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Biological Data Definition
Biologicaldata are“the information,ncludingassociateddescriptors,erived fromthe structurefunction,o processofabiolgicalsystem(s)that iseithermeasured,collected, oraggregated for analysis Bolgicaldata and associatedmetadata ilminate howbiologybehaves,fromindividualcomponentsof cellstothebehavior of whole groups of organisms and theirecosystems.Biologicaldata also describethe necessary conditions for production of medications such as vaccines and antibodies, materials such as those derived from mushroom leatherorspidersilks,and chemicalsthat areproducedfrommicrobes.
4.1aRecommendation
Congress must authorize the Department of Energy (DOE) to create a Web of Biological Data (WOBD), a single point of entry for researchers to access high-quality data.
Currently,U.S.biological data is generated from a widevarietyofsourcesand organizedwithdifferent purposes in mind.These data are organized differentlyacrossorganizationsinacademia,government, and industry,and even across individual labswithin the same organization.232
This uncoordinated approach makes collating large datasets a burdensome process for researchers, slowing potential discoveries.It might takemonths to answera singlequestion,assumingtheinformation exists inthe firstplace.
Thereareseveral noteworthyexamplesofbiological databasescreatedbyfederaldepartmentsand agencies,buteachisincompleteforafuture that requiresdatafornewAl models.Forexample,the National CenterforBiotechnologyInformation (NCBl)attheNational InstitutesofHealth(NiH)is oneofthemostcomprehensivegenomicdatabases in the world.233But its datasets are in reality spread over different databases and data types and are not designedtobeused comprehensively,akeyrequirementfortrainingAl models.Targetedprogramsto makebiologicaldatamorecompatiblewouldhelp toensurethateffortssuchastheNCBldrivethe futureofbiotechnology.The Joint Genome Institute atLawrenceBerkeleyNational Laboratoryleadsan exemplarydataprogramonmicrobialsequencesand ecosystems,buttheprogram isfocusedona small subset of microbiome data.234 Expanding efforts like thistoincludealargerclassoforganismsandother types of biological information, such as protein data, would addvaluabletoolsneededforthefutureof biotechnology.
Having the ability to standardize,combine,and analyzebiological data generatedfrom different places, organisms,orexperiments is criticalto advancing research and trainingAlmodels.Inmanycases,the combinationofdifferentdatasetsismorevaluable than the individual parts.
Thecreationofaresourcethatcombinesbiological datasetsinausablewaywouldallowresearchers to spend less time curatingbiological data and more timetestinghypotheses,trainingmodels,and designing novelbiologicalfunctions.Such a resource would:
serveasasinglepointofentryforresearchers toaccessdifferentsourcesofbiologicaldata, allofwhichwouldbestandardized,usable,and interoperable;
enablediscoverywithadvancedcomputational methods;and
protectand control accesstoU.S.biological data
To create theseresources,Congress must authorize theDepartmentofEnergy(DOE)tocreatetheWeb ofBiological Data(WOBD),acomprehensivecentral biologicaldatainfrastructurethatwouldserveas singlepointofentryforaccessingbiologicaldata, have built-insecurity and access controls,and provideopportunitiesfor advanced computation and analysis.TheWOBDwouldstartwithdatacollected fromfederallyfundedeffortsandhavethepotential toexpand tocollectothersourcesof data.
AWebofBiologicalDatawould:
serve as an access point for high-quality biologicaldatafromdifferentlocations; host new biological data; developandmaintaintoolsforusingthese biological data such as bioinformatics pipelines, models, and ontologies (i.e.,the categories, properties,and relationshipsbetweenconcepts and conventionsthatdefine a field);and havearequirementthatanydatasetsincluded ontheplatformmustbestandardized.
Thiscentralizedresourcewould havethe added benefit of incorporating cybersecurity and access controlsinto the earliest stages ofits design and development.Thereare many considerationswhen designingsecurity and accesscontrolsforbiological data.Forexample,plantgenomesequencesfrom basicresearchprojectswouldneed differentaccess controlsandcybersecurityprotocolsthansensitive medical recordsorhumangenomicdata.TheWOBD wouldbemeanttoencompassmanydifferenttypes ofbiologicaldata,andasitexpands,itwouldneedto carefullybuildinsecurityandtakeintoaccountall appropriate privacylaws.
ImplementationfortheWOBDwithin itsfirsttwo yearswouldinclude:
assigningaNational Laboratorytoserveasthe manageroftheWOBD; havingthat National Laboratoryworkwith existingdatasetsandcollaboratewiththeNiST tostress-testthedigitalinfrastructureand developframeworksforinteroperability;and requiringtheDOEtoreporttoCongressonthe progressithasmadeonthesetasks.
Afterthefirsttwoyears,theWOBDshouldstart establishingconnectionstoallexistingbiologicaldata fromfederallyfundedsources.Theultimategoal is for theWOBD to connect as manysources of biological data aspossible through a single point of entry.
TheWOBDwouldalsohaveaR&Darmthatwould supporthuman-centered design and ensure that its interface is user-friendly.As researchers and otherusersbeginincorporatingtheWOBDintodaily researchlife,itwouldgrowandevolvewiththefield.
Security Considerations for Biological Data
Securityconsiderationsarenothe samefordifferenttypesofbiolgicaldata.Safeguardsimplementedonthe Web of Biological Data (WOBD) should be proportionate tothe sensitivity ofthe data, ensuring access is appropriatelymanaged,whileencouragingscientificcollaboration.
While much ofthe security and access control implemented throughthe WOBD would be decided onacase-bycasebasis,therearesomebasicdistinctionsinthetypesofbiolgicaldatathatexist.Whilenotanexhaustive list,these include:
Moleculardataversus functionaldata
Moleculardataprovideinformation aboutwhatabiologicalsystem is(suchasDNAsequencesand proteinstructure),whilefunctional dataprovideinformationaboutwhat abiologicalsystemdoes(suchas physical characteristics and enzymaticproduction).While the security concernsforthesetwotypesofdata arefairlysimilar,specialconsideration should be given tofunctional data that providekeyinsightsinto biology.
Chapter4
Humandataversus non-humandata
Whilemost non-human data, includingthatfromplants,animals, microbes,andfungi,areavailable inopen-sourcedatabases,access restrictionsandsecuritymustbeappliedappropriatelytohuman-related data.Biologicaldatafornon-human organismsmayalsobesensitive. For example,biomanufacturing conditionsorfarmyieldsmaybe consideredproprietaryinformation that mayneed tobe secured.
Humanhealthdataversus non-healthhuman data
Human health dataisgoverned by specificlaws and typicallyrequires controlled accessand additional securitymeasures.Non-health humandata,suchaslocationor demographicinformation,could bemoreopentothepublic,unless usedtoidentifyindividuals,inwhich casethedatabecomesensitiveand require stricter controls.
Current State of Biodata
02
03
Researchermanually searches andrecallsdata.
Researchermanuallycleanseach dataset.
Researchermanuallycombines datasets.
Recommendation:Al-ReadyBiodata +Web of Biodata
02
03
Agencies generate data in-line with NIST standardsforAl-ready biodata.
AgenciesconnectdatatoDOE WebofBiodata.
Researcher pulls Al-ready data fromWebofBiodata.
Human genomic data
Animal,microbial, andplantdata
Plantgenomic data
Human healthdata
4.1bRecommendation
Congress should authorize the National Institute of Standards and Technology (NIST) to create standards that researchers must meet to ensure that U.S. biological dataisreadyforuseinAlmodels.
National infrastructure, metrology (the study of metrics),and standardsforbiological data are critical toadvancingthefield and maintainingAmerican leadership,especiallywhenitcomestoAl-ready data.Butthelackofuniversalstandards,centralized accesssystems,orevena commonlanguagefor biologicaldatahasexacerbated thecurrentdisconnected approach.
The federal government can fix this problem by buildingnationalinfrastructureandframeworksfor biologicaldatathatmaximizetheabilitytocombine biologicaldatasetsthataregreaterthanthesumof theirparts.Creating standards and frameworksfor datawouldalsorequiretheNiSTtoexpanditsportfolioofworkrelatedtobiometrology,whichisthestudy of metrics and standards related to biotechnology. Takentogether,thesestepswould helpcreateusable biologicaldatasetsthatwouldreducetheamountof timeandeffortresearchersspendcuratingbiological data.Theresultingdatasets could beused totrain advancedAlmodelsthatcouldprovidenovelbiological insights atunprecedentedlevelsofperformance.
An expanded biotechnology portfolio at the NIST shouldincludeexpandedcapabilitiesforbiometrology.Theseshouldincludeadditionalinstrumentation andresearchthatwouldtranslateintousableframeworks,metrics, and units, allbuilt in collaboration withthebiotechnologyindustry.Thesecapabilities wouldsupportthebuildingofAl-readyrequirements.(Formore details onbiometrology and the expanded NIST portfolio,see Appendix C.)The NIST iswellpositionedtotakeonthismissionbecauseit leadstheestablishmentofnationalstandardsfor critical and emergingtechnologies such as Al and semiconductors.Indeed,ithasalreadyundertaken someeffortstostandardizebiologicaldata,suchas hosting the Genome ina Bottle Consortium,which seekstocharacterizehumangenomedata.235While sucheffortsarehelpful,thereisstillaneedfora concentratedfocusondevelopingAl-readydata.In particular,thereisa need tomaximizethepotential of biological research by requiring that recipients of federalfunding collect Al-ready data.
Congressshould authorizetheNiSTto develop standards and frameworks for biological data, prioritizing theestablishmentofadefinitionof,andparameters for, Al-ready biological data. The NIST should design standardsthatsupportinteroperabilitybetweennew and existingU.S.biologicaldatasets and thatsupport theuseofbiologicaldatainAlmodels.
TodeveloptheAl-readybiologicaldatadefinitions andframeworks,thereshouldbeatwo-phased approachthatwouldcomplementotherworkon standards as part of an expanded biotechnology portfolioattheNIST.
Aphased approachiscriticalbecausedevelopinga definitionofAl-readybiological data is a complicated processduetothesheernumberandbreadthof biological data types. Accordingly, it is important to establishinitialevaluationcriteriabeforefullyimplementinganAl-readybiologicaldatarequirement.
PhaseI: Define Al-Ready Biological DataandPressure-TestFrameworks
PhaseIwouldoccuroverthefirsttwoyears,during whichtheNiSTwould defineAl-readydataand pressure-test thedefinitiontoensureit doesnot impose anundueburdenontheresearchcommunity. TheNiSTshouldcreate a definitioninconsultation withkeyfederal,academic,and industry stakeholders.The definition,ataminimum,should specifythat Al-readybiologicaldata:
arecompatiblewiththeWOBD(seerecommendation 4.1a);
are accessible via an application programming interface (APl) within one yearof collection;
includemachine-readablemetadatathatenables reusability;
can be normalized to support aggregation with otherbiological datasets;
include alldatacontrols and outputs;and
areavailableinaraw,unprocessedformat.
Phase ll: Fully Implement Al-Ready Data Requirement
In Phase ll ofthe program, which would take place overthenextthreeyears,theNiSTwould expand itsworktoprovidedatamanagementresources forbiological data,build completecybersecurity frameworks,hireadedicatedstaff,andcoordinate withrelevantfederalfundingagenciesonAl-ready data requirements.In this phase,the NiST would fully implement the requirements.
In parallel with developing theseguidelines,theNIST shouldworkwithdepartmentsthataremembersof theFederalAcquisitionRegulation(FAR)Councilto updatetheFARtoincorporateabase-levelrequirement that federal funders produce Al-ready biological data.Thisrequirementshouldbeapplicable to largebiological datasets,withthresholdsdefined by theNIST.UpdatestotheFARshould applytoall relevantagencies,whileallowingforauthorizedexemptions on a case-by-case basis.TheNiST should serve asahubforhelpingrecipientsoffederalfundingthat are subjecttoAl-readyprovisions ensure thattheir data areindeed Al-ready.
4.1cRecommendation
Congress should authorize and fund the Department of Interior (Dol) to create a Sequencing Public Lands Initiative to collect new data from U.S. public lands that researchers can use todrive innovation.
Effortstocollectbiological data intheUnitedStates are not strategically planned and executed, leaving gaps in biological data holdings and preventing researchersfrom understandingwhatdataisneeded. TheUnitedStateswouldbenefitfromdatacollection inanumberofdifferentsectors,includinghealthcare,agriculture,andbiomanufacturing.Whilethe Commission identified many gaps in U.S. biological data collection,thereis a particularneedfornon-humanbiological data,includingdatafrom animals, plants,microbes,andfungi,inordertobetterunderstand thebreadthofAmerica'sbiological landscape.
The United States has one of the most extensiveandvariedpubliclands systems in the world, encompassing enormousdistributionsofpreserved ecologyandbiologicalorganisms.The National Parks alonecover85million acres,includingextremelandscapes suchasDeathValley,withitsrecord-breakingheat,andGatesofthe Arctic, with its glacial wilderness.236
Thenational parks arehome to uniqueorganisms and ecosystems,includingthecoralformations at DryTortugasNationalParkinFlorida,many different speciesofsalamanders atGreatSmokeyMountain NationalParkinNorthCarolina andTennessee,and thegypsum dunefields andendemicmothspeciesof WhiteSands National Park in NewMexico.237
Genomic data fromplants,fungi,animals,andmicroorganismsareessentialresourcesforresearchin genetics,evolution,and biochemistry,as well asfor applied purposes such asmedicine,food, and conservation.Genomicdata collectedfromorganisms livinginextremeenvironments,such asthehydrothermalsitesinYellowstoneNationalPark,couldpro vide insightsintohow organisms adapttoliveinthese extremeenvironments.Similartohowpenicillinwas discovered bystudying afungusthatproduced the antibiotic forits own survival, studying a wide range of differentorganismsfrompubliclandscould contribute to biotechnology innovations.238
Thereisnocoordinatedfederalefforttocatalogthe genomiclandscapeofU.S.federallands.Whilethere areeffortstocollectgenomicsequencedata,these aretailoredtothemissionsofspecificdepartments andagencies,andtheylackinteroperability,collaboration,overarchingdatastandards,andshared interagency goals.
Congressshould authorizeandfund theDepartment oftheInterior(Dol)to create aSequencingPublic Lands Initiative to collect data from U.S. public landsthatresearcherscanusetodriveinnovation. Thismajorinitiativewouldseektosequence and catalogue thegenomes ofanimals,plants,fungi,and bacteriaacrosstheUnitedStates.
Thebiological data collectedfromthisinitiative, whichwouldbemadeavailablethroughtheWOBD (see recommendation4.1a),would helpprotect NationalParklands,allowresearcherstolearnfrom naturetodevelopinnovations,and enhancebroad educational opportunities.
The Sequencing Public Lands Initiative should proceedinthreephases,sothattheprojectiscarefully executed andgradually expanded,culminatingin an opportunitytosequence awidevarietyoforganisms fromdifferentfederallymanaged lands.
Phase I: SelectingFive National Parks:
The Sequencing Public Lands Initiative should start withatwo-yearinitialphaseinwhichfivenational parksareselectedthroughacompetitiveprocess based onfour criteria,including:
Biological Resources:Eachparkshouldconduct aninventory of itsownbiologicalresources, includinginformationonthebreadthofknown species and therarity of present species.
ImplementationPlan:Eachparkshoulddevise an implementation plan thatincludes input from experts on regional organisms,genomic sequencing,and taxonomy.These experts would coordinate sampling and collection logistics,as well as a proposed sequencing timeline.
Educationand OutreachPlans:Eachpark should haveplanstoestablishpartnershipswith localpublicuniversitiestoprovideopportunities forrecentgraduates toworkonsamplecollection and processing.Furthermore,parks should haveplansforoutreachandpubliceducation efforts.
SpecificResearch Questions:Each park should feature scientist-generatedresearchquestions particulartothatparkanditsuniquebiome
A newlyestablishedofficeintheDolwouldwork withtheselected nationalparkstoestablishhow to safelyand appropriately collectsamples,who wouldperformthecollection,whattrainingwouldbe necessary,and howtoworkwiththeNiSTtoestablishdatastandards.TheDolwouldalsoworkwith the U.S.Departmentof Agriculture(USDA)and the Smithsonian Institutiontoestablishbest practices forstoringsamples.PhaseI wouldrequirethatthe DOl report to Congress with an implementation plan for the entire initiative and give an annual update on progress.It is criticalto setup thesystems that make upPhaseI beforemovingontoPhasell.
Phase ll: Sequencing Twenty National Parks
TheDOlwouldexpandtheinitiativeto20additionalnationalparks.Each additional parkshould berequiredtoconductasurveyofthebreadthof biological organismswithinitsboundariesandcreate implementationandeducationandoutreachplans, aswell asscientist-ledresearchquestions.
PhaseIll:Sequencing Public Lands
Thefinalphasewouldentailthefullrealizationofthe program,whichwouldexpandtomorefederallands, andseektocaptureaholisticpictureofthebiological landscape oftheUnited States.Land managed by the DOl's Bureau of Land Management,itsFish and WildlifeService,andtheUSDA'sU.S.ForestService would be included, and genome sequencing would fit intothepreviouslyestablishedinfrastructure and pipelines.Theoutcome ofthisinitiative would consist of biological data, such as whole genome sequences, andnecessarymetadatatoensurethedataareAlready.These data would comprisea databasewithin an established data storage system—namely,the proposedWOBD(seerecommendation4.1a).
The Sequencing Public Lands Initiative would require closecollaborationwithlocalcommunitiesand landowners. At every step, program coordinators would have to consult with the Assistant Secretary forIndianAffairsandotherrelevantpartnersto incorporate their views and expertise intothe project.
Education andoutreachwould bekey componentsof theSequencingPublicLandsInitiative.Theinitiative would provide an opportunity to engage with scientists,students,andbroadercommunitiesonthe environmentanditsinhabitants,aswellasonthe importance ofbasic science and genomic data.This initiativewould alsoofferopportunitiesforstudents, recentgraduates,and postdoctoral fellowstogain
technicalexperience intheresearchpipeline,from collecting samples to assembling and annotating genomes.TheSequencingPublicLandsInitiative couldserveasaspringboardforbioliteracyacross thecountry.Nationalparks could developcurricula forlocal studentsfromelementarythroughhigh schooltolearn abouttopics such as ecology,molecularbiology,and computerscience,all whileworking onprojectsthatfeaturerealbiologicalsystemsin their area.While thesegenomic data would become avaluableresourceforscientists,thediscoveries fromthesebiologicaldatacould alsobeincorporated intoeducationandoutreachmaterialsthattheparks could use togeneratefurtherinterestintheUnited States'rich ecosystems.
What can the U.S. National Parks tell us about biology?
A grand proposal fortheDepartment ofthe Interiorto collect,read,and archive the wealth of non-human biological information in U.S. public lands through genomic sequencing.
4.1dRecommendation
Congress should authorize the National Science Foundation (NSF) to establish a network of "cloud labs," giving researchers state-of-the-art tools to make data generation easier.
TogainanadvantageinAlcapabilitiesrelated tobiotechnology,the UnitedStatesneeds more high-quality training data forAl models.Currently, however,therearelimitedresearchopportunitiesfor biological datacollection usingrobotics and automation.Robotics and automationareredefiningwhatis possibleforlarge-scale,high-throughputbiotechnology research and data collection.
The costs to build a highly automated laboratory are significant,as are the costs of sustaining a highly specializedworkforcetokeep the laboratory operational.Thereareexamplesofseveralcommercial automated laboratoryfacilities,called“cloud labs"
thatprovide suchresources,butthere aresignificant barriers toentryforbothbuilding and usinga cloud lab,mostlyrelated to cost.239
Giventhese costs and thebenefitsthatcomefrom themassivequantityofhigh-qualitydatathatacloud labcangenerate,automatedlaboratoriesshould be viewed as an opportunitytoinvest in economies of scale.The United States could create an opportunityforresearcherstogeneratelarge amounts ofhigh-qualitybiological data throughnewand existingautomated instrumentationinfrastructure. Theresultingdatawouldbecriticalforthefutureof biological Al models.240
Next-Generation Laboratory Definitions
Laboratory automation Autonomouslaboratories Cloudlaboratories
referstoprocesses thatinvolve robotics, computers,liquid handling,and other advanced technologiestocompletebiologi cal experimentation.liv
arefullyautomatedandguided by artificial intelligence and machine learningsoftwareto plan,execute,learn,improve,and repeatexperimentsbasedona desiredoutcome.Autonomous laboratories are sometimes calledself-drivinglabsbecause a human does not define each step ofthe experimentalprotocol or perform any experiments.
arephysicallaboratoriesthatare equippedwithlabautomation thatcanbeprogrammed and controlled remotely by scientists to conduct biological experiments.Cloudlaboratoriesare typically semi-automated and oftenoperateonafee-for-service basis.v
Congressshould authorizetheNational Science Foundation(NSF)toestablishanetworkofcloud labs.Togive researchers access tostate-of-the-art automatedinstrumentationforbiotechnologydata collection and experimentation,theNSFwould coordinatethedifferentcapabilitiesofexistingcloud labfacilitiesinadditiontoestablishingnewcloudlab infrastructure.
This program should be executed in three phases, includingacarefulinitialplanningphase.
Phase I: Assessment and Planning
TheNSF,in consultationwith the National Biotechnology Coordination Office(NBCO)(see recommendation1.1a),theDOE,and the NIST,would assessthe stateofexistingcloudlabinfrastructure in theUnitedStates.TheNSFwouldalsodevelopan implementation planforthe program,in consultation withrelevantpublicandprivatesectorstakeholders, includinga planforcreatingnewcloud labfacilities in theUnited States.
Phase lIl: Initial AwardsforNewCloud Laboratories
The NSF would award grants on a competitive basis todevelopandoperate atleasttwonewcloudlabs, whilecontinuingtoupdateand maintainitsnetwork of existing cloud labs.
Phase ll: Additional Awards forNew Cloud Laboratories
The NSF would award grants to develop and operate atleastthreeadditionalcloudlabs.
"Biotechnology has held promise for decades as the revolutionaryfrontieroftomorrow,butIfirmlybelieveweareatthe most critical inflectionpoint. We are barrelingtoward never-before-seen capabilities: Al and related cutting-edge tech nologiesaresuperchargingour ability todiscoverbiobased products. The need is clear: Emerging national security threats, such as supply chain insecurity, the strengthening ofadversaries,andpublichealththreatsrequireinnovative, world-leadingsolutions.Thebiotechnologymindsetisshifting: Our companies, universities, and leaders are increasingly realizingbiotechnology product-market fit which will impact allAmericans,whetheritbeservicemembers,farmers,r families.
All of this is happening right now at an unprecedented pace, and it's happening around the world. I'm excited that our recommendationswillmakeiteasyfortheUnitedStatesto runthefastestandwinthisraceathome.Wecan'taffordto let up."
·CommissionerAlexanderTitus
Section 4.2
Block China from Obtaining Sensitive U.S. Biological Data
While theUnitedStateshasnt prioritiedbilgicaldata, hinahasmphasizedits mportancetobtechlogva tionraisigocaoutanamacengnetidatajingavestsndprttitwbilgialdtawhila advantageofunprotecteddatafromabroadWithalthidatatheChinesegovernmentcanlinindividualstoth geneticinformation,trackthersusceptibilitytoparticularealthproblems,orlarnabout therancestry4
Data alsoffes mitary advantages.Inthehandsof researchersbackedbythePeople's LiberationAmy (PLA)andsupercharged withadvanced Al, high-qualitybiologicalatacoul enableChineseadvances inusingbiotechnologytofght wars andto enhancehumanperformance45 verall Chinastrategic investments nbiolgicaldataenhanceitsglobalposit inbiotechnology,contrarytoU.S.valuesandinterests.
4.2a Recommendation
Congress must conduct oversight of existing policies, and add new authorities as warranted, to ensure that China cannot obtain bulk and sensitive biological data from the United States.
Insomecases,thecurrentfederalframeworkforbiologicaldataprotectionenablesforeignanddomestic entitiestoacquiresensitivebiological data aboutU.S. personsthroughlegallypermittedbulkdatatransfers.Recentlawsandexecutiveordershavetriedto address this concern.
“"Sensitive biological data”are data that have thepotentialtobeusedtopersonallyidentifyan individual orgroupof individuals.
They include but are not limited to human genomic data,other-omicsdata,andbiometricdata.
TheMarch2024ExecutiveOrder(EO)14117on PreventingAccesstoAmericans'BulkSensitive PersonalDataandUnitedStatesGovernmentRelatedDatabyCountriesofConcernisintended torestricttransactionsfortypesofdata,including biologicaldata,andtoprotectthatdataassensitive and personal.Butthere arelimitationstorelyingon thiskindofexecutivebranchaction,whichcanbe overturned andfacelegal challenges.246
In 2024, Congress passed the Protecting Americans' Data fromForeignAdversaries(PADFA)Act,which complementsEO14117'sfocusontypesofdataby preventingarangeofsensitivedatabrokeragetransactions.247 Future assessments may be necessary to evaluatewhethertheDepartmentofJustice's(DoJ) efforts,combinedwiththePADFA,striketheright balancebetweennationalsecurityand theneedsof academia and industry.
Congress must conduct oversight of PADFA and EO 14117 implementation (through a DOJ rulemaking)to ensurethatChinacannotobtainbulkandsensitive biological datafromtheUnited States.Suchoversight wouldrequirehearingsfromappropriateofficialsat theDOJandtheFederalTradeCommission(FTC),in whichtheseofficialswouldreportonprogressmade onthedataprotectionmechanismsthey arerespon siblefor. Congress should specifically inquire about protectionsrelated tobulkandsensitivebiological data.Relatedly,Congressshould continually assess whatnewauthoritiesmightbeneeded and necessary toensurebulkdata protections,addingnew authoritiesasneeded.
Inparticular,Congressshould assesswhatbiological data typesmaybesensitive,sincenewadvances andtechnologiescanchangebiologicaldatatypes. Forexample,datarelatedtothemicrobesthatlive inthegutwerepreviouslyconsideredharmless,but afterlarge-scaleeffortsofcollectionand analysis,the sameinformationwasshowntocarryuniqueforensic signatures thatcanbe used toidentify individuals.248
Section 4.3
Launch Grand Research Challenges to Unlock Leap-Ahead Capabilities
Dedicated funding and infrastructure would inspire American innovatorsto pursue once-impossible goals and solve the most challenging research problems.
4.3aRecommendation
Congress must establish Centers for Biotechnology within the existing National Laboratory network to support grand research challenges.
TheUnitedStatesneedsspecializedandcoordinated federal research infrastructure for biotechnology. Innovation in this sector requires interdisciplinary connections and accesstokey equipment.
Thefederalgovernmenthascutting-edgeR&D facilities,includingfourBioenergy Research Centers, twoofwhichareledbyDOENational Laboratories (i.e.,LawrenceBerkeleyNational Laboratory and OakRidgeNational Laboratory).Buttheseresearch centerstend tofocusnarrowlyonearly-stageR&D relatedtoaspecificmission andplacelessemphasis on translating research into products.249 Moreover, theUnitedStateslackssomeR&Dinfrastructurethat is critical foremerging biotechnologies,including:
risk-assessmenttestbeds;
datacollection and computing powerfor
biotechnology;
advancedmeasurementdevelopmentand
instrumentation;
chemical and material production using biology; and
biotechnologyscale-upinnovationandinfrastructurethatspanbasicand appliedresearch.
To achievebreakthroughsinbiotechnology discoveryakintowhat Lawrence LivermoreNational Laboratoryhasdonewithfusionresearchorwhat LosAlamosNational Laboratoryhasdonewith nuclearresearch,Congressmustestablishsix Centers of Biotechnology within the 17 existing National Laboratories,eachcenterwith its own area of focus.250
The main purposes of these biotechnology centers wouldbeto:
provide facilities forinterdisciplinary
biotechnology research, discovery, and
development;
encouragelarge-scaleresearchprojectsthat have someriskoffailurebutcould leadtohuge leaps in the study,development,or adoption of biotechnology; and
providebiotechnologypractitioners accessto expensiveresourcesand instrumentation,such assupercomputersandadvancedmeasurement capabilities.
These new CentersforBiotechnology would complementexistingresearchefforts andenablebiotechnologyprogress acrosstheNational Laboratory system,incollaborationwithpartnersfrom academia and industry.They would also provide anopportunity forresearchers acrossgovernment,academia,and industrytoaccessstate-of-the-artequipmentand instrumentation,similartowhatthefiveNanoscale Science ResearchCenters at theDOEhave accomplished.251 By providing instrumentation and interdisciplinarycollaboration,thesehubswouldalsoenable progressonthegrandresearchchallengesproposed in this section.
The appropriate DOE office should manage each center. The DOE's Offce of Critical and Emerging Technologies(OCET)shouldfacilitatethe
coordination of biotechnologyefforts across the DOE, including the activities of all six biotechnology centers and otherbiotechnologycapabilitiesat the National Laboratories.The OCETshould helptolead a biotechnologygroupwithintheDOEthatwould developa strategicplanforestablishingand selecting theCentersforBiotechnology.Thecenterswould be selected throughacompetitiveprocessamongthe existing 17 National Labs.
4.3bRecommendation
Congress should initiate a grand research challenge focused on making biotechnology predictably engineerable.
WhiletheUnitedStateshasledtheworld inbiotechnology innovationfor many decades,that lead is at risk. This is largely owed to a lack of federal funding and prioritizationforbiotechnologyresearchto unlock"leap-ahead capabilities”"ordisruptive technol ogiesthatofferunprecedented newfunctionalities, in the United States.The U.S.researchenterpriseis eitherstagnant orfallingbehind insomekey areas.
Fundingforbiotechnologyresearchtypicallygoes to ideas that represent incremental progress,and it is diffcult to find funding for risky and innovative ideas. Some funding mechanisms, such as those at the Defense Advanced Research Project Agency (DARPA)oratAdvanced ResearchProjectAgencies (ARPA) within other departments,have long funded high-riskresearch,buttheyrepresentonlya small portion of all government researchfunding.252New programssuchastheNational ScienceFoundation's (NSF)CatalyzingAcrossSectorstoAdvancethe Bioeconomy (CASA-Bio) use interagency goals and interdisciplinary teams to seek common priority areas in biotechnology.253But while CASA-Bio is a helpful mechanism through which an interagency group coalesced around important biotechnology goals,it is not a funding program.
To build on these programs,theUnited States needstoactboldly,inspiringitsinnovationbaseand encouraging a range of projects, small and large, acrossthe country by initiatinggrand research challenges.
One of biotechnology's most importantquestsistomake biology predictably engineerable.
Whilethebiotechnologycommunityhasworked towardthisgoalfordecades,ithasyettoreachthe maturityofmanyengineeringfields,includingelectricalengineering,computerengineering,and mechanicalengineering,whichhaveallreached apointwhere buildingendproductsisroutine.Biotechnologyis still in anearlierstage.Challengingthesectortoharness natureintransformativewaysthatcouldbenefit all would bring biological engineeringto a similar maturity.Breakthroughsrelatedtothisgoalcould beappliedto all different typesof livingorganisms, includinganimals,plants,microbes,and fungi,and wouldsubsequentlyenable advancesinbiotechnology and biomanufacturing.
Currently,however,broaderfundingbythefederal government related tosuch a goal is sparse and diffuse,preventingbreakthroughs.
To inspire more biotechnology breakthroughs, Congressshouldinitiateandfund agrandresearch challenge to make biology predictably engineerable. That grand challenge should be:
an inspiring goal that captures the public
imagination;
amissiontheprivatesectoris unlikelytopursue on its own;
a challenge requiring an interdisciplinary
approach;
a project that fosters innovation and progress beyond theprimarygoal of the grand challenge; and
agoalthatisbroad and ambitiousenoughtobe pursuedacrosstheresearchcommunityand advancedbybothincrementaldiscoveriesand majorbreakthroughs.
The U.S. government should appropriate a minimum of 5$ billion over five years to achieve this goal. Any lesserinvestmentwould riskbeingtoosmall to enablefuturebiotechnologyinventionandproduct development in the United States.254
Aportionofthisnewfundingshould be designed to reward successinsolvinghard,ambitiousscientific challenges thatunlockimportantleap-ahead capabilities.Structuring thefundinginsuch a way would imbuegrandresearchchallengeswitha spiritof constructive competition, while only deploying taxpayer dollars when ambitiousgoals are met.(For more detail onthisgrand challenge,includinga potential funding structure,seeAppendixD.)
This grand challenge would require bolstering the engineeringparadigmof“make,model,and measure”forbiological systems.Therefore,government fundersshould developcomponentchallengesthat breakdownpredictableengineeringintoindividual tasks.Some otherkey stepstoimplement thisgrand research challenge include:
creatinganinteragencyprogramand establishingaleadagencythatwouldworkwith otherdepartments and agencies toward this goal; consultingwiththeDirectoroftheNBCO(see recommendation1.1a)attheWhiteHouse;and workingwithphilanthropicfunderstogetbuy-in onresearchareasandtoincreasethepoolof moneyforfundingresearchprojects.
4.3cRecommendation
Congress should initiate a grand research challenge focused on making biomanufacturing scale-up predictable, rapid, and cost-competitive.
Biotechnology processes and production must also scalepredictably—anotherchallenge involvinginterdisciplinary science, technology, and engineering.
After decades of outsourcing the manufacturing of both legacy and next-generation biotechnology products,theUnitedStates haswoefully deprioritized researchthatwouldreducethecomplexityandcosts ofscalingbiological processes.
Even with the U.S.biotechnology sectors'tools and expertise,transitioningfrom small-scaleresearch tolarge-scaleproductionisinefficient,slow,and expensive.255ExpandingtheUnitedStates'numberof physical facilities,while critical,is not sufficienton its own.Innovations in the science of biomanufacturing scale-up,in tandem with increased physical capacity, lie at the cruxofensuringthatAmericanbiotechnology products make it to market.Advances in U.S.biomanufacturing spurred by solving scale-up questions in early-stageresearch—aswell asequipment and technologiesthatspanthebioprocessingchain— promisetounlocknewwaysofcreatingbiomanufactured products.256 Prioritizing the science of scale-up wouldhelpcreatedistributed,diversified,andflexible biomanufacturing across the United States.
To accomplish this, Congress should fund a grand research challenge to develop novel biomanufacturing technologiesthatmakescale-uppredictable,rapid, and cost-competitive.Thisgrand challenge should prioritizeinterdisciplinaryresearchfocusingacross fourkeyresearch areas:
chassis;
feedstocks;
processtechnology and equipment; and critical inputs.
Advancements in the first three research areas (chassis,feedstocks,andprocesstechnologyand equipment)wouldexpandthenumberofbioproducts thatcould becreatedwithbiomanufacturing,ensure thatbiomanufacturingislocation-agnostic,and draw onplentiful raw material inputs such as location-specific agricultural biomass.Moreover,unitingand simplifyingscale-upprocesseswould decrease the money and expertise needed to transitionbioproductstothemarket.
Advancementsinthefourth area(critical inputs) woulddiversify andsecure thesupplychainof low-marginchemicals andbiologicalmaterialssuch as aminoacidsthatarenecessarytosustainscaled biomanufacturing.Demandforthesematerialsis expectedtogreatlyincreaseastheUnitedStates expandsitsbiomanufacturingsector,butforthemost part,theseinputsaresourcedabroadandoftenhave marketpricesthataresolowthattheydisincentivize innovationsto cost-effectivelyproducethem domestically.257
Otherkeyimplementation details forthis grand research challengeinclude:
congressionaldesignation of afederalagency toleadeffortsforeachresearcharea,basedon considerations such as current or past agency efforts and missionspaces;
collaborationamonglead agenciesand across theinteragencyto ensure thatthis multidisciplinarygrandchallengedrawsonallrelevant expertisewithinthefederalgovernment;
coordinationthroughtheDirectoroftheNBCO (see recommendation 1.1la) at the White House, to ensure collaboration,prevent duplicative research,andhaveatechnicaladvisortoassess progress;and
milestone-based funding,contingent onannual progressreports submitted bylead agenciesto Congress. Congress could authorize incrementallylargerfundingamountseachadditionalyear to ensure that fundingis given inproportion to demonstrated progress.(Furtherfurther guiding detail on this scale-up grand research challenge, including suggestedfunding amounts and examplesof lead agencies,see Appendix D.)
Thefouridentified areasofscale-upresearch— chassis,feedstocks,processtechnologyand equipment, and critical inputs—haveimplications for a widerangeofbiomanufacturingareasandcanbe applied broadlytobiomanufacturingforchemicals, medicines, fuels, materials, and other biotechnology products.These areas alsotouchonbiopharmaceuticals,especiallywhenitcomestorapidvaccine production and newvaccine types.
Section 4.4
Protect Against the Harms of Biotechnology
U.S.-led biotechnology revolution requires American innovatorstodowhattheydobest:createnewtechnologiesto solve hard problems.The Commission has seen and heard firsthand U.S.innovators'commitmenttoensuringthattheirworkissafe,secure, andresponsible.Andpeopleworkingonbiotechnologyinbothindustryandacademiahavelongcalled forgovernmenttoimprovethewayitmakespolicy andenforcesbiotechnologysafety,security,andresponsibility.The current systemplacesundueburden onresearchersand innovatorstonavigateunwieldy bureaucraticprocesseswhileenduringmarketand academicpressures.
Just as the United States should be the placewheretheworld'smostinnovative scientificdiscoveriescometomarket,so tooshouldAmerica.behometothemost innovativeworktodevelopthesciences of biosafety and biosecurity.
This is where theU.S.government has animportant role.Itcan operate outside of marketpressures, funding and incentivizinginnovations that themarket will not necessarily produce on itsown.Right now, however,governmentimposessafety,security,and responsibilityrequirements and yetdoesnotwork alongsideresearcherstobuild thetools andcapabilitiestomeetthoserequirements.
CurrentToolsareBluntandReactive
TheUnitedStatesreliesona limitedsetoftools toensuresafety,security,andresponsibilityn biotechnology.
The first ofthese is the moratorium—-essentially a stop-work order on innovation. Academia, industry, andgovernmentalikereachforthistoolwhenresearch movesbeyond existingoversight systems and governancecannotadapt.Intheearlydaysofgenetic engineering,forexample,researcherscalledfora
pauseontheirownworkandspentyearscollaboratingwiththegovernmentonasetofsafetyandethical Oversight systems.258
SimilarcallsfollowedOpenAl'sreleaseofChatGPT in thefall of 2022.Manyindustry leaders raised the alarm and demanded apauseonlargeAlexperimentsto mitigate,as anopen letterputit,“profound risks to society and humanity."259 Despite the unprecedentedpopularityofChatGPT,ittookayearforthe governmenttocreatetheAlSafetyInstitute,which is part of the NIST.260 Lawmakers are still grappling withtherightwaytolegislateonAl safety.ButtheU.S. government'sreactiveapproachloweredconfidence in its ability to oversee transformational technology.
Everytimeinnovatorshave tohitthebrakes unexpectedly, they lose time, money, and public trust. Biotechnologyhasnot yetreached itsChatGPT moment.Inthefaceofrapid advancementsoriginating in China,theUnited States cannot afford forinnovation inbiosecurityandbiosafetygovernancetohappen in stops and starts.
AnotheroversighttooltheUnited Statesusesis listsofbiological hazards,suchasorganismswith destructivepotential.List-based systems,such as theFederalSelectAgentProgram(FSAP),aremost appropriatewhenresearchersand innovatorsknow howconcernedtheyshouldbeaboutaparticular organismortypeofexperiment.List-basedsystems worklesswellforemergingorpoorly understood risks.261
While these tools are good starting points, the governmentfailstoroutinelyevaluatetheireffectiveness.262The United States,therefore,does not know howmuchinnovationislostorhowmuchsafetyand securityisgained through these approaches.
Government Leadership is Fragmented
Despite theUnited States'historicleadershipinbiosecurity and biosafety,existinggovernment policies arefragmentedacrossfederalagencies,leadingto redundancies,gaps, and inefficiencies.These policies includetheFSAP,BiosafetyLevels(BSL)designation and laboratorybiosecurity and biosafetyguidance, and gene synthesis screening guidance.
Forexample,amultitudeofagenciesandoffces conduct inspections and require reportingforlaboratoryoversight.lnspectionslookatthesamethings andaskthesamequestions,butoperateondifferent timelines,imposing a frustrating compliance burden onlaboratorystaff.
Anotherexampleoffragmentationconcernsthe security of gene synthesis. The process of creating physicalgenesbasedondigitalsequencedata, called gene synthesis, is critical for the growth of the biotechnologyindustry.Whileindustryisunited in callingforameasured,enforceable,andstandardized approach,theU.S.governmentisunabletorespond tosuchrequestswiththeneededagility.Policies regardinggenesynthesissecurityaredistributed acrossmultiplefederal agenciesand offices,includingtheDepartmentofHealthand HumanServices (HHS),theFederal Bureau of Investigation (FBI),and theExecutiveOfficeofthePresident(EOP)orOffice ofScienceandTechnologyPolicy(OSTP).Asof February2025,these arevoluntary standards,not mandatory ones.
Furthermore,the Commissionfound that manyofthe agenciesdesignatedtoaddressdifferentaspectsof biosecurityandbiosafetyseethisworkasperipheral totheircoremissionsandmandatesandlackthe incentivetotacklethese issues.
Policies are Quickly Outdated as Technology Advances
Biosecurity practices and policies have traditionally revolved aroundpreventingthemisuseofbiological pathogens,primarilythroughcontrollingaccessto them.However,as researchers develop novel biodesigncapabilities,suchasgeneeditors,genesynthesis capabilities,andAl-poweredproteindesign,these practicesandpoliciesmustevolve.
The U.S. government is not modernizing policies quickly enough tokeep up with biotechnology development.Ittook13yearstoupdateguidance on genesynthesisscreening,andtheresultingframeworksremainlimitedtofederalresearch.263Ittook10 yearstomodernizeoversightofDual UseResearchof Concern(DURC)andresearchinvolvingPathogens withEnhancedPandemicPotential(PEPP).264Calls
forafoundationalreassessmentoftheFSAPhave still not resulted in the necessary changes.265 Listbasedpolicies areparticularly likelytolagbehind the leadingedge ofbiotechnology.266
Going Forward
TheUnited Statesneedsa sharpersetoftools.The governmentbodythatdevelopsthosetoolsmust itselfbe attheleadingedgeoftechnology,notjust in biotechnologyinnovationbut alsoin developing the science ofbiosecurity,biosafety,and responsibility.
Governancemust keeppace with innovation.Todo so,thegovernmentmuststreamlinepoliciesand developaproactive culture,cultivate dedicated expertise,and secure aresource streamforadvancinggovernancecapabilities.Policiesshouldnotstifle innovation.Rather,theyshould ensure riskawareness and mitigation while maximizing benefit.
The United States should lead by example in building biosecurity andbiosafetyintoresearchandinnovationprocesses.International collaborationwill be essentialtorealizingthefullbenefitsofadvancesin biosecurity,biosafety,andresponsibleinnovation.
Fixingthe U.S.government's outdated approach in theseareaswouldsecureAmerica'stechnological lead by giving thenation's industry and academia the confidencetodowhattheydobest:out-innovatethe world.
The U.S.government could continueto have each agency with a hand in biotechnology innovation performitsownbiosecurityand biosafetymeasures. Forexample,inDecember2024,theHHS andthe DepartmentofHomelandSecurity(DHS)announced theBiosafety andBiosecurity Innovation Initiative PlanfortheBioeconomy,a suite ofrecommendations for each biotechnology agencytoimplementon their own.267 But this approach does not adequately addresstheproblemsdescribedabove.
Instead,the United States could take a new approach:createaconsolidated,dedicatedcapability toprotect againstharmsfrom biotechnology in a waythatintegratesleading-edge science and evidence-based policymakinginto enforcement and regulation,allowingpolicies and enforcementto continuously adapt.
4.4aRecommendation
Congress must direct the executive branch to advance safe, secure, and responsible biotechnology research and innovation.
After 20 years of trying and failing to protect against harmswithoutstiflinginnovation,Congressmust pursue a different approach.One solutionisfor Congresstocreate a newentitythatbothserves asa resource to innovators at the forefront of technology developmentandmodernizeslegacysafetyand securitypolicymakingandenforcement.268
TheDepartmentofCommerce(DoC)isthelogical placetohouse such anentity:ithas a culture of promotinginnovationand economic development acrossthecountry,experiencewithmetrologyand standards-setting through theNiST,and a focus on security.ItcouldworkcloselywiththeNBCO(see recommendation 1.la),the Centers for Biotechnology (seerecommendation4.3a),andimplementersofthe proposedgrandresearchchallengesforbiotechnology(seerecommendations4.3band4.3c).
This entity would have five main responsibilities:
1. ldentify emerging risks and vulnerabilities with biotechnology and existing oversight.
To do so, it would:
performcontinualevaluationandassessment ofvulnerabilities,weaknesses,and threats,
including lab testing of equipment and advanced tools;
analyzeinputsfromregulardisclosures(which alreadyexist)andano-faultreportingsystem (whichshould bedeveloped)fromindustry and academiaonpotentialconcerns;and
runawhistleblowermechanismandhostregular forumsforindustryand academiatoidentify gapsintechnicalcapabilitiesand concernswith existing oversight.
2. Fund basic and applied biosecurity, biosafety, and responsibility innovation and tool development.
Taking an ARPA-style approach to solving hard problemsquickly,theentitycouldfundprojects addressing:
technical advances on biosecurity and biosafety by design capabilities; theuseofmachinelearningtoassessthelevelof concern of novel sequences or organisms; methodologiesforbiosafetyofficerstohandle concernsaboutspecificresearchprojectsthat do not fit neatly into existing policies; methodsandorganizational designsforsafe, secure,and responsible biotechnology;and systematicandstreamlinedriskassessmentsto inform biotechnology innovation pathways.269
Theentitycould alsopilot,test,andrefinenewtechnologicalandorganizationalabilitiesinacontrolled sandboxwithkey stakeholders.
3. Develop and incentivize the adoption of best practices.
Thiswould include:
standardizingbest practicesforbiosecurity, biosafety, and responsibility across funding agencies;
promotingthe adoptionofinnovationsthatarise from the entity's research;and
collaboratingwithindustry and academia to train and developtheworkforceforbiosecurity, biosafety, and responsibility.
4. Consolidate and oversee biosecurity, biosafety, and responsibility policies.
This would entail:
immediatelymodernizing andoverseeingthe FSAP and enforcing gene synthesis screening procedures;
overtime,updatingand adaptingotherbiosecurity and biosafetypolicies;
helping other agencies adapt policies affecting biotechnologywhere it convergeswithother technologyareas(forexample,workingwiththe DHS and the Cybersecurity and Infrastructure SecurityAgency(ClSA)oncybersecuritypolicies thatinvolvebiological algorithms and data);
establishingacomprehensivelicensingsystem forBSL-3/4facilitiesandaccreditationfor relevant biosecurity and biosafetypersonnel;and maintainingstrongconnectionswithlaw enforcement agencies,includingtheFBl and the DHS,to enable effective enforcementofrelevant criminal statutes.
5. Work with the international community.
This would include improving best practices and standards and sharinginformation and technical advancestopreventmisuseandencouragetrustin emerging biotechnology.
Advancing Safe, Secure, and Responsible Biotechnology Research and Innovation
HHSAdministrationforStrategic PreparednessandResponse
Synthetic nucleicacid screening guidelines Digital-physical cyberprotectionissues
HHSNational InstitutesofHealth
Laboversight
National ScienceAdvisoryBoardon Biosecurity
RecombinantDNAresearchguidelines Novel and Exceptional Technology and ResearchAdvisoryCommittee
DHS Cybersecurityand Infrastructure Security Agency
Bio-specific cybersecurity protection Gene synthesis security stress testing
ExecutiveOfficeofthePresident
ExecutiveOrderonSafeandSecureAl Frameworks forNucleic Acid Synthesis Screening
DualUseResearchforConcern-Patho gens with EnhancedPandemicPotential (DURC-PEPP)
USDAAnimalandPlantHealth InspectionServiceandHHSCenters forDiseaseControlandPrevention
SelectAgentProgram,Laboversight
Additonalactivitiesnotcurrently addressed by any agency
No-fault reporting system Biosecurity and Biosafety training Others...
A ConsolidatedApproach
Identify emerging risks andvulnerabilities.
Incentivizethe adoption of bestpractices.
Collaboratewiththe internationalcommunity.
Fund applied innovation andtooldevelopment.
Chapter4
Intermission
HowWill YouParticipate In The Biorevolution?
FromstudentstwrkerstitzensallethitStateveryoneasthtentialtntributetheirtalntss and innovationstobiotechnologyTheCommissionencouragesall mericanstoseekout biotechnologyinactionintheir localcommunities—often,itiscloserthanyouthink!
Consumersmaynotrealizethatbiotechnologyis alreadyavailableonstoreshelves, fromsweaterstofoodcontainers,whilenew productslikebiomanufacturedfragrances or computers that useDNA as storage could onedaybefound inlocalstores.
Students cantry out biomanufacturing coursesatlocal communitycolleges,which willhelpthementertheworkforceorcontinue tofour-yearuniversitiesandbeyond.
Teachersattendteachereducation workshops and bring hands-on activities in bioengineeringtotheirstudents.
Community scientists are everyday citizens who encounterbiotechnology labs inlocal settings,such as thelibrary,and feel inspired to innovate.
Healthcare specialists are actively using biotechnology to treat diseases with biologics and antibodies, and emerging biotechnologies are enabling even more effective, personalized treatments.
Chapter4
Farmersarealreadyusingbiotechnologyin theirday-to-dayoperations,and newproductscanfurtherhelptheirfarmsincrease yields,withstandpests,andendureweather extremes.
Nature lovers who engage in gardening, hunting,fishing,and foragingcanbetter understand howbiotechnology might benefit the environment.
Citizens who cook and ferment in their kitchens at home already interact with biotechnology as a partoftheirdaily routines.
Mid-careerworkers from other sectors learnthroughlocal workforce development programs that many of theirexisting skills can be transferred to the field of biotechnology.
Entrepreneurs can uselocal feedstocks and resourcesto create newproductsthat are healthier for society,employing local workers to drive their venturesforward.
Build the Biotechnology Workforce of the Future
America's greatest strength has always been its people. Bold, creative, and driven individuals have propelled the United States' unyielding pursuit of progress. That same spirit of progress must be harnessed to build a workforce that can lead the world in biotechnology innovation.
Tofullyrealizebiotechnology'spotentialtodefend, build,nourish,andheal,theUnitedStatesmust strengthenandsustainatalentpipeline.
Theneed fortalented biotechnologyworkers has neverbeenmoreurgent.Tomorrow'sbiotechnology workforcewill becomprised ofpeopleof allbackgrounds,experiences,and skillsets.The United States will still need scientists,researchers, andwillalsoneedtechnicians,educators,policymakers,businessleaders,and innovatorsatevery level.270 It is these problem-solvers and creative thinkerswhowill lead the charge into a healthier, moresecure,andmoreprosperousfuture.
Tobuild thisworkforce,theU.S.government, academic community,andprivatesectormust worktogetherto advancebioliteracy.Bioliteracy is the abilitytounderstand andengagewith biologyandbiotechnology.271Ideally,Americans will soonunderstandbiology andbiotechnology in thesamewaythattheyunderstand howcomputers and informationtechnologyinteractwiththeir dailylives.Widespreadbioliteracywillmeana moreinformed,empowered,andresilientsociety capableofleveragingscience and technology to solve a wide range of global challenges.
There are threecritical workforcegaps that this chapteraddresses:theU.S.federalworkforce,the country'sdomesticworkforce,andforeigntalent.
Congressional offices and federal agencies consistentlyhighlightthegrowingdemandforskilled biotechnology professionals. There are very few biotechnologyexpertsinthefederalgovernment, and many of those existingworkers arebusy runningcurrentbiotechnologyprograms.Thereare veryfewseniorofficialsattheAssistantSecretary level or higher that are trained in biotechnology orlifesciences.AsmallfractionofMembers of Congressaretrainedscientists.Acrossthe restofthefederalgovernment,manyworkers have not had biology training since high school. Governmentofficialscannotdesign orexecute policies and programs affecting biotechnology withoutageneralunderstandingoftheunderlying concepts.
The United States is also not prepared to meet the broaderdomesticworkforce needsofthe country'sgrowingandevolvingbiotechnologyindustry. There has been a major,sustained demand for workersfamiliarwithnewvaccineplatforms, advancedcomputationalandAl-drivenbiotechnology,cellandgenetherapies,andprecision medicine since 2017. But the United States' supply ofworkersisfailingtomeetthisdemand.
"In order to support the biotechnology industry of the coming decades, weneedtoinvestinourworkforce.Wearefortunatetoliveinatime wherebiotechnologywill havesuchanenormousimpactonoureverydaylives.lhavehadtheprivilegeofworkingwith,encouraging,and mentoringthenextgenerationofSTEMinnovators,fromkindergartners throughpostdoctoralfellows,inmy3OyearsasaSTEMeducator.ln thoseyears,Ihaveworkedwitheagerlearnerswhoareimmensely curious and have a drive for innovation to solve the most challenging problemsfacingournation andourplanet.Toprepareabiotechworkforceofthefuture,weneedtoinvestinourdomestictalentpipelines. And aswe continuetobuild and supportourhomegrowntalent,itis importantthatwecreateawelcomingandsupportiveecosystemwhere thebestglobaltalentwillseektocome andcontributetoourinnovation ecosystem.
Toprepare and enable thefuture workforce to lead us,we now have the opportunity as well as theurgency to build policies that support the developmentofaworkforcecapable andconfidentindevelopingand implantingthenextinnovationstoheal,nourish,feed,andprotectthe nation.Thesepoliciessupportingtalentdevelopmentwill exposepeople atall stagesof learning,fromouryoungestlearnerstoourcountries leaders,tocuttingedgeSTEMtechnologiesand theirpotentials.They willalsoprovideaccesstoneweducationalpathwaystofuturebiotech careers,especiallyintranslatingandscalingtechnologies,whichwill requireabasicSTEM understandingand aninterdisciplinaryskillset. And theywillprovideopportunitiesfortheAmericanpeopletofeel comfortablewiththecomplexconceptsofbiotechnology,asitrelates totheirhealth,theirfood,andtheirenvironment."
·CommissionerAngelaBelcher
Inthisglobalraceforbiotechnologytalent,theUnited States is losing ground to China.272 The sheer size of China'spopulationgivesthecountrya natural advantage overthe United Statesin human capital. ChinaproducesfarmoreSTEMPhDsand master's degreeholdersthantheUnitedStatesdoes,andit andothercountriesarequicklybecomingcompelling alternativedestinationsfortheworld'sbestbiotechnology minds.273Top U.S.scientistshave been offered custombuildings,facilities,and entire departments atinstitutionsinChina.Evenearly-stageresearchers havebeentargeted,withpost-docsreceivingextremely competitiveofferstostart labs inChina.
Ifthe United States is to stay globally competitive, itmustremainthetopdestinationforthebestand brightestinbiotechnology.Maintainingthatposition will requirenewmechanismsto attractandretain trusted,highlyskilledtalentfromaroundtheworld,as wellasimprovedvettingandscreeningmechanisms toprotectagainstforeignespionage andforced technology transfer.Thegovernment mustalso ensure thatthosevetting andscreeningmechanisms donotdiscourageinternational students and innovatorsfrombringingtheirtalents and innovations to the United States.
Thefederalgovernmenthasaclearanddistinct role in addressingworkforcedevelopment in the federalgovernment,inthecountry atlarge,and internationally. The U.S.government is in charge of itsownfederal workforce;Congresshasthepower to set policiesforrecruiting,retaining,and screening foreigntalent;and there isprecedentforthefederal governmenttoprioritizenational-leveleducation initiatives of strategic national security importance.274
Mostdomesticworkforce and educationinitiatives, however,arehandledatthestateandlocallevels. While the Commission is focused on actions that the federalgovernment isuniquelypositionedtotake, stateandlocalpoliciescanbolsteritseffortswith the support oftheprivatesector.Industry can also supportcommunitybioliteracy alongsideworkforce development.
Section 5.1
Equip the U.S. Government with Necessary Biotechnology Resources and Expertise
New technologies and concepts emerge inbiotechnology allthe time, and biotechnology is increasingly converging with other emerging technologies, including Aland quantum. The U.S.government workforce must maintain suffcient, up-t-ateunderstanding of biotechologyinordertffectivellgislate, mlement, and assesbiotechnology policy.276 Properly trained and equipped federaldepartments and agencies, along with Congressional offces, can readily act on U.S. national priorities for biotechnology.
5.1aRecommendation
Congress must direct the Office of Personnel Management (OPM) to provide workforce training in biotechnology across the interagency.
The OPM plays a key role in federal workforce training,including overseeing training programs across agencies.Asthefederal governmentincreasingly stands upnewprogramming andinitiativesforbiotechnology,itisonlybecomingmoreimportantthat federalemployeesand contractors have theright knowledgeandproficiencytocarry outoperations.
Congress must direct the OPM andrelevantexecutive agencies to develop cross-disciplinary training programsforfederalemployeesthatarefocusedon biotechnology, Al, and other critical and emerging technologies.
TheOPM should consult with leadership and workforcetrainingmanagersatrelevantexecutive agenciestodevelopthetrainingand determine whichfederalemployeesand contractorsmusttake andimplementit.TheOPMshouldcreatedifferent trainingtrackstomeetawiderangeofneedsacross thefederalworkforce.Curriculacanbetailoredfor employeesindifferentroles,whetherinleadership andpolicypositionsortechnicalandacquisitions ones.
At a minimum,training programs should cover:
the science underlying biotechnology;
technological features of biotechnology;
waysinwhichAlcanbeleveragedtoadvance discoveries in biotechnology;
waysinwhichthefederalgovernmentcanbenefit from biotechnology;
the risksposed by biotechnology and ways to mitigate them;and
future trends in biotechnology such as inter
sectionswithquantumcomputing,autonomous systems,advancedmanufacturing,andother technologies.
Training programs should be updated each year to coveradvancesinbiotechnologyanditsconvergencewithothercriticalandemergingtechnologies.
Tocomplementthistraining,thefederalgovernment shoulddevelop a national biotechnologyworkforce framework,conduct aninteragency assessmentof workforceneeds,andofferguidanceonfederal agencies'authoritiesforbiotechnology-relatedhiring.(For more details on a national biotechnology workforce framework,see AppendixE.)
Develop a National Biotechnology WorkforceFramework
Successfulbiotechnologytraining,includingwithin thefederalgovernment,requiresaccuratedataon thebiotechnologyworkforce.Butunlikewithmore establishedindustries,theUnitedStatesneedsa commonlanguagetodefine and categorizebiotechnologyjobsandskillsacrossthepublicandprivate sectors.276 As a result,government, industry, and academiahave a limited understandingsoftheirbiotechnologyworkforceneedsandofsubsequentbest practicesfordrivingthatworkforce development.
To train federal employees in biotechnology,the OPM needsabaselineframeworkthatdefinesbiotechnologyjobsandtheknowledgeandskillsneededtoperformthem.TheNational InstituteofStandardsand Technology(NiST)shoulddevelopthisframeworkin partnershipwithacademia,industry,nonprofits,and relevantfederalagencies.Fortheframeworktobean enduringand useful resource,itshouldberegularly updated at least once everythreeyearstokeep pace with changes inoccupations as biotechnology evolves.
Conduct an Interagency Assessment ofBiotechnologyWorkforceNeeds
The OPM should assess the interagency workforce to identify training gaps and create effective workforce development programs forfederal government personnel and contractors.The OPM should consultwith theleadershipofrelevantfederaldepartmentsand agenciestoquantifyandcharacterizecurrentU.S. government positions contributing to biotechnology, as well aspositions that will be needed in the next five
Conduct an Interagency Assessment
Congressional Staffer
Advises members of Congress on science and technology-related legislation,including biotechnology,andthepotentialimpactson their constituents.
Department of State Regional Technology Officer
LiaisesbetweentheUnitedStatesandother countriesontechnologyissues,includingbiotechnology,topromotecollaborationandensure that U.S.interests and priorities are protected.
Departmentof DefenseAcquisition Officer
Identifies,advances,and procurescritical biotechnology solutionstomeet military needs by contractingwith biotechnology companies, research institutions, and others.
Department of Homeland Security Intelligence Analyst
Conducts intelligence assessments of risks and threats related tobiotechnology to inform policymakers charged with ensuring public safety and protectingU.S.national security interests.
National Science Foundation Program Director
Manages U.S.governmentfundingforresearch and education programs and initiatives across different fields of science and engineering, including biotechnology.
Department of Energy National Labs Scientist
Engages ingroundbreakingresearchto advance national priorities, such as developing scalable biotechnologyinnovationstoaddressU.S. energy,health,andnationalsecurityneeds.
DepartmentofAgriculture Biotechnologist
Regulatesthetestingandmovementoforganismsproducedwithbiotechnologytoprotect U.S.agriculture and the environmentwhile promoting innovation.
DepartmentofCommerceAdvisor
Analyzes imports, exports, and investments related to critical technologies,including biotechnology,to promote U.S. supply chain resilience and economic competitiveness.
and tenyearstoadvancefederalbiotechnologyefforts.Descriptionsofpositionsshouldincludedetails onrequired competenciesandqualifications,includingsecurityclearances.Federal agenciesshouldalso assess additional education needs and challengesto developing the biotechnology workforce.Overseeing biotechnologyworkforcedevelopmentcouldalsobe one of the functions of the National Biotechnology CoordinationOffice(NBCO)(seerecommendation 1.1a).
Establish Guidance for Biotechnology Hiring Authorities by Federal Agencies
TheOPMshouldprovideguidancetofederal agenciesonexistinghiringauthoritiestorecruitbiotechnology talent, aswellas pilot mechanismstoimprove hiring processes.
AnexampleofonesuchpilotmechanismisSubject MatterExpertQualificationAssessments(SME-QA), aprocesswherebyexpertspartnerwithfederal human resource specialiststoexpeditethe hiring of qualified technicaltalent.277
Additionalexamplesofhiringauthoritiesincludedirecthiringauthorities,such asthegovernment-wide STEM direct hiring authority, which expedites hiring ofSTEMpersonnel;excepted service authorities, suchastheDepartmentofEnergy's(DOE)'sEJ PayPlan,whichallowsfortherecruitmentand
compensation of highly qualified scientificpersonnel; andfellowships,suchastheAmericanAssociation fortheAdvancementofScience(AAAS)Science& TechnologyPolicyFellowship,whichprovidesscientists and engineersopportunitiesto serve acrossall branchesofthefederalgovernment.
By increasing awareness and providingclearguidance ontheuseofexisting authoritiestorecruit biotechnologyprofessionals,thefederalgovernment wouldbebetterpositionedtobuildaqualifiedpoolof talent and expertise.
ExpandtheUseofExistingPublicPrivateTalent Exchange Authorities
Federal agencies should expand their use of existing public-privatetalentexchangeauthorities,suchas thoseestablishedbytheGovernmentEmployees TrainingAct,tobolsterthebiotechnologyworkforce.
Thegovernmentneedstostimulateinformation exchangewithacademia andindustrytokeepgovernmentworkers'knowledgecurrent.Public-private talent exchanges help upskill federal biotechnology personnel,particularlythoseresponsibleforpurchasing,investing in,or regulatingbiotechnology products. Theseexchanges alsohelpgovernmentemployees betterunderstandcommercialperspectives,work moreeffectivelywithindustrypartners,andrespond to cutting-edge industry trends.278
5.1bRecommendation
Congress must ensure that federal agencies have the necessary expertise across national security and emerging biotechnology issues.
The U.S.federal government must increase its understanding of biotechnology, particularly among diplomatic and national securitypersonnel. The followingactionswouldensureabioliteratenational securityfederalworkforce.
Require Mandatory Biotechnology and Biosecurity Training for Relevant FederalAgenciesandPersonnel
Congress shouldrequire thatrelevantfederal agenciesdefinecorecompetenciesforbiotechnology andbiosecurity,includingoutliningrequirements forrefreshertrainingonthelatestadvancesin
biotechnology science,laboratory work,equipment, andsoftware.DepartmentsincludingtheDepartment ofAgriculture(USDA),theDepartmentofHealth andHumanServices(HHS),andtheDepartmentof Energy(DoE) should developand updatecore competencies,orrequiredskills,forbiotechnologyand biosecurity,with relevant staff receiving that training everytwotothreeyears.Agencies should disseminate thesecorecompetenciestotheDepartmentof Defense (DOD) and intelligence community (IC)(see recommendation 3.2e).
InitiateSecurityClearancesforAdditional Personnel Workingon BiotechnologyAcross the U.S.Government
AcrosstheU.S.government,therearetoofew personnelwhoworkonbiotechnology-relatedissues that have security clearances. Some biotechnology expertsatagenciessuchastheUSDAortheHHS arenotappropriatelyclearedtoreceiveinformation thatwould behighlyrelevantto theirjobs.Those agenciesalsolacktheadministrativeandoperational infrastructuretoensurethattheirclearedpersonnel canaccessrelevantclassifiedinformationinatimely manner.
Congress should direct relevant federal agencies, includingtheUSDAandtheHHS,toensurethat therightpeopleareworkingonbiotechnologyand thattheyhavethesecurityclearancestheyneedto effectivelymakepolicydecisionsonbehalfofthe American people.
MaintainaBenchofCleared Biotechnology Experts to Advise on National Security Issues
The U.S. government needs access to biotechnology expertsoutsideofgovernment,aswell asthe ability toshareclassified informationwiththemasnecessary,sothatthoseexpertscanprovidetargeted technical expertise that informs policy decisions.
Additionally,theU.S.governmentalreadyspends time and money investigating and grantingclearances to in-house biotechnology experts who may leave the government and lose their clearances.This is an inefficient use ofgovernment resources and institutional knowledge.Itwouldbeinthegovernment's bestinteresttomaintainrelationshipswiththese clearedexpertsevenaftertheyleavegovernment.
Congressshoulddirectrelevantfederal agenciesto maintainabenchofclearedbiotechnologyexperts, whichshouldincludeformerfederalemployeeswhen possible,who canadviseonnationalsecurityissues.
Expand the Number of Biotechnology Professionals in the Department of State
The Department of State (DOS) should use existing hiring authoritiestoexpand therepresentation of biotechnology experts in its regional and functional bureausandinitsOfficeoftheSpecialEnvoyfor Critical and Emerging Technology (S/TECH). To engageinbiotechnologydiplomacy,theDOSmust understand both biotechnology itself and the geopolitical implicationsofthissector.DoSshouldbewell resourced and staffedwithdiplomatswithexpertise inemergingbiotechnology.Oneexampleofan existingDOSprogramthattheUnitedStatesshould leverage and expandistheRegional Technology Officer(RTO)program.RTOsdedicatedtobiotechnologyacrossregional bureauswould improve U.S. biotechnology diplomacy, allow for more knowledgeableinformationgathering,andputtheUnitedStates ina betterpositiontonegotiate and leverageinternational technology agreements.
The DOS should expand the number of biotechnology experts in its regional and functional bureaus, as well as within the S/TECH.Appointing a senior official withbiotechnologyexperienceundertheS/ TECH and designating new RTOs would elevate the importanceofbiotechnologyandsignaltotherestof the world that America is readytolead.
Train U.S.Diplomats on Biotechnology
TheDOSincentivizesForeignServiceOfficers (FSOs) and other civil servants to pursue training opportunitiesrelatedtoemergingtechnologies.As America's envoys abroad,FSOsneedtobewellversed in emerging technology, including biotechnology,to effectively assessopportunities and risks and advanceU.S.interests.TheDOSshouldestablisha strongemergingtechnologytrainingprogramtohelp Americandiplomatsdevelopbioliteracy.It should also create a biotechnology“deep dive”course aimed at educatingstaffwhoseworkismorecloselytiedto biotechnology.
5.1cRecommendation
Congress should receive accurate, timely, and nonpartisan scientific and technical counsel.
Congressneedslastingeducationalarchitecturethat combineseasyaccesstoexternal biotechnologyexpertswithup-to-dateinternal resources.279Overthe pastthreedecades,resourcesdedicatedtoin-house Congressional science and technology assessment have fallen.280 Most notably, the Office of Technology Assessment (OTA), a legislative branch agency established to investigate, assess, and analyze emergingtechnologiesforCongress,wasdefundedin1995 aspartofabroaderefforttoreducethesizeofthe federal government.281 Currently, both the Science, TechnologyAssessment,and Analytics(STAA)office,whichis partofthe GovernmentAccountability Office(GAO),andtheCongressional Research Service (CRS) provide Congress with issue-specific technical expertise.282 But as lawmakers increasingly vote on legislation related to biotechnology,they will need more consistent access to biotechnology expertisetolegislateeffectively.
Congress should establish enduring in-house expertise to advise lawmakers on issues of biotechnology and national security policy. Specifically, Congress should:
Strengthen hiring and pay authorities for CRS so that itcanbettersecure therequisite technicalexpertisetoadviseCongressat the intersection oftechnology and national security;
CodifytheGAO'sSTAAofficeandappropriateadditionalfundssothatitcanhiremore scientists and engineers.Congress should adoptrecommendationNo.141oftheSelect CommitteeontheModernizationofCongress's FinalReport,whichwould authorizeSTAAand make it a permanent part oftheGAO.283 The GAOalsoneedsatleast50morescientists and engineers to support additional technology assessmentsandbolsteritstechnologyforecasting capacity.
Establish an Office ofthe Congressional Science and TechnologyAdvisor(OcSTA). OCSTA would help to coordinate the successful workalreadybeingdonebyCRSandSTAA andensurethatCongressionalofficesarekept regularlyapprisedoftheresourcesavailableto them.
Establishafellowshippipelinethatprovides opportunitiesforexecutivebranchemployeeswithbiotechnology expertiseto complete rotationsinCongressionaloffices.
Hostabiannual scienceand technologyfellowshipfair.This exhibition would be a recurring opportunitytomatchavailablescienceand technology fellowsfrom existing programs with Congressional offices in need.
Establish a standing Congressional Commission on Responsibility and Ethics in Innovation(CREl).Thisindependent standing body would provide nonpartisanguidance and policy options on the ethical aspects of future legislative pathways regarding emerging technology.
(Forspecificimplementation detailsontheserecommendationstobetterresourceCongressfortechnologycompetition,seeAppendixE.)
In additiontotheserecommendations,Congress should receiveregularbriefingsfromtherelevant federal agencies related tobiotechnologypolicy, includingopportunities,threats,and criticaltechnologydevelopments.Manyrecommendationswithin thisreportwould require Congressional oversight, and Congress should be appropriately conversant in the underlying technology.
Support Job Creation Across the United States for Americans at All Skill Levels
In the United States, education and training programs are not aligned with the skills that the biotechnology industry demands.As a result, American workers are not being adequately prepared for biotechnology careers.
To increase bioliteracy across the country, Americans of all ages wil need tobe excited about biology. The Commission learned about good ways tofoster such enthusiasm,from community“LABraries" to curricula developers likeBioBuildertohighschoolers'participation in international competitionslikeInternational Genetically Engineered Machine (iGEM).284 There are more biotechnology educationeffortsthat are not within the federal government's purview but are valuable components of broaderbioliteracy.State and local governmentshave additional authoritiesto strengthen biotechnology educationfrom kindergartenthrough post-secondary programs.rivate companies,non-profits, and communityleaders should also play anactive role in contributing tolocal biotechnology. In the coming months, the Commission wil seek more opportunities to raise awarenessof positive examplesofbioliteracyinactiontoinspirelocalcommunitiestopursuesimilarobjective.
At the same time,the Commission recognizes that the federal government has a specifc role to play in supportingjob creationnamely, standardizing credentials, agregating national data, and drivingfuture-focused educationand trainingprograms.
5.2aRecommendation
Congress must maximize the impact of biomanufacturing workforce training programs.
Exemplaryfederalworkforceandtrainingefforts include the InnovATEBIO National Biotechnology EducationCenter,theNationalScienceFoundation's (NSF) Experiential Learningfor Emerging and Novel Technologies(ExLENT)program,Bioindustrial Manufacturingand Design Ecosystem's(BioMADE) ScalableComprehensiveWorkforceReadiness Initiatives,BioFabUSA'sBiofabricationTechnician RegisteredApprenticeshipProgram,andthe National InstituteforInnovationinManufacturing Biopharmaceuticals's(NlIMBL)eXperience program.285 The Department of Defense SkillBridge ProgramandBioMADE'sWarfighter-to-Scientist workshops train servicemembers for biotechnology careers.286
These federally funded programs and initiatives aim toreachhighschools,vocational-technical schools, communitycolleges,four-yearinstitutions,communityworkforcedevelopmentcenters,andeven individualstudents.TheyprepareAmericansforbiotechnology andbiomanufacturingcareers,particularly entry-level technician positions. These programs exposestudentsandworkerstocareersinbiotechnology,providetrainingwithindustry-informed curricula,presenthands-onlearningopportunities, and offer credentials that validate skillstoemployers. They also engage veterans, who bring unique skills and experiences to the industry.287 Currently,these programshavelimitedcapacity,infrastructure,and reach.Withtherightresources,theycould havean evenbroadernationwideimpact.
Congressmustexpand these andotherfederal biomanufacturingworkforcetrainingprograms and enablemoreparticipationfrommoreregionsand states.Congressmustalsorequire thatprograms coordinate trainingsto maximizetheirimpact,aswell asrequirethatprograms assesstheirefficacy and accreditation.
Congress should stipulate that federal biotechnology and biomanufacturingworkforce trainingprograms not only bring more workers intotheindustry but also helpworkersupskill and staycurrentwiththelatest advances.
StandardizingBiomanufacturingSkills and Accreditation
A majorimpedimenttothebiomanufacturingworkforceisthelackofstandardizationofskills-based training.Skills-based trainingprogramsrangefrom courses taught at vocational-technical schools to apprenticeships.Without standardizing the training and accreditationoftheseprograms,however,employers maynot knowwhatspecific skills ajob applicanthas gainedfromthem.Atthesametime,biomanufacturingworkersmighthavetorepeattrainingstosatisfy jobrequirements,wastingmoneyandtime.
Accreditation provides a standardized way tovalidate a worker's knowledge,skills,and competencies, ensuringthat they meetindustry-recognized benchmarks.Althoughthere arediscrete skills assessment effortsinthebiosciences industry,these mechanisms have not been widely adopted.288 Thefederal governmenthastheauthoritytodevelopandpromulgate benchmarksforworkforcestandardization,butthere isnocurrentefforttodosoforbiomanufacturing.
Congressshould requiretheDepartmentof Commerce(DOC),the DepartmentofLabor(DOL), andotherrelevantagenciestodevelopandpromote nationallyrecognized competencymodelsfor biomanufacturing training and education.
Such accreditation programs should focuson a wide variety of biotechnology training, spanning pharmaceuticals,agriculture,andresearchlabs.For example, microcredentials for specific manufacturing disciplines,forcommonbiotechnologytechniques like growingcells in a laboratory,and for laboratory safetywouldbebroadlyusefulacrosstheindustryandthereforevaluableforworkersandprospective employers.
"Biotechnology is rapidly transforming national security, yet Congresslackstheinternaltechnicalexpertisetoprovide effectiveoversight.AsStaffDirectorfortheHouseArmed Services Committee,I saw firsthand how this emerging tech nologydrivestransformativeinnovationsinmaterial science, health, energy, and supply chains while its convergence with Al amplifies opportunities and risks. Despite these growing challenges,Congressreliesheavilyonexternal experts, leavinglawmakerswithoutthein-houseknowledgetocritically evaluate input and alignpolicieswith national security priorities.To address thisgap,Congress must invest in staff development,offercompetitivesalaries,andstrengthen partnershipsto ensurepolicymakers are equipped tosafeguard America's security and global leadership in this rapidly evolvinglandscape."
·Commissioner Paul Arcangeli
5.2bRecommendation
Congress should expand educational efforts in biotechnology for American students.
Not all statesmake biology a high school graduation requirement.Lessthan30percentofpublichigh school biology classes include molecular biology, a foundational precursor to biotechnology.289 High school isoftenthefinal opportunitymostAmericans havetoreceiveaSTEMeducation,includingthe chancetotakebiologyandbiotechnologyclasses. GivenhowmanyAmericansentertheworkforce immediately afterhighschool,thisjunctureis a critical moment to motivate interest in biotechnology careersandprovidequalityeducationtoenable success in biotechnology jobs.
Previousfederalefforts,suchastheNational Defense EducationAct(NDEA)of1958,helped laythefoundation for science education in the United States.290 Tomeettherisingdemandforskilledprofessionals, especiallyincritical andemergingtechnologies, leadingexpertshavecalledforaNDEA2.0toinvest in modernized STEM education.291For example,the NextGenerationScienceStandards(NGSS)is a state-levelinitiativedevelopedwithinputfromfederal agenciesthatprovidesvoluntarystandardsforstates toimproveSTEMeducation.Todate,however,only 20statesand theDistrictofColumbiahave adopted these benchmarks.292 Limited resources—-including tosupportteachers—andinsufficientclassroomtime have slowed theuptake ofthese standards.293
Whilethefederalgovernment'sroleindirectly affectingeducationpolicies and curricula islimited, there are specific federal authorities to support and encourage state-leveleducation inbiotechnology—includingworkforce trainingandtechnical
education—byprovidingresources,funding,and guidancetohelpstatesstrengthentheireducational programs and align them with national priorities.
The federal government can help enable a comprehensiveecosystemtosupportstudentsuccess fromhigh schoolto career.Congress should expand biotechnologyeducationthrough:
anewNationalScienceFoundation(NSF)grant programtosupportstudent-to-careerpathways inbiotechnologythatensureaseamlesstransfer of relevant credentials(such as certificates, degrees,and apprenticeships)amongeducationalinstitutionsforstudentstoobtainalllevels of biotechnologyjobs;
a Biotechnology Scholarshipfor Service program toincentivizeundergraduateandgraduatestudentstopursuebiotechnology-relatedfieldsof studywithconditionalguaranteeofgovernment employment; and
aBiotechnologyforAll HighSchool Students initiative comprisingagrant program and establishingaconsortiumtoadvancenationwide secondary education(grades9-12)through the NSFand theDepartmentofEducation.
(Foradditional detailsonsupportingstudent-to-careerpathways,aBiotechnologyScholarshipfor Service program,and a BiotechnologyforAll High School Studentsinitiative,see AppendixF.)
Less than 30 percent of public highschool biologyclassesteach molecular biology, a foundational precursor to biotechnology.
Section 5.3
Attract and Retain Trusted Foreign Talent
TheUnited Statesremainsatopdestinationforthe world's leading STEM researchers and promising young scientists,thanks toitsresearchuniversities, openresearchenvironment,freeexchangeofideas, and regional innovation clusters.294:295 The number ofinternationalstudentswhocometotheUnited Statestopursuedegreesinbiological andbiomedical scienceshasgrownsteadilysince1999,reachingan all-time high of over 53,000 in 2024.296 These students,alongwithbuddingbiotechnologyinnovators fromabroad,havebeenaboontotheUnitedStates.
But theUnited States strugglestoretain much ofthis talent.Current policies make it difficult forforeign STEM students and professionalsto stay permanentlyinAmerica,startbusinesses,and contribute to theU.S.economy and innovation base,particularly in thedefensesector.297TheCommissionheard fromexpertsinindustryandacademia thatChinais activelyrecruitinggraduatesfromAmericanuniversitiesaspartofalong-termefforttosurpasstheUnited States.
Today,theUnitedStateseducatesand trains foreign-born experts,but its competitors end up reapingtherewardsofthatinvestment.And those rewardsareconsiderable:thesehighlyeducated and credentialedbiotechnologistshave accessto Americanresearchand intellectualproperty,they oftengeneratepathbreakinginventions,and they oftengoontoestablishvaluablestartups.Butmanydo so outside ofthe United States,largely because U.S. immigration policyforces them to leave.Thisfailure putstheUnitedStatesat a strategic disadvantage.
China's approach to recruiting and retaining foreign talent standsinstarkcontrast.TheChinesegovernmentinvestsvastsumsofmoneytoattractinternational students and workers,using state-of-the-art, multi-million-dollarresearchfacilities andlargecash incentivestolurethemtoChina.
It isnotjust adversariesthat aretakingadvantageof Americanweaknessbutallies,too.In2023,Canada introducedapilotprogramofferingthree-yearwork permitsforworkerswhoareintheUnited Stateson temporaryH-1Bspecialtyoccupationvisas,which caninclude advanceddegreeholdersinbiotechnology.298 The program was so popular that it reached its 10,000 limit in a single day.299 Competitive efforts ofthiskindwillonlybecomemoreambitiousand effectiveiftheUnitedStatesdoesnotacttoretain the best and brightest.
"The status quo is changing. COVID-19 has shifted the dreams of many Chinese students. Maybe top students used to want to come to the United States for their \mathsf{P h D} or postdoc, but I sense the proportion is now decreasing...Students in China don't think about America as some 'scientific Mecca' in the same way their advisors might have done. U.S. policymakers should take note and build better educational programs here."
-NikoMcCarty,FoundingEditorofAsimovPress
5.3aRecommendation
Congress should authorize new green cards for biotechnology talent, especially from allied and partner countries.
These newgreen cardswould helptheUnited States retain more ofthe thousandsofforeignstudents whograduatewithrelevantdegreesorequivalent professional qualifications in biotechnology and other related felds.
CongresscouldauthorizetheSecretaryofHomeland Securityto determine the eligibility of foreign biotechnology experts based on factors including education,work history,special skills,and lettersof endorsementfrompublicandprivateentities.
In the 118th Congress,Senator Todd Young (R-IN) introducedS.5644,theHeartlandVisaActof2024 whichsimilarlyfocusesonincreasingthe numberof high-skilled immigrants in the United States.3o0While this billdoes not focus solely onbiotechnology or criticaland emergingtechnologies,itwouldprovide a mechanismforanewvisacategoryforhigh-skilled foreigntalentto seekemployment ineconomically disadvantagedU.S.countieswherethepopulation isdeclining.Thislegislationwouldcomplementthe proposed biotechnologygreencards,sincethebill focuses on location while thisproposal focuses on critical subject-matter expertise.
5.3bRecommendation
Congress should optimize the vetting process for foreign nationals to prevent illicit technology transfer.
The U.S. government should gather the information itneedstodevelop,update,andenforceitspolicies regardingvisascreening,vetting,andrestrictionsto both protectand promote U.S.interests.Areviewof currentfederal visacontrol processeswould improve thegovernment'scapabilities and decision-making tobetterprotectagainstthreatstosensitive technologies,while stillenablingtopforeigntalenttocontribute to the U.S.economy. Drawing on the findings ofthatreview,policymakerscouldmakeinformed decisions about the efficacy of current processes.
TheGAO should audit theU.S.government'scurrent visa restrictions,screening,and vetting and make recommendations to betterprotect against espionage and illicit transferof critical and emerging technologiesbycountriesofconcern.Recentfederal effortsinthisareaincludetheNational Science Foundation'sSafeguardingtheEntireCommunity oftheU.S.ResearchEcosystem(SECURE)Center, which servesasaninformationclearinghouseforthe researchcommunitytomitigateforeignriskstothe U.S.researchenterprise;Presidential Proclamation 10043,whichprohibitsChinesestudentswith People's LiberationArmy (PLA)associationsfrom obtainingstudentand exchangevisitorvisas;and the National VettingCenter,whichcoordinatesinteragency vetting efforts.301
In its audit,theGAOshouldreviewresearchsecurity policies,procedures,and resources,includingthose regardingfederalagencies,institutionsofhigher education, and technology companies(such as new federal agencyguidelines and the SECURECenter). TheGAOshould also assess the effectivenessof thosecurrentpoliciesandprocedures.
Intermission
NSCEB on the Road
Overthelast twoyears,theCommissontraveledtheworldtogainadeeperunderstanding oftheglobalbiotechnology landscapeTheCmmissionmet withscientists,goverment ministers bmanfacturing workers, ambassadors indst leaders,andstart-upfounderwitessinfrsthandbiotechnolgyvatinsaroadheCommissinbservedt unique strengthsofurallsandparters,fmstate-ofthart cale-upnfrastructuretoobust trainingproramt regulatoryenvironmentsthataccelerateinnovation.
Asbiotechlgntiuestevoleandpresentwpportunitiesandriskcrossorderollaborationswithallad partnerpanningjoint reearchefforts, tradeagrements, andtalent exchanges—willbekeytfosteringabright moreprosperous,andsaferfuture.
Belgium
Belgium is a global leader in biomanufacturing, with state-of-the art scale-up facilities.Commissionerswentona hard-hattourofSteelanol,acompanythat isharnessingmicrobesthatcanconvertindustrialgasemissionsintoethanol, whichisrepurposed intoconsumerproducts like athleticgear.The Commission also visited the BioBase Europe Pilot Plant(BBEPP),apilot-scale facilitythat helpsinnovatorsscaleupbiotechnology-basedproducts.
Ina seriesof discussions withNATO'sDeputySecretaryGeneral andgovernment leadersfrom the European Union,the Commission discussed thealignment of European and U.S.priorities onbiotechnology and national security,as well astheimportanceof bioliteracyingovernment.
Denmark
Denmark's highlyintegrated ecosystem acceleratesbiotechnologyinnovation by fostering collaboration between thepublic sector and private industry.
The Commission met with Novo Nordisk,the biopharmaceutical powerhouse behindtheweight-lossdrugsOzempicandWegovy,thathasamarketvalue greaterthan Denmark's GDP.The Commission learned how the Danish government'suniquerelationshipwithindustry,includinggovernmentincentives andsupport,positionsDenmarkasaglobalbiotechhub.TheNovoNordisk Foundation further strengthens this ecosystem by supporting biotechnology entrepreneursthroughinitiativessuchastheBiolnnovationInstitute,a life sciencesincubator.
Germany
In Germany,the Commission got a frsthand look, and firsthand taste,of cutting-edgebiotechnologyresearch and development(R&D).Commissioners had theopportunitytomeetwithleadersofFormo and trytheirbiomanufactured cheese.Commissionersalsometwitha companythat is3Dprintinghuman tissuewith thehopeof being able tomakeorgansforuseintransplants.
Singapore
Commissioners learned how Singapore's government is providing biotechnology companieswithefficient,predictable,andflexibleregulatoryframeworksthat enablerapidtransitionfromresearchtocommercialization.Commissionersmet with Singapore's Deputy Prime Minister and the Ministers of Trade and Industry, Defence,andForeignAffairs,aswellasindustryleaders,todiscusshowbiotechnologycanstrengthentheU.S.-Singaporerelationship.
Japan
Japan is onthecuttingedgeof notonly biotechnologyR&Dbut alsogovernment policy.The country's forward-thinking approach was evident during a tour of SanatechSeed'sgreenhouses,whereCommissionershadtheopportunityto taste GABA-enriched tomatoes,the first CRISPR-edited food toentertheinternational market.In meetingswithJapan'sCouncil forScience,Technology,and Innovation,the Commissionlearned howJapanisleveraging itslegacyexpertise in technology innovation and manufacturing, ranging from regional technology hubs to producing high-end research instrumentation,to guide the country's whole-of-government approach to advancing biotechnology.
Sweden
Sweden's recent accessionto the NorthAtlanticTreaty Organiation(NATO) opened opportunities to discuss its whole-of-government approach to integrating national security and biotechnologyinnovation.Through aseriesof meetings withgovernmentofficials,includingtheMinisterof ForeignAffairs andmembers oftheNationalSecurityCouncil,CommissionersdiscussedSweden'srecently adopted National SecurityStrategy.Thisstrategy shared themeswiththe Commission's own work,touching ontopics including technological adoption, China's growing military and technological ambitions, and the importance of workingwithlike-mindedcountries.
United Kingdom
AsoneoftheUnitedStates'closest allies,theUnitedKingdomoffersnumerous opportunitiestoleverage andstrengthentheSpecial Relationshipforbiotechnology advancement.TheCommissionmet with industryinnovators,investors, andgovernmentleaders,includingtheMinisterforScience and leadersofthe UK Biobank.The Commission also explored potential joint efforts on biological data collection,financing technologies fornational security,and fostering biotechnologyinnovationandcommercialization.
Chapter 6
Mobilize the Collective Strengths of Our Allies and Partners
Momentumforbiotechnologyisbuilding around the world, and the United States must keep pace. To collectivelymaximize thebenefitsofbiotechnology,it mustworkwith alliesand likeminded countriestopoolexpertise,talent,and capital,all inanefforttodefend,build,heal,andnourish.
U.S.allies and partners are prioritizing biotechnology.TheNorthAtlanticTreatyOrganization (NATO),for example, released a strategy in 2024 tofostertheresponsibledevelopmentandadoptionofemergingbiotechnologies.302The alliance is alsoinvestingintechnologieswithnational securityimplicationsthroughitsDefenceInnovation AcceleratorfortheNorthAtlantic(DlANA)and its NATO Innovation Fund (NIF).303 There are opportunitiestoleveragesharedresources, whethertheybejointcapital,data,orresearch anddevelopment(R&D)capabilities,insupportof biotechnology advancement.
TheUnited States must renew its commitment to its closest allies and forge new partnerships with nations that have complementarygoals,capabilities, and expertise.Nearly every countryhassomething valuabletooffer:someboastadvancedbiomanufacturingcapabilities,othersareattheleadingedgeof computational biology,and others still are pioneering bio-based chemicals and regenerative medicine.304
The U.S. government should expand biotechnology diplomacy,includingcommercial and regulatory diplomacyto expand marketaccess and boost aggregatedemandforbiotechnologyproducts.The UnitedStatesmustworkwithalliestoensurethat biotechnologiesarenotmisusedandtogetherset normsandstandardsbasedonsharedvalues.The United States and its alliesandpartnersmust also worktogethertostandardizeapproachestobiotechnologyprotection.
Thefollowingrecommendationschartacourseof actionforthe United Statesto promote and protect biotechnology alongside its allies and partners.
"We have seen our allies and partners make considerable strides in addressing all aspects of biotechnology, recognizing as they do that maintaining the Free World's lead in all fields is a national security imperative. Working togetherwe will realize synergies that will ensure that lead for years to come'
·Commissioner Dov Zakheim
Section 6.1
Promote Biotechnology with U.S. Allies and Partners
Advancing biotechnologyis an internationalendeavor;it requirestheUnited Statestoidentifycomplementary capabilities, expertise, and resources withallies and partners.TheCommission'srecommendations in this sectionsupport thefederaldepartments and agenciesthat engage inbiotechnologydiplomacy.Bypooling their capabilities, theUnited States and its allies and partners can develop shared solutions touniversal challenges.
In recent years,the Department ofState (DOS)has greatly expanded its capacityfor technology diplomacy, particularlyoncyber anddigitalissues,throughthe creationof newpositions,trainings,and grants.Butit and otherfederalagencieshave neithertheresourcesnorthe staffneededtocoverthe breadth and depthof biotechnology diplomacy.
6.1aRecommendation
Congress must include biotechnology in the scope of the Department of State's (DOS) International Technology Security and Innovation (ITSl) Fund to appropriately fund international biotechnology policy, research and development (R&D), and secure supply chains.
Congressestablished theITSIFund in 2022to strengthentelecommunicationsnetworksand semiconductorsupply chainsecurity,authorizing 500$ million over five years.305 This fund is designed toenabletheDoStonimblydeployresourcestoward digitaldiplomacy and high-valuecooperationopportunitiesinthe semiconductorsector.
Congress must expand the scope oftheITSl Fund toencompassawiderrangeoftechnologiesand setasidededicatedfundsforbiotechnology.The SecretaryofStateshouldcoordinatewithleadership acrossrelevantU.S.departments and agenciesto maximize the impact of international biotechnology diplomacyand complementotherfederalfunding sources.The Secretary should alsosubmit annual reportstoCongressdetailingtheuseofthesefunds, includingprograms,projects,and activitiesconducted with foreign partners. Suggested programs includecoordinatedR&Dandstrengthenedglobal supply chainsforbiomanufacturing.The DOS should examinehowtodirectfundsandresourcestoother federalagenciesthatworkwithforeignpartnerson biotechnology to advance shared goals.
Snapshotofthetopfvecountriesrankedbytheirproportionofhigh-impactresearchoutputsfrom2019-2023inbiotechnology,genetechnologies, andvaccines.Technolgmonopol risk"measurestheriskofconcentrationof scientiand technologicalresearchexpertisewithinasinglecountry.Ahightechnolgymonopolrisk(redisapotentialidicatorfor futurebreakthroughs intechnologycapabity.Thismetricisacombinationoftwofactors:(1theladcountrysshareofth world's top10 institutions,and (2)thelead country'slead overits closest competitor(ratio oftop 10% publications). (Source:ASPl'sTwo-decadeCritical TechnologyTracker)vi
Advancing biotechnology is an international endeavor;it requires the United States to identify complementary capabilities,expertise,andresourceswithallies and partners.
6.1bRecommendation
Congress should direct the Department of State (DOS) and other agencies to promote the U.S. biotechnology industry in foreign markets, including through commercial diplomacy.
Commercial diplomacy aimsto create business opportunitiesbetweencountries.ltcaninclude tradepromotion,economic cooperation,and shared policydevelopment.Multiplefederal agencies engageincommercial diplomacy,includingtheDos, the Department ofCommerce (DOC),the Foreign Agricultural Service(FAS) within the U.S.Department ofAgriculture(USDA),and theOfficeoftheUnited States Trade Representative (USTR). These agencies negotiatebilateralandmultilateraltradeagreements, coordinatetrade missions,and mitigate tradebarriers.Expandingmarketaccessisparticularlycritical toensuringthatAmericanbiotechnologyproducts sell well internationally.Currently,federal staffingand fundingfortheseactivitiesisinsufficient and uncoordinated, particularly when it comes to biotechnology diplomacy.
Congress should ensure that commercial diplomacy effortsforbiotechnology are appropriatelyfunded and coordinated.Inparticular,Congressshould directtheDOS,theDOC,theFAS,theUSTR,and otherrelevantagenciestopromotetheU.S.biotechnology industry in foreign markets, including by offeringbiotechnologytrainingforForeignService Officers(FSOs)(seerecommendation5.1b).The National Biotechnology Coordination Office (NBCO) (seerecommendation1.1a)wouldhelpcoordinate U.S.governmentefforts within and across sectors. Congressshouldalsoensureadequatefundingfor U.S.trade and diplomatic agencies,including the DOS,USTR, and the FAS, to support bioliteracy programsthatclearlycommunicatethebenefits andrisksofbiotechnology,therebyfosteringpublic acceptance andexpandingmarkets.
6.1cRecommendation
Congress should expand regulatory diplomacy for biotechnology.
Different countries regulate biotechnology products throughdifferentframeworks,resultingindivergent standards and datarequirements.Thesedifferences canposetradebarriersanddelaythecommercialization of useful products.Through regulatory diplomacy,theUnitedStatesworkswithothercountries toresolvetradebarriersthatoccurduetoregulation. Aswithcommercial diplomacy,multipleagenciesare involvedinregulatorydiplomacy,includingtheDOS, theUSTR,theFoodandDrugAdministration(FDA), theEnvironmentalProtectionAgency(EPA),and multiple agencieswithin theUSDA.Tobeeffective, regulatorydiplomacyneedstobewell-funded,wellstaffed,andcoordinatedacrossfederalagencies.
Commercial diplomacy and regulatory diplomacy are closelylinked.Without anefficientregulatory system, therecannotbea thrivingglobal market,andwithout market demand,governments generally do not prioritizeestablishing orreformingregulatoryframeworks. TheCommissionrecommendsthatcommercialand regulatorydiplomacybecoordinatedacrossU.S. agenciesand thatsimilarpersonneland approaches thatareleveragedforcommercialdiplomacybeused for regulatory diplomacy.
Congressshoulddirectandresourcediplomatic, regulatory,andtradeagenciestoincreaseand coordinatetheireffortsonregulatorydiplomacyin bothbilateral and multilateral settings,including international standard-settingbodies.Alltheseefforts should worktowardglobal regulatoryconvergence for biotechnology products.Regulatory convergence couldincludesynchronizedapprovals,sharedor concurrentreview,oralignmentwithinternational standardsforriskassessment.
(For more details on expanding regulatory diplomacy for biotechnology, see Appendix G.)
6.1dRecommendation
Congress should require the Department of State (DoS) to form reciprocal biological data-sharing agreementswith other countries.
Onits own,theUnited Stateshas a finite amount of high-quality biological data that is Al-ready,limiting the types of advancements itcanmake.These biological data include:
Typesofbiological samples that areparticularto acountry,suchasgeneticsequencesfromnative plants,animals,fungi,andbacteria.
InSection4.1ofthisreport,theCommissionrecommendsaSequencingPublicLandsInitiativetocollect newdatatodriveinnovations.TheUnitedStates couldsharethisdatawithothercountriesthatare willingtoreciprocate.Many othercountries, including close allies such as the United Kingdom,Australia, Japan,andSouthKorea,maintaintheirownsetsof biological data,whichincludeuniquedata assets (suchasdata aboutorganismsthatcannotbefound elsewhere).
Specificmeasurementcapabilitiesbasedon technologicaladvancement.
Thescientific areasthatdifferentcountriesfocus onshape thetypesofdata collectioncapabilities theyhave.Forexample,Australia'sstateandfederal governmentshaveinvestedheavilyinthestudyof RNA,which could yield unparalleled capabilities to sequenceandmeasureRNA.306
Despitethiswealthofdata amongU.S.allies,the United Stateslacks adequatemechanismstocollaboratewiththesecountriestocollectivelyadvance biotechnologyandotherdata-driventechnologies.
Working with allies on biological data becomes increasingly important when adversaries are building their own large biological data repositories, including through unethical or coercive practices.
To encouragesecure and effective collaborations, theDOS,inconsultation with theNational Instituteof Standardsand Technology(NiST)and otherrelevant agencies,shouldforminternationalagreementsand standing bodies with U.S.allies and partners to:
facilitate reciprocal pooling and sharing of biologicaldatatoadvancecollaborativeresearch; implementandenforcedatastandardstoensure thatshared dataisAl-ready;and reach agreements on the fair collection, storage, and useofbiological data thatareinlinewith shared norms and values.
Thesestandardswouldensurethatadequate informed consent is provided when collecting data andthatthereisreciprocityofbiologicaldata sharingbetweencountriestopreventasymmetries. The agreements should alsopromote theuseof public-privatepartnerships tobolster collaborativeresearchinvolvingtheexchangeofbiological data,provided there are adequate protections and reciprocity.
These agreementscould take the form of new bilateralormultilateralagreementswithcountries that have a proventrackrecord of robustbiodata collection efforts.Orthey could leverage existing multilateral relationships such the AUKUS security partnership—especiallywithinPillarTwo,which concernsthecollaborativedevelopmentofadvanced technologies——ortheQuad orG7.307
Becausebilateral and multilateral agreements are established on a project-by-projectbasisby U.S. researchersandtheircollaborators,theCommission encouragestheDoS to expand these agreements as needed and in a form thatmost benefits thebiotechnologycommunity.
6.1eRecommendation
Congress should direct the Department of State (DOS) and the Department of Defense (DOD) to encourage North Atlantic Treaty Organization (NATO) countries to aggregate demand and pool purchasing power for biotechnology products.
Without clear and consistent government signals for demand,biotechnologieswithdefenseapplications will failtoscale.Defensemarketcommitmentsfrom theUnitedStatesalonemaynotbeenoughtoshift theglobal landscapeforbiotechnology,butU.S. allies are alsolookingtobiotechnologyto meet their national security needs.
In2023,NATOmembersfromEuropeandCanada collectivelyspentanestimated $$429.2$ billion on defense,whiletheUnitedStatesspentanadditional $$875.6$ billion on defense.308 The alliance's 32 member countriesrepresent anuntapped marketforce forbiotechnology innovation,which opens up an opportunityforcompaniestoaddressthecombined defenseneedsofNATOallies.
Establishingjointadvancemarketcommitments and offtake agreementsto aggregate demand would createstrongermarket incentivestoscaleproducts. Pastexamplesofadvancemarketcommitments havebeentrialedsuccessfullyattheinternational level.Forexample,withtheCOVID-19Vaccines GlobalAccess(COVAX)initiative,theUnitedStates andothercountriesmadejointmarketcommitments tobiopharmaceuticalcompanies,aneffortthat provedcriticaltothesuccessfulcommercializationof COVID-19 vaccines.309
The United States should encourageNATO countries to aggregatedemand andpooltheirpurchasing power for biotechnology products. Congress should directtheDOS,inconsultationwiththeDOD,to develop a diplomatic strategy for establishing a forum within NATOforthe purposes of poolingthe
purchasing power of NATO allies towards emerging biotechnologies.This strategy should:
thedeterminationofcriteriaforcriticalneeds thatcould befulfilledbybiotechnology tofurther NATO's aims such as biobased energetics; the establishmentofinformation-sharingand contractingmechanismstocarryoutthe advancemarketcommitmentsandofftakeagreements amongNATO allies; and And initial determination of U.S. market supply anddemandinthebiotechnologyindustrythat wouldmeettheaboveoutlinedcriticalneeds.
Upon completionofthe strategy,theDOS should reportthestrategytoCongress,andtheDoSandthe DODshould carry it out.
DeepenCollaborationwithAlliesand Partners
Congressshouldestablishafellowshipprogramfor nationalsofNATOmemberstatestocollaboratewith U.S.federal researchers andpolicymakersoninitiatives at the intersection of emerging biotechnology, international security, and defense.
Creating a NATO fellowship program with the express goal offosteringthose tiesinbiotechnology would benefittheUnitedStatesanditsallies.Fellowswould workatCongressionalofficesandfederalagencies, providingscientific and technical expertise to advancepoliciesandresearch.
Section 6.2
Protect Biotechnology with U.S. Allies and Partners
At the same time as it promotesbiotechnologies withits alles and partners,theUS.government must coordinate efforts with themto protect biotechnology from misuse by adversaries and prevent it from causing unanticipated harm.The U.S.government should work with alies and partners to standardize approaches toward adversarial capital (see Section 2.5),country-wide export controls (see Section 3.3), and data security (see Section4.2)to ensure that US. and allied technologies are not misused by adversaries.These efforts should also include ensuring that international norms and standards are rooted in safety, security, and responsibility.
6.2aRecommendation
Congress should direct the Department of State (DOS), along with the National Institute of Standards and Technology (NiST), to support the development of international norms and standards, including defining shared values and interests in biotechnology.
U.S.participationin standards setting bodies, like theInternational OrganizationforStandardization (ISO),hasremained flatoverthepasttwo decades. Meanwhile,China's participation in such bodies has ballooned. China participates in 200 more ISO technicalcommitteesthatworktosetinternational standards,compared totheUnitedStates.310
The international community is increasingly convergingona commonsetofbiotechnologystandards. Active and engaged U.S.leadershipintheseforums willbecriticaltoensuringthatAmericaninterests arefullyrepresentedasglobal standards areset. AllowingChinatodominatetheconversationdiminishes both theUnited States'biotechnology industry and itsownnational security.The ISO,forexample, has already published a variety of biotechnology standards covering topics ranging from cleanrooms tobiobanking to DNA sequencing.311
WhiletheUnitedStateshasavoiceintheseforums, thelimitedsizeofitsdelegationsconstrainsits effectiveness.TheDOS,alongwith theNIST and otheragencies,shouldworkwithaffectedstakeholders in industry and academia to foster greater U.S. engagement and leadership in these forums. TheDoSshouldfurtherensurethattheseactivities arecoordinatedwithinteragencypartners,including trade agenciesand agencieswitharoleinbiosafety and biosecurity(seeSection4.4a).
6.2bRecommendation
Congress should require the Department of State (DOS) to create a strategy for harmonizing multilateral export controls.
TheUnitedStatesshould alsoworkwith its alliesand partnersto protect against biotechnologymisuse by harmonizing multilateral export controls.Currently, however,emergingtechnologiesevolvefasterthan countriescanharmonizemultilateralexportcontrols,a process that can take years.This dynamic is compoundedbyotherlong-standingproblemswith existingmultilateralexportcontrol regimes.
For example,the Wassenaar Arrangement onExport ControlsforConventionalArmsandDual-UseGoods and Technologiesincludes Russia and operates by consensusand,asaresult,hasmadeonlyminor updatestoits control lists inrecentyears.312Without harmonization,countriescandifferonwhatbiotechnology-related equipmenttheyrestrict.Thelackofa unified monitoringsystemallows adversariestoshop aroundandbuytechnologyfromcountrieswithmore lax restrictions.
Exportcontrolsoftenlagbehindbothtechnological advances andgeopolitical changes.Without aforcing mechanismto continuouslyupdate them,theUnited States and its allieswill find thatbiotechnology-relatedequipmentrestrictionsbecomelessrelevant andthereforelesseffectiveovertime.
Withinthenextyear,theDOSshoulddevelopa new strategyforharmonizingmultilateralexportcontrols onconventional arms anddual-usegoodsand technologies.Thisstrategyshouldlayouthowexport controls can reflect contemporary geopolitical and technologicaldynamics,suchasovercomingthe limitations in the Wassenaar regime. Working with the National Security Council,relevant agencies,and key allies and partners,theDOS should reportto Congress on the new strategy and a plan for implementing it.
Chapter6
Appendices
Technical Glossary
Advancemarketcommitment
A buyer's agreement topurchase a productthatdoes not yetexist,ifadevelopercanmakeitatscale.
Autonomouslaboratories
Fullyautomated andguided byartificial intelligence and machinelearningsoftwaretoplan,execute,learn,improve, andrepeatexperimentsbasedonadesiredoutcome.
Biobased
A product orprocess that is composed oforderived from, in whole orin significantpart,biological material.
Biodefense
Actionsdesignedtocounterbiologicalthreats,reduce risks,andpreparefor,respondto,andrecoverfrom bioincidents,whethernaturally occurring,accidental,or deliberate inorigin and whetherimpacting human,animal, plant,orenvironmentalhealth.
Bioliteracy
Theconceptofimbuingpeople,personnel,orteamswith an understandingof and abilitytoengagewithbiology and biotechnology.
“Biologicaldominance”orzhishengquan（制生權(quán)）
TherecognitionbyChina'sgovernmentandmilitaryof biologyasadomainofwarfareanditselevationintheir strategic thinking.
Biological data
Theinformation,includingassociateddescriptors,derived fromthestructure,function,orprocessofbiological systemsthatiseithermeasured,collected,oraggregated for analysis.
Biomass
Anymaterial ofbiological originthat is available ona renewableorrecurringbasis.Examplesofbiomassinclude plants,trees,algae,and waste material such as crop residue,woodwaste,animalwasteand byproducts,food waste,and yard waste.
AppendixA
Biomanufacturing
The useofbiological systemstoproducegoods and servicesatcommercialscale.
Biomining
Tousemicroorganismstoextractmetalsofeconomicinterestfromrockoresorminewaste.Biominingtechniques mayalsobeusedtocleanupsitesthathavebeenpolluted with metals.
Bioprocessing
Theuseofbiologicalsystemstoprocessmaterialsforbiomanufacturing,includingtransformationofbiomassbefore areaction(upstreamprocessing)orseparationorpurificationoftheresultingmaterials(downstreamprocessing). Sometimes used synonymously with biomanufacturing.
Bioremediation
A process whereby organisms,cells,orcellularcomponentsareusedforenvironmentaldecontamination.
Biosafety
Practices,controls,and containmentinfrastructure that reducetheriskofunintentionalexposureto,contaminationwith,releaseoforharmfrompathogens,toxins,and biological materials.
Biosafetylevels
Usedtoidentifytheprotectivemeasuresneededina laboratorysettingtoprotectworkers,theenvironment, andthepublic.Atanygivenbiosafetylevel,therearestrict requirementsforlaboratory design,personal protective equipment,andbiosafetyequipment.
Biosecurity
Securitymeasuresdesignedtopreventtheloss,theft, misuse,diversion,unauthorizedpossessionormaterial introduction,orintentionalrelease ofpathogens,toxins, biologicalmaterials,andrelatedinformationand/or technology.
Biosurveillance
Asystematicprocesstosurveytheenvironmentorlocationofinterestforbacteria,fungiviruses,orotherbiologicalentitiesthatmightcausediseaseinpeople,animals,or plantsinsupportofdetection andidentificationeffortsand correspondingpublichealthorsafety.
Biotechnology
The applicationofscience andengineeringinthedirect orindirectuseoflivingorganisms,orpartsorproductsof livingorganisms,includingmodifiedforms.
CurrentGoodManufacturingPractice(CGMP)
RegulationsenforcedbytheFDAthatprovideforsystems thatassureproperdesign,monitoring,andcontrolof manufacturingprocessesandfacilities.
Chassis
Inthecontextofbiomanufacturing,abiologicalframeor architecture,usuallyanorganism,wherecomponentscan beadded,changed,orremovedtocreatenew
Clinical trials
Researchstudies designedto answerspecificquestions aboutthesafetyoreffectivenessofdrugs,vaccines,other therapies,ornewwaysofusingexistingtreatments.
Cloud labs
Physicallaboratoriesthatareequippedwithlabautomation that can be programmed and controlled remotely by scientiststoconductbiologicalexperiments.
Commercial diplomacy
Diplomacythataimstocreatebusinessopportunitiesbetween countries.It can include tradepromotion,economic cooperation,andsharedpolicydevelopment.
Countervailing duty
Anadditionaltaxortariffplacedonimportedgoodsto offsetcertainkinds of subsidiesprovided by anexporting country.
Critical inputs
Rawmaterialsorconsumableswhose shortages have the potential to cause a significant delay in biomanufacturing. Theseareoftenlow-marginchemicalsandbiological materials,includingaminoacids,thatarenecessaryto sustainscaledbiomanufacturing.
Criticalandemergingtechnologies(CETs)
A subsetofadvanced technologiesthatarepotentially significant to U.S.national security.
CRISPR-Cas9
Shortfor"clustered regularlyinterspaced shortpalindromic repeats,"CRISPRis a technology that scientists use to selectively modify theDNA of living organisms. CRISPRwas adaptedfromnaturallyoccurringsystems found inbacteria.
Dual use research of concern
Lifesciencesresearchthat,basedoncurrentunderstanding,can be reasonably anticipated to provide knowledge, information,products,ortechnologiesthatcouldbe misappliedtodoharmwithno,oronlyminor,modification topose a significant threatwithpotential consequences topublichealthandsafety,agricultural crops andother plants,animals,theenvironment,materiel,ornational security.
Exportcontrols
Federal lawsandregulationsthatlimitthetransferoffunds, goods,services,andtechnologytonon-U.S.individualsand organizationstopromotenationalsecurityinterests.
FederalSelectAgentProgram
AjointprogrambetweenCDCandAPHISthatoversees thepossession,use,andtransferofselectagentsandtox ins,whichposeathreattopublic,animal,orplanthealth.
Feedstock
Materialsused directlyinmanufacturingprocessesand transformedintointermediateorfinishedproducts.
Forecasting
Statementsorassertionsaboutfuture eventsbased on quantitativeandqualitativeanalysisandmodeling.
Foresight
Methodforsystematicallyconsideringalongertime horizon and broaderscope of issues than otherforms of planning.
Gene synthesis
Methodsused in syntheticbiologythat enable thecreation andmodificationofgeneticsequencesbyassemblingand constructingnucleicacids.AlsoknownasDNAsynthesis.
Gene synthesisscreening
A processbywhichgene synthesis activities are screened forpotentialriskbyunderstandinga)whetherthecombinationofsequencesorthecustomerorderingthem isconcerning,b)whetherthe sequencesprinted match what was ordered,and c) who is responsible foracting whenconcernsarise.Alsoknownasnucleicacidsynthesis screening.
Genomics
Thestudyofallorasignificantportionofgeneticmaterial and their function(s) in an organism.
Greenfieldinvestments
Aformofforeigndirectinvestment(FDl) inwhicha companyestablishesacompletelynewbusinessoperation ina foreign country by constructing newphysical facilities. Thistypically involvesbuilding newfactories,offices,or distribution centers, rather than purchasing or merging withanexistingenterpriseinthehostcountry.
Laboratory automation
Process that involvesrobotics,computers,liquid handling. andotheradvancedtechnologiestocompletebiological experimentation.
Microorganisms/microbes
Smallivingorganismssuchasbacteria,algae,andfungi. Although viruses are not considered living organisms,they aresometimesclassifiedasmicroorganisms.
Military-CivilFusion(MCF)
Anaggressive,nationalstrategyoftheChinese CommunistParty(CCP)toenable thePRCtodevelopthe mosttechnologicallyadvancedmilitaryintheworld.Akey partofMCFistheeliminationofbarriersbetweenChina's civilianresearchandcommercialsectors,anditsmilitary anddefenseindustrialsectors.
Offtake agreement
A buyer's agreementtopurchase anexistingproductover multipleordersoveraperiodoftime.
Precision medicine
A formof medicinethatuses information abouta person's genes,proteins,environment,and lifestyletoprevent, diagnose,ortreatdisease.
Protein design
A techniquebywhichscientistscreateproteins,sometimeswithenhancedornovelfunctionalproperties.Also known as protein engineering.
Regulatorydiplomacy
Diplomacythataimstoresolvetradebarriersthatoccur duetoregulation.Itcanincludesynchronizedapprovals, sharedorconcurrentreview,oralignmentwithinternationalstandardsforriskassessment.
Scale-up
Theincreaseofmanufacturingprocesses,includingproductionlevelsandtechnologies,fromalaboratoryscaleto acommercialscalethatmeetsmarketdemand.
Strategicinvestment
Investmentsmadetoachievespecificobjectivesbeyond financialreturns,such asnational securitygoals orgaining accessto new technologies.Strategic investments align with the investor's long-term goals, such as achieving competitiveadvantageorsynergies.
SubjectMatterExpertQualificationAssessments (SME-QA)
In 2019,the first TrumpAdministrationpiloted afederal hiringprocesswherebysubjectmatterexperts(SMEs) developrequired qualificationswithhumanresources specialiststohelpfederalhiringmanagersreceivehigher qualitycandidatelistsandhirequalifiedexpertsmore quickly.
Syntheticbiology
Thedesign,construction,and/orassemblyofthecomponents of living systems (including genetic circuits, enzymes,metabolicpathways,etc.)toachieveanintended function oroutcome.
Wargaming
The simulationofamilitaryoperationinvolvingtwo or moreopposingforcesusingrules,data,andprocedures designedtodepictanactualorassumedreallifesituation.
WassenaarArrangement
Amultilateralexportcontrolregimecomprising42 ParticipatingStatesthatwasestablishedtocontributeto regionalandinternationalsecurityandstabilitybypromotingtransparencyandgreaterresponsibilityintransfersof conventionalarmsanddual-usegoodsandtechnologies.
Appendix B
Acronyms Found in this Report
AAAS AmericanAssociationfortheAdvancementof Science
ABPDU
Advanced Biofuels and BioproductsProcessDevelopment
Unit
AI artificial intelligence
AI/ML artificial intelligence/machine learning
AMC advancemarketcommitment
APHIS AnimalandPlant HealthInspectionService
APIs activepharmaceuticalingredients(Chapter2)
AppendixB
API applicationprogramminginterface(Chapter4)
ASPR AdministrationforStrategicPreparednessandResponse
B2B business-to-business
BARDA Biomedical AdvancedResearchDevelopmentAuthority
BBEPP BioBased EuropePilotPlant
BGI previouslyBeijingGenomicsInstitute
BIO-ISAC Bioeconomy InformationSharingand AnalysisCenter
BioMADE Bioindustrial ManufacturingandDesignEcosystem
BRAG
Biotechnology Risk Assessment Research Grants
BSL-3/BSL-4
Biosafety level 3/4
BWC
UN Biological Weapons Convention
CASA-Bio
Catalyzing Across Sectors to Advance the Bioeconomy
CBP
Customs and Border Patrol
CCL
Commerce Control List
CCP
Chinese Communist Party
CFIUS
Committee onForeign Investment in theUnited States
CGMP
Current Good Manufacturing Practice
CIA
Central lntlligence Agency
CISA
Cybersecurity and Infrastructure Security Agency
CMC
Chemistry, Manufacturing and Controls
COVAX
COVID-19 Vaccines Global Access
CREI
Congressional Commission on Responsibility and Ethics in
Innovation
CRISPR/CRISPR-CaS
clustered regularly interspaced short palindromic
repeats-Cas
CRS
Congressional Research Service
CTA
Critical Technology Areas
CVD
Countervailing Duties
DARPA
Defense Advanced Research Projects Agency
DBIMP
Distributed Bioindustrial Manufacturing Program
DHS
Department of Homeland Security
DIA
Defense Intelligence Agency
DIANA
Defense InnovationAccelerator for the North Atlantic
DIB
Defense Innovation Board
DNA
deoxyribonucleic acid
DOC
Department of Commerce
DOD
Department of Defense
DOE
Department of Energy
DOI
Department of the Interior
DOJ
Department of Justice
DOL
Department of Labor
DOS
Department of State
DPA
DefenseProductionAct
DURC
dual use research of concern
EO
Executive Order
EOP
Executive Offce of the President
EPA
Environmental Protection Agency
ExLENT
Experiential Learning for Emerging and Novel Technology
FAR
Federal Acquisition Regulation
FAS
Foreign Agricultural Service (U.S. Department of
Agriculture)
FBI
Federal Bureau of Investigation
FDA
Food and Drug Administration
FIRRMA
Foreign Investment Risk Review Modernization Act
FSAP
Federal Select Agent Program
FSO
Foreign Service Officer
FTC
Federal Trade Commission
FY
Fiscal Year
GAO
Government Accountability Office
GHIC
Global Health Investment Corporation
GSA
General Services Administration
AppendixB
