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'''Latest Version Per Nick/ Laura's additions/ edits. Needs citations inserted as noted, and needs feedback from Cheryl/ Nauvanie.'''

Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow (add other prevention mechanisms as seen in USA- note refs as they apply only to US?). Biosafety is used to protect from harmful incidents. Many laboratories handling biohazards employ an ongoing risk management assessment and enforcement process for biosafety. Failures to follow such protocols can lead to increased risk of exposure to biohazards or pathogens. (citation)

The international Cartagena Protocol on Biosafety deals primarily with the agricultural definition but many advocacy groups seek to expand it to include post-genetic threats: new molecules, artificial life forms, and even robots which may compete directly in the natural food chain.

Biosafety in agriculture, chemistry, medicine, exobiology and beyond will likely require the application of the precautionary principle, and a new definition focused on the biological nature of the threatened organism rather than the nature of the threat.

When biological warfare or new, currently hypothetical, threats (i.e., robots, new artificial bacteria) are considered, biosafety precautions are generally not sufficient. (link to incident report, i.e such as problems with CDC research labs in 2014)The new field of biosecurity addresses these complex threats.

Biosafety level refers to the stringency of biocontainment precautions deemed necessary by the Centers for Disease Control and Prevention (CDC) for laboratory work with infectious materials.(site CDC BMBL here, and refer to new work group on biosafety following 2014 incidents)- Cheryl, were you working on biocontainment? Maybe link out to reference on the policies/ guidance for containment in USA, like the biosafety cabinet that are required, proper storage, autoclaving, etc? Some of this is in the CDC BMBL.

Typically, institutions that experiment with or create potentially harmful biological material will have a committee or board of supervisors that is in charge of the institution's biosafety. They create and monitor the biosafety standards that must be met by labs in order to prevent the accidental release of potentially destructive biological material. (note that in the US, several groups are involved, and efforts are being made to improve processes for government run labs, but there is no unifying regulatory authority for all labs- citation to work group reports following 2014 from CDC- note that this applies only to CDC/ govt research labs, and private labs may not be under the same scrutiny- needs a few citations).

Biosafety is related to several fields:


 * In ecology (referring to imported life forms from beyond ecoregion borders),
 * In agriculture (reducing the risk of alien viral or transgenic genes, genetic engineering or prions such as BSE/"MadCow", reducing the risk of food bacterial contamination)
 * In medicine (referring to organs or tissues from biological origin, or genetic therapy products, virus; levels of lab containment protocols measured as 1, 2, 3, 4 in rising order of danger),
 * In chemistry (i.e., nitrates in water, PCB levels affecting fertility)
 * In exobiology (i.e., NASA's policy for containing alien microbes that may exist on space samples. See planetary protection and interplanetary contamination), and
 * In synthetic biology (referring to the risks associated with this type of lab practice)

The international Cartagena Protocol on Biosafety deals primarily with the agricultural definition but many advocacy groups seek to expand it to include post-genetic threats: new molecules, artificial life forms, and even robots which may compete directly in the natural food chain.

In synthetic biology
High-security facilities are necessary when working with synthetic biology as there are possibilities of bioterrorism acts or release of harmful chemicals and or organisms into the environment. 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 enhance the knowledge of virology and immunology.

In medicine and health care settings
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 (http://www.merriam-webster.com/dictionary/biosafety) (CITATION), to ensure the safety of health care workers, researchers/ lab staff, patients, and the general public. Laboratories are assigned a biosafety level of 1-4 based on their potential biohazard risk level with 1 categorized as “least risk” and 4 being of “highest risk” of handling biohazardous materials.(Citation) Investigations have shown that there are hundreds of unreported biosafety accidents, with laboratories self-policing the handling of biohazardous materials and lack of reporting. (Citation). Poor record keeping, improper disposal, and mishandling biohazardous materials result in increased risks of biochemical contamination for both the public and environment. (Citation).

Biosafety Policy and Practice in the United States
In June 2009, 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. (ref here).

In 2014, following incidents at the CDC (ref here), it was found that there was a significant lack of adherence to safety protocols, which may indicate a lack of proper training or reinforcement of training on regular basis for lab personnel. (ref here) Biosafety understanding seems inconsistent and incomplete from state to state, and not all programs address the issues from all necessary perspectives, including not just personal safety, but also emphasizing an understanding among laboratory personnel of exposure impacts on the environment, and general public. Following these incidents, the CDC Established an External Laboratory Safety Workgroup(ref here), and suggestions have been made to reform effectiveness of the Federal Select Agent Program(ref here).

Currently, the federal government does set standards and recommendations for States to meet their standard for Occupational safety plans, often focused on transportation, disposal, and risk assessment, allowing caveats for safety audits, but ultimately leaves training in the hands of the employer (ref here). Only 15 states have federally approved Occupational Safety plans, which may not all specifically have a comprehensive program for all aspects of biohazard management from start to finish. Focus is often only in regards to storage and transport, and sometimes limited only to workers in transportation specific job titles. (ref here) With the exception of DoD lab personnel, CDC lab personnel, First responders, and DoT employees, enforcement of training is inconsistent, and while training is required to be done, specifics on the breadth and frequency of refresher training does not seem consistent from state to state; penalties may never be assessed without larger regulating bodies being aware of non-compliance, and enforcement is limited. (ref here). Whistleblower policies also discourage lab staff from reporting failures for labs to train staff and consistently adhere to their safety protocols. (ref here)”

Agencies involved in procuring the policies surrounding biosafety within a hospital, pharmacy and clinical laboratory include, the CDC, FDA, USDA, HHS, DoT, EPA and potentially other local organizations including public health departments. (ref here) Currently, there is no single, regulating agency directly responsible for ensuring the safety of biohazardous handling and disposal, but many of these agencies have their own manuals and guidance documents relating to training and certain aspects of biosafety, including transportation, storage and handling of blood borne pathogens (OSHA, DoT/ IATA). The enforcement and training on such regulations can vary from lab to lab based on the State’s plans for occupational health and safety. (citation).

The US Code of Federal Regulations addresses aspects of biosafety relating to occupational health, transportation, and safety plans for laboratories, but leaves much of the governing authority and design of implementation up to states and local authorities. Many government sectors have made guidelines/recommendations for increasing biosafety measures across all labs, yet states are left to make the final determinations. Understandably, there are separate needs for government, academic, and private industry labs. (citation?)Training is the responsibility of lab employers and is not consistent across labs. (we need ref from works cited list for CFR sections and comments on training- have 2-3 refs I think?) Laws relating to biosafety are not easily accessible and there are few federal regulations that are readily available for a potential trainee to reference. States are therefore left to create their own regulations which vary widely in scope and enforcement across the United States. While biological agents, in most cases, pose similar threats independent of their area of infection.