principles for the oversight of synthetic biology-embargoed

8/2/2019 Principles for the Oversight of Synthetic Biology-embargoed

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EMBARGOED UNTIL 11 A.M. EDT, TUESDAY, MARCH 13, 2012


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Te Principles or the Oversight

o Synthetic Biology

Drated through a collaborative process among civil society groups.

For more inormation or copies o this declaration, contact:Eric HomanFood and technology policy campaignerFriends o the Earth U.S.1100 15th St. NW, 11th Floor

Washington, D.C. [email protected]

www.oe.org

Jaydee HansonPolicy directorInternational Center or echnology Assessment660 Pennsylvania Ave., SE, Suite 302

Washington, D.C. 20003202.547.9359

[email protected]

Jim TomasResearch program managerEC Group5961 Rue Jeanne MarceMontreal, QuebecCanada+1.514.273.9994

[email protected]

Te views expressed in this declaration represent those o the signers and donot necessarily represent those o individual contributors to Friends o theEarth U.S., International Center or echnology Assessment, EC Group

or the unding organizations.

Funding thanks to CS Fund and Appleton Foundation.
mailto:%[email protected]://www.foe.org/mailto:%[email protected]://www.icta.org/mailto:%[email protected]:%[email protected]://www.icta.org/mailto:%[email protected]://www.foe.org/mailto:%[email protected]


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Te undersigned, a broad coalition of civil

society groups, social movements, local and

indigenous communities, public interest,

environmental, scientif ic, human rights,

religious and labor organizations concerned

about various aspects of synthetic biologyshuman health, environmental, social,

economic, ethical and other impacts, ofer the

following declaration, Te Principles for the

Oversight of Synthetic Biology.

Te Principles or the

Oversight o Synthetic Biology


4/201 Te Principles or the Oversight o Synthetic Biology

Executive Summary

Synthetic biology, an extreme orm o genetic engi-neering, is developing rapidly with little oversight orregulation despite carrying vast uncertainy. Standardorms o risk assessment and cost-benet analyses reliedon by current biotechnology regulatory approaches areinadequate to guarantee protection o the public andthe environment. Te Precautionary Principle is un-damental in protecting the public and our planet romthe risks o synthetic biology and its products.

A precautionary approach requires synthetic biolo-gy-specic oversight mechanisms that account or theunique characteristics o synthetic organisms and theirproducts. Additionally, it assesses the novel consequenc-es o synthetic organisms and products o synthetic biol-ogy as well as ull consideration o alternative options.Ensuring public health, worker saety and ecosystemresilience requires a committed ocus on developing acritical public interest research agenda that includes riskresearch and development o alternatives, a robust pre-

market regulatory regime, strong enorcement mecha-nisms, immediate action to prevent potential exposuresuntil saety is demonstrated and ongoing monitoringor unintended consequences and immediate actionto prevent potential exposures until saety is demon-strated. Protection o the public includes a ban on usingsynthetic biology to manipulate the human genome inany orm, including the human microbiome. Decisiveaction must also be taken to protect the environmentand human health and to avoid contributing to social

and economic injustice. Developers and manuactur-ers must be responsible or the saety and eective-ness o their processes and products and must retainliability or any adverse impacts. Troughout, researchand regulation shall be transparent and provide publicaccess to all inormation regarding decision-makingprocesses, saety testing and products. Open, meaninguland ull public participation at every level is essential

and should include consideration o synthetic biologyswide-ranging eects, including ethical, social and eco-nomic results. No synthetic organism or their syntheticbuilding blocks should be commercialized or releasedwithout ull disclosure to the public o the nature o thesynthetic organism and results o saety testing.

Tis document outlines the ollowing principles nec-essary or the eective assessment and oversight o theemerging eld o synthetic biology:

I. Employ the Precautionary Principle

II. Require mandatory synthetic biology-specicregulations

III. Protect public health and worker saety

IV. Protect the environment

V. Guarantee the right-to-know and democraticparticipation

VI. Require corporate accountability andmanuacturer liability

VII. Protect economic and environmental justice

Governmental bodies, international organizations andrelevant parties must immediately implement strongprecautionary and comprehensive oversight mechanismsenacting, incorporating and internalizing these basicprinciples. Until that time, there must be a moratoriumon the release and commercial use o synthetic organ-isms and their products to prevent direct or indirectharm to people and the environment.i


5/20Te Principles or the Oversight o Synthetic Biology 2

Introduction

Synthetic biology practitioners begin with computer-assisted biological engineering to design and attempt toconstruct new biological organisms or biological build-ing blocks, or to redesign existing biological organisms.In building new lie orms rom scratch using publishedgene sequence inormation or by buying inexpensive,made-to-order DNA strands rom so-called DNAoundries, synthetic biologists are not just reading andrearranging genetic code, but writingit. Synthetic biol-

ogy is extreme genetic engineering re-engineeringand designing genes and creating entire genomes thatdo not exist in nature as well as designing and buildingmolecules, cell compounds and organelles to desiredspecications.

Governments, universities, research institutes and cor-porations around the world are now racing to developand commercialize products using synthetic biology.Synthetic biologists have already synthesized working

viruses, including the deadly 1918 inuenza virus and

the poliovirus. In May 2010, the J. Craig Venter Insti-tute announced that its lab had built the rst synthetic,sel-replicating bacterial cell that is, researchers in-serted an entirely synthetic genome into an existing

working cell; the cell accepted the synthetic genomeand reproduced. Tis technical eat is a wake-up callto governments around the world.

Despite industry claims that these technologies aresae, this new technological rontier poses signicant

health, saety and environmental hazards, as well asproound social, economic and ethical challenges.

Te technical ability to synthesize DNA and createsynthetic organisms ar outpaces our understanding ohow these novel products may work. Even engineeringsupposedly simple organisms could have major eco-logical and health eects. Tis unpredictability makes

the task o precautionary risk assessment that muchmore difcult, but also all the more necessary. Researchon the eects o these new technologies and syntheticbiology-specic regulations must keep pace with thetechnologies development. Commercializing syntheticbiology at this stage is premature.

Te risks o releasing synthetic organisms into theenvironment intentionally or unintentionally havebarely begun to be dened, and the urgently needed

ethical, legal and regulatory oversight mechanisms re-main undeveloped. Without proper saeguards, we riskletting synthetic organisms and their products out othe laboratory with unknown potential to disrupt eco-systems, threaten human health and undermine socialeconomic and cultural rights.

Tis document outlines the ollowing principles nec-essary or the eective assessment and oversight o theemerging eld o synthetic biology:


II. Require mandatory synthetic biology-specicregulations



V. Guarantee the right-to-know and democraticparticipation

VI. Require corporate accountability andmanuacturer liability

VII. Protect economic and environmental justice




Te Precautionary Principle must be applied to syn-thetic biology because the risks of the technology areinherently unpredictable with potentially far-reachingand irreversible impacts. Te Precautionary Principle,integrated into many international conventionsii andnational laws, is aptly described in the WingspreadConsensus Statement on the Precautionary Principle:

When an activity raises threats o harm tohuman health or the environment, precaution-ary measures should be taken even i some cause

and eect relationships are not ully establishedscientifcally. In this context the proponent o an

activity, rather than the public, should bear theburden o proo. Te process o applying the Pre-

cautionary Principle must be open, inormed and

democratic and must include potentially aected

parties. It must also involve an examination o

the ull range o alternatives, including no ac-tion.iii

Applying the Precautionary Principle to the eld osynthetic biology rst necessitates a moratorium on therelease and commercial use o synthetic organisms,cells, or genomes until government bodies, with ullparticipation o the public, have:

Developed a research agenda guided by thepublic interest.

Ensured that alternative approaches to syntheticbiology applications have ully been considered.

Conducted ull and inclusive assessments o theimplications o this technology, including butnot limited to devising a comprehensive meanso assessing the human health, environmental,

and socio-economic impacts o synthetic biolo-gy and preventing harms where they are present

Developed national and international oversightand security mechanisms equipped to keep pacewith the risks as synthetic biology technologiesdevelop.

Te Cartagena Protocol on Biosaety provides guide-lines or the sae handling, transport and use o any

living modied organism.iv

Te 193 nations that areParties to the UN Convention on Biological Diversity(CBD) agreed at their 10th Conerence in 2010 that therelease o synthetic biologys products requires precau-tion. Te agreement rom the 10th Conerence o theParties reads:

Parties and other Governments [are] to ap-ply the precautionary approach in accordancewith the Preamble to the Convention, and theCartagena Protocol, to the introduction and use

o living modifed organisms or the productiono biouels as well as to the feld release o syn-thetic lie, cell, or genome into the environment,

acknowledging the entitlement o Parties, in ac-

cordance with domestic legislation, to suspend the

release o synthetic lie, cell, or genome into theenvironment.v

Additionally, the CBD agreed to study urther therisks this technology poses to the environment, biodi-

versity, livelihoods and human health.

he Principles



II. Require mandatory synthetic biology-specifc regulations

Implementing enforceable and prosecutable synthet-ic biology-specic regulations must be a prior con-dition or uture developments in synthetic biology.Such regulations should complement and strengthen,not replace, any other applicable regulations, such as

worker protections, environmental regulations, druglaws and restrictions on pathogens, among others. Tese

regulations should also be considered as a rameworkor new biotechnology laws as the current regulationsaround biotechnologies are inadequate and outdated.

Voluntary sel-regulation by practitioners is not a sub-stitute or synthetic biology-specic regulations enactedby governments and international treaties. Sel-regula-tion does not allow or oversight or public participation,diminishes transparency and does not provide recoursein the event o worker/public health accidents, environ-mental disruption or economic harms.

In time, dierent methods and techniques o syntheticbiology may need dierent orms and levels o oversightTereore any new risk assessments, cost-benet analy-ses and regulations must exibly encompass dierenapplications, uses and products. Furthermore, assess-ments should include ull comparative considerationo alternative approaches.

Regulations should speciy civil and criminal penaltiesor violations. Penalties should be imposed or ailure

to obtain proper licenses, ailure to adhere to labora-tory standards, unauthorized release o synthetic DNARNA, or synthetic organisms, ailure to train and equipworkers, exposing workers to harm and ailure to reportadverse incidents to government authorities.

Te absence o mandatory synthetic biology-specicregulations necessitates a moratorium on release andcommercialization o synthetic organisms, cells or ge-nomes.

Te Precautionary Principle must be applied to synthetic biology because the r isks o the technology are in herently unpredictable with poten-tially ar-reaching and irreversible impacts.




Adequate and efective synthetic biology oversightrequires an immediate emphasis on preventing knownand potential human exposures to synthetic organismsthat have not been proven sae.

Workers in synthetic biology laboratories will likelybe the rst to be exposed to any potential hazards. Ex-isting workplace saety procedures and laws must be

augmented to take into account the unique risks andchallenges to human health posed by organisms cre-ated through synthetic biology. Many o the organismsengineered through synthetic biology (e.g., algae) areeasily aerosolized and can easily escape connementor be inhaled. Because these products are impercep-tible, workers could unknowingly carry them out o the

workplace and into the broader community. Protocolsmust be in place and strictly adhered to in order toensure that synthetic organisms and their products areadequately contained.

Te public must be inormed i such work is beingconducted in their community. Workers and the publicmust be inormed o the risks involved with syntheticbiology and those working with synthetic organismsmust generate clear and reliable means to track, disableand/or destroy strains as a prerequisite to carrying outexperiments with them.

Additionally, workers should be allowed to reuse

work without ear o retaliation or termination i theyreport saety concerns regarding the use o syntheticbiology products and associated technologies. Work-ers must have access to qualied saety representatives

with whom they can disclose and assess health andenvironmental saety concerns.

Occupational medical and exposure records must beavailable to workers and their representatives imme-

diately upon request, and disclosure o such recordscannot be withheld as condential business or tradesecret inormation.

All employees must be notied whenever syntheticbiological products are being used within their imme-diate vicinity or anywhere within their laboratory orworkplace.

All containment ailures, worker injuries or illnesses

and human exposures must be documented and report-ed to the proper workplace saety authorities, and detailsmust be available upon request. Te public must haveprompt access to complete accident reports on govern-ment websites, including specic accident locations andthe synthetic constructs or organisms involved. Te soleexemption should be or personal medical inormation

Te environmental and health risks o synthetic organ-isms, their synthetic building blocks and their productsmust be assessed and disclosed prior to any intendedor unintended release or commercial use. Continuedsystematic disclosure o health and saety inormationthroughout the liecycle o the organism and its prod-ucts is necessary to improve oversight o governmenand industry decisions, help people protect themselvesand encourage development o saer alternatives.

Te use o synthetic biology to change the humangenetic makeup including the human genomeepigenome and human microbiome must be pro-

hibited.

Te convergence o synthetic biology with other tech-nologies such as gene transer through viral, nanomate-rial or stem cell vectors creates the troubling possibilityo altering the human genome. Any alterations to thehuman genome through synthetic biology particu-larly inheritable genetic changes are too risky andraught with ethical concerns.




Synthetic biology requires the strictest levels ophysical, biological and geographic containment as

well as independent environmental risk assessmentor each proposed activity or product.

Synthetic biologys environmental risks are unknown.In order to identiy potential environmental risks andregulatory gaps, governments must require that pre-

market environmental impact and liecycle risk assess-ments are conducted or each distinct synthetic organ-ism, each synthetic construct and each product derivedrom synthetic organisms and constructs.

Te capacity o each synthetic organism to survive inthe environment and reproduce must be known beoreany such organisms leave the laboratory. Unlike mostother environmental contaminants that become morediuse over time, synthetic organisms are designed toreproduce and will evolve. Once released into the en-

vironment, these organisms may be impossible to recallor eliminate.

When synthetic organisms are released into the en-vironment, either intentionally or unintentionally, theycould nd an ecological niche and become a new in-

vasive species that disrupts ecosystems. Moreover, theability o many microorganisms to take up DNA romliving and even dead organisms means that syntheticDNA can be spread in the environment even ater the

synthetic organism dies.



Connement strategies or preventing the release osynthetic organisms into the biosphere must include:

1) Means to prevent the whole organism, and itscomponents, rom entering and surviving in areceiving environment.

2) Means to prevent gene contamination rom thesynthetic organism to wild or naturally occurringorganisms.

Adequate containment must include:

1) Physical containment to keep the synthetic or-ganism rom entering the environment.

2) Geographical containment that only allows grow-ing an organism in a location where it cannotsurvive in the surrounding environment i it es-capes. Tis also includes locating acilities outsideearthquake ault zones, coastal zones where tsu-namis or strong storms could damage the acility,or in ood plains.

3) Biological containment to inhibit the move-ment o the synthesized organisms, to inhibit theability o the organism to reproduce outside acontained system, to prevent reproduction once itenters the environment, and to prevent expressiono synthesized genetic constructs in other wild-type organisms in the environment.

Some proponents have suggested relying on methodso biological containment originally designed or geneti-

cally engineered plants and animals, such as so-calledsuicide genes and other types o sel-destruction tech-nologies. Tese methods are no substitute or physical,geographical and biological containment designed toprevent the release o synthetic organisms. Scientists

who have studied terminator technologies in seedshave concluded that they are not ailsae. Frequentlyoccurring mutations allow organisms to overcome the

intended sterilization, thereby allowing those organ-isms to remain viable. Specically, suicide genes andother genetic use restriction technologies represent anevolutionary disadvantage; selective pressures will leadorganisms to overcome intended biological constraints.v

Attempts to develop alternative genetic systems (suchas xenobiology1, mirror biology2 or novel amino acids3)are not well enough understood to claim they providesaety. Tey should not be tested outside the laboratory

Importantly, the UN Convention on Biological Diver-sity has mandated an international moratorium on theuse o terminator technologies, such as suicide genes,and other genetic use restriction technologies, whichhas been in place or the past decade. Reliance on anunproven technology that has been deemed unaccept-able by 193 nations as a principal method to containsynthetic organisms is irresponsible and legally dubious

Additionally, the intentional release o synthetic or-

ganisms into the environment or such things as bio-remediation or other applications must be prohibited.

Te ailure to prioritize (e.g., properly und) risk-relevant environmental impact researchvii necessitatesa moratorium on the commercial use o synthetic or-ganisms, cells or genomes and their release into theenvironment.

1 Xenobiologists explore the possibility that lie might be created without relying oncarbon or water or using the 20 usual amino acids ound in lie on Earth.

2 Mirror biology is a biology based on the mirror image o amino acids. Mirrorimage molecules were not at rst thought to be a problem. Tat is why the 1960scontroversy over the antinausea drug thalidomide was such a surprisetheright-handed version calmed morning sickness in pregnant women, but the let-handed version caused birth deects.

3 Chemists long have been aware o literally hundreds o amino acids in addition tothe normal 20 that make up all protein molecules coded by DNA in biology.



V. Guarantee the right-to-know anddemocratic participation

Comprehensive public and worker participationshould be provided throughout the decision-makingprocesses involving synthetic biology.

Inormation about human health and environmentaleects must be communicated throughout the completestream o commerce so that all users o products o

synthetic biology know the hazards o the organismsand products they use.

Researchers and companies seeking approval or devel-opment and commercialization o any products derived

rom synthetic biology must provide government agen-cies with the necessary tests to detect synthetic organ-isms in the case o unintended release or exposure. Inaddition to requiring synthetic biology researchers toreport their activities in detail to the communities in

which they work, to their national governments, andpublicly on the Internet, researchers must also developprotocols or destroying the organisms when the re-search is completed and reporting the results to theircommunities and nations.

All accidental releases into air, water or soil shouldbe reported immediately to the local community andnational authorities, and contact inormation or such

Synthetic biology requires the strictest levels o physical, biological and geographic containment as well as independent environmental riskassessment or each proposed activity or product.



reporting must be prominently posted in all laboratoriesand acilities. Saety data should be available or publicinspection on websites and reported to public bodies.

All containers holding synthetic organisms or theirsynthetic parts should be clearly labeled. Mandatorylabeling will help governments track these syntheticorganisms. Products, including medicines, vaccines,biouels and other industrial materials created throughsynthetic biology should be labeled at all phases in

the lab, while in transport and, i commercialized, onthe physical products. Marketing materials and adver-tisements or these products must state that they areproducts o synthetic biology.

Closely linked with the right-to-know is our essentialright-to-participate in decisions about environmentaland societal hazards that aect our lives.

Te public must have the legally enforceable right tohalt dangerous applications, not just comment aterdecisions have been made. Governments must providemeaningul involvement or the public and workersthroughout the entire decision-making process relatedto the development o synthetic biology and the prod-ucts o synthetic biology., including setting the researchagenda, the context and the scope o the risk assessment.

Tis includes making sure that communities have ac-cess to independent scientic and legal opinions on theproposed projects. Opportunities or participation indecisions on synthetic biology should not be narrowed

to only scientic input. Other orms o knowledge in-cluding traditional knowledge as well as analysis o cul-tural, legal, social and economic considerations shouldalso carry weight in decision-making processes.

Public involvement must be open, acilitating equalinput rom all interested and aected parties aroundthe globe including and especially:

1) Communities that could be impacted espe-cially poor communities where many o the rstcommercial acilities using synthetic organismswill be located.4

2) Labor unions and workplace saety groups con-cerned about exposure.

3) Communities concerned about eedstock pro-curement, land use and other social, economicand cultural implications (See Principle VIIbelow).

Te use o synthetic biology techniques to developdrugs and vaccines is already underway. Data on anyhealth eects rom these techniques cannot be consid-ered condential business inormation by companiesand researchers. Additionally, long-term ollow-upstudies o patients taking synthetic biology-derivedmedicines or therapies must be mandatory and theremust be ull disclosure o all the material acts romthese studies.

4 For example, Amyris Biotechnologies is currently raising synthetic yeast or theproduction o biouels and cosmetics in Brazil. Tis is to have access to largeamounts o cheap sugarcane to eed their yeast.



VI. Require corporate accountability andmanuacturer liability or all products osynthetic biology

Tose using synthetic biology must be nanciallyand legally accountable or any harm caused to thepublic, worker health or the environment.

For a product produced through synthetic biology tobe placed on and remain in the market, manuactur-ers must provide all available saety inormation aboutthe synthetic organism and its products. Te inorma-tion must be sufcient to permit a reasonable evalua-tion o the saety o the synthetic organism on humanhealth and the environment, including hazard, use andexposure inormation. Tis means that i there are nodata, the product should not be on the market. Prior toregulatory approval o the products o synthetic biol-ogy, developers must demonstrate that they are able toaccept the nancial and legal liability that could comerom manuacture, use and disposal o their products.

Developers o synthetic biology and their unders mustestablish nancial mechanisms, even at the researchstage, to assure that adequate unds are available tomitigate and compensate or health, worker or envi-ronmental damages. I commercial insurers are unwill-ing to provide insurance or this purpose, governmentsshould not insure the developers o synthetic biology. Ithe risk is too great or private investors, it is too greator the public.

Synthetic biology companies should bear the cost oproducing accurate environmental and health saety in-ormation. Tis inormation must be a precondition orproducts intended or marketing and be issued beoresignicant quantities o a product are manuactured toassist in protection o workers. Industry should pro-duce data on the earliest phases o the research and

development o its products, but ull assessments onhealth and saety should be generated and conductedby governments or independent laboratories at industryexpense to ensure the inormation is publically availableand reliable.

Strict standards that prohibit conicts o interestshould be maintained in the oversight o synthetic bi-ology research, including but not limited to prohibitingpersons with nancial interests in synthetic biology re-

search, development and commercialization rom rolesin its health and saety oversight.

Synthetic algae growing in a greenhouse.



VII. Protect economic and environmentaljustice

It is necessary to ensure that the development of syn-thetic biology does not deepen economic and socialinjustices.

Te impacts that synthetic biology could have onecosystems and communities in the global South areo special concern. At present, most commercial inter-

est in synthetic biology is ocused on enabling a newbiomass-based economy in which any type o plantmatter can be used as eedstock or tailored syntheticmicrobes to transorm into high value commercialproducts anything rom uels to plastics to indus-trial chemicals. As major industries shit to biomass-

derived eed stocks, larger and larger quantities o plantmaterial will be required. Biomass to eed syntheticmicrobes will be extracted rom or cultivated mostlyin the global South, disrupting ragile ecosystems andexacerbating environmental damage rom industrialcrop production. Further pressure will be placed on landand water resources, already in short supply or oodproduction. Tere is simply not enough land (or plantmatter) or all the uses that are being contemplatedFurthermore, a number o current applications o syn-thetic biology propose to replace botanical productiono natural plant-based commodities (e.g., rubber, plantoils, artemsinin) with vat-based production systemsusing synthetic microbes or to move production to ge-netically engineered plants. In time, these substitutions

Most commercial interest in synthetic biology is ocused on enabling a new biomass-based economy in which any type o plant matter can be used aseedstock or tailored synthetic microbes to transorm into high value commercial products anything rom uels to plastics to industrial chemicals.



could have devastating economic impacts on arming,shing and orest communities who depend on naturalcompounds or their livelihoods. Tese impacts andthe impacts o biomass extraction and associated landgrabbing must be considered in any assessment o risk.Tese assessments must include the ull and active par-ticipation o the communities that will be impacted.

Corporations have already applied or extremelybroadly worded patents on synthetic biology techniques.

I granted, they could give a small number o companiesvirtual de acto monopoly control over entire economicsectors, aecting the rights o small producers, patients(in the case o pharmaceutical patents) and the public atlarge. Patents on synthetic biology processes, syntheticorganisms or products derived rom synthetic biology

could urther the privatization and control o naturallyoccurring products and processes. Companies and re-searchers must not be permitted to patent syntheticversions o natural organisms. Tese patents could openup new avenues or bio-piracy and ways to circumvenaccess and benet-sharing agreements. ransparencypublic saety and environmental protection must takelegal precedence over any patent or intellectual propertyprotections.

Until the above principles are incorporated into in-ternational, ederal and local law as well as researchand industry practices, there must be a moratoriumon the release and commercial use o synthetic or-ganisms.

Synthetic biology products depend upon ermenting large quantities o sugarcane. Te production and harvesting, including burning, o cane eldsreleases large amounts o carbon dioxide and causes other environmental and social harms.



Synthetic biologists predict that new and extremegenetic engineering will usher in dramatic changesin all areas o human lie.While some have arguedthat synthetic biology can be a research tool to betterunderstand biology, it poses signicant and unprec-edented hazards. Te development o synthetic biology

without proper oversight and regulation could resultin inadequate control over the development o otherpotentially harmul emerging technologies.

Synthetic biology must, thereore, be accompanied byprecautionary mechanisms to saeguard the health o

workers and local communities, to preserve the biodi-versity o the planet, to ensure public participation, toprovide or democratically decided social goals, and torestore public trust in scientic researchers and govern-ment regulators. Te undersigned organizations call orthe governments o the world to incorporate these prin-ciples into local, national and international rameworksto provide oversight to this extreme orm o biological

engineering.

Conclusion



Endnotesi Tis declaration in no manner limits or binds the signatories rom any other relevant actions or statements, including unilateral or joint super-

seding statements on synthetic biology policy. Each organization continues to ulll their respective mission statements in accordance withtheir own undamental guiding principles. Tis joint declaration supplements our organizations work in this and related areas. Tis declara-tion is not intended to be a comprehensive statement o all possible oversight principles or to encompass all subsequent steps needed or theirimplementation; rather, it is a starting point rom which uture implementations o oversight policy can build.

ii See, e.g., RIO DECLARAION ON ENVIRONMEN AND DEVELOPMEN, June 14, 1992, 31 I.L.M. 874, 879 ( Where there arethreats o serious or irreversible damage, lack o ull scientic certainty shall not be used as a reason or postponing cost-eective measuresto prevent environmental degradation.); CARAGENA PROOCOL ON BIOSAFEY, Jan. 29, 2000, 39 I.L.M. 1027 Art. 10(6)(Lack o scientic certainty due to insufcient relevant scientic inormation and knowledge regarding the extent o the potential adverseeects o a living modied organism on the conservation and sustainable use o biological diversity in the Part o import, taking also intoaccount risks to human health, shall not prevent that party rom taking a decision, as appropriate, with regard to the import o the livingmodied organism in question . . . in order to avoid or minimize such potential adverse eects.); U.N. FRAMEWORK CONVEN-

ION ON CLIMAE CHANGE, May 9, 1992, 21 I.L.M. 849, (Te Parties should take precautionary measures to anticipate, preventor minimize the cause o climate change and mitigate its adverse eects. Where there are threats o serious or irreversible damage, lack oull scientic certainty should not be used as a reason or postponing such measures.); HE WORLD CHARER ON NAURE, G.A.Res. 37/7, 11, U.N. Doc. A/RES/37/7 (Oct. 28, 1982) (Activities which might have an impact on nature shall be controlled, and the bestavailable technologies that minimize signicant risks to nature or other adverse eects shall be used.); HE LONDON CONVENIONON HE PREVENION OF MARINE POLLUION BY DUMPING WASES AND OHER MAER, 1996 Protocol to thePrevention o Marine Pollution by Dumping o Wastes and Other Matter, Mar. 24, 2006, art. 3, para. 1 ( Appropriate preventative mea-sures are[to be] taken when there is reason to believe that wastes or other matter introduced into the marine environment are likely to causeharm even when there is no conclusive evidence to provide a causal relation between inputs and their eects.); AGREEMEN FOR HEIMPLEMENAION OF HE PROVISIONS OF HE UNIED NAIONS CONVENION ON HE LAW OF HE SEAOF 10 DECEMBER 1982 RELAING O HE CONSERVAION AND MANAGEMEN OF SRADDLING FISH SOCKSAND HIGHLY MIGRAORY FISH SOCKS, G. A. 164/37, art. 6, U.N. Doc. A/CONF164/37 (States shall apply the precautionaryapproach widely to conservation....).

iii Te Wingspread Consensus Statement on the Precautionary Principle. Science & Environmental Health Network, 26 Jan. 1998. .iv ext rom the Cartagena Protocol to the Convention on Biological Diversity can be viewed here: http://bch.cbd.int/protocol/text/.v COP 10 Decision X/37. Biouels and Biodiversity. UN Convention on Biological Diversity, Oct. 2011. .vi Steinbrecher, Ricarda A.V-GURs (erminator) as a Biological Containment ool?Rep. EcoNexus, June 2005. .vii One study o U.S. and European government unding into synthetic biology research conducted by the Wilson Centers Synthetic Biology

Project ound that while the U.S. government has spent around $430 million between 2005 and 2010, only 4% o this money went to exam-ine the ethical, legal and social implications o synthetic biology. When researchers searched or projects looking into risk assessment relatedto potential accidental release o synthetic organisms rom a lab or connement, or risks rom intentional release o synthetic organisms theyound no such projects. See: rends in Synthetic Biology Research Funding in the United States and Europe.Synthetic Biology Project.

Woodrow Wilson International Center or Scholars, June 2010. Web. .
http://www.sehn.org/wing.htmlhttp://www.sehn.org/wing.htmlhttp://www.cbd.int/decision/cop/?id=12303http://www.cbd.int/decision/cop/?id=12303http://www.econexus.info/sites/econexus/files/ENx_V-GURTs_brief_2005.pdfhttp://www.econexus.info/sites/econexus/files/ENx_V-GURTs_brief_2005.pdfhttp://www.synbioproject.org/process/assets/files/6420/final_synbio_funding_web2.pdf?http://www.synbioproject.org/process/assets/files/6420/final_synbio_funding_web2.pdf?http://www.synbioproject.org/process/assets/files/6420/final_synbio_funding_web2.pdf?http://www.synbioproject.org/process/assets/files/6420/final_synbio_funding_web2.pdf?http://www.econexus.info/sites/econexus/files/ENx_V-GURTs_brief_2005.pdfhttp://www.econexus.info/sites/econexus/files/ENx_V-GURTs_brief_2005.pdfhttp://www.cbd.int/decision/cop/?id=12303http://www.cbd.int/decision/cop/?id=12303http://www.sehn.org/wing.htmlhttp://www.sehn.org/wing.html



Arican Biodiversity Network

Agricultural Missions, Inc (AMI) (U.S.)

Alliance or Humane Biotechnology (U.S.)

Amberwaves (U.S.)

Amigos de la ierra Espaa

Asociacion ANDES (Peru)

Asociacin para la Promocin y el Desarrollo de laComunidad CEIBA / Friends o the Earth Guatemala

Basler Appell gegen Gentechnologie (Appeal o Basleagainst Genetic-Manipulation) (Switzerland)

Biouelwatch (International)

Biotechnology Reerence Group o the Canadian Councilo Churches

Biowatch South Arica

Brazilian Research Network in Nanotechnology, Society,and Environment - RENANOSOMA

Bund r Umwelt und Naturschutz Deutschland / Friendso the Earth Germany

Canadian Biotechnology Action Network (CBAN)Center or Biological Diversity (U.S.)

Center or Food Saety (U.S.)

Center or Genetics and Society (U.S.)

Center or Humans and Nature (U.S.)

Center or International Environmental Law (U.S.)

Centro Ecolgico (Brazil)

Centre or Environmental Justice/Friends o the Earth SriLanka

CESA - Amigos de la ierra, El SalvadorCitizens Environmental Coalition (U.S.)

COECOCEIBA - Friends o the Earth Costa Rica

Columban Center or Advocacy and Outreach (U.S.)

Community Alliance or Global Justice (CAGJ) (U.S.)

Development Fund (Norway)

Diverse Women or Diversity (India)

Doctors or Food Saety & Biosaety (India)

Econexus (International)

Ecoropa (Europe)

Envirocare (anzania)

Environmental Rights Action/Friends o the EarthNigeria

EC Group (International)

Ethiopian Society or Consumer Protection(EHIOSCOP)

European Network o Scientists or Social andEnvironmental Responsibility (ENSSER)

Family Farm Deenders (U.S.)

Federation o German Scientists

Food Democracy Now! (U.S.)

Food & Water Watch (U.S.)

Friends o the Earth Australia

Friends o the Earth Brazil

Friends o the Earth Canada

Friends o the Earth Cyprus

Friends o the Earth Latin America and the Caribbean(AALC )

Friends o the Earth Mauritius

Friends o the Earth U.S.

Friends o EC Group (U.S.)

Gaia Foundation (U.K.)

Gene Ethics (Australia)

GeneWatch UK

GLOBAL 2000/FoE Austria

Global Forest Coalition (International)

GM Freeze (UK)

GMWatch (UK)

IBON International

Indian Biodiversity Forum

Endorsing organizations



Indigenous Peoples Council on Biocolonialism (U.S.)

Initiative or Health & Equity in Society (India)

Injured Workers National Network (U.S.)

Institute or Agriculture and rade Policy (U.S.)

Institute or Responsible echnology (U.S.)

International Center or echnology Assessment (U.S.)

International Peoples Health Council (South Asia )

International Union o Food, Agricultural, Hotel,Restaurant, Catering, obacco and Allied WorkersAssociations (IUF) (International)

Jamaican Council o Churches

Karima Kaaithiegeni Ambaire (CBO) (Kenya)

Latin American Nanotechnology & Society Network(ReLANS)

Loka Institute (U.S.)

MADGE Australia Inc

Maendeleo Endelevu Action Program (MEAP) (Kenya)

Maryknoll Ofce or Global Concerns (U.S.)

MELCA-Ethiopia

Midwest Environmental Justice Organization (U.S.)

Movimiento Madre ierra (Honduras)

Mupo Foundation (South Arica)

Nanotechnology Citizen Engagement Organization (U.S.)

National Association o Proessional Environmentalists(Friends o the Earth Uganda)

Navdanya (India)

NOAH Friends o the Earth Denmark

Non-GMO Project (U.S.)

No Patents on Lie! (Germany)

Northeast Organic Farming Association -- InterstateCouncil (NOFA-IC) (U.S.)

Organic Seed Growers and rade Association (U.S.)

Otros Mundos AC/Amigos de la ierra Mxico

Our Bodies Ourselves(U.S.)

Partners or the Land & Agricultural Needs o raditionaPeoples (PLAN) (U.S.)

Pesticide Action Network North America

Pro-Choice Alliance or Responsible Research (U.S.)

Pro Natura Friends o the Earth Switzerland

Public Employees or Environmental Responsibility(PEER)

Rescope Programme (Malawi)

Research Foundation or Science, echnology, and

Ecology (India)Rural Coalition (U.S.)

Save our Seeds (Europe)

Say No to GMOs! (U.S.)

Schweizerische Arbeitsgruppe Gentechnologie SAG(Swiss Working Group on Genetic Engineering)

Science & Environmental Health Network (U.S.)

Seed Stewards Association o urkey

Sobrevivencia Amigos de la ierra Paraguay

Sustainability Council o New ZealandSustainable Living Systems (U.S.)

estbiotech (Germany)

Tird World Network (International)

imberwatch Coalition (South Arica)

ree Is Lie rust (Kenya)

USC Canada

VivAgora (France)

Washington Biotechnology Action Council (U.S.)

Women in Europe or a Common Future (International)

World Rainorest Movement (International)

Please e-mail Eric Homan o Friends o the Earth U.S. [email protected] your organization wishes to endorse thePrinciples or i you have any questions.
mailto:%[email protected]:%[email protected]


20/20

Synthetic biology, the next wave o genetic engineering,

allows seed, pesticide and oil companies to redesign lie

so that they can make more money rom it. Tese com-

panies now want to take over the orests and land o the

Global South to make so called biouels or planes and

boats o the military or to make new cosmetics or the

rich. Using synthetic biology, a biouels dictatorship joins

the ood dictatorship wrought by the frst kind o genetic

engineering. Te Principles for the Oversight of Synthetic

Biology is an important tool to help people reign in thesenew technologies. Vandana Shiva

- Vandana Shiva is the ounder o Navdanya International, which aims to deend and

protect nature and the rights o people to access to ood and water and dignifed jobs and

livelihoods. Dr. Shiva is a renowned environmental activist and winner o the 1993

Right Livelihood Award (the Alternative Nobel Peace Prize).

principles for the oversight of synthetic biology-embargoed

Documents