Biosafety

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Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. [1] These prevention mechanisms include the conduction of regular reviews of biosafety in laboratory settings, as well as strict guidelines to follow. 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. Human error and poor technique contribute to unnecessary exposure and compromise the best safeguards set into place for protection.

Contents

Positive-pressure biosafety suit Positive-pressure biosafety suit.jpg
Positive-pressure biosafety suit

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.[ citation needed ]

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. 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.

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.

Biosafety is related to several fields:

Hazards

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. [2]

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. [2]

In synthetic biology

A complete understanding of experimental risks associated with synthetic biology is helping to enforce the knowledge and effectiveness of biosafety. [3] 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. [4] 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. [5] 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. [6] 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, [7] 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. [8] The employing authority, through the laboratory director, is responsible for ensuring that there is adequate surveillance of the health of laboratory personnel. [9] The objective of such surveillance is to monitor for occupationally acquired diseases. [10] The World Health Organization attributes human error and poor technique [10] as the primary cause of mishandling of biohazardous materials.

Biosafety is also becoming a global concern and requires multilevel resources and international collaboration to monitor, prevent and correct accidents from unintended and malicious release and also to prevent that bioterrorists 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 $2 billion to combat the epidemic. [11] 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. [10]

Classification of biohazardous materials is subjective and the risk assessment is determined by the individuals most familiar with the specific characteristics of the organism. [10] There are several factors taken into account when assessing an organism and the classification process.

See World Health Organization Biosafety Laboratory Guidelines (4th edition, 2020): World Health Organization Biosafety Laboratory Guidelines

Investigations have shown that there are hundreds of unreported biosafety accidents, with laboratories self-policing the handling of biohazardous materials and lack of reporting. [13] Poor record keeping, improper disposal, and mishandling biohazardous materials result in increased risks of biochemical contamination for both the public and environment. [14]

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: [10]

  1. Inhalation risks (i.e. aerosol production) when using loops, streaking agar plates,
  2. pipetting, making smears, opening cultures, taking blood/serum samples, centrifuging, etc.
  3. Ingestion risks when handling specimens, smears and cultures
  4. Risks of percutaneous exposures when using syringes and needles
  5. Bites and scratches when handling animals
  6. Handling of blood and other potentially hazardous pathological materials
  7. 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. [9]

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. [9]

Policy and practice in the United States

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. [15] 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. [16] 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. [17]

International Biohazard Warning Symbol International Biohazard Warning Symbol.svg
International Biohazard Warning Symbol

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 [18] and Primary Containment for Biohazards: Selection, Installation and Use of Biosafety Cabinets [18] 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. [17]

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 toxin" [17] which is followed by three recommended sources for laboratory reference:

  1. The CDC/NIH publication, "Biosafety in Microbiological and Biomedical Laboratories." [17]
  2. The Occupational Safety and Health Administration (OSHA) regulations in 29 CFR parts 1910.1200 and 1910.1450. [17]
  3. The "NIH Guidelines for Research Involving Recombinant DNA Molecules" (NIH Guidelines). [17]

While clearly the needs of biocontainment and biosafety measures vary across government, academic and private industry laboratories, biological agents pose similar risks independent of their locale. [19] 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. [17] [18] Therefore, training is the responsibility of lab employers [17] 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.

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, DoT, 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. [20] 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. [21] 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, [22] IATA). The American Biological Safety Association (ABSA) has a list of such agencies and links to their websites, [23] 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. [24] 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. [25] Not all state programs address biosafety from all necessary perspectives, which should not just include personal safety, but also emphasize an full understanding among laboratory personnel of quality control and assurance, exposure potential impacts on the environment, and general public safety. [26]

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. [27]

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. [28] 22 states have approved Occupational Safety plans by OSHA that are audited annually for effectiveness. [20] 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 biohazard 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 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. [29]

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 [30] 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. [30] 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 healthcare centers, hospitals veterinary clinics, clinical laboratories and other facilities generate over one million tons of waste each year. [30] Although the majority of this waste is as harmless as common household waste, as much as 15 percent of this waste poses a potential infection hazard, according to the Environmental Protection Agency (EPA). [30] Medical waste is required to be rendered non-infectious before it can be disposed of. [30] 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: [30]

Different forms of biohazardous wasted required different treatments for their proper waste management. This is determined largely be each states regulations.

Incidents of non-compliance and reform efforts

The United States Government has made it clear that biosafety is to be taken very seriously. [31] In 2014, incidents with anthrax and Ebola pathogens in CDC laboratories [32] [33] 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), [34] and suggestions have been made to reform effectiveness of the Federal Select Agent Program. [35] 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. [36]

In 2016, the Association of Public Health Laboratories (APHL) had a presentation at their annual meeting focused on improving biosafety culture. [37] 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." [38]

See also

Related Research Articles

<span class="mw-page-title-main">Personal protective equipment</span> Equipment designed to help protect an individual from hazards

Personal protective equipment (PPE) is protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection. The hazards addressed by protective equipment include physical, electrical, heat, chemical, biohazards, and airborne particulate matter. Protective equipment may be worn for job-related occupational safety and health purposes, as well as for sports and other recreational activities. Protective clothing is applied to traditional categories of clothing, and protective gear applies to items such as pads, guards, shields, or masks, and others. PPE suits can be similar in appearance to a cleanroom suit.

<span class="mw-page-title-main">Biosafety level</span> Set of biocontainment precautions

A biosafety level (BSL), or pathogen/protection level, is a set of biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels in a publication referred to as BMBL. In the European Union, the same biosafety levels are defined in a directive. In Canada the four levels are known as Containment Levels. Facilities with these designations are also sometimes given as P1 through P4, as in the term P3 laboratory.

<span class="mw-page-title-main">Biological hazard</span> Biological material that poses serious risks to the health of living organisms

A biological hazard, or biohazard, is a biological substance that poses a threat to the health of living organisms, primarily humans. This could include a sample of a microorganism, virus or toxin that can adversely affect human health. A biohazard could also be a substance harmful to other living beings.

<span class="mw-page-title-main">Hazard symbol</span> Warning symbol on locations or products

Hazard symbols are recognizable symbols designed to warn about hazardous or dangerous materials, locations, or objects, including electromagnetic fields, electric currents; harsh, toxic or unstable chemicals ; and radioactivity. The use of hazard symbols is often regulated by law and directed by standards organizations. Hazard symbols may appear with different colors, backgrounds, borders, and supplemental information in order to specify the type of hazard and the level of threat. Warning symbols are used in many places in place of or in addition to written warnings as they are quickly recognized and more universally understood, as the same symbol can be recognized as having the same meaning to speakers of different languages.

<span class="mw-page-title-main">Chemical hazard</span> Non-biological hazards of hazardous materials

Chemical hazards are hazards present in hazardous chemicals and hazardous materials. Exposure to certain chemicals can cause acute or long-term adverse health effects. Chemical hazards are usually classified separately from biological hazards (biohazards). Chemical hazards are classified into groups that include asphyxiants, corrosives, irritants, sensitizers, carcinogens, mutagens, teratogens, reactants, and flammables. In the workplace, exposure to chemical hazards is a type of occupational hazard. The use of personal protective equipment may substantially reduce the risk of adverse health effects from contact with hazardous materials.

<span class="mw-page-title-main">Dangerous goods</span> Solids, liquids, or gases harmful to people, other organisms, property or the environment

Dangerous goods (DG), are substances that when transported are a risk to health, safety, property or the environment. Certain dangerous goods that pose risks even when not being transported are known as hazardous materials. An example for dangerous goods is hazardous waste which is waste that has substantial or potential threats to public health or the environment.

<span class="mw-page-title-main">Environmental hazard</span> Harmful substance, a condition or an event

Environmental hazards are those hazards that affect biomes or ecosystems. Well known examples include oil spills, water pollution, slash and burn deforestation, air pollution, ground fissures, and build-up of atmospheric carbon dioxide. Physical exposure to environmental hazards is usually involuntary

<span class="mw-page-title-main">Workplace Hazardous Materials Information System</span> Canadian national hazard communication standard

The Workplace Hazardous Materials Information System is Canada's national workplace hazard communication standard. The key elements of the system, which came into effect on October 31, 1988, are cautionary labelling of containers of WHMIS controlled products, the provision of material safety data sheets (MSDSs) and worker education and site-specific training programs.

Hazardous Waste Operations and Emergency Response is a set of guidelines produced and maintained by the Occupational Safety and Health Administration which regulates hazardous waste operations and emergency services in the United States and its territories. With these guidelines, the U.S. government regulates hazardous wastes and dangerous goods from inception to disposal.

<span class="mw-page-title-main">Biocontainment</span> Physical containment of pathogenic organisms or agents in microbiology laboratories

One use of the concept of biocontainment is related to laboratory biosafety and pertains to microbiology laboratories in which the physical containment of pathogenic organisms or agents is required, usually by isolation in environmentally and biologically secure cabinets or rooms, to prevent accidental infection of workers or release into the surrounding community during scientific research.

<span class="mw-page-title-main">Occupational hazard</span> Hazard experienced in the workplace

An occupational hazard is a hazard experienced in the workplace. This encompasses many types of hazards, including chemical hazards, biological hazards (biohazards), psychosocial hazards, and physical hazards. In the United States, the National Institute for Occupational Safety and Health (NIOSH) conduct workplace investigations and research addressing workplace health and safety hazards resulting in guidelines. The Occupational Safety and Health Administration (OSHA) establishes enforceable standards to prevent workplace injuries and illnesses. In the EU, a similar role is taken by EU-OSHA.

Crime scene cleanup is a term applied to cleanup of blood, bodily fluids, and other potentially infectious materials (OPIM). It is also referred to as biohazard remediation, and forensic cleanup, because crime scenes are only a portion of the situations in which biohazard cleaning is needed. Incidents which may require this type of cleanup include accidents, suicide, homicides, and decomposition after unattended death, as well as mass trauma, industrial accidents, infectious disease contamination, animal biohazard contamination or regulated waste transport, treatment, and disposal.

Biorisk generally refers to the risk associated with biological materials and/or infectious agents, also known as pathogens. The term has been used frequently for various purposes since the early 1990s. The term is used by regulators, security experts, laboratory personnel and industry alike, and is used by the World Health Organization (WHO). WHO/Europe also provides tools and training courses in biosafety and biosecurity.

<span class="mw-page-title-main">Biomedical waste</span> Waste containing infectious material

Biomedical waste or hospital waste is any kind of waste containing infectious materials generated during the treatment of humans or animals as well as during research involving biologics. It may also include waste associated with the generation of biomedical waste that visually appears to be of medical or laboratory origin, as well research laboratory waste containing biomolecules or organisms that are mainly restricted from environmental release. As detailed below, discarded sharps are considered biomedical waste whether they are contaminated or not, due to the possibility of being contaminated with blood and their propensity to cause injury when not properly contained and disposed. Biomedical waste is a type of biowaste.

<span class="mw-page-title-main">Hazard</span> Situation or object that can cause damage

A hazard is a potential source of harm. Substances, events, or circumstances can constitute hazards when their nature would potentially allow them to cause damage to health, life, property, or any other interest of value. The probability of that harm being realized in a specific incident, combined with the magnitude of potential harm, make up its risk. This term is often used synonymously in colloquial speech.

<span class="mw-page-title-main">Biosafety cabinet</span> Type of laboratory equipment

A biosafety cabinet (BSC)—also called a biological safety cabinet or microbiological safety cabinet—is an enclosed, ventilated laboratory workspace for safely working with materials contaminated with pathogens requiring a defined biosafety level. Several different types of BSC exist, differentiated by the degree of biocontainment they provide. BSCs first became commercially available in 1950.

The American Biological Safety Association (ABSA) was founded in 1984 to promote biological safety as an essential principle and serve the needs of biosafety professionals. The association's goals are to represent the interests and desires of practitioners of biosafety, and to be a dispenser of biosafety information.

Many laboratories contain significant risks, and the prevention of laboratory accidents requires great care and constant vigilance. Examples of risk factors include high voltages, high and low pressures and temperatures, corrosive and toxic chemicals and chemical vapours, radiation, fire, explosions, and biohazards including infective organisms and their toxins.

<span class="mw-page-title-main">Extraterrestrial sample curation</span> Use and preservation of extraterrestrial samples

The curation of extraterrestrial samples (astromaterials) obtained by sample-return missions takes place at facilities specially designed to preserve both the sample integrity and protect the Earth. Astromaterials are classified as either non-restricted or restricted, depending on the nature of the Solar System body. Non-restricted samples include the Moon, asteroids, comets, solar particles and space dust. Restricted bodies include planets or moons suspected to have either past or present habitable environments to microscopic life, and therefore must be treated as extremely biohazardous.

The hazards of synthetic biology include biosafety hazards to workers and the public, biosecurity hazards stemming from deliberate engineering of organisms to cause harm, and hazards to the environment. The biosafety hazards are similar to those for existing fields of biotechnology, mainly exposure to pathogens and toxic chemicals; however, novel synthetic organisms may have novel risks. For biosecurity, there is concern that synthetic or redesigned organisms could theoretically be used for bioterrorism. Potential biosecurity risks include recreating known pathogens from scratch, engineering existing pathogens to be more dangerous, and engineering microbes to produce harmful biochemicals. Lastly, environmental hazards include adverse effects on biodiversity and ecosystem services, including potential changes to land use resulting from agricultural use of synthetic organisms.

References

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  4. ↑ Collins, James (2012). "Synthetic Biology: Bits and pieces come to life". Nature. 483 (7387): S8–S10. Bibcode:2012Natur.483S...8C. doi: 10.1038/483S8a . PMID   22378128. S2CID   5072168.
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  6. ↑ Silvia Ribeiro, Ribeiro (December 3, 2010). "News Release: Biofuels, Bioenergy and Biochar: False Solutions Lead to Land-Grabbing". Archived from the original on 1 May 2012. Retrieved 12 April 2012.
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  16. ↑ "FDsys - Browse Code of Federal Regulations (Annual Edition)". Archived from the original on October 24, 2016. Retrieved October 18, 2016.
  17. 1 2 3 4 5 6 7 8 "E-CFR: TITLE 42—Public Health. Vol TITLE 42—Public Health" . Retrieved October 18, 2016.
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  19. ↑ Tian D, Zheng T. Comparison and Analysis of Biological Agent Category Lists Based On Biosafety and Biodefense. PLoS One. 2014;9(6). doi : 10.1371/journal.pone.0101163.
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  29. ↑ Buyon, Lucas. "Biological Laboratories: Risks and Regulations" (PDF). Council for Responsible Genetics. Archived from the original (PDF) on 2016-05-27. Retrieved 2016-11-15.
  30. 1 2 3 4 5 6 "Regulated Biohazard Waste Regulations". Biohazard Waste Regulations. Archived from the original on 24 October 2016. Retrieved 18 October 2016.
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  34. ↑ "Laboratory Safety at CDC". 15 July 2019. Archived from the original on 16 July 2017. Retrieved 8 September 2017.
  35. ↑ "Federal Select Agent Program". Archived from the original on 2019-04-12. Retrieved 2016-11-15.
  36. ↑ "Biosafety and biosecurity memo" (PDF). whitehouse.gov . October 29, 2015. Archived (PDF) from the original on 2017-01-21. Retrieved 2016-11-15– via National Archives.
  37. ↑ https://www.aphl.org/conferences/proceedings/Documents/2016_Annual_Meeting/23Monroe%5B%5D
  38. ↑ Gigi Kwik Gronvall; Matthew P Shearer; Hannah Collins (July 2016). "NATIONAL BIOSAFETY SYSTEM" (PDF). UPMC Center for Health Security. Archived from the original (PDF) on 2016-11-09. Retrieved 2016-11-15.
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