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{{Short description|Dangers presented by artificial and modified organisms}}
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{{Synthetic biology}}

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.

In general, existing [[Hierarchy of hazard controls|hazard controls]], risk assessment methodologies, and regulations developed for traditional [[genetically modified organism]]s (GMOs) also apply to synthetic organisms. "Extrinsic" [[biocontainment]] methods used in laboratories include [[biosafety cabinet]]s and [[glovebox]]es, as well as [[personal protective equipment]]. In agriculture, they include isolation distances and [[pollen]] barriers, similar to methods for [[Biocontainment of genetically modified organisms|biocontainment of GMOs]]. Synthetic organisms might potentially offer increased hazard control because they can be engineered with "intrinsic" biocontainment methods that limit their growth in an uncontained environment, or prevent [[horizontal gene transfer]] to natural organisms. Examples of intrinsic biocontainment include [[auxotrophy]], biological [[kill switch]]es, inability of the organism to replicate or to pass synthetic genes to offspring, and the use of [[Xenobiology|xenobiological]] organisms using alternative biochemistry, for example using artificial [[xeno nucleic acid]]s (XNA) instead of DNA.

Existing risk analysis systems for GMOs are generally applicable to synthetic organisms, although there may be difficulties for an organisms built "bottom-up" from individual genetic sequences. Synthetic biology generally falls under existing regulations for GMOs and biotechnology in general, as well as any regulations that exist for downstream commercial products, although there are generally no regulations in any jurisdiction that are specific to synthetic biology.

== Background ==
[[Synthetic biology]] is an outgrowth of [[biotechnology]] distinguished by the use of biological pathways or organisms not found in nature. This contrasts with "traditional" [[genetically modified organism]]s created by transferring existing genes from one cell type to another. Major goals of synthetic biology include re-designing genes, cells, or organisms for [[gene therapy]]; development of [[minimal cell]]s and artificial [[protocell]]s; and development of organisms based on [[Xenobiology|alternative biochemistry]].<ref name=":0" /> This work has been driven by the development of [[Artificial gene synthesis|genome synthesis]] and [[Genome editing|editing]] tools, as well as pools of standardized [[synthetic biological circuit]]s with defined functions. The availability of these tools has spurred the expansion of a [[do-it-yourself biology]] movement.<ref name=":3" />{{Rp|5}}<ref name=":2" />

Synthetic biology has potential commercial applications in energy, agriculture, medicine, and the production of chemicals including pharmaceuticals.<ref name=":0" /> Biosynthetic applications are often distinguished as either for "contained use" within laboratories and manufacturing facilities, or for "intentional release" outside of the laboratory for medical, veterinary, cosmetic, or agricultural applications.<ref name=":3" />{{Rp|24}} As synthetic biology applications become increasingly used in industry, the number and variety of workers exposed to synthetic biology risk is expected to increase.<ref name=":1" />

== Hazards ==

=== Biosafety ===
[[File:Biomedical_Engineering_Laboratory.jpg|thumb|Microbiology laboratories present multiple [[Chemical hazard|chemical]], [[Biological hazard|biological]], and [[physical hazard]]s that can be mitigated with [[laboratory safety]] methods.]]
[[Biosafety]] hazards to workers from synthetic biology are similar to those in existing fields of biotechnology, mainly exposure to pathogens and toxic chemicals used in a laboratory or industrial setting.<ref name=":0" /><ref name=":1" /> These include [[Chemical hazard|hazardous chemicals]]; [[biological hazard]]s including organisms, [[prion]]s, and biologically-derived toxins; [[physical hazard]]s such as [[ergonomic hazard]]s, [[radiation]], and [[Occupational noise|noise hazards]]; and additional hazards of injury from [[autoclave]]s, [[Laboratory centrifuge|centrifuges]], [[Gas cylinder|compressed gas]], [[Cryogenics|cryogens]], and [[Electrical injury|electrical hazards]].<ref>{{cite web |date=2011 |title=Laboratory Safety Guidance |website=U.S. [[Occupational Safety and Health Administration]] |pages=9,15,21,24–28 |url=https://www.osha.gov/Publications/laboratory/OSHA3404laboratory-safety-guidance.pdf |access-date=2019-01-17}}</ref>

Novel protocells or xenobiological organisms, as well as gene editing of higher animals, may have novel biosafety hazards that affect their risk assessment. As of 2018, most laboratory biosafety guidance is based on preventing exposure to existing rather than new pathogens.<ref name=":1" /> [[Lentiviral vector]]s derived from the [[HIV-1]] virus are widely used in gene therapy due to their unique ability to infect both dividing and non-dividing cells, but unintentional exposure of workers could lead to [[cancer]] and other diseases.<ref name=":0">{{cite journal |last1=Howard |first1=John |last2=Murashov |first2=Vladimir |last3=Schulte |first3=Paul |date=2017-01-24 |title=Synthetic Biology and Occupational Risk |language=en-us |journal=Journal of Occupational and Environmental Hygiene |volume=14 |issue=3 |pages=224–236 |doi=10.1080/15459624.2016.1237031 |pmid=27754800 |s2cid=205893358 |url=https://blogs.cdc.gov/niosh-science-blog/2017/01/24/synthetic-biology/ |access-date=2018-11-30}}</ref><ref name=":1">{{cite journal |last1=Howard |first1=John |last2=Murashov |first2=Vladimir |last3=Schulte |first3=Paul |date=2016-10-18 |title=Synthetic biology and occupational risk |language=en |journal=Journal of Occupational and Environmental Hygiene |issn=1545-9624 |doi=10.1080/15459624.2016.1237031 |pmid=27754800 |volume=14 |issue=3 |pages=224–236|s2cid=205893358 }}</ref> In the case of an unintentional exposure, [[Antiviral drug|antiretroviral drugs]] can be used as post-exposure [[prophylaxis]].<ref name=":1" />

Given the overlap between synthetic biology and the [[do-it-yourself biology]] movement, concerns have been raised that its practitioners may not abide by risk assessment and biosafety practices required of professionals,<ref name=":3" />{{Rp|39}} although it has been suggested that an informal code of ethics exists that recognizes health risks and other adverse outcomes.<ref name=":2" />{{Rp|15}}

=== Biosecurity ===
[[File:Polio EM PHIL 1875 lores.PNG|thumb|[[Poliovirus]] was among the first virus genomes synthesized from scratch and used to create viruses capable of infection. This has led to concern that it and other infectious viruses could be manufactured for harmful purposes.<ref name=":7" />{{Rp|39}}]]
The rise of synthetic biology has also spurred [[biosecurity]] concerns that synthetic or redesigned organisms could be engineered for [[bioterrorism]]. This is considered possible but unlikely given the resources needed to perform this kind of research.<ref name=":0" /> However, synthetic biology could expand the group of people with relevant capabilities, and reduce the amount of time needed to develop them.<ref name=":7" />{{Rp|2–7}}

A 2018 [[National Academies of Sciences, Engineering, and Medicine]] (NASEM) report identified three capabilities as being of greatest concern. The first is the recreation of known pathogens from scratch, for example using [[genome synthesis]] to [[Synthetic virology|recreate historical viruses]] such as the [[Spanish flu|Spanish Flu virus]] or [[Poliovirus|polio virus]].<ref name=":2" />{{Rp|12, 14}}<ref name=":7" />{{Rp|2–7}} Current technology allows genome synthesis for almost any mammalian virus, the sequences of known human viruses are publicly available, and the procedure has relatively low cost and requires access to basic laboratory equipment. However, the pathogens would have known properties and could be mitigated by standard public health measures, and could be partially prevented by screening of commercially produced DNA molecules. In contrast to viruses, creating existing bacteria or completely novel pathogens from scratch was not yet possible as of 2018, and was considered a low risk.<ref name=":7">{{cite book |date=2018-06-19 |title=Biodefense in the Age of Synthetic Biology |language=en |publisher=[[National Academies of Sciences, Engineering, and Medicine]] |doi=10.17226/24890 |pmid=30629396 |isbn=9780309465182|last1=National Academies Of Sciences |first1=Engineering |author2=Division on Earth Life Studies |last3=Board On Life |first3=Sciences |author4=Board on Chemical Sciences Technology |s2cid=90767286 }}</ref>{{Rp|39–43, 54–56}}

Another capability of concern cited by NASEM is engineering existing pathogens to be more dangerous. This includes altering the [[Host tropism|targeted host]] or [[Tissue tropism|tissue]], as well as enhancing the pathogen's replication, [[virulence]], [[Transmissibility (epidemiology)|transmissibility]], or stability; or its ability to produce toxins, reactivate from a dormant state, evade natural or vaccine-induced immunity, or evade detection. The NASEM considered engineered bacteria to be a higher risk than viruses because they are easier to manipulate and their genomes are more stable over time.<ref name=":7" />{{Rp|5, 44–53}}

A final capability of concern cited by NASEM is engineering microbes to produce harmful biochemicals. [[Metabolic engineering]] of microorganisms is a well established field that has targeted production of fuels, chemicals, food ingredients, and pharmaceuticals, but it could be used to produce [[toxin]]s, [[antimetabolite]]s, [[controlled substance]]s, [[explosive]]s, or [[chemical weapon]]s. This was considered to be a higher risk for naturally occurring substances than for artificial ones.<ref name=":7" />{{Rp|59–65}}

There is also the possibility of novel threats that were considered lower risks by NASEM due to their technical challenges. Delivery of an engineered organism into the [[Human microbiota|human microbiome]] has the challenges of delivery and persistence in the microbiome, though an attack would be difficult to detect and mitigate. Pathogens engineered to alter the human immune system by causing [[immunodeficiency]], [[Hypersensitivity|hyperreactivity]], or [[autoimmunity]], or to directly alter the human genome, were also considered lower-risk due to extreme technical challenges.<ref name=":7" />{{Rp|65–83}}

=== Environmental ===
Environmental hazards include toxicity to animals and plants, as well as adverse effects on [[biodiversity]] and [[ecosystem services]]. For example, a toxin engineered into a plant to resist specific insect [[Pest (organism)|pests]] may also affect other invertebrates.<ref name=":3" />{{Rp|18}} Some highly speculative hazards include engineered organisms becoming [[Invasive species|invasive]] and outcompeting natural ones, and [[horizontal gene transfer]] from engineered to natural organisms.<ref name=":4">{{cite journal |last=Trump |first=Benjamin D. |date=2017-11-01 |title=Synthetic biology regulation and governance: Lessons from TAPIC for the United States, European Union, and Singapore |language=en |journal=Health Policy |issn=0168-8510 |doi=10.1016/j.healthpol.2017.07.010 |pmid=28807332 |volume=121 |issue=11 |pages=1139–1146|doi-access=free }}</ref><ref name=":8">{{cite web |date=September 2016 |title=Future Brief: Synthetic biology and biodiversity |language=en |website=European Commission |pages=14–16 |url=http://ec.europa.eu/environment/integration/research/newsalert/multimedia/synthetic_biology_and_biodiversity.htm |access-date=2019-01-14}}</ref> [[Gene drive]]s to suppress disease vectors may inadvertently affect the target species' fitness and alter ecosystem balance.<ref name=":8" />

In addition, synthetic biology could lead to land-use changes, such as non-food synthetic organisms displacing other agricultural uses or wild land. It could also cause products to be produced by non-agricultural means or through large-scale commercial farming, which could economically outcompete small-scale farmers. Finally, there is a risk that conservation methods based on synthetic biology, such as [[de-extinction]], may reduce support for traditional conservation efforts.<ref name=":8" /><ref>{{cite book |date=2016-04-04 |title=Final opinion on synthetic biology III: Risks to the environment and biodiversity related to synthetic biology and research priorities in the field of synthetic biology |language=en |website=EU Directorate-General for Health and Food Safety |pages=8, 27 |isbn=9789279549731 |url=https://publications.europa.eu/en/publication-detail/-/publication/9b231c71-faf1-11e5-b713-01aa75ed71a1/language-en/format-PDF |access-date=2019-01-14}}</ref>

== Hazard controls ==

=== Extrinsic ===
[[File:Superciste_prostory.jpg|alt=A person in white lab gear sits in front of a rigid transparent enclosure.|thumb|[[Biosafety cabinet]]s are designed to contain [[bioaerosol]]s and are an example of extrinsic containment.]]
Extrinsic [[biocontainment]] encompasses physical containment through [[engineering controls]] such as [[biosafety cabinet]]s and [[glovebox]]es,<ref name=":1" /><ref name=":6">{{cite web |date=2018-04-20 |title=Biosafety in Microbiological and Biomedical Laboratories |edition=5th |language=en-us |website=U.S. [[Centers for Disease Control and Prevention]] |at=[https://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_sect_III.pdf Section III – Principles of Biosafety] |url=https://www.cdc.gov/biosafety/publications/bmbl5/index.htm |access-date=2019-01-07}}</ref> as well as [[personal protective equipment]] including gloves, coats, gowns, shoe covers, boots, respirators, face shields, safety glasses, and goggles. In addition, facilities used for synthetic biology may include decontamination areas, specialized ventilation and air treatment systems, and separation of laboratory work areas from public access.<ref name=":6" /> These procedures are common to all microbiological laboratories.<ref name=":1" />

In agriculture, extrinsic biocontainment methods include maintaining isolation distances and physical [[pollen]] barriers to prevent modified organisms from fertilizing wild-type plants, as well as [[sowing]] modified and [[Wild type|wild-type]] seed at different times so that their flowering periods do not overlap.<ref name="sustainableag2">{{cite book |last1=Devos |first1=Yann |last2=Demont |first2=Matty |last3=Dillen |first3=Koen |last4=Reheul |first4=Dirk |last5=Kaiser |first5=Matthias |last6=Sanvido |first6=Olivier |editor-last1=Lichtfouse |editor-first1=Eric |editor-last2=Navarrete |editor-first2=Mireille |editor-last3=Debaeke |editor-first3=Philippe |editor-last4=Véronique |editor-first4=Souchere |editor-last5=Alberola |editor-first5=Caroline |date=2009-11-11 |title=Sustainable Agriculture |publisher=Springer Science & Business Media |chapter=Coexistence of Genetically Modified and Non-GM Crops in the European Union: A Review |language=en |isbn=9789048126668 |pages=210–214 |chapter-url=https://books.google.com/books?id=7cP-2jIIO2wC&pg=PA210}}</ref>

=== Intrinsic ===
[[File:AUXOTROPHY Fig 1Replica plating growth comparison between Arg- Auxotroph and Prototroph cropped.png|thumb|[[Auxotrophy]] is an intrinsic biocontainment method where an organism is unable to synthesize a particular compound required for its growth. This is intended to reduce the risk that it can survive after an accidental release or exposure event.]]
[[File:GNA-T vs. natural DNA-T.png|thumb|Synthetic organisms that use [[xeno nucleic acid]]s ''(example, left)'' instead of DNA ''(right)'' have been proposed as an intrinsic biocontainment strategy to prevent contamination of natural organisms through [[horizontal gene transfer]].]]

Intrinsic biocontainment is the proactive design of functionalities or deficiencies into organisms and systems to reduce their hazards. It is unique to engineered organisms such as GMOs and synthetic organisms, and is an example of [[hazard substitution]] and of [[prevention through design]]. Intrinsic biocontainment can have many goals, including controlling growth in the laboratory or after an unintentional release, preventing [[horizontal gene transfer]] to natural cells, preventing use for bioterrorism, or protecting the [[intellectual property]] of the organism's designers.<ref name=":1" /> There has been concern that existing genetic safeguards are not reliable enough due to the organism's ability to lose them through mutation. However, they may be useful in combination with other hazard controls, and may provide enhanced protections relative to GMOs.<ref name=":3">{{cite book |date=2016-02-12 |title=Opinion on synthetic biology II: Risk assessment methodologies and safety aspects |website=EU [[Directorate-General for Health and Consumers]] |language=en |doi=10.2772/63529 |url=https://publications.europa.eu/en/publication-detail/-/publication/bfd7d06c-d3ae-11e5-a4b5-01aa75ed71a1/language-en|author1=European Commission. Directorate General for Health Consumers |publisher=Publications Office of the European Union |isbn=9789279439162 }}</ref>{{Rp|6, 40–43}}<ref name=":1" />

Many approaches fall under the umbrella of intrinsic biocontainment. [[Auxotrophy]] is the inability of an organism to synthesize a particular compound required for its growth, meaning that the organism cannot survive unless the compound is provided to it. A [[kill switch]] is a pathway that initiates cell death that is triggered by a signal from humans.<ref name=":3" />{{Rp|40–43}}<ref name=":1" /> Inability of the organisms to replicate is another such method.<ref name=":3" />{{Rp|50}}

Methods specific to plants include [[cytoplasmic male sterility]], where viable pollen cannot be produced; and [[transplastomic plant]]s where modifications are made only to the [[chloroplast DNA]], which is not incorporated into pollen.<ref name="sustainableag2" />

Methods specific to viral vectors include splitting key components between multiple plasmids, omitting accessory proteins related to the wild-type virus' function as a pathogen but not as a vector, and the use of self-inactivating vectors.<ref name=":1" />

It has been speculated that [[xenobiology]], the use of alternative biochemistry that differs from natural DNA and proteins, may enable novel intrinsic biocontainment methods that are not possible with traditional GMOs. This would involve engineering organisms that use artificial [[xeno nucleic acid]]s (XNA) instead of DNA and RNA, or that have an altered or [[expanded genetic code]].<ref name=":3" />{{Rp|33–36, 43, 49}} These would be theoretically incapable of horizontal gene transfer to natural cells. There is speculation that these methods may have lower failure rates than traditional methods.<ref name=":3" />{{Rp|33–36, 43, 49}}<ref name=":1" />

== Risk assessment ==
While the hazards of synthetic biology are similar to those of existing biotechnology, [[risk assessment]] procedures may differ given the rapidity with which new components and organisms are generated.<ref name=":3" />{{Rp|5}} Existing risk analysis systems for GMOs are also applicable for synthetic organisms,<ref name=":2" /> and [[workplace health surveillance]] can be used to enhance risk assessment.<ref name=":1" /> However, there may be difficulties in risk assessment for an organism built "bottom-up" from individual genetic sequences rather than from a donor organism with known traits.<ref name=":2">{{cite web |last1=Bailey |first1=Claire |last2=Metcalf |first2=Heather |last3=Crook |first3=Brian |date=2012 |title=Synthetic biology: A review of the technology, and current and future needs from the regulatory framework in Great Britain |website=UK [[Health and Safety Executive]] |url=http://www.hse.gov.uk/research/rrpdf/rr944.pdf |access-date=2018-11-29}}</ref>{{Rp|v, vii}} Synthetic organisms also may not be included in preexisting classifications of microorganisms into risk groups.<ref name=":3" />{{Rp|20}} An additional challenge is that synthetic biology engages a wide range of disciplines outside of biology, whose practitioners may be unfamiliar with microbiological risk assessment.<ref name=":2" />{{Rp|v}}

For biosecurity, risk assessment includes evaluating the ease of use by potential actors; its efficacy as a weapon; practical requirements such as access to expertise and resources; and the capability to prevent, anticipate, and respond to an attack.<ref name=":7" />{{Rp|2–7}} For environmental hazards, risk assessments and field trials of synthetic biology applications are most effective when they include metrics on non-target organisms and ecosystem functions.<ref name=":3" />{{Rp|18}} Some researchers have suggested that traditional [[life-cycle assessment]] methods may be insufficient because unlike with traditional industries, the boundary between industry the environment is blurred, and materials have an information-rich description that cannot be described only by their chemical formula.<ref>{{Cite journal |last1=Seager |first1=Thomas P. |last2=Trump |first2=Benjamin D. |last3=Poinsatte-Jones |first3=Kelsey |last4=Linkov |first4=Igor |date=2017-06-06 |title=Why Life Cycle Assessment Does Not Work for Synthetic Biology |language=en |journal=Environmental Science & Technology |issn=0013-936X |doi=10.1021/acs.est.7b01604 |pmid=28504514 |volume=51 |issue=11 |pages=5861–5862|bibcode=2017EnST...51.5861S |doi-access=free }}</ref>

== Regulation ==

=== International ===
Several treaties contain provisions which apply to synthetic biology. These include the [[Convention on Biological Diversity]], [[Cartagena Protocol on Biosafety]], [[Nagoya–Kuala Lumpur Supplementary Protocol on Liability]], [[Biological Weapons Convention]], and [[Australia Group]] Guidelines.<ref name=":5" />

=== United States ===
In general, the United States relies on the regulatory frameworks established for chemicals and pharmaceuticals to regulate synthetic biology, mainly the [[Toxic Substances Control Act of 1976]] as updated by the [[Frank R. Lautenberg Chemical Safety for the 21st Century Act]], as well as the [[Federal Food, Drug, and Cosmetic Act]].<ref name=":4" />

The biosafety concerns about synthetic biology and its gene-editing tools are similar to the concerns lodged about [[recombinant DNA]] technology when it emerged in the mid-1970s. The recommendations of the 1975 [[Asilomar Conference on Recombinant DNA]] formed the basis for the U.S. [[National Institutes of Health]] (NIH) guidelines, which were updated in 2013 to address organisms and viruses containing synthetic nucleic acid molecules.<ref name=":0" /> The [[NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Molecules]] are the most comprehensive resource for synthetic biology safety. Although they are only binding on recipients of NIH funding, other government and private funders sometimes require their use, and they are often voluntarily implemented by others. In addition, the 2010 [[NIH Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA]] provides voluntary guidelines for vendors of synthetic DNA to verify the identity and affiliation of buyers, and screen for sequences of concern.<ref name=":5">{{cite book |last1=Pei |first1=Lei |last2=Bar-Yam |first2=Shlomiya |last3=Byers-Corbin |first3=Jennifer |last4=Casagrande |first4=Rocco |last5=Eichler |first5=Florentine |last6=Lin |first6=Allen |last7=Österreicher |first7=Martin |last8=Regardh |first8=Pernilla C. |last9=Turlington |first9=Ralph D. |date=2012 |title=Regulatory Frameworks for Synthetic Biology |language=en |work=Synthetic Biology |publisher=John Wiley & Sons, Ltd |doi=10.1002/9783527659296.ch5 |isbn=9783527659296 |pages=157–226}}</ref>

The [[Occupational Safety and Health Administration]] (OSHA) regulates the health and safety of workers, including those involved in synthetic biology. In the mid-1980s, OSHA maintained that the [[general duty clause]] and existing regulatory standards were sufficient to protect biotechnology workers.<ref name=":0" />

The [[United States Environmental Protection Agency|Environmental Protection Agency]], [[United States Department of Agriculture|Department of Agriculture]] [[Animal and Plant Health Inspection Service]], and [[Food and Drug Administration]] regulate the commercial production and use of genetically modified organisms. The [[United States Department of Commerce|Department of Commerce]] [[Bureau of Industry and Security]] has authority over [[dual-use technology]], and synthetic biology falls under [[select agent]] rules.<ref name=":5" />

=== Other countries ===
In the [[European Union]], synthetic biology is governed by Directives 2001/18/EC on the intentional release of [[Genetically modified organism|GMOs]], and 2009/41/EC on the contained use of genetically modified micro-organisms,<ref name=":1" /><ref name=":2" />{{Rp|vi}} as well as Directive 2000/54/EC on biological agents in the workplace.<ref name=":4" /> As of 2012, neither the European Community nor any member state had specific legislation on synthetic biology.<ref name=":5" />

In the [[United Kingdom]], the [[Genetically Modified Organisms (Contained Use) Regulations 2000]] and subsequent updates are the main law relevant to synthetic biology.<ref name=":2" />{{Rp|16}}<ref name=":5" /> [[China]] had not developed synthetic biology specific regulations as of 2012, relying on regulations developed for GMOs.<ref name=":5" /> [[Singapore]] relies on its Biosafety Guidelines for GMOs,  [[Biological Agents and Toxins Act]], and the [[Workplace Safety and Health Act]].<ref name=":4" /><ref name="Schiemann-et-al-2019">{{cite journal | last1=Schiemann | first1=Joachim | last2=Dietz-Pfeilstetter | first2=Antje | last3=Hartung | first3=Frank | last4=Kohl | first4=Christian | last5=Romeis | first5=Jörg | last6=Sprink | first6=Thorben | title=Risk Assessment and Regulation of Plants Modified by Modern Biotechniques: Current Status and Future Challenges | journal=[[Annual Review of Plant Biology]] | publisher=[[Annual Reviews (publisher)|Annual Reviews]] | volume=70 | issue=1 | date=2019-04-29 | issn=1543-5008 | doi=10.1146/annurev-arplant-050718-100025 | pages=699–726| pmid=30822113 | s2cid=73460651 | doi-access=free }}</ref>

==See also==
*[[Biosafety level]]
*[[Regulation of genetic engineering]]
*[[Biocontainment of genetically modified organisms]]

==References==
{{reflist}}

[[Category:Synthetic biology]]
[[Category:Occupational hazards]]
[[Category:Biological contamination]]
[[Category:Regulation of biotechnologies]]