Editing Biosafety

{{Short description|Prevention of large-scale loss of biological integrity}}
{{Distinguish|Biosecurity}}
'''Biosafety''' is the prevention of large-scale loss of [[biological integrity]], focusing both on [[ecology]] and [[human health]].<ref>{{cite book|title=Biosafety and the environment: An introduction to the Cartagena Protocol on Biosafety|url=http://www.cbd.int/doc/press/presskits/bs/cpbs-unep-cbd-en.pdf|series=GE.03-01836/E|publisher=United Nations Environment Programme|page=8|access-date=2012-01-17|archive-date=2020-02-15|archive-url=https://web.archive.org/web/20200215033209/https://www.cbd.int/doc/press/presskits/bs/cpbs-unep-cbd-en.pdf|url-status=live}}</ref>
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.
[[File:Positive-pressure biosafety suit.jpg|thumb|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|date=July 2024}}

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. (In the US, several groups are involved, but there is no unifying regulatory authority for all labs.{{cn|date=April 2025}})

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 [[biocontainment|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)

== Hazards ==
[[Chemical hazard]]s typically found in laboratory settings include [[carcinogen]]s, [[toxin]]s, [[Irritation|irritants]], [[Corrosive substance|corrosives]], and [[Sensitization (immunology)|sensitizers]].  [[Biological hazard]]s include viruses, bacteria, fungi, [[prion]]s, and biologically derived toxins, which may be present in body fluids and tissue, [[cell culture]] specimens, and [[laboratory animal]]s.  Routes of exposure for chemical and biological hazards include [[Inhalation exposure|inhalation]], [[ingestion]], skin contact, and eye contact.<ref name=":0">{{Cite web|url=https://www.osha.gov/Publications/laboratory/OSHA3404laboratory-safety-guidance.pdf|title=Laboratory Safety Guidance|date=2011|website=U.S. [[Occupational Safety and Health Administration]]|pages=9, 15, 21, 24–28|access-date=2019-01-17|archive-date=2019-12-15|archive-url=https://web.archive.org/web/20191215174945/https://www.osha.gov/Publications/laboratory/OSHA3404laboratory-safety-guidance.pdf|url-status=dead}}</ref>

[[Physical hazard]]s include [[ergonomic hazard]]s, [[Ionizing radiation|ionizing]] and [[non-ionizing radiation]], and [[Occupational noise|noise hazards]].  Additional safety hazards include [[burn]]s and [[Wound|cuts]] from [[autoclave]]s, injuries from [[Laboratory centrifuge|centrifuges]], [[Gas cylinder|compressed gas]] leaks, [[cold burn]]s from [[Cryogenics|cryogens]], [[Electrical injury|electrical hazards]], [[Fire safety|fires]], [[Lockout-tagout|injuries from machinery]], and [[Fall protection|falls]].<ref name=":0" />

==In synthetic biology==
A complete understanding of experimental risks associated with synthetic biology is helping to enforce the knowledge and effectiveness of biosafety.<ref>{{cite journal|last=Serrano|first=Luis|title=Molecular Systems Biology|url=http://www.nature.com/msb/journal/v3/n1/full/msb4100202.html|journal=Nature|access-date=2013-12-03|archive-date=2013-05-13|archive-url=https://web.archive.org/web/20130513074756/http://www.nature.com/msb/journal/v3/n1/full/msb4100202.html|url-status=live}}</ref>
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.<ref>{{cite journal|last=Collins|first=James|title=Synthetic Biology: Bits and pieces come to life|journal=Nature|volume=483|issue=7387|pages=S8–S10|doi=10.1038/483S8a|pmid=22378128|year=2012|bibcode=2012Natur.483S...8C|s2cid=5072168|doi-access=free}}</ref> Scientist that favor the development of synthetic biology claim that the use of biosafety mechanisms such as [[suicide gene]]s and nutrient dependencies will ensure the organisms cannot survive outside of the lab setting in which they were originally created.<ref>{{cite web|title=First Self-Replicating Synthetic Bacterial Cell|url=http://www.jcvi.org/cms/research/projects/first-self-replicating-synthetic-bacterial-cell/faq/#q8|publisher=J. Craig Venter Institute|access-date=12 April 2012|archive-url=https://web.archive.org/web/20120531182030/http://www.jcvi.org/cms/research/projects/first-self-replicating-synthetic-bacterial-cell/faq#q8|archive-date=2012-05-31|url-status=dead}}</ref>  Organizations like the [[ETC Group (AGETC)|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.<ref>{{cite news|last=Silvia Ribeiro|first=Ribeiro|title=News Release: Biofuels, Bioenergy and Biochar: False Solutions Lead to Land-Grabbing|url=http://www.etcgroup.org/en/node/5243|access-date=12 April 2012|date=December 3, 2010|url-status=dead|archive-url=https://web.archive.org/web/20120501211305/http://www.etcgroup.org/en/node/5243|archive-date=1 May 2012}}</ref> 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 vaccine]]s 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==
{{See also|Biosafety level}}

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,<ref>{{cite web|title=Definition of BIOSAFETY|url=http://www.merriam-webster.com/dictionary/biosafety|access-date=October 8, 2016|archive-date=November 8, 2019|archive-url=https://web.archive.org/web/20191108150225/https://www.merriam-webster.com/dictionary/biosafety|url-status=live}}</ref> 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.<ref>{{cite web|url=http://www.biosafety.be/RA/Class/ClassINT.html#UNITED_STATES|access-date=October 9, 2016|title=International classification schemes for micro-organisms based on their biological risks # UNITED STATES|date=January 14, 2013|archive-url=https://web.archive.org/web/20161015205833/http://www.biosafety.be/RA/Class/ClassINT.html#UNITED_STATES|archive-date=2016-10-15|url-status=dead}}</ref> The employing authority, through the laboratory director, is responsible for ensuring that there is adequate surveillance of the health of laboratory personnel.<ref name=":1">{{cite web|title=Laboratory Biosafety Manual - Third Edition|url=https://www.who.int/csr/resources/publications/biosafety/en/Biosafety7.pdf|website=World Health Organization|publisher=WHO|access-date=18 October 2016|archive-date=12 July 2018|archive-url=https://web.archive.org/web/20180712171806/http://www.who.int/csr/resources/publications/biosafety/en/Biosafety7.pdf|url-status=live}}</ref> The objective of such surveillance is to monitor for occupationally acquired diseases.<ref name=CDCMan/> The World Health Organization attributes human error and poor technique<ref name=CDCMan/> 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.<ref>{{cite web|url=https://2009-2017.state.gov/t/us/2015/237560.htm|title=Biosecurity in the Time of Ebola|access-date=2017-06-24|archive-date=2019-11-08|archive-url=https://web.archive.org/web/20191108150218/https://2009-2017.state.gov/t/us/2015/237560.htm|url-status=live}}</ref> 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.<ref name=CDCMan/>

Classification of biohazardous materials is subjective and the risk assessment is determined by the individuals most familiar with the specific characteristics of the organism.<ref name=CDCMan/> There are several factors taken into account when assessing an organism and the classification process.

*Risk Group 1: (no or low individual and community risk) A [[microorganism]] that is unlikely to cause human or animal disease.<ref name="auto">{{cite web|url=http://www.biosafety.be/RA/Class/ClassINT.html#UNITED_STATES|title=International Classification Systems for Micro-organisms|last=SBB©2003|access-date=2016-11-15|archive-url=https://web.archive.org/web/20161015205833/http://www.biosafety.be/RA/Class/ClassINT.html#UNITED_STATES|archive-date=2016-10-15|url-status=dead}}</ref>
*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.<ref name=CDCMan>{{cite web|title=Laboratory Biosafety Manual|url=https://www.who.int/csr/resources/publications/biosafety/en/Biosafety7.pdf|website=World Health Organization|publisher=World Health Organization|access-date=8 October 2016|archive-date=12 July 2018|archive-url=https://web.archive.org/web/20180712171806/http://www.who.int/csr/resources/publications/biosafety/en/Biosafety7.pdf|url-status=live}}</ref>
*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.<ref name=CDCMan/>
*Risk Group 4 : (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.<ref name=CDCMan/>

See World Health Organization Biosafety Laboratory Guidelines (4th edition, 2020): [https://www.who.int/publications/i/item/9789240011311 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.<ref>{{cite web|author1=Young A|author2=Penzenstadler N, TODAY|title=Inside America's secretive biolabs|work=USA Today|date=May 28, 2015|url=https://www.usatoday.com/longform/news/2015/05/28/biolabs-pathogens-location-incidents/26587505/|access-date=September 1, 2016|archive-date=November 19, 2015|archive-url=https://web.archive.org/web/20151119211646/http://www.usatoday.com/longform/news/2015/05/28/biolabs-pathogens-location-incidents/26587505/|url-status=live}}</ref> Poor record keeping, improper disposal, and mishandling biohazardous materials result in increased risks of biochemical contamination for both the public and environment.<ref>{{cite web|title=White House issues report on improving biosafety at federal labs|work=Reuters|url=https://www.reuters.com/article/us-usa-whitehouse-biosafety-idUSKCN0SN34F20151029|date=October 29, 2015|access-date=September 3, 2016|first=Julie|last=Steenhuysen|archive-date=November 8, 2019|archive-url=https://web.archive.org/web/20191108150221/https://www.reuters.com/article/us-usa-whitehouse-biosafety-idUSKCN0SN34F20151029|url-status=live}}</ref>

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:<ref name=CDCMan/>
#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.<ref name=":1" />

The third point, the personnel must be informed about any special [[Hazard|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.<ref name=":1" />

==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.<ref>{{Cite web  |url=https://www.ars.usda.gov/is/br/bbotaskforce/biosafety-FINAL-REPORT-092009.pdf  |title=Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight  |date=July 2009  |publisher=ars.usda.gov  |access-date=2016-11-15  |archive-date=2017-01-18  |archive-url=https://web.archive.org/web/20170118212842/https://www.ars.usda.gov/is/br/bbotaskforce/biosafety-FINAL-REPORT-092009.pdf  |url-status=live  }}</ref> 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.<ref>{{cite web|title=FDsys - Browse Code of Federal Regulations (Annual Edition)|url=https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR|access-date=October 18, 2016|archive-date=October 24, 2016|archive-url=https://web.archive.org/web/20161024052039/https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR|url-status=live}}</ref> [[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.<ref name=E-CFR>{{cite web|title=E-CFR: TITLE 42—Public Health. Vol TITLE 42—Public Health|url=http://www.ecfr.gov/cgi-bin/text-idx?SID=868d2d34fe582976da6e893468fa7eb6&pitd=20150101&tpl=/ecfrbrowse/Title42/42cfr73_main_02.tpl|access-date=October 18, 2016}}</ref>
[[File:International Biohazard Warning Symbol.svg|thumb|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<ref name=CDCbiosafety>{{cite web|title=Biosafety Publications and Forms|publisher=CDC|url=https://www.cdc.gov/biosafety/publications/index.htm|access-date=October 18, 2016|archive-date=October 9, 2016|archive-url=https://web.archive.org/web/20161009062830/http://www.cdc.gov/biosafety/publications/index.htm|url-status=live}}</ref> and Primary Containment for Biohazards: Selection, Installation and Use of Biosafety Cabinets<ref name=CDCbiosafety /> 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.<ref name=E-CFR />
 
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"<ref name=E-CFR /> which is followed by three recommended sources for laboratory reference:

#The CDC/NIH publication, "Biosafety in Microbiological and Biomedical Laboratories."<ref name=E-CFR />
#The Occupational Safety and Health Administration (OSHA) regulations in 29 CFR parts 1910.1200 and 1910.1450.<ref name=E-CFR />
#The "NIH Guidelines for Research Involving Recombinant DNA Molecules" (NIH Guidelines).<ref name=E-CFR />

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.<ref name=TIAN2014>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}}.</ref>  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.<ref name=E-CFR /><ref name=CDCbiosafety /> Therefore, training is the responsibility of lab employers<ref name=E-CFR /> 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]], [[United States Department of Health and Human Services|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 (United States)|Occupational Safety and Health Act]] of 1970.<ref name="osha.gov">{{cite web|url=https://www.osha.gov/dcsp/osp/|title=Directorate of Cooperative and State Programs - State Plans|publisher=Occupational Safety and Health Administration|access-date=2016-11-15|archive-date=2016-11-09|archive-url=https://web.archive.org/web/20161109123212/https://www.osha.gov/dcsp/osp/|url-status=live}}</ref> 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.<ref>{{cite web|url=https://www.epa.gov/regulatory-information-topic/regulatory-information-topic-waste#hazardous|title=Regulatory Information by Topic: Waste|first=US|last=EPA, OEI, OIAA, IAD|date=10 November 2014|access-date=15 November 2016|archive-date=16 November 2016|archive-url=https://web.archive.org/web/20161116015120/https://www.epa.gov/regulatory-information-topic/regulatory-information-topic-waste#hazardous|url-status=live}}</ref> 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,<ref>{{Cite web |url=https://www.osha.gov/Publications/osha3186.pdf |title=Model Plans and Programs for the OSHA Bloodborne Pathogens and Hazard Communications Standards |year=2003 |publisher=Occupational Safety and Health Administration |access-date=2016-11-15 |archive-date=2016-12-20 |archive-url=https://web.archive.org/web/20161220232735/https://www.osha.gov/Publications/osha3186.pdf |url-status=live }}</ref> [[IATA]]).  The American Biological Safety Association (ABSA) has a list of such agencies and links to their websites,<ref>{{cite web|url=https://www.absa.org/resbslinks.html|title=ABSA - Biosafety Links|access-date=2016-11-15|archive-date=2016-11-16|archive-url=https://web.archive.org/web/20161116015150/https://www.absa.org/resbslinks.html|url-status=dead}}</ref> 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.<ref>{{cite web|url=http://www.phe.gov/Preparedness/legal/boards/biosafetytaskforce/Pages/taskforcemembership.aspx|title=BioSafety Task Force Membership - PHE|access-date=2016-11-15|archive-url=https://web.archive.org/web/20170103173822/https://www.phe.gov/Preparedness/legal/boards/biosafetytaskforce/Pages/taskforcemembership.aspx|archive-date=2017-01-03|url-status=dead}}</ref> 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.<ref>{{cite web|url=http://www.triumvirate.com/State-by-state-Biosafety-Regulations|title=State-by-state Biosafety Regulations - Resource Page|first=Triumvirate|last=Environmental|access-date=2016-11-15|archive-date=2016-11-16|archive-url=https://web.archive.org/web/20161116015156/http://www.triumvirate.com/State-by-state-Biosafety-Regulations|url-status=live}}</ref> 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.<ref>{{Cite web |url=https://www.osha.gov/Publications/laboratory/OSHA3404laboratory-safety-guidance.pdf |title=Laboratory Safety Guidance |year=2011 |publisher=Occupational Safety and Health Administration |access-date=2016-11-15 |archive-date=2019-12-15 |archive-url=https://web.archive.org/web/20191215174945/https://www.osha.gov/Publications/laboratory/OSHA3404laboratory-safety-guidance.pdf |url-status=dead }}</ref>

[[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.<ref>{{Cite news|last=Ord|first=Toby|url=https://www.theguardian.com/science/2020/mar/06/worst-case-thinking-prevent-pandemics-coronavirus-existential-risk|title=Why we need worst-case thinking to prevent pandemics|date=2020-03-06|work=The Guardian|access-date=2020-04-11|language=en-GB|issn=0261-3077}}</ref>

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.<ref>{{Cite web |url=https://www.aaas.org/sites/default/files/migrate/uploads/AAAS-Biosafety-report.pdf |title=Biological Safety Training Programs as a Component of Personnel Reliability |type=Workshop Report |publisher=American Association for the Advancement of Science |author1=Kavita Marfatia Berger |author2=Kathryn A. Luke |author3=Mark S. Frankel |author4=Jennifer L. Sta.Ana |year=2009 |access-date=2016-11-15 |archive-url=https://web.archive.org/web/20171230195019/https://www.aaas.org/sites/default/files/migrate/uploads/AAAS-Biosafety-report.pdf |archive-date=2017-12-30 |url-status=dead }}</ref>  22 states have approved Occupational Safety plans by OSHA that are audited annually for effectiveness.<ref name="osha.gov"/> 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.<ref>{{Cite web |url=http://www.councilforresponsiblegenetics.org/pageDocuments/T6CQ5HCITM.pdf |title=Biological Laboratories: Risks and Regulations |last=Buyon |first=Lucas |publisher=Council for Responsible Genetics |access-date=2016-11-15 |archive-url=https://web.archive.org/web/20160527192522/http://www.councilforresponsiblegenetics.org/pageDocuments/T6CQ5HCITM.pdf |archive-date=2016-05-27 |url-status=dead }}</ref>

==== Medical waste management in the United States ====
{{See also|Medical Waste Tracking Act}}
[[Medical waste]] management was identified as an issue in the 1980s, with the [[Medical Waste Tracking Act]] of 1988<ref name="auto1">{{cite web|title=Regulated Biohazard Waste Regulations|url=http://biohazardwasteregulations.com/|website=Biohazard Waste Regulations|access-date=18 October 2016|archive-date=24 October 2016|archive-url=https://web.archive.org/web/20161024052606/http://biohazardwasteregulations.com/|url-status=live}}</ref> 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.<ref name="auto1"/> 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.<ref name="auto1"/> 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).<ref name="auto1"/> Medical waste is required to be rendered non-infectious before it can be disposed of.<ref name="auto1"/> 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:<ref name="auto1"/>
* [[Incineration]]
* Microwave
* [[Autoclaves]]
* Mechanical/Chemical Disinfection
*[[Irradiation]]

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.<ref>{{cite web|url=https://www.dhs.gov/science-and-technology/biosafety-and-biosecurity-united-states|title=Biosafety and Biosecurity in the United States - Homeland Security|date=16 December 2014|access-date=15 November 2016|archive-date=16 November 2016|archive-url=https://web.archive.org/web/20161116015444/https://www.dhs.gov/science-and-technology/biosafety-and-biosecurity-united-states|url-status=live}}</ref>  In 2014, incidents with anthrax and Ebola pathogens in CDC laboratories<ref>{{cite web|url=https://www.cdc.gov/media/releases/2015/s0204-ebola-lab.html|title=CDC Press Releases|access-date=2017-09-08|archive-date=2017-07-19|archive-url=https://web.archive.org/web/20170719180347/https://www.cdc.gov/media/releases/2015/s0204-ebola-lab.html|url-status=live}}</ref><ref>{{cite web|url=https://www.cdc.gov/anthrax/news-multimedia/lab-incident/|title=CDC Lab Incident: Anthrax, June 2014 - Anthrax - CDC|access-date=2017-09-08|archive-date=2017-12-22|archive-url=https://web.archive.org/web/20171222230210/https://www.cdc.gov/anthrax/news-multimedia/lab-incident/|url-status=live}}</ref> prompted the CDC director [[Tom Frieden]] to issue a [[Moratorium (law)|moratorium]] for research with these types of [[select agent]]s.  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),<ref>{{cite web|url=https://www.cdc.gov/about/lab-safety/laboratory-safety-workgroup/workgroup.html|title=Laboratory Safety at CDC|date=15 July 2019|access-date=8 September 2017|archive-date=16 July 2017|archive-url=https://web.archive.org/web/20170716151540/https://www.cdc.gov/about/lab-safety/laboratory-safety-workgroup/workgroup.html|url-status=live}}</ref> and suggestions have been made to reform effectiveness of the Federal Select Agent Program.<ref>{{cite web|url=http://www.selectagents.gov/|title=Federal Select Agent Program|access-date=2016-11-15|archive-date=2019-04-12|archive-url=https://web.archive.org/web/20190412014131/https://www.selectagents.gov/|url-status=live}}</ref> 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.<ref>{{Cite web |url=https://obamawhitehouse.archives.gov/sites/default/files/docs/10-2015_biosafety_and_biosecurity_memo.pdf |title=Biosafety and biosecurity memo |date=October 29, 2015 |access-date=2016-11-15 |archive-url=https://web.archive.org/web/20170121010203/https://obamawhitehouse.archives.gov/sites/default/files/docs/10-2015_biosafety_and_biosecurity_memo.pdf |archive-date=2017-01-21 |via=[[NARA|National Archives]] |work=[[whitehouse.gov]] |url-status=live }}</ref>

In 2016, the Association of Public Health Laboratories (APHL) had a presentation at their annual meeting focused on improving biosafety culture.<ref>https://www.aphl.org/conferences/proceedings/Documents/2016_Annual_Meeting/23Monroe{{Dead link|date=November 2018 |bot=InternetArchiveBot |fix-attempted=yes }}</ref> 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."<ref>{{Cite web |url=http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf |title=NATIONAL BIOSAFETY SYSTEM |author1=Gigi Kwik Gronvall |author2=Matthew P Shearer |author3=Hannah Collins |date=July 2016 |publisher=UPMC Center for Health Security |access-date=2016-11-15 |archive-url=https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf |archive-date=2016-11-09 |url-status=dead }}</ref>

==See also==
{{col div|colwidth=40em}}
* [[Biological hazard]]
* [[Cartagena Protocol on Biosafety]]
* [[Centers for Disease Control]]
* [[European BioSafety Association]]
* [[Interplanetary contamination]]
* [[Quarantine]]
{{colend}}

==References==
{{Reflist}}

==External links==
{{wikibooks|Genes, Technology and Policy}}
*[https://www.who.int/publications/i/item/9789240011311 WHO Biosafety Manual]
*[https://www.cdc.gov/safelabs/resources-tools/biosafety-resources-and-tools.html CDC Biosafety pages]
*[https://web.archive.org/web/20081204131159/http://www.icgeb.org/biosafety International Centre for Genetic Engineering and Biotechnology (ICGEB): Biosafety pages]
*[http://greenpeace.org Greenpeace] {{Webarchive|url=https://web.archive.org/web/20120603051341/http://www.greenpeace.org/ |date=2012-06-03 }} safe trade campaign
*[https://absa.org/ American Biological Safety Association]
*[https://www.cdc.gov/labs/BMBL.html Biosafety in Microbiological and Biomedical Laboratories]

{{Authority control}}

[[Category:Genetic engineering]]
[[Category:Bioethics]]
[[Category:Safety]]
[[Category:Biological hazards]]