and E. coli in the mid-70s. The Guidelines were developed to control the inadvertent or deliberate creation of novel microorganisms with harmful or dangerous properties not encountered in wild type variants.

The NIH Guidelines are applicable to:

• All recombinant DNA research within the United States (U.S.) or its territories that is within the category of research described in below.
• Research that is conducted at or sponsored by an institution that receives any support for recombinant DNA research from NIH, including research performed directly by NIH. An individual who receives support for research involving recombinant DNA must be associated with or sponsored by an institution that assumes the responsibilities assigned in the NIH Guidelines.
• Research that involves testing in humans of materials containing recombinant DNA developed with NIH funds, if the institution that developed those materials sponsors or participates in those projects. Participation includes research collaboration or contractual agreements, not mere provision of research materials.
• All recombinant DNA research performed abroad that is within the category of research described above.
• Research supported by NIH funds.
• Research that involves testing in humans of materials containing recombinant DNA developed with NIH funds, if the institution that developed those materials sponsors or participates in those projects. Participation includes research collaboration or contractual agreements, not mere provision of research materials.
• If the host country has established rules for the conduct of recombinant DNA research, then the research must be in compliance with those rules. If the host country does not have such rules, the proposed research must be reviewed and approved by an NIH-approved Institutional Biosafety Committee or equivalent review body and accepted in writing by an appropriate national governmental authority of the host country. The safety practices that are employed abroad must be reasonably consistent with the NIH Guidelines.

As a condition for NIH funding of recombinant DNA research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines.

Prior to the publication of either the BMBL or the NIH Guidelines, there was little that a research investigator could find to aid in assessing how dangerous certain pathogens and procedures could be while performing research activities.

Both agencies, the CDC and the NIH have specific regulatory authority over many aspects of research activities. The Occupational Health and Safety Administration, and the US Environmental Protection Agency have general regulatory authority over research activities with respect to employee and external environmental health and safety.

The Biosafety Program at Icahn School of Medicine serves as a "clearing house" and resource for obtaining information on how to conduct research activities in a safe manner.

The Biosafety Program also serves to guide and document compliance activities performed by the Principal Investigators at the School of Medicine in conformance to the requirements of the agencies cited above.

The Biosafety Program serves to complement and integrate other aspects of health and safety within The Mount Sinai Medical Center.

CDC’s BMBL Web site:
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm