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GTLA GlobalTechnologyLeadershipAct

NIPP National InfrastructureProtectionPlan

HHS U.S.Department of Health and Human Services

NIST National Institute of Standards and Technology

NIU National Intelligence University

NREL National RenewableEnergyLaboratory

NSA National SecurityAgency

NSCEB NationalSecurity Commissionon EmergingBiotechnology

NSF NationalScienceFoundation

OCET Officeof CriticalandEmergingTechnology

OCSTA
Office ofthe Congressional Science and Technology(S&T)
Advisor

ODNI OfficeoftheDirectorofNational Intelligence

OGCA OfficeofGlobal CompetitionAnalysis

OIRA Officeof Information and RegulatoryAffairs

OMB OfficeofManagementand Budget

HSI
Homeland Security Investigations
IBRF
Integrated Biorefinery Research Facility
IC
Inteligence Community
iGEM
International Genetically Engineered Machine
IQT
In-Q-Tel
ISO
International Organization for Standardization
ITA
International Trade Administration
ITSI
International Technology Security and Innovation
ITC
International Trade Commission
LLM
Large Language Model
MCF
Military-Civil Fusion
MIL-SPECs
military specifications
NASA
National Aeronautics and Space Administration
NASEM
National Academies of Sciences, Engineering, and
Medicine
NATO
North Atlantic Treaty Organization
NBCO
National BiotechnologyCoordinationOffice
NCBI
National Center for Biotechnology Information
NDAA
National Defense Authorization Act
NDEA
National Defense Education Act
NGSS
Next Generation Science Standards
NIF
NATOInnovation Fund
NIH
National Institutes of Health
NIIMBL
National Institute for Innovation in Manufacturing
Biopharmaceuticals

OPM OfficeofPersonnel Management

OSTP OfficeofScience andTechnologyPolicy

OTA OtherTransactionAuthority(Chapters2and3)

OTA OfficeofTechnologyAssessment(Chapter5)

PADFA ProtectingAmericans'DatafromForeignAdversariesAct

PEPP PathogenswithEnhancedPandemicPotential

PPD PresidentialPolicyDirective21

PFAS Per-andpolyfluoroalkylsubstances

PLA People's Liberation Army

PRC People'sRepublicof China

PVP ProcessVerifiedProgram

QbD Quality by Design

AppendixB

Quad QuadrilateralSecurityDialogue

R&D research&development

RNA Ribonucleicacid

RTO Regional Technology Officer

SBICCTInitiative
Small Business Investment Company Critical Technology
Initiative

SBA SmallBusinessAdministration

SBIR SmallBusinessInnovationResearch

SEC U.S.SecuritiesandExchangeCommission

SECURE
Safeguarding the Entire Community oftheU.S.Research
Ecosystem Center(NSF)

SME-QA Subject Matter Expert Qualification Assessments

STAA Science,TechnologyAssessment,and Analytics (GAO)

S/TECH
Office of the Special Envoy for Critical and Emerging
Technology

STTR Small Business Technology Transfer

S&T Science and Technology

T-BRSC
Tri-ServiceBiotechnologyfora ResilientSupplyChain
program

TSA Transportation SecurityAdministration

USDA U.S.DepartmentofAgriculture

USGS U.S.Geological Survey

USTR UnitedStatesTradeRepresentative

VIP VeterinaryInnovationProgram

WHO World HealthOrganization

WOBD WebofBiological Data

Appendix C

More Details on Biological Data Standards (4.1)

4.1 Treat Biological Data as a Strategic Resource

4.3bRecommendation

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.

Authorize a Hub for Biotechnology, Biometrology, and Biological Data Standards

CongressshouldauthorizetheNational Instituteof Standards and Technology (NisT) as a hub for biotechnology,biometrology, and biological data standards.

Everyaspectofbiotechnology,fromdatatobiomanufacturing processes to safety and security, needs standards thatareagreeduponbystakeholdersfromtheprivate sectorandacademia.Establishingasuiteofstandardsand

AppendixC

frameworksforbiotechnologydevelopmentwillestablish one common‘language'forthebiotechnology industry. Standardswould improveresearch,manufacturing,product adoption,and collaboration alongthe product developmentpipeline.Thedevelopmentofsuchstandardswillgive industrytheopportunitytoworkcloselywithgovernment toensuretheneedsofdifferentcompaniesareheardand incorporated inthedevelopmentofstandards.

Toaccomplishthis,andensureastablepathforward for biotechnology, Congress should authorize the NIST toserve as a hubforbiotechnology and biologicaldata standards.

Thescopeof responsibilitiesfora newlyemboldened biotechnology arm at NIST should include developing:

definitionsand frameworksforAl-ready biological data;
instrumentation and practices for biometrology;
standards for industrial biomanufacturing;
necessary standards necessary for biomanufacturing processes;
standardsforphysical biomanufacturing
infrastructure;
standards forbiosafety,biosecurity,and responsible innovation;and
a continuallyupdatedlexiconrelatedtobiotechnology and biomanufacturing.

Congress should appropriate $$640$ million to the NIST overfive yearsforthis work,with $$20million per year foryearsoneandtwoand200 millionayearbeyond that.During the first twoyears,the NIST would inventory existingbiological data and biotechnologystandards andworkwithpartnersandstakeholderstosetupthe program.Inyearthreeand beyond,theNiSTwould expand theprogramtoprovide datamanagement resourcesforbiologicaldata,providecompletecybersecurityframeworks, hire necessarystaff,workwiththebiotechnologyindustry, andcoordinatewithfederalfundingagenciesrelatedtoall aspectsofbiotechnologystandards.

Appendix D

More Details on Grand Challenges for Biotechnology (4.3)

4.3 Launch Research Grand Challenges to Unlock Leap-Ahead Capabilities

4.3bRecommendation

Congress should initiate a grand research challenge focused on making biotechnologypredictably engineerable.

The engineeringparadigmofmodel,make,andmeasure, explainsaniterativecycleofdesigningaproductor process("model"),creatingsomethingbasedonthat model("make"),collectingdataonhowwelltheproduct orprocessworks("measure"),and thenstartingthewhole processoveragainbasedontheinformationobtained from previous cycles.To accomplish this engineering paradigmforbiological systems,theCommission proposes componentchallengesthatwouldbreakdownpredictable engineeringintoindividualtasks.

1.Solve the Genotype-To-PhenotypeRelationship: Engineeringbiologyina safeandpredictable way requiresresearcherstounderstandtherelationship betweengeneticmake-up(genotype),and howthis orchestrates the physical characteristics of living things (phenotype).

2.Develop More Precise Engineering Tools:In select contexts,researchershavedevelopedimpressive abilitiestoengineerthebiologyofanimals,plants, andmicroorganisms.Moreprecisebiologicaltools areneededtomakepredictableandreliableeditsin organismsthatavoidunintendedeffects.

AppendixD

3.CreateaDigitalTwinoftheCell:Muchlikehowmeteorologistscanobserveandmodelweatherconditions anywhere intheworldfromtheir owncomputer, a digital twincouldallowresearcherstodigitallymonitorand predicttheactivityofitsphysicalcounterpart.

4.ldentify Indicators of Successful Bioengineering Scale-up:Researchersshouldestablishmeasurements andteststodeterminethepotentialscalabilityofbiologicalprocessesandincorporatethoseconsiderations into early-stageresearch and development(R&D).

Solving these component problems would bringthe United Statesclosertoprogrammingbiologyinwaysthatwould revitalizetheU.S.manufacturingbaseandhelpAmericans live longer and healthier lives.In addition, these challenges wouldspurcountlessotherresearcheffortstosolve the additional,smallerchallengeswrapped upineach question.

The Commission categorizes these smaller challenges, orkeystone challenges,intofour areas:foundational research,advancedmeasurementtechniques,experimentaltools,andcomputationalmodels.Throughextensive

research,stakeholderinterviews,andsurveys,the Commission developed a list of keystone challengesthat arecriticaltosolvinglargerproblemsandrealizingmajor advances for humankind.This list is not comprehensive, but theseresearch areasare agood startingpointforthe United States'broader grand challenge of engineering biology. Additionally, while many of these are longstanding areasofresearch,they aretopicswherekeyknowledge gapsimpedebiotechnologyadvances.

Area1-FoundationalResearch

AdvanceUnderstandingof HowProteinsFunction:

Eventhoughproteins areextraordinarilywell-studied, there is still a critical gapinpredicting and understanding whatfunctions a particularproteinwillhave.Buildingon recentleapsinpredictingproteinstructure,thereisaneed forabetterunderstandingofhowsequenceand chemical changes affect proteinfunction.This would complement the existingfield ofDNAresearchand strengthen scientists'understandingofhowcellsbehave.

DeepenKnowledge of RNA Biology:Muchis still unknown aboutRNA's chemistry,structure,and function. BetterunderstandingRNA'svariousformsandfunctions couldunlockevengreatertherapeuticandbiological engineering potential.

Characterize All Metabolites:The current state ofmeasurementandanalyticaltechniquesmakeit prohibitivelydifficulttogetacompletesnapshotofallthe small chemicalcomponentsinlivingcells.Studyingand identifyingthesesmallmoleculeswouldunlockadvances inbiomanufacturingbyrevealingwhichchemicalsand materialscanbeproduced bydifferent organisms.

EnhanceUnderstandingofMicrobiomes:While manyhave heard ofthe well-studied gut microbiome, communitiesofmicroorganismsexisteverywherein theworld.Exploringthe constitution andinteractionsof microbialcommunitieswouldopennewpossibilitiesfor health,environmentalremediation,andagriculture.For example,understandingandoptimizingtheecosystemof microbes in the soils could promote crop growth and help preventplant-relateddisease.

UnderstandQuantumEffectsinBiologicalSystems: Studying quantum effectsinbiological systems,such as electrontransferinphotosynthesis,couldprovidevital insightsintobiologicalprocesses.Theseinsightscould inform the development of novel ways to treat disease, produce energy,and navigatetheplanet.

Build Minimally Synthetic Cells:Creating syntheticcells acrosslifedomains(suchasmicrobes,plants,and animals) wouldaccelerateresearchers'understandingofbiology's basicbuildingblocks,openingthedoorto advancesin engineeringbiologicalsystems.

IncreaseUnderstandingofaWiderArrayofPlant Species:To date,most plant research hasfocused on a verysmallnumberofspecies.Deepeningresearchers understandingofthe molecular make-up and physiological characteristicsof different plant species would lead to highercropyieldsandcriticaladvancesindevelopingfood.

Area2-AdvancedMeasurement Techniques

DevelopNon-DestructiveMeasurementTechnologies: Emergingmeasurementinnovationssuch asquantum sensingandRamanspectroscopyallowresearchers to test biological sampleswithout destroying them, preservingvaluablespecimensforfurtheranalysis.

CreateaRapid,High-QualityData CollectionCapacity: Thedevelopmentofautomated instrumentationfordata collectionensuresfaster,standardized datagathering, which is critical for advancingcomputational modeling and analysis.

DevelopInstrumentationthatIncludesSpatial andTime-PointInformation:Movingbeyond 2D measurementswouldgeneratedatathatincludean understandingofwhereandwhenthedatacollection happened.Thiswould enablea more accurate understandingofdynamicbiologicalsystems.

ImproveMappingandMeasuringofMolecular Interactions:Improvements intrackinghow biomolecules bindandinteractwithoneanotherwouldmakeiteasierto developpharmaceuticalsthatbindtoaparticulartarget andsupportthedevelopmentofmoreprecisetoolsfor engineering biology.

Area3-Experimental Tools

DevelopUniqueCapabilitiesforDNA/RNASynthesis:

WhiletheaffordabilityandscalabilityofDNAandRNA synthesis is critical,new techniques are needed to synthesize longersegments of DNA orRNA,incorporate newnucleicacidstructures,andaccomplishbothtasks faster.Thesetechniqueswouldbecriticalforallaspects of biotechnology and havefar-reachingnational security applications.

CharacterizeNewOrganisms:Currentresearch focusesonasmall numberofwell-researchedandwellcharacterized organisms.Discovering,characterizing,and optimizingnewandemergingorganismswouldfurther basicbiologicalresearchandprovidemoreoptionsfor biomanufacturing.

Harness Miniaturization, Nanofabrication, and Microfluidics:Whilethereisalargebodyofresearchon miniaturizationforbiotechnology,themovementfrom small-scaledemonstrationtoimplementationisusually fraughtwithchallenges.Additionalresearchisneeded toachieveprecisecontrolovermicro-andnano-scale processes,controlthatwouldenhancedatacollectionand improve.

AdvanceOrganoidsand Organs-on-a-chipModelsto UnlockUnique Experimental Capabilities:These3D cell culture techniques such as organoids and organson-a-chipenhancescientists'understandingofcomplex biologicalprocesses,whilebridgingthegapbetween animalmodels,humanclinicaltrials,and invitrotesting. Improvingscalabilityandreliabilityoforganoidsand organs-on-a-chip models could improve drug discovery andreducerelianceon animal modelsfordrugtesting.

Establish and CharacterizeStandardsforKey Biological Inputs:Currently,thereareveryfew internationallyrecognizedstandardsrelatedto biotechnology,adearththatleadstoinconsistenciesin R&Dmethodologies and problems with reproducibility. Similartohoweveryelectric circuit,no matterwhere it is produced acrossthecountry,hasthe same component partsthat are described and named inlinewithnational standards,theUnitedStatesneedsstandardinputsto supportbiotechnologyresearch,experimentation,and scale-up.

Area4-Computational Models

ImproveBio-AlToolsand EncourageSafeIntegration intoResearch:Bio-Altools can assist in designing proteins,viralvectors,andotherbiologicalagents.As thesetoolscontinuetoevolveandprovideknownand updatedbiologicalinformation,theywillspeedupresearch andreduceexperimentationtime.

Train Scientific Large Language Models (LLMs) with Biological Data:LLMstrainedonbiological data,such as DNA or protein sequences, will improve exponentially over time and drivenovel molecularinsights.

Breakthroughs on any ofthesekeystone challenges would have a catalyzing effect on other biotechnology research.Butthegreatestpromiseliesintheir convergence,especiallywheninterdisciplinaryareas such ascomputational modelingmergewithphysical biotechnologyR&D.Thislistdoesnotaimtoexcludesuch convergencesbutratherencouragethemthroughthe identification ofoverarchingtopics.

4.3cRecommendation

Congress should initiate a grand research challenge focused on making biomanufacturing scale-up predictable, rapid, and cost-competitive.

Thesecondgrandchallengerecommendationisrelated tothescienceofscale-up.BelowtheCommissionoutlines specificareasofscale-upresearchandcostdistribution.

Area1-Chassis

DevelopEmergingChassisand Cell-FreeSystems: Researchandcharacterizationintobiologicalsystems andcomponentsatdifferentscaleswouldenablenew engineeringtools and improve theperformance of platforms,called“chassis,”thatarecustomizedtoproduce bioproducts.Thisresearchwouldacceleratetheuseof emergingchassis,suchasmulticellular,multi-species, andcell-freesystems,expandingwhatcanbemadewith biology.

Area 2-BiomassandFeedstocks

OptimizeBiomass Conversion and Develop

Alternatives:Developing neworimproved conversion technologieswouldmaximizetheusabilityandyieldfrom bothtraditionalsourcesofagricultural-derived biomass andnext-generationfeedstocks,suchasmunicipal andmanufacturingwaste.Inadditiontobreakingdown biomassintosugar,efficientconversionsshouldexpand toyield otherfeedstocktypes and usablebioproducts, helpingtheUnitedStatesusewhatithastomakewhatit needs.

Area 3- Process Technology and Equipment

CreateHardware,Software,and DigitalSignal ProcessingTools:Process intensificationthroughthe developmentofbiomanufacturing-specifichardware, software,and digital signalprocessingtoolswould enable theadoptionandverticalintegrationofbioproductionat everyscale.Prioritizingholistic,asopposedtostandalone, R&D in these areas would enhance access and efficiency acrossallbioprocessingoperations,includingmodular equipment.

Area 4- Critical Inputs

Reimagine BiomanufacturingBasicBiological

Components and Chemicals:Leveragingbreakthroughs across theotherthree areasofthis challengeto specifically reimagine cost-competitive biomanufacturing processeswouldproducevitalproductioninputsforwhich the United States relies onforeign suppliers, including adversaries who could weaponize this reliance by cutting off U.S.access.Keyexamples of such inputs include amino acids,manyofwhicheitherrelyonorstruggletocompete atcostwithoffshoreproduction.

Inspiring Innovation Through Outcomes-Driven Funding

Related tothe aboveenablingrecommendations on grand challenges,the Commission proposes a specific implementationmodelthatwouldfocusonoutcomesdriven funding.

With theimmenselandscapeof biotechnologyresearch funding that currentlyexistswithin theU.S.government, the Commissiondeliberatelychosetonotmakespecific recommendationson which departmentsoragencies should fund whichgrandchallenge components.Many oftheseagencieswillhaveequitiesandinterestsinthe researchareasnotedabove.Itisimportanttoallow expertstomakedecisionsaboutprojectsthatfitintheir portfolio andtodevelopwaystocoordinatewithother departmentsoragenciestoward specificgoals.

Onewaytoencouragethekindofresearchthatadvances abiotechnologygrand challenge istouse anoutcomesdrivenmodelthatimplements a mechanism to“pay for success."Mostearly-stage researchfundinginthe United States is distributed based onhypothesis-driven orexploratoryscientificquestions(forinstance,“we believeacellworksinthisway,”or"wewanttobetter understand howthis partofa cell operates").While this styleof scientificexplorationis a critical part ofthe U.S. researchenterprise,Americaninnovatorsneedfunding

AppendixD

that drivestoward specific outcomes(suchas,"create a computationalrepresentationoftheentirecell").

Suchfundingmodelstend toproduceusableresultsmore quicklybecauseoftheirincentivestructure.Versions ofoutcomes-drivenresearchfundingareusedbythe DefenseAdvanced ResearchProjectsAgency(DARPA) andotheragenciesthatusetheDARPAmodel,and there aremyriadresearchchallengeswheredepartmentsor agenciesaskresearchersanddeveloperstoaccomplish anendgoalwithplanstorewardsuccess.

Thesefunding models provide opportunitiesforteams to compete in pursuit of a commongoal and for successful teamstoreceivefurtherfunding.Suchamodelshould include the following parameters:

Abaseleveloffundingforallparticipatingteams: Allselectedresearchteamsreceiveabaselevelof funding totackle the challenge.

Tiered outcomes and awards:The selected teams wouldhave differentopportunitiesthroughoutthe researchprocesstoreachmilestonesandreceive fundingtocontinuetheirresearch.

Defined outcomes and milestones:Require programmanagerstodevelopandmakeavailablethe parameterstheywilluseto assessprojects.

Incentivize interdisciplinary collaboration: Asapartoftheselectionoroutcomecriteria, interdisciplinaryteamsworkingcollaborativelywith other institutions or groups should be favored.

Significant awards for solving a grand challeng: Fora team(orteams)that are successful,there should be significant awards in the form of funding, accesstoscale-upinfrastructure,oropportunitiesto connectdirectlywithventurecapital.

Thegrand challengesresearchfunding described above isaslightvariationonexistingmodels,withtheintentof bringingtogetherinterdisciplinaryteamsandcreatingan environmentthatfostersfasterinnovationandmovesallof biotechnologyforward.

A portion of new funding meant to address an overarching grand challengeforbiotechnologyresearchshould be builttorewardsuccessinsolvinghard,ambitiousscientific challengesthatunlockimportantleap-aheadcapabilities.

Acentraldepartmentoragency,incollaborationwithother researchfundingagencies,couldbuildandcoordinatea programtoaccomplishthisrecommendation.TheDARPA, forexample,haslongworked withotheragencies onrewarding successforambitiouschallenges.Anotherexample of a collaborative research funding model is Catalyzing AcrossSectorstoAdvancetheBioeconomy(CASA-Bio,) whichisaneffortledbytheNational ScienceFoundation (NSF) withinput from multipleotherdepartments and agencies.TheNSFcreatedBioeconomyInitiatives,which focus on different biotechnology research goals such as "acceleratedbreedingforaresilientbioeconomy."

Anadditionalcomponenttoconsiderrelatedtothis recommendationiscreatingwaystogetbuy-infrom privatefunders.Anydepartmentoragencycould work withprivatefunderstocollaborateonspecificgrand challenges.TheUnitedStatescouldleverageprivate foundationfundinginbasicresearchtoincreasethepool ofavailablefundingtoreachtheseambitiousgoals.

Suchfunding structures would imbueresearch challenges withaspiritofconstructivecompetition,whileonly deployingtaxpayerdollarswhenambitiousgoalsaremet. Thefruitsofthisfundingcouldenablenewcapabilitiesthat wouldmakebiotechnologymore affordableandeffective forAmericans.

Appendix E

More Details on Equipping the U.S. Government Workforce (5.1)

5.1 Equip the U.S. Government Workforce with Necessary Biotechnology Resources and Expertise

5.1aRecommendation

Congress must direct the Office of Personnel Management (OPM) to provide workforce training in biotechnology across the interagency.

Develop a National Biotechnology WorkforceFramework

Congress should direct theNational Institute of Standards and Technology(NisT)todevelopaworkforce frameworkthatdefinesbiotechnologyjobs,alongwith the knowledge and skills necessary to perform them.

A nationalworkforceframeworkforbiotechnology would modeloffthe successful National InitiativeforCybersecurityEducation(NiCE)frameworkdeveloped bythe NIST.Employerswithin and outside ofgovernment,could usethisframeworktoconductworkforceassessments andidentifyskillandknowledgegaps,improvehiringand retention,andestablishstrategicworkforcedevelopment initiatives.Educatorscould useittodevelopcurricula and

AppendixE

skillsassessmentsthatreflectemployers'needs.Meanwhile,rospectivetalent,includingstudents,jobseekers, andcurrentemployeescouldusetheframeworktolearn aboutpositionrequirements,identifygapsintheirown skills,andbetterpreparetodemonstratetheircapabilities.

The NiST should develop theframeworkinpartnership withacademia,industry,nonprofits,andfederalagencies andincludeinformationforhowindividualswithnontechnicalorothernontraditionalbackgroundsandeducation may usetheirskills.Theframework should bereviewed and updatedatleastonce everythreeyears.Toencourage adoption and success,theNIST should focusoncommunicating thevalue ofthe framework and developing a frameworkperformanceassessment.

5.1cRecommendation

Congress should receive accurate,timely, and nonpartisan scientific and technical counsel.

TheU.S.governmentlackssufficientunderstandingand capacitytoengagewithbiologyand biotechnology.As lawmakersincreasinglyvoteonlegislationrelatedto biotechnology,theywouldneedmoreconsistentaccessto biotechnology expertisetolegislate effectively.

InlightofrecentSupremeCourtrulingsrelatedtoadministrativelaw,Congressmust now draftlegislationwith greatertechnical precisionto ensure specificoutcomes,as thefederalagenciestheyoverseemayhavelessauthority tointerpretbroaderpolicies.

Atpresent,Congressionalofficeshavelimitedaccessto biotechnologyexpertise:

IndividualCongressionalofficescandirectlyhiresubjectmatterexpertsiftheychoosetodoso.However, resourcingformemberandcommitteeofficesvaries, andmembersmustweighhiringspecifictechnical expertsagainstpolicyprofessionalswhocover broaderissue sets.

Congressional offices can request technical informationintheformofprimersorbriefingsfromthe Congressional ResearchService(CRS).TheCRS releases approximately7o0reportsperyear,the majorityofwhichsummarizepolicyissuesanddo notincludetechnicalassessments.TheCRSalso haslimitedstafftoaddressthemanyrequests fromoffices.StaffingattheCRSdecreasedby29 percentbetween1985and2017.Additionally,the CRSisapoint-in-timeresourceandreliesheavilyon officesknowingtherightquestionstoask.TheCRS's mandatedoesnotrequirecontinuallyengagingwith agencies to identify and monitor biotechnology-specific advancements, offering its employees continuing education opportunitiestokeep themupto date on recent breakthroughs,orregularlyreporting findings backto Congressionaloffices.

TheGovernmentAccountabilityOffice(GAO)establishedtheScience,TechnologyAssessment,and Analytics(STAA)office in 2019 tobolster its capacity fortechnicalreports.TheSTAAofficereleases regularassessmentsondiscreteissues,typicallyin response toa Congressional requestor mandate. Thiswork alsoincludesshorterspotlightsand trends papers covering topics such as generative Al in healthcare,gene editing,and plasticsbiorecycling.

Congressionalofficescanalsohirefellowsfroma rangeofprograms(suchastheAmericanAssociation for the Advancement of Science (AAAS), Brookings, Horizon,and TechCongress)to augment full-time staff.Atpresent,however,Congressionalofficesbear the burden offindingfellows from organizations,applyingforthefellowstojointheiroffices,and training themforashort-termrotation.Whenfellowshipsend, expertise leaves with them.The existing process can be especially difficult fornew Congressional offices orofficeswithoutanestablishedinternalprocessfor fellowships.

Someresources,suchasassessmentsfrom the GAOor detaileesfromlegislativeandexecutiveagencies,primarily support Congressional committee chairs and ranking members.Committeeshavetaken advantage ofthe opportunityto detail employeesfrom externalagencies, asdetaileeshaveincreasedby300percentinthepast30 years,buttheseresourcesmoreregularlybenefitcommitteesandreturningmemberoffices.

Thefollowing detailsforrecommendation5.1c envision alegislativebranchthatisequippedandempoweredto maximizetheeffectoflegislationtopromote andprotect U.S.leadership at the nexus of emerging biotechnology andnationalsecurity.Congressionalstaffersshould have theconfidencetoengagewith,write,and champion meaningful legislation on theseissues.The more bioliterate policymakersare,thebettertheycansupportandgovern U.S. biotechnologies.

Support the Congressional Research Service(CRS)to Better Advise Congressional Offices on Biotechnology and National Security

Congressshouldstrengthenhiringandpayauthorities fortheCongressional ResearchService(CRS)tobetter securetherequisitetechnicalexpertisetoadvise Congress at the intersection of technology and national security.

TheCRSmaintainsarobust internal systemtoreceiveand taskbiotechnology-specificrequestsfrom staffers and members of Congress,including cross-disciplinary review of questions and proposed responses. As biotechnology becomesincreasinglyintegrated across allsectorsof theeconomy,Congressshouldrequireabiannualreport fromtheCRS aboutitspersonnel needs,sothattheoffce alwayshasexpertisethatmatchesCongress'sreal-time needs.UItimately,theCRSshouldmaintainacadreof

biotechnology experts and interdisciplinary technology expertstoprovidesupporttoCongressional officesin need.

Codify the GAO's Science, Technology Assessment, and Analytics office to Support Additional Technology Assessments andBolsterits Technology Forecasting Capacity

CongressshouldcodifytheGovernment Accountability Office's (GAO) Science, Technology Assessment, and Analytics (STAA) office and appropriateadditionalfundssothatitcanhiremorescientistsand engineers.

Congressshould adopt RecommendationNo.141ofthe SelectCommitteeontheModernizationofCongress's FinalReport,whichwouldauthorizetheSTAAofficeand make it a permanent partofthe GAO.Congress should also appropriatefundsto hire50morescientists and engineerstosupportadditional STAAtechnologyassessments and bolstertheirtechnologyforecastingcapacity.This expansionwouldroughlydoubletheSTAAoffice'sscience andengineeringstaff,providingCongressadditional technical expertisethrougha range of workproducts.

This permanence, along with an expansion of technology assessmentstaffwouldallowtheSTAAofficetodramatically expand its bandwidth for current projects and increase its technologyforecasting capacity.

Establish an Office ofthe Congressional Science and Technology Advisor

Congressshould establishan Office ofthe CongressionalScienceandTechnologyAdvisor(OcSTA).

Congressionalofficesareoftenshortontimeandcover awiderangeoftopics.Whiletheseofficebenefitfrom successful science and technology (S&T) work being done bythe CRS and STAA office,they donot have a centralpointofcontactfornonpartisantechnicaladvice. ItisimportantthatCongressionalofficesareawareofthe resourcesavailabletothemandhave anefficientwayto requestinformationandresources.Thisproposalseeksto ensure thatCongressional offices andcommitteeseasily find rigorous, relevant, and up-to-date scientific advice.

BasedontheNationalAcademyofPublicAdministration (NAPA)'srecommendation,Congressshouldestablishan OfficeoftheCongressional Science and TechnologyAdvisor(OCSTA)tocoordinatewiththeCRSandtheSTAA office.TheOCSTA'smandatewouldbetoreceiveand actionrequestsfortechnology education andlonger-term technologyassessmentsfromanymemberofCongress.

This mandate would include conveningmonthlybipartisan and bicameral briefingswith industryleaders.These

sessionswouldserveasoff-the-recordtimeforstaffersto hearfrom experts on the latest innovations and opportunities acrossdisciplines.It would alsoinclude supportingthe recruitmentandhiringofemergingtechnologyadvisors formajorcommittees,maintainingadatabaseofopen scienceandtechnologyfellowshipopportunitieswithin officesandavailablefellowsforplacementforboththe House andSenate,andevaluatingpossibleconflictsof interest forfellowships from external organizations.

Expand IntegrationofScience and Technology Experts into Congressional Offices

Congress should establisha fellowship pipeline that providesopportunitiesforexecutivebranchemployeeswithbiotechnology expertisetocompleterotations in congressional offices.

Congress should require thattheOCSTAmaintaina databaseofopenscience andtechnologyfellowship opportunitieswithinofficesandavailablefellowsfor placementforboththeHouseofRepresentativesand Senate.This should includeprofilematching between Congressional offices seekingfellows,agencyfellowships and detaileeopportunities,andvettedexternalorganizationsseekingtoplacefellows.TheOCSTAshould also hold a biannual briefingfor Congressional offices onhowto integratefellowsfromexistingprograms and howtodesign internal programsforfellows to contribute topolicy work. TheHouseshouldconsider adoptingtherecommendationfromtheSelectCommitteeontheModernizationof Congress'Final Reporttoclarifyrulestoallowfellows and detaileestoreceivethesameresourcesasprofessional staff.

PartoftheOCSTA'spurviewshouldbetoevaluatethe perceptionandpossiblepresenceofconflictsofinterest for fellowships from external organizations. This vetting wouldbeessentialformemberoffices.

HostaBiannualJobFairtoMatch AvailableFellowswithCongressional Offices

The ChiefAdministrativeOfficerand theSenate EmploymentOfficeshouldco-hostabiannualscience andtechnologyfellowshipfair,bringingtogethercongressionalofficesthatarelookingforsubjectmatter expertisewithtechnologyfellowshipprogramsthat have availablepersonnel.

Regularopportunitiesfor Congressional stafftolearn firsthand about technologyfellowshipprogramswould ensurethatmemberandcommitteeofficesknowabout theresources availabletothem and can accessthese esteemed networks.

Just asCongress has taken a greaterinterestin Al, lawmakers and Congressional staff should engage permanently and seriouslywith biotechnology.Congressional offices are on thefront lines ofU.S.technologypolicy development,leadingtheUnitedStates'agenda to promote andprotectcritical andemergingtechnologies. Takentogether,theaboverecommendationswouldensure holistic and consistent accesstobiotechnology expertise acrossthelegislativebranch,empoweringU.S.policymakerswiththetoolstheyneedtounleashAmericanpotential anddrivethebioindustrialrevolutionforward.

The Commission strongly supports efforts to increase bioliteracyforeveryAmerican,includingthoseservingin Congressandthefederalgovernment,tobestcapture the benefits ofthebioindustrial revolution and support the premierbiotechnologyworkforceofthefuture.

Launch a Congressional Commission on Responsibility and Ethicsin Innovation

Congressshould establisha standingCongressional CommissiononResponsibilityand EthicsinInnovation

toprovideguidanceontheresponsibleandethical aspectsoffuturelegislativepathwaysregarding emergingtechnology.

In additiontogaps in itstechnical knowledge,Congress is alsograpplingwitharangeofethicalandresponsibleinnovationissuesrelatedtobiotechnology.Congress'sabilityto deliberateoverethicallychargedissuesaroundresearch and innovation is key to its effectiveness as a legislature, but thereiscurrentlyno standingbodyto deliberate on theseissues.Whilepastdeterminedbythecourtsorby presidentialcommissions,Congresswouldbenefitfroman independent,bipartisan,consultativebodyofexperts.

Establishingsuchabodywouldbothprovideadedicated spaceforaddressingcontentiousissuesandenable Congresstocraftlegislationthatalignsthenormative goals ofthe law with the technical likelihood ofthem being achieved.

Appendix F

More Details on Supporting American Job Creation (5.2)

5.2 Support Job Creation Across the United States for Americans at All Skill Levels

5.baRecommendation

Congress should expand educational efforts in biotechnology for American students.

Support Student-to-Career Pathways

CongressshoulddirecttheNational Science Foundation(NsF)toestablisha newgrantprogram tosupportstudent-to-careerpathwaysthatensure seamlesstransferofcredentials.

Fundingatboththefederalandstateleveldoesnotencouragepartnershipsand collaboration amonghigh schoolsand,two-yearandfour-yearinstitutionsofhigher education(IHEs).Educationalinstitutionsoftenoperatein silosanddonotcoordinatetheircurricula,makingithard forstudentstoexplaincredentialsfromoneinstitutionto another.Thedemandforhighlyskilledtechnicalworkersin anevolvingbiotechnologysectoroftenrequiresindividuals to“stack”credentials,movingsequentially alongatraining pathway toincreasingly advanced and higherpaying jobs.Withoutwaysofaccumulatingcredentials,students

AppendixF

mustoftenrepeatcoursework,whichrequiresadditional resourcesandtimebeforetheycanentertheworkforce. Lackingseamlesseducationpathwayswithoff-ramps towell-payingjobs,studentsencounterdead-endsand mismatchesbetweentheircredentials and theindustry's needs.

Thefederal government should encourage coordination ofworkforcetrainingbyofferingfundingtohighschools, communitycolleges,vocational-technicalschools,collegesanduniversitiestopartnerwithoneanotherandwith industry stakeholderstodevelopcurricula and training programsthatwouldbetterservetheneedsofthelocal andregionalbiotechnologyworkforce.Coordinatingworkforce trainingacrosseducational institutionsandenabling studentstoaccumulatecredentialstoadvancetodifferent and higherpayingjobswouldbuildstrongerlocal and regionaltalentpipelinesofskilledworkersforbiotechnologyjobsateverylevel.

Agrantprogramestablished withintheNSFwould support student-to-careerpathwaysfrom high schooltotwo-year IHEs and from two-yeartofour-year IHEs.The grant program should operateinthreephases:

PhaseI-Partnership and Development:In this phase, the NSFwould issuegrants to educationteams(comprised offaculty,deans,andprogramdirectorsfromhighschools andtwo-andfour-yearIHEs)todeveloparticulatedcareer pathwayswithstackablecredentials(suchasdiplomas, certificates,apprenticeships,anddegrees)andexitpoints leading to alllevels of biotechnology jobs.Teams should consultwithlocalandregionalindustrystakeholdersto determinetheneededskills,competencies,andpositions. TheNSFshouldprioritizefundingforruraland under-resourcedareasthatmightnototherwisebeabletostand up such programs on theirown.The NSFwould issue 30 annualgrantsof$300,000apiece.

Phase Il-Implementation:TheNSFwould then select educationteamsthathavesuccessfullycompletedPhase Itoreceive largergrantstoimplementarticulationplans, codevelopcurricula,andcollectdataonstudentoutcomes.Teamswouldhavetoappointandregularlyconsult withanindustryadvisoryboardtoensurethatcurriculaalignwithindustryneeds.Thesecurriculashouldbe cross-disciplinary and coversupply chainissues,Al,advancedmanufacturing,and otherrelevantfields.TheNSF wouldissue15additionalgrantsof 2$ millionapiece.

Experiential,hands-onlearningiscritical ateverylevelof educationtoensurethattrainingsimulatesindustrywork environments.Teamscouldrequest $$50,000$ to $$350,000$ insupplementalfundingtopurchasetrainingequipment andinstrumentationsimilartowhatisusedinindustry. Teamswould alsobeencouragedtopartnerwithlocal or regionalnationallabs,municipallabs,andcompaniesto obtainaccesstofacilitiesandinstrumentation.

PhaseIlI-Sustainment:Aftertheimplementationphase, teamswouldfocusonsustainingarticulatedpathwaysand workingwithstateandlocalpartnerstopromotetheadoptionofthosepathways.Updatestocurricula,skillstandards,andtrainingequipmentwouldbemadetoensure thattheindustry'sworkforceneedscontinuetobemet.

Create a Biotechnology Scholarship for Service Program

Congressshould establish a Biotechnology ScholarshipforServiceprogramtoincentivizeundergraduate and graduate students in biotechnology programs.

Toencouragemoretechnicallytrainedstudentsandprofessionals to pursue careers in public service, the governmentneedstocreatemoredirectcareerpathwaysinto the public sector.Asthebiotechnology sectorcontinues

AppendixF

toexpand,thedemandfortechnicaltalentwillonlygrow. Providingyoung biotechnologytalent from colleges and universitieswithclearpathwaysintoandconditionalguaranteesofgovernmentemploymentwouldenticestudents from a widerrange of backgrounds to pursue a governmentcareertheymightnothaveotherwiseconsidered.

CongressshouldcreateaBiotechnologyScholarshipfor Serviceprogramtosupport undergraduate andgraduate (Master'sandPhD) studentsinbiotechnologyand related programs,withapublicserviceobligationimmediatelyfollowinggraduationthatisequivalentinlengthtothatoftheir scholarship.

The NSF should establisha biotechnologyscholarshipfor serviceprogram.Recipientswouldhavetoagreetoapublicserviceobligationatafederalagency(oranapproved state,local,ortribalgovernment agency)followinggraduationthatisequivalentinlengthtothatofthescholarship. TheOfficeofPersonnel Management(OPM)andtheNSF shouldcreatememorandumsofunderstanding(MoUs) withfederalagenciestoensureconditionaloffersofemploymentforstudentswhocompletethedegreeprogram.

Successfulscholarscould contributetotheU.S.government'sexpertisethroughbiotechnologyresearchand development(R&D)activities atfederalagenciesincludingtheNationalInstitutesofHealth(NIH),theDepartment of Defense(DOD),and theDepartmentofEnergy(DOE). They could also dosobyprovidingtechnical expertise across different funding agencies program offces, policy offices,regulatoryagenciessuchasattheDepartmentof Agriculture(USDA),the Environmental Protection Agency (EPA),the Office ofScience and TechnologyPolicy(OSTP), and theNSF.Scholarscouldalsocompletetheirpublic serviceatthelocallevelthroughstateormunicipalpolicy offices and labs.

Strengthen High School Biotechnology Education

Congressshould establish aBiotechnologyforAll High School Studentsinitiativethatwouldcompriseagrant programandwouldestablishaconsortiumto advancebiotechnologyeducationatthesecondarylevel (grades9-12)nationwide.

Educationis a strategiclong-term investment,and the UnitedStatesdoes nothave time towaste.Investments todayinhigh-qualitybiotechnologyeducationforhighschool studentswould yield a pipeline ofhomegrowntalent inthe comingdecades thatwould driveU.S.innovation,competitiveness,andeconomicsecurity.Introducingstudentsto biotechnologyearlyintheireducationexposesthemto scientificconceptsanddevelopstheirconfidenceinscience,technology,engineering,andmathematics(STEM) and critical thinking.

CongressshouldestablishaBiotechnologyforAllHigh School Studentsinitiativethatwould compriseagrant programandwouldestablishaconsortiumtoadvancebiotechnologyeducationatthesecondary(grades9-12)level nationwide.TheNSFand theDepartmentofEducation would administerthegrant program,offeringhigh school teachersprofessionaldevelopmentopportunitiestoteach biotechnology courses.The programwould also provide stateandlocalschooldistrictswithresourcesandtoolsto defineandevaluatebiotechnologyeducationpathways at the high school level.

Theconsortium,comprisedoffederal,state,andlocal leaders,would advise and assistonmattersrelatingto highschoolbiotechnologyeducation.Itwouldcoordinate public-privatepartnershipsacrossfederal,stateandlocal stakeholders;supporteducatortrainingandprofessional development;andenableaccesstoinstructionalmaterial andresourcesforcurriculumdevelopment.

Appendix G

More Details for Promoting Biotechnology with U.S. Allies and Partners (6.1)

6.1 Promote Biotechnology with U.S. Allies and Partners

6.1cRecommendation

Congress should expand regulatory diplomacy for biotechnology.

As described inSection6.1ofthisreport,differences in thewaysthatcountriesregulatebiotechnologyproducts cancreatetradebarriers.Delaysin approvalforbiotechnologyproductsbytradingpartnerscandelayorprevent commercializationof thoseproductsintheUnited States. Diplomatic,regulatory,andtradeagenciescanworktowardsglobalregulatoryconvergencesinmultiplevenues, includingmultilateralorganizations,bilateral engagements, and technical workinggroups.

Therearemanymultilateralorganizationswherethe United States should continue toengage and,where possible,strengthenitsparticipation.Forexample,the OrganizationforEconomicCooperationandDevelopment (OECD) has longworked toadvance shared approaches forbiotechnologyriskassessment.Partnerships such as Asia-PacificEconomicCooperation(APEC)andthe Inter-AmericanInstituteforCooperationonAgriculture (llCA)haveresulted inslowbutsteadymovementtowards science-based,risk-proportionateregulation.Inrecent years,multipleAfricancountries havemoved to establish regulatoryframeworksandapprovethecultivationofbiotechnology crops,includingSouthAfrica,Kenya,Nigeria, and Malawi.

By expandingits engagement with and investment ininternationalorganizationsandindividualcountries,theUnited States could bettersupport science-based biotechnology regulation and build stronger partnerships in every region oftheworld.Currently,theDepartmentofState(DoS) providessomebiotechnology-relatedprojectfundingto postsoverseastosupportactivities,suchasworkshopsfor scientists,regulators,andpolicymakers.Theseactivities canhelpadvancescience-basedregulationandpromote the acceptanceofbiotechnologyproducts,leadingto increased market access for American biotechnology products.

To strengthen diplomatic efforts,theU.S.government shouldconsiderestablishingadditionaltechnical workinggroupswithothercountries.Thesewouldfocuson exchangingtechnical informationbetweenregulatorsto informpolicyandexplore agreementsfordata sharing.As globalinvestmentinthissectorincreases,othernations, bothinside and outsideoftheNorthAtlanticTreaty Organization(NATO),willookto create thesekinds of agreements and alignregulations.

In addition,to address tradewith countriesthat delay or denyregulatory approvalsforU.S.biotechnologyproducts, the U.S.governmentcould encourage mechanismsthat enable“identity preservation”duringproductionand handling.This would allowbiotechnology products that areapprovedintheUnitedStatestobeproducedandsold domestically,whileensuringthatproductsarenotexportedtocountriesthat havenotyetprovidedregulatory approval.ldentitypreservationis alreadyusedvoluntarily inagriculturaltrade,suchastoseparatesoybeanswith heart-healthyoilsfromconventionalsoybeans.Onewayto verifyidentity-preservedsystemsiswiththird-partyaudits (seerecommendation 2.1a).Anidentity-preserved system for some biotechnology products could foster confidence amongtradingpartnersandwouldfacilitatetradeoverall.

Appendix H

Five-Year Recommendation Funding Table

3:Maximize theBenefitsof Biotechnologyfor Defense

$15.142billion

NSCEBStaff

Staff\*

HannahAnderson-Brownlee
Dev Basumallik
JennBeddor
Charlotte Benedict
Avantika Bhaduri
Carson Billingsley
Anastasia Bodnar
Bronwen Boyd
Joe Buccina
Callie Chappell
AllisonCheck
Samuel Curtis
AlexanderDiller
IsaiahDennings
NathanDinh
MariaDooling
ElleEkman
EnochEllis
SamWeiss Evans
CaitlinFrazer,
ExecutiveDirector
JenniferGreen
Kathryn Hamilton
Jamie Hammon
ElijahHarbut
Lauren Hesse
Elizabeth Hinton
Michelle Holko
Emily Horne
Bailey Johnson
Nils Justen
NormKahn
James Karabin
Kayla Knilans
Hannah Kelley
Andrew Luong
MeaganLizarazo
Kimberly Ma
Loren Dealy Mahler
Dennis Mayo
Alina Meltaus
Joe Mertens
Soumya Mohan
KatelynMoon
Sara Madolyn Moore
Emma Morrison
PeterMorgan
StevenMoss
Keeley Mui
ColinMurphree
Balaji Narain
Zeena Nisar
Divita Pandita
OliviaParker
VictoriaRiehle
Helia Samani
Jessica Souder
Aishwarya Sriraman
Kilin Tang
MattWalsh
Hope Wang
AnnaWestbrook
Kyle Wilgus
Anmei Zeng

Commissioner Staff Designees

Jennifer Bagi JessicaBarker Prerna Bhargava EmilyButton AidanCamas Willy Chertman TimothyChu Joel Daly Sarah Drory

KevinFox Sara Garcia Andrea Hodgson Christine Hughes PeterJansen Charlie Ladd Maya Levin Nicole Mata MaryMaxon

BurkeMiller Ali Morton AndrewMoore Suzanne Mulet BethNelson LaurenO'Brien John Pinegar Alli Smith GeoSaba

Symonne Smith Mike Stumborg Jett Thompson Jose (JJ)Villalvazo ZachWilson SelinaXu

Acknowledgements

Specialthanksto:

JasonKelly MeganPalmer

Bunsen Studios

Diane DiEulis Drew Endy RyanJacobs Ben Kellogg Gideon Leek Jake Leffew

Chris Love
ShanaMansbach
LaurelPruchaMoran
JohnPendleton
Bill Petrich
StuartReid
Liza Tobin
PaeWu
Office of Senate Security
Senate Small
BusinessCommittee

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Graphic& CaseStudyEndnotes

TheRoyawedishcademficesThoblPrizhmistry24ThoblPriztober924tts www.nobelprize.org/prizes/chemistry/2024/press-release/.
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ii JunZhangandBinghenFihtingARCo2withStrucuralBiolgMthdsNaueMthds19n.April2: 381-83,https://doi.org/10.1038/s41592-022-01448-9.
iv ResearchCollaboratoryforStructuralBiinformatics,CSBPDBRCSBProteinataBank acessedFebruary425 https://www.rcsb.org/. StephenK.Burleyet al,ProteinataBank(PDB):TheSingleGlobalMacromolecularStructureArchiveMethodsin MolecularBiology1607(2017):627-41,https://doi.org/10.1007/978-1-4939-7000-1_26.
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XX JeanB.Ristainetal,ThePersistenthreatfEmergingPlatDiseasePandemicstoGloalFoodSeurity”Prceedingf theNataadmyfcesMay1:21tp://rg0nas2 CentersforisaseControlandPrevention,irdFCurrentSituation,AvianIflunzaBirdlu)Februar https://ww.cdcgov/bird-f/situation-summary/index.hmlWorldOrganisationforAnimalHealth,Africanwineever WorldOraisationrmlalthassdFbuar95hts:wwoor//isae/fricani
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