Biosafety Guidelines

Biosafety guidelines provide guidelines, policies, and procedures that must be observed by all personnel who work in facilities handling microbiological agents, such as bacteria, viruses and parasites, fungi and prions. These guidelines are required for all institutions, including clinical and microbiological labs, biomedical research laboratories, teaching and training laboratories, and other healthcare institutions (e.g. hospitals, clinics, and health centers).

These guidelines will help to ensure that all levels of organization are aware of and comply with biosafety policies and programs. Depending on the facility, the essential components of the biosafety guideline include some or all of the following: microbiological risk assessment, identification, and specific biosafety steps. These measures cover code of practice, laboratory design, equipment acquisition, maintenance, staff training, and safe handling chemicals with fire, radiation, and electricity safety. Other components, such as certification and commissioning guidelines, may also be included.

The biosafety guidelines should be clear, simple, and appropriate for each facility. They must also be easily accessible for all staff. Although it offers guidance on the use of biosafety techniques, it cannot guarantee a safe working environment unless each individual is committed to following the guidelines. Future guidelines can be improved by continuous research into biosafety.

Definition of Biosafety

There are many definitions of “biosafety”, depending on what discipline it is (veterinary, food or medical), as well as its linguistic roots and the country where it is used. Here are some examples:

“Safety in respect of the effects biological research on humans or the environment”.(Merriam-Webster, 2019).
“(Laboratory) Biosafety describes the containment principles and technologies that are used to prevent accidental exposure to pathogens or toxins” (WHO 2006).
“Principles & Practices for the Prevention of Unintentional Release of or Accidental Exposure to Biological Agents and Toxics” (OIE 2017).
“Practices and controls that lower the risk of unintentional accidental exposure or release biological materials” (ISO 2019, 2019).
“The need for protection of human health and the environment against the possible adverse effects from modern biotechnology products,” also known as biosafety, which was introduced in 2000 by the Cartagena Protocol (SCBD).
The concept of biosafety, in terms of outer space is known as “planetary protection the practice of protecting solar system body (i.e. planets, moons and asteroids), from contamination by Earth life and protecting Earth against possible life forms that might be returned from other bodies of the solar system” (NASA 2019, 2019).

History of Biosafety

The 1908 publication by Winslow, which was originally called “microbiological safety”, is a significant milestone in biosafety. It describes a new way to examine the air for bacteria. Meyer and Eddie reviewed the 1941 survey that described laboratory-acquired Brucellosis. This also showed that similar infections could be a danger to non-laboratorians. In 1947, the NIH Building 7 established the first peacetime research lab specifically designed for microbiological safety. These and other breakthroughs were just some of the many studies that have highlighted the importance of biosafety for healthcare and research institutions.

Together with the history and principles of biosafety, the American Biological Safety Association has been able to develop. The Federation of American Scientists briefly describes the history of the American Biological Safety Association (ABSA) as it began in 1955. It was attended by military personnel and the main topic was “The Role of Safety In the Biological Warfare Effort”. The following meetings were attended by the US Centers for Disease Control and Prevention, the National Institutes of Health, universities, laboratories, hospitals, and representatives of the industries. Since then, regulations were written to regulate the shipping of biological agents, safety programs and training, and the creation of biological safety level classification. In the 1980s, international issues related to biosafety, and studies on an individual or group, became the main focus. Apart from research focusing on specific biohazard levels or pathogens, new strategies have been developed to increase risk assessment capabilities, biosecurity and biocontainment, including regulation of biosafety through international and national policies. Biosafety is also being considered in other industries, such as agriculture and biotechnology.

Biosafety Objectives

Protecting Workers and the Public Against Hazardous Biological Agents
Protecting Animal and Plant Health
Dealing With Uncertainty/Protecting the Environment

Biosafety Committees

In order to develop appropriate policies and procedures for regulation of biotechnology, the first step is to create a national advisory committee on biosafety. Next, the national committee must quickly establish policies and procedures that govern modern biotechnology use in the country.

1. National Biosafety Committee (NBC):

An Egyptian National Biosafety Committee has been established. It includes policy makers and designers, scientists in Agriculture, Health, Industry, and Environment from government and academic research institutions.

Roles and Responsibilities of NBC:

The national committee’s purpose is to create policies and procedures that govern modem biotechnology use in the country. The guidelines of the National Biosafety Committee (NBC Guidelines), are published to be used at the national level. This committee would also offer technical advice to regulatory authorities and institutions involved in biotechnology development in the country.

National Biosafety Committee Members

It is highly recommended that the NBC includes:

Representatives from the Ministry of Agriculture
Representatives from the Ministry of Education
Representatives from the Ministry of Industry
Representatives from the Ministry of Health
Representatives from the Sector of Environmental Affairs
Representatives from the private sector
Consultants and policy makers who are knowledgeable about policies and the applicable laws
Members who are not technical and represent the interests of the community in respect to the protection of the environment and health of the residents

Activities of NBC

Formulate, implement and update safety codes: NBC will formulate safety policies for both contained and non-contained applications. These guidelines will cover small-scale field trials, laboratory practices, greenhouses, commercial release, and ultimately, commercial release. These guidelines will also include recommendations for research with exotic natural organisms.
Risk assessment and license issuance: NBC will review any new initiatives in order to assess the potential benefits and risks of conducting research using modified organisms. NBC must review the safety guidelines and containment measures in place after a license has been issued.
Coordination with international and national organizations: NBC would maintain contact with national and international organizations and keep them in touch, taking into consideration new scientific and technological knowledge. It would also monitor developments in intellectual property rights issues at both the national and international levels.
Provide training and technical advice: NBC is responsible for ensuring that all employees involved in biosafety issues are properly trained on the latest safety procedures. It could also offer technical advice to Institutional Biosafety Committees.
Report at least annually to governmental authorities: A progress report covering NBC activities during the year would be submitted annually to governmental officials.

Principal Investigator (PI)

One or more principal investigators would be designated by the National Biosafety Committee. Their duties include:

To determine if the institutes are following the guidelines and regulations of the NBC, inspect them.
Upon receipt of a permit request the PI will visit the site to assess its facilities. The PI will then submit a report and the NBC will issue or deny the permit.
To ensure safety concerns, instruct and advise employees.

2. The Institutional Biosafety Committee (IBC):

The National Biosafety Committee should ask that all institutions involved in R-DNA research form an Institutional Biosafety Committee.

Roles and Responsibilities of IBC

The IBC is responsible to ensure that r-DNA research follows the NBC Guidelines. The IBC has the general responsibility of implementing the NBC Guidelines. However, it may also establish additional procedures to regulate the institution’s activities.

Institutional Biosafety Committee Members

It is highly recommended that:

The IBC includes experts in R-DNA technology who cover all research directions at the institute.
The IBC includes experts in biological safety, physical containment, and other areas.
The IBC has consultants who are experts in policies, institutional commitments and law applicable to them
IBC designates a Biologic I Safety Officer, (BSO), that meets the requirements.

Activities of IBC

Create a complete set of research-related and containment-oriented guidelines that is tailored to the research activities at the institute and that conforms with the NBC Guidelines.
To ensure compliance with requirements, establish a program of inspection.
Evaluation of the facility procedures and practices, and training and expertise for R-DNA personnel.
To ensure that R-DNA research is being done at the institute meets the requirements of the NBC Guidelines, it is important to review the results periodically.
Prepare emergency plans to cover accidental spillages and contamination of personnel resulting from such research.
Regularly review containment procedures and facilities, taking into consideration new scientific and technical information relevant to disposals and spillages of biohazardous materials.
Monitoring the development of intellectual property rights at both the national and international level.
Annual reports to the National Biosafety Committee

Biological Safety Officer (BSO):

The institute should appoint a Biological Safety Officer who should be familiar with the biosafety requirements for the R-DNA work and the facilities. His duties include the following:

Enforces policies and regulations approved ensuring that these regulations are not compromised by other considerations.
Ensure through periodic inspections that laboratory standards are rigorously followed.
Ensure safety of laboratory work and prevent the accidental escape of R-DNA modified organisms.
Maintain a data base on all aspects of biosafety related to mandate crops.
Checks and gives advice on biosafety issues on a day to-day basis.
Monitor worldwide biosafety requirements for R-DNA, also act as a member of the biosafety committee, reporting all related issues.

Biosafety guidelines were created to ensure that biotechnology products have no adverse effects on agriculture and the environment. They also prevent accidental release of harmful organisms. These guidelines are used. From the initial research phase to commercialization.