Biosafety

Chemical hazards typically found in laboratory settings include carcinogens, toxins, irritants, corrosives, and sensitizers. Biological hazards include viruses, bacteria, fungi, prions, and biologically derived toxins, which may be present in body fluids and tissue, cell culture specimens, and laboratory animals. Routes of exposure for chemical and biological hazards include inhalation, ingestion, skin contact, and eye contact. Physical hazards include ergonomic hazards, ionizing and non-ionizing radiation, and noise hazards. Additional safety hazards include burns and cuts from autoclaves, injuries from centrifuges, compressed gas leaks, cold burns from cryogens, electrical hazards, fires, injuries from machinery, and falls. ==In synthetic biology==

A complete understanding of experimental risks associated with synthetic biology is helping to enforce the knowledge and effectiveness of biosafety. With the potential future creation of man-made unicellular organisms, some are beginning to consider the effect that these organisms will have on biomass already present. Scientists estimate that within the next few decades, organism design will be sophisticated enough to accomplish tasks such as creating biofuels and lowering the levels of harmful substances in the atmosphere. Scientist that favor the development of synthetic biology claim that the use of biosafety mechanisms such as suicide genes and nutrient dependencies will ensure the organisms cannot survive outside of the lab setting in which they were originally created. Organizations like the ETC Group argue that regulations should control the creation of organisms that could potentially harm existing life. They also argue that the development of these organisms will simply shift the consumption of petroleum to the utilization of biomass in order to create energy. These organisms can harm existing life by affecting the prey/predator food chain, reproduction between species, as well as competition against other species (species at risk, or act as an invasive species). Synthetic vaccines are now being produced in the lab. These have caused a lot of excitement in the pharmaceutical industry as they will be cheaper to produce, allow quicker production, as well as enhance the knowledge of virology and immunology. ==In medicine, healthcare settings and laboratories==

Biosafety, in medicine and health care settings, specifically refers to proper handling of organs or tissues from biological origin, or genetic therapy products, viruses with respect to the environment, to ensure the safety of health care workers, researchers, lab staff, patients, and the general public. Laboratories are assigned a biosafety level numbered 1 through 4 based on their potential biohazard risk level. The employing authority, through the laboratory director, is responsible for ensuring that there is adequate surveillance of the health of laboratory personnel. The objective of such surveillance is to monitor for occupationally acquired diseases. The bureau of international Security and nonproliferation (ISN) is responsible for managing a broad range of U.S. nonproliferation policies, programs, agreements, and initiatives, and biological weapon is one their concerns Biosafety has its risks and benefits. All stakeholders must try to find a balance between cost-effectiveness of safety measures and use evidence-based safety practices and recommendations, measure the outcomes and consistently reevaluate the potential benefits that biosafety represents for human health. Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures required for working with agents from the various risk groups. Classification of biohazardous materials is subjective and the risk assessment is determined by the individuals most familiar with the specific characteristics of the organism. • Risk Group 2 : (moderate individual risk, low community risk) A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited. • Risk Group 3 : (high individual risk, low community risk) A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. Poor record keeping, improper disposal, and mishandling biohazardous materials result in increased risks of biochemical contamination for both the public and environment. Along with the precautions taken during the handling process of biohazardous materials, the World Health Organization recommends: Staff training should always include information on safe methods for highly hazardous procedures that are commonly encountered by all laboratory personnel, and which involve: • Inhalation risks (i.e. aerosol production) when using loops, streaking agar plates, • pipetting, making smears, opening cultures, taking blood/serum samples, centrifuging, etc. • Ingestion risks when handling specimens, smears and cultures • Risks of percutaneous exposures when using syringes and needles • Bites and scratches when handling animals • Handling of blood and other potentially hazardous pathological materials • Decontamination and disposal of infectious material. == Biosafety management in laboratory ==

First of all the laboratory director, who holds immediate responsibility for the laboratory, is tasked with ensuring the development and adoption of a biosafety management plan as well as a safety or operations manual. Secondly, the laboratory supervisor, who reports to the laboratory director, is responsible for organizing regular training sessions on laboratory safety. The third point, the personnel must be informed about any special hazards and be required to review the safety or operations manual and adhere to established practices and procedures. The laboratory supervisor is responsible for ensuring that all personnel have a clear understanding of these guidelines, and a copy of the safety or operations manual should be readily available within the laboratory. Finally, adequate medical assessment, monitoring, and treatment must be made available to all personnel when needed, and comprehensive medical records should be maintained. ==Policy and practice in the United States==

Legal information In June 2009, the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight recommended the formation of an agency to coordinate high safety risk level labs (3 and 4), and voluntary, non-punitive measures for incident reporting. However, it is unclear as to what changes may or may not have been implemented following their recommendations. United States Code of Federal Regulations The United States Code of Federal Regulations is the codification (law), or collection of laws specific to a specific to a jurisdiction that represent broad areas subject to federal regulation. Title 42 of the Code of Federal Regulations addresses laws concerning Public Health issues including biosafety which can be found under the citation 42 CFR 73 to 42 CFR 73.21 by accessing the US Code of Federal Regulations (CFR) website. Title 42 Section 73 of the CFR addresses specific aspects of biosafety including occupational safety and health, transportation of biohazardous materials and safety plans for laboratories using potential biohazards. While biocontainment, as defined in the Biosafety in Microbiological and Biomedical Laboratories and Primary Containment for Biohazards: Selection, Installation and Use of Biosafety Cabinets Laws relating to biosafety are not easily accessible and there are few federal regulations that are readily available for a potential trainee to reference outside of the publications recommended in 42 CFR 73.12. but currently, there is no single federal regulating agency directly responsible for ensuring the safety of biohazardous handling, storage, identification, clean-up and disposal. In addition to the CDC, the Environmental Protection Agency has some of the most accessible information on ecological impacts of biohazards, how to handle spills, reporting guidelines and proper disposal of agents dangerous to the environment. Many of these agencies have their own manuals and guidance documents relating to training and certain aspects of biosafety directly tied to their agency's scope, including transportation, storage and handling of blood borne pathogens (OSHA, IATA). The American Biological Safety Association (ABSA) has a list of such agencies and links to their websites, along with links to publications and guidance documents to assist in risk assessment, lab design and adherence to laboratory exposure control plans. Many of these agencies were members of the 2009 Task Force on BioSafety. There was also a formation of a Blue Ribbon Study Panel on Biodefense, but this is more concerned with national defense programs and biosecurity. Ultimately states and local governments, as well as private industry labs, are left to make the final determinants for their own biosafety programs, which vary widely in scope and enforcement across the United States. Not all state programs address biosafety from all necessary perspectives, which should not just include personal safety, but also emphasize a full understanding among laboratory personnel of quality control and assurance, exposure potential impacts on the environment, and general public safety. Toby Ord puts into question whether the current international conventions regarding biotechnology research and development regulation, and self-regulation by biotechnology companies and the scientific community are adequate. State occupational safety plans are often focused on transportation, disposal, and risk assessment, allowing caveats for safety audits, but ultimately leaves the training in the hands of the employer. 22 states have approved Occupational Safety plans by OSHA that are audited annually for effectiveness. Medical waste management in the United States Medical waste management was identified as an issue in the 1980s, with the Medical Waste Tracking Act of 1988 becoming the new standard in biohazard waste disposal. Although the Federal Government, EPA & DOT provide some oversight of regulated medical waste storage, transportation, and disposal the majority of biohazard medical waste is regulated at the state level. In 2014, incidents with anthrax and Ebola pathogens in CDC laboratories prompted the CDC director Tom Frieden to issue a moratorium for research with these types of select agents. An investigation concluded that there was a lack of adherence to safety protocols and "inadequate safeguards" in place. This indicated a lack of proper training or reinforcement of training and supervision on regular basis for lab personnel. Following these incidents, the CDC established an External Laboratory Safety Workgroup (ELSW), and suggestions have been made to reform effectiveness of the Federal Select Agent Program. The White House issued a report on national biosafety priorities in 2015, outlining next steps for a national biosafety and security program, and addressed biological safety needs for health research, national defense, and public safety. In 2016, the Association of Public Health Laboratories (APHL) had a presentation at their annual meeting focused on improving biosafety culture. This same year, The UPMC Center for Health Security issued a case study report including reviews of ten different nations' current biosafety regulations, including the United States. Their goal was to "provide a foundation for identifying national-level biosafety norms and enable initial assessment of biosafety priorities necessary for developing effective national biosafety regulation and oversight." ==See also==