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Biological materials require specific packaging, labeling, and documentation. Infectious materials (materials containing or expected to contain pathogens affecting humans) are regulated by the US Department of Transportation (DOT) and the International Air Transport Association (IATA).

This guidance is provided for the use of experimentally infected animals housed in indoor research facilities (e.g., vivaria), and is also useful in the maintenance of laboratory animals that may naturally harbor zoonotic infectious agents. In both instances, the institutional management must provide facilities, staff, and established practices that reasonably ensure appropriate levels of environmental quality, safety, security and care for laboratory animal.

Since the publication of the 4th edition of BMBL manual in 1999, significant events have brought national and international scrutiny to the area of laboratory security. These events, including the anthrax attacks on U.S. citizens in October 2001 and the subsequent expansion of the United States Select Agent regulations in December 2003, have led scientific and institutional leaders to consider the need for improving the security of biological agents and toxins within their facilities.

This chapter describes basic strategies for decontaminating surfaces, items, and areas in laboratories to eliminate the possibility of transmission of infectious agents to laboratory workers, the general public, and the environment. Factors necessary for environmentally mediated infection transmission are reviewed as well as methods for sterilization and disinfection and the levels of antimicrobial activity associated with liquid chemical germicides.

Although risk of laboratory infection from working with cell cultures in general is low, risk increases when working with human and other primate cells, and primary cells from other mammalian species. There are reports of infection of laboratory workers handling primary rhesus monkey kidney cells, and the bloodborne pathogen risks from working with primary human cells, tissues and body fluids are widely recognized.

The CDC and USDA have designated certain biological agents and toxins as Select Agents, because they have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. These materials require federal registration and approval to receive, posses, or transfer them.

This document explains the University's approach to providing occupational health support for biomedical research. An occupational health program that supports staff with access to biological hazards, such as infectious agents or toxins, should aim to alleviate the risk of adverse health consequences due to potential exposures to biohazards in the workplace. Health services should be risk-based and tailored to meet the needs of individual staff and the research institution.

This document provides guidance on conducting a risk assessment, implementing a risk mitigation program, communicating during and after the assessment, and developing practices to support ongoing application of the risk assessment process to ensure safe laboratory operations.

This document describes the University's approach to pest management. Many pests, such as flies and cockroaches, can mechanically transmit disease pathogens and compromise the research environment. Even the presence of innocuous insects can contribute to the perception of unsanitary conditions.

The essential elements of the four biosafety levels for activities involving infectious microorganisms and laboratory animals are summarized in Table 1 of this chapter and discussed in Chapter 2. The levels are designated in ascending order, by degree of protection provided to personnel, the environment, and the community. Standard microbiological practices are common to all laboratories.

A comprehensive biosafety risk assessment is a key component of a successful biosafety program and should be part of an all-hazards risk assessment; it should be conducted on a continual basis to address evolving risks within the laboratory environment.

The National Institutes of Health (NIH) Office of Science Policy (OSP) serves as primary advisor to the NIH Director regarding biomedical policy issues. In order to effectively promote safe and ethical practices within the research community, the OSP integrates reports from several specialized offices to develop comprehensive and pragmatic policies.

Risk assessments for arthropod research are multifaceted and focus on risks to individual researchers (harm, injury, disease) and impacts that a breach in containment may have on the community (increased/new vector reservoir, improved vector characteristics). Specific containment recommendations for arthropods deemed to be influential on public health can be found in the "Arthropod Containment Guidelines."

Biohazardous agents are infectious microorganisms, or their toxins, which cause or may cause human disease. Although the OSHA "Occupational Exposures to Hazardous Chemicals in Laboratories" (referred to as the "Laboratory Standard") does not apply to biological agents, the policy on this campus is to apply the same basic requirements - responsibilities, training, laboratory safety plan, reporting of accidents/exposures, etc. - to biological agents.

List of Index A: Acronyms