Thursday, September 5, 2019

Researcgers announce new regulation to investigate future chemical or bio-hazards

bio safety 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 biosafety is used to protect from harmful incidents many laboratories handling bio hazards employ an ongoing risk management assessment and enforcement process for biosafety failures.

To follow such protocols can lead to increased risk of exposure to bio hazards or pathogens human error and poor technique contribute to unnecessary exposure and compromise the best safeguards set into place for protection the International Carter HANA 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 ie robots new artificial bacteria are considered bio safety precautions are generally not sufficient linked to incident report ie 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 bio containment precautions deemed necessary by the Centers for Disease Control and Prevention CDC for laboratory work with infectious materials 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 by safety 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 biosafety is related to several fields in ecology referring to imported life-forms from beyond ich origin borders in agriculture reducing the risk of alien viral or transgenic genes genetic engineering or prions such as BSE mad cow 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 one two three four in rising order of danger in chemistry ie nitrates in water PCB levels affecting fertility in exobiology ie 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 topic 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 scientists 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 etcetera 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 actors and 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 biology and immunology topic in medicine healthcare settings and laboratories biosafety in medicine and healthcare 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 healthcare workers researchers lab staff patients and the general public laboratories .

These are assigned a biosafety level numbered one through four 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 World Health Organization attributes human error and poor technique as the primary cause of mishandling of biohazardous materials biosafety is also becoming a global concern and requires multi-level resources and international collaboration to monitor prevent and correct accidents from unintended and malicious release and also to prevent that bio terrorists get their hands on biologics sample to create biologic weapons of mass destruction even people outside of the health sector needs to be involved as in the case of the Ebola outbreak the impact that it had on businesses and travel required that private sectors international banks together pledged more than two billion dollars to combat the epidemic the Bureau of international security and non-proliferation isn is responsible for managing a broad range of US non-proliferation 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 there are several factors taken into account when assessing an organism and the classification process risk group one no or low individual and community risk a microorganism that is unlikely to cause human or animal disease risk group to 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 risk group for high individual and community risk a pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another directly or indirectly effective treatment and preventive measures are not usually available see World Health Organization biosafety laboratory guidelines.

WHO- World Health Organization biosafety laboratory guildelines investigations have shown that there are hundreds of unreported biosafety accidents with laboratory self-policing the handling of biohazardous materials and lack of reporting poor record-keeping improper disposal and mishandling biohazardous materials result in increased risks of biochemist 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 ie aerosol production when using loops streaking agar plates / petting 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 topic policy and practice in the United States topic legal information in June 2019 the trans federal task force on optimizing biosafety and biotin 'men oversight recommended the formation of an agency to coordinate high safety risk level labs three and four 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 topic 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 43 of the Code of Federal Regulations addresses laws concerning public health issues including biosafety which can be found under the citation 42 CFR 73 2 42 CFR 73 point 2 1 by accessing the US Code of Federal Regulations CFR web site title 42 section 74 of the CFR addresses specific aspects of biosafety including occupational safety and health transportation of biohazardous materials and safety plans for laboratories using potential bio hazards while bio containment as defined in the biosafety in microbiological & biomedical laboratories.

Primary containment for bio hazards selection installation and use of biosafety cabinets manuals available at the Centers for Disease Control and Prevention website much of the design implementation and monitoring of protocols are left up to state and local authorities the United States CFR States an individual or entity required to register as a user of biological agents must develop and implement a written biosafety plan that is commensurate with the risk of the Select agent or sin which is followed by three recommended sources for laboratory reference the CDC NIH publication biosafety in microbiological & biomedical laboratories the Occupational Safety and Health Administration OSHA regulations in 29 CFR parts 1910 point one two zero zero and 1910 point one four five zero the NIH guidelines for research involving recombinant DNA molecules NIH guidelines while clearly the needs of bio containment and biosafety measures vary across government academic and private industry laboratories biological agents pose similar risks independent of their local 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 seventy three point one two there for training is the responsibility of lab employers and is not consistent across various laboratory types thereby increasing the risk of accidental release of biological hazards that pose serious health threats to the humans animals and the ecosystem as a whole topic agency guidance many government agencies have made guidelines and recommendations in an effort to increase biosafety measures across laboratories in the United States agencies involved in producing policies surrounding biosafety within a hospital pharmacy or clinical research laboratory include the CDC FDA USDA DHHS EPA and potentially other local organizations including public health departments the federal government does set some standards and recommendations for States to meet their standards most of which fall under the Occupational Safety and Health Act of 1970 but currently there is no single federal regulating agency directly responsible for ensuring the safety of biohazardous handling storage identification cleanup and disposal in addition to the CDC the Environmental Protection Agency has some of the most accessible information on ecological impacts of bio hazards 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 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 2019 taskforce on biosafety there was also a formation of a blue-ribbon study panel on bio defense 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 and full understanding among laboratory personnel of quality control and assurance exposure potential impacts on the environment and general public safety 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 the audited annually for effectiveness these plans apply to private and public sector workers and not necessarily state government workers and not all specifically have a comprehensive program for all aspects of bio hazard management from start to finish sometimes biohazard management plans are limited only to workers in transportation specific job titles the enforcement and training on such regulations can vary from lab to lab based on the state's plans for occupational health and safety with the exception of Dodd 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 topic 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 and dot provides some oversight of regulated medical waste storage transportation and disposal the majority of biohazard medical waste is regulated at the state level.

Each state is responsible for regulation and management of their own biohazardous waste with each state varying in their regulatory process record-keeping of biohazardous waste also varies between states medical health care centers hospitals veterinary clinics clinical laboratories and other facilities generate over 1 million tons of waste each year although the majority of this waste is as harmless as common household waste as much as 15% of this waste poses a potential infection hazard according to the Environmental Protection Agency EPA medical waste is required to be rendered non-infectious before it can be disposed of there are several different methods to treat and dispose of biohazardous waste in the United States the primary methods for treatment and disposal of biohazard medical and sharps waste may include incineration microwave autoclaves mechanical chemical disinfection irradiation different forms of biohazardous wasted require different treatments for their proper waste management this is determined largely by each state's regulations currently there are several contracted companies that focus on medical sharps and biological hazard disposal Stara cycle and daniel's health are two national leaders in medical waste and pharmaceutical disposal in the United States topic incidents of non-compliance and reform efforts the United States government has made it clear that biosafety is to be taken very seriously in 2014 incidents with anthrax and Ebola pathogens in CDC laboratories prompted the CDC director 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 Els W 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 bio safety and security program and addressed biological safety needs for Health Research national defense and public safety in 2018 the association of public health laboratories aphl had a presentation at their annual eating focused on improving biosafety culture this same year.

The UPMC Center for Health Security issued a case study report including reviews of ten different nation's 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 topic see also biological hazard protocol on biosafety Center for Disease Control European biosafety Association.           

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