u.s. coordinated framework for regulation of biotechnology · • national academy of sciences ......

U.S. Coordinated Framework for Regulation of

Biotechnology Brief

History, Overview and Current Issues J. Thomas Carrato

Creative Biotech Solutions LLC June 2017

Co-Authorship Credits to: •Stanley H. Abramson, Partner

•Karen E. Carr, Partner •Arent Fox, LLP

•Washington, D.C.

1

Coordinated Framework Background

• Public concern with laboratory experiments/Congressional hearings (early 1970’s)

• National Academy of Sciences (1974) – “Go slow” recommendation

• Asilomar Conference (1975) – Builds scientific consensus – Supports self-regulation with federal oversight

© J. Thomas Carrato, Esq. Creative Biotech Solutions, LLC .

2


• National Institutes of Health (NIH) Guidelines (1976 – Present) – Mandatory for recipients of federal funds – Voluntary compliance by private sector

(established de facto standard) – Science-based review process – Criteria adjusted with experience – NIH cancer research upheld

• Mack v. Califano (DDC 1978)


3


• NIH Approval of 1st Field Test (1984) – University of California – “Ice Minus” microbe engineered to resist frost

formation on crops – Enjoined by federal court

• Inadequate environmental assessment under National Environmental Policy Act (NEPA)

• Foundation on Economic Trends (FOET) v. Heckler (DDC 1984; DC Cir. 1985) (Judge John Sirica)

© J. Thomas Carrato, Esq.

Creative Biotech Solutions, LLC .

4

Coordinated Framework Background • Proposal and Request for Public Comments

– White House Office of Science and Technology Policy (OSTP)

– 49 FR 50856 (Dec. 31, 1984) • Publication of Regulatory Matrix and

Establishment of Biotechnology Science Coordinating Committee (OSTP) – 50 FR 47174 (Nov. 14, 1985)


5


• Final Policy announced by OSTP after public comment period – Lead Regulatory Agencies: USDA, EPA &

FDA – 51 FR 23302 (June 26, 1986)


6

Coordinated Framework Key Concepts

• Federal “Safety Net” – All products covered

• microorganisms, animals, seeds, plants, foods, drugs, pesticides, & other chemicals

– Mandate for science-based regulation under existing, product-based statutes

– Each product judged on its merits and must meet the same standard of safety as any other similar product


7

Coordinated Framework Key Concepts – Biotech crops must be as safe to grow and safe

to eat as conventional crops – Individual products or categories eligible for

exemption over time based on experience and data

– Same “precautionary” approach traditionally applied by the U.S. under existing health, safety and environmental statutes


8

Coordinated Framework Key Concepts • No New Legislation Needed

– Existing statutes adequate to address all products and assess safety

– Supreme Court precedent – holding that genetically engineered microorganism subject to protection under Patent Act in same manner as other new inventions

• Diamond v. Chakrabarty (1980)


9

Coordinated Framework Statutory Authority • Department of Agriculture (USDA)

– Plant Protection Act (PPA) – Animal Health Protection Act (AHPA) – Animal Welfare Act – Federal Seed Act (FSA) – Virus-Serum-Toxin Act (VSTA) – National Environmental Policy Act (NEPA) – Endangered Species Act (ESA)


10

Coordinated Framework Statutory Authority

• Food and Drug Administration (FDA) – Federal Food, Drug, and Cosmetic Act

(FFDCA) – National Environmental Policy Act (NEPA)


11

Coordinated Framework Statutory Authority

• Environmental Protection Agency (EPA) – Federal Insecticide, Fungicide, and Rodenticide

Act (FIFRA) – Federal Food, Drug, and Cosmetic Act

(FFDCA) – Toxic Substances Control Act (TSCA) – Endangered Species Act (ESA)


12

Coordinated Framework Product Oversight • Pesticides (including plant-incorporated

protectants (“PIPs”) and microbials) – EPA • Plants and seeds, animal biologics, meat and

poultry – USDA • Food and feed, food and feed additives, human

and animal drugs, human biologics and medical devices – FDA

• Chemicals and microbials not otherwise regulated – EPA


13

Coordinated Framework Early Challenge

• Federal Policy Upheld – Complaint dismissed

• FOET v. Johnson (DDC 1986) – First of several challenges to be filed since

1986 against the Coordinated Framework or actions taken by agencies under the Framework

– No successful challenges until NEPA cases against USDA beginning in 2006


14

Coordinated Framework First Commercial Crop Products

• FDA and USDA – FLAVR SAVR™ tomato (whole food) - 1994

• Delayed ripening trait • Public comment • Public hearings • Scientific peer review • EA/FONSI under NEPA (USDA)

• EPA – Plant-incorporated protectant (NewLeaf®

potato) – 1995


15

Coordinated Framework Implementation – Plants – USDA

• USDA’s Animal and Plant Health Inspection Service (APHIS) regulates the introduction (field test, import, movement) of biotech organisms & products – Plant Protection Act (PPA) and 7 CFR Part 340 – Organism is a “regulated article” if:

• altered or produced using recombinant DNA techniques, AND

• APHIS determines or has “reason to believe” it is a “plant pest”


16

Coordinated Framework Implementation – Plants – USDA – Field tests/movement/import authorized by

• permit or • expedited permit process referred to as notification

(if six eligibility requirements and six performance standards are satisfied)

– Commercial introduction may occur following formal “determination of nonregulated status” (“deregulation”) by APHIS

• organism no longer considered to be a “regulated article” because it is not (unlikely to be) a plant pest


17

Coordinated Framework Implementation – Plants – USDA

– Determination of nonregulated status clears a previously regulated plant for commercialization and use like any other plant

• extensions can be requested (e.g., extension of trait to additional plant line)

• stacks not separately regulated – Developer can also request “up-front” response from

APHIS to “letter of inquiry” confirming that plant is not regulated

• 36 from 2011 - 2016


18

Coordinated Framework Implementation – Plants – EPA

• EPA regulates pesticides and pesticidal ingredients of biotech plants under FIFRA’s standard of “no unreasonable adverse effects on the environment” – Includes risk to human health and the environment – Regulations at 40 CFR Part 174

• Pesticide residues in food must meet FFDCA § 408 safety standard of “reasonable certainty that no harm will result from aggregate exposure” to pesticide chemical residues



19

Coordinated Framework Implementation – Plants – EPA

• Plant Incorporated Protectant (PIP) – Pesticidal substance that is intended to be produced in a

living plant, or the produce thereof, and the genetic material necessary for production of that substance

– 85 PIPs registered since 1995 with associated tolerance exemptions, including Cry proteins, viral coat proteins and 47 stacks/seed blends

– Most PIP registrations for corn are time limited • Pesticides used with biotech plants

– Herbicides approved for use “over-the-top” of HT crops


20

Coordinated Framework Implementation – Plants – FDA

• FDA regulates: – Safety of whole food (incl. feed) based on

“adulteration” standard under FFDCA § 402 – Safety of food ingredients under “reasonable

certainty of no harm” standard under FFDCA § 409


21


• FDA’s 1992 Policy – Foods Derived from New Plant Varieties – 57 FR 22984 (May 29, 1992) – Rebuttable presumption: new plant varieties are

as safe and nutritious as their parental varieties – Transferred genetic material and intended

expression product(s) could be treated as food additives if not “generally recognized as safe” (GRAS)



22


• Voluntary Consultation Process – FDA reviews submissions by developers to

identify any unresolved issues including: • significantly increased levels of plant toxicants or

anti-nutrients • reduction of important nutrients • new substances including allergens • unexpected effects (e.g., undesirable traits)


23


• Consultation process is made de facto mandatory by food chain and trading partners

• Successful consultation – Submitter receives “no further questions” letter – Essentially same result used to conclude GRAS

notification process for new food ingredients – 171 consultations completed since 1995

• 171 events in a variety of different plants


24

• With intensive governmental, academic and commercial oversight since 1986: – not a single instance of actual harm to health, safety or

the environment has ever been demonstrated for any biotech crop on the market today that has successfully completed the U.S. regulatory process

– nor has any court ever overturned an agency action based on a finding that such a crop has caused health, safety or environmental harm

• With the collateral effect that it is widely estimated to cost over $100MM to bring a “traditional” transgenic crop product from concept to market


25

Coordinated Framework Impact & Effect

© J. Thomas Carrato , Esq. Creative Biotech Solutions, LLC .

26

Coordinated Framework Impact & Effect • Unprecedented Regulation of Plants and Plant Products

– Health, safety and environmental data reviewed by three federal agencies over multi-year period

– Plus USDA can regulate existing products that present plant pest or noxious weed risk under PPA

– Plus continued FDA authority over “adulterated” food & feed – Plus ongoing EPA oversight over PIP’s including IRM,

conditions on registration, and time-limited registrations • No comparable oversight for plants derived from

conventional breeding or mutagenesis

Coordinated Framework Current Issues • Coexistence and Trade

– Low Level Presence – Asynchronous Approvals – Specialty Traits

• Scope of EPA & USDA Oversight – OSTP/NAS Reviews

• New Breeding Techniques including “Gene Editing”

• Food Labeling/Right-To-Know/“Natural” • State and Local Anti-biotech Initiatives • NEPA/ESA Litigation


27

Crop Biotechnology References • USDA: www.aphis.usda.gov/aphis/ourfocus/biotechnology • EPA: www.epa.gov/regulation-biotechnology-under-tsca-and-fifra • FDA: www.fda.gov/Food/FoodScienceResearch/GEPlants/default.htm • USDA Economic Research Service. 2014: Adoption of Genetically

Engineered Crops in the United States: http://www.ers.usda.gov/publications/err-economic-research-report/err162.aspx

• International Service for the Acquisition of Agri-Biotech Applications. 2016. ISAAA Brief 51-2015: www.isaaa.org/resources/publications/briefs/51/executive summary/default.asp


28

http://www.aphis.usda.gov/aphis/ourfocus/biotechnology

http://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra

http://www.fda.gov/Food/FoodScienceResearch/GEPlants/default.htm

http://www.ers.usda.gov/publications/err-economic-research-report/err162.aspx

http://www.ers.usda.gov/publications/err-economic-research-report/err162.aspx

http://www.isaaa.org/resources/publications/briefs/51/executive

Crop Biotechnology References • Graham Brookes & Peter Barfoot, 2016. GM crops: global socio-

economic and environmental impacts 1996-2014. PG Economics Ltd. http://www.pgeconomics.co.uk/pdf 2016globalimpactstudymay2016.pdf

• Wilhelm Klumper & Matin Qaim, 2014. A Meta-Analysis of the Impacts of Genetically Modified Crops. PLOS One http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0111629

• Genetically Engineered Crops: Experiences and Prospects; National Academies of Sciences, Engineering, and Medicine, 2016. http://www.nap.edu/catalog/23395/genetically-engineered-crops-experiences-and-prospects


29

http://www.pgeconomics.co.uk/pdf/2016globalimpactstudymay2016.pdf

http://www.pgeconomics.co.uk/pdf/2016globalimpactstudymay2016.pdf

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0111629

http://www.nap.edu/catalog/23395/genetically-engineered-crops-experiences-and-prospects

http://www.nap.edu/catalog/23395/genetically-engineered-crops-experiences-and-prospects

Crop Biotechnology References • Directorate-General for Research & Innovation, European Commission,

A decade of EU funded GMO research (2001-2010): http://ec.Europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf

• American Association for the Advancement of Science, 2012. Statement by the AAAS Board of Directors On Labeling of Genetically Modified Foods: http://www.aaas.org/sites/default/files/AAAS_GM_statement.pdf

• World Health Organization, Frequently asked questions on genetically modified foods (2014): http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/


30

http://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf

http://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf

http://www.aaas.org/sites/default/files/AAAS_GM_statement.pdf

http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/

http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/

Background Slides

31

Coordinated Framework U.S. Crop Biotechnology Overview • Over 20,000 USDA-regulated field trials (or “releases”)

have been conducted of bioengineered (“biotech”) plants in the U.S. since 1985

• Field trials have been conducted on nearly 100,000 sites in virtually every state and have involved over 1.6M genetic constructs and a variety of different traits including: – resistance to harmful insect pests and diseases – tolerance to application of herbicides to growing crops – product quality (e.g., flavor, nutrition) or agronomic traits

(e.g., tolerance to cold, drought, frost, salinity)


32

Coordinated Framework U.S. Crop Biotechnology Overview

• 123 bioengineered plants have been cleared for commercialization in the U.S. since 1995 – 90% or more of corn, cotton, soybeans, canola, & sugar

beets grown in the U.S. contain at least one biotech trait – major commodity crops on the market today are either

insect resistant (Bt), herbicide tolerant (HT), or both


33

Coordinated Framework U.S. Crop Biotechnology Overview

• Bioengineered plants were grown commercially on 175.2M acres in the U.S. in 2015 – three crops (corn, cotton, and soybean) make up the

bulk of the total U.S. biotech acres planted, or about half of the estimated total land used to grow all crops in the U.S.

– other crops include tomato, potato, papaya, rice, squash, alfalfa, plum, apple, rose, tobacco, flax and chicory


34

Coordinated Framework Global Crop Biotechnology Overview

• Since the original commercial plantings in 1996 in the U.S., the first billionth acre of biotech crops was planted worldwide in 2005

• The second billionth acre of biotech crops was planted worldwide in 2008

• Nearly 5 billion cumulative acres of biotech crops were planted globally in the 20 years from 1996 to 2015, with estimated farmer benefits of $150B

• An estimated 17-18M farmers planted biotech crops in 2015 on 444M acres in 28 countries


35


In decreasing order of acreage, the 28 countries planting biotech crops in 2015 include:

1. U.S. 10. Uruguay 19. Sudan 2. Brazil 11. Bolivia 20. Honduras 3. Argentina 12. Philippines 21. Chile 4. India 13. Australia 22. Portugal 5. Canada 14. Burkina Faso 23. Vietnam 6. China 15. Myanmar 24. Czech Republic 7. Paraguay 16. Mexico 25. Slovakia 8. Pakistan 17. Spain 26. Costa Rica 9. South Africa 18. Colombia 27. Bangladesh 28. Romania The top 13 countries each grew 1.7M acres (0.7M has.) or more of biotech crops;

countries in bold each grew 123,553 acres (50,000 has.) or more of biotech crops


36


• Of the 28 countries planting biotech crops in 2015, 20 are developing (with 54% of global biotech acreage) and 8 are industrial (46%)

• Of the 17-18M farmers planting biotech crops in 2015, ~90% are small, resource-poor farmers from developing countries

• Stacked traits represented ~33% of the global acreage in 2015


37

Coordinated Framework Global Crop Biotechnology Overview • Biotech crops support sustainable development in

numerous ways including: – Contributing to food security and more affordable food – Conserving biodiversity – Contributing to the alleviation of poverty and hunger – Reducing agriculture’s environmental footprint – Mitigating climate change and reducing greenhouse

gases – Contributing to cost-effective production of biofuels – Contributing to sustainable economic benefits


38

Coordinated Framework Early Field Tests

• Plants and Microorganisms (1980’s) – EPA – ice minus bacterium – 1985

• Approval required under interim FIFRA policy (1984)

• Scientific peer review/ public comment • Preliminary injunction denied - FOET v.

Thomas (DDC 1986) – EPA – nitrogen-fixing bacterium – 1988

• Cleared under TSCA


39

Coordinated Framework Early Field Tests • Plants and Microorganisms (1980’s)

– USDA – insect resistant tobacco – 1986 • Permit under Plant Pest Act (predecessor to

Plant Protection Act) • Environmental assessment (EA)/finding of no

significant impact (FONSI) under NEPA • Public comment


40

Coordinated Framework First Commercial Products • EPA

– Microbial pesticides – late 1980’s – Enzyme producing bacterium – early 1990’s – Plant-incorporated protectant (NewLeaf®

potato) – 1995 • USDA

– Recombinant pseudorabies vaccine – 1986 • Approval upheld – FOET v. Lyng (DDC 1988)


41

Coordinated Framework First Commercial Products • FDA

– Human insulin (drug) – 1982 – Chymosin enzyme (food additive/generally

recognized as safe or “GRAS”) – 1990 • Used to make cheese • Public comment


42

Coordinated Framework First Commercial Products

• FDA – Recombinant bovine somatotropin (new animal

drug) – 1993 • Scientific peer review • Public hearings • EA/FONSI under NEPA • Approval upheld – Stauber v. Shalala (WD Wis.

1995)


43

Coordinated Framework Case Study – Crop Biotechnology

• Insect-resistant Corn (MON 810) • Protected Against European Corn Borer and

Other Damaging Insect Pests • Plant Expresses Bt (Bacillus thuringiensis)

Insecticidal Protein – Derived from naturally-occurring soil microbe

used by conventional and organic farmers for decades


44

Coordinated Framework Case Study – USDA

• Field Testing Under PPA (no acreage threshold) – First permit application (1991) – Testing under permits and then notifications

(1992 – 1996) – Reports to USDA’s Animal and Plant Health

Inspection Service (APHIS)

© J. Thomas Carrato , Esq Creative Biotech Solutions, LLC .

45

Coordinated Framework Case Study – USDA • Determination of Plant Pest Status (PPA)

– Petition submitted (1995) – Public comment, Environmental Assessment

(EA) and Finding of No Significant Impact (FONSI) under NEPA

– Determination of Non-Regulated Status (1996)


46

Coordinated Framework Case Study – FDA • Food Safety & Nutrition Review

– Covers whole food (not Bt protein) • Must be as safe as conventional foods • Significant changes may require food additive

regulation – Initial consultation (1995)

47

Coordinated Framework Case Study – FDA – Submission of food and feed safety data

summaries (1995-96) – Additional data submission (1996) – FDA letter concluding process (1996)

• Same as letter that concludes the GRAS notification process for food ingredients

48

Coordinated Framework Case Study – EPA

• Field Testing Under FIFRA – First application for experimental use permit

(EUP) (1993) – Large-scale testing under EUPs (1994-96) – Reports to EPA

49


• Tolerance Exemption for Insecticidal Protein (Cry1Ab) Under FFDCA – Petition submitted (1995) – Temporary exemption granted (1996) – Full exemption granted (1996)

© J. Thomas Carrato , Esq


50

Coordinated Framework Case Study – EPA • Registration Under FIFRA

– Original application (1995) – Limited seed propagation application (1995) – Limited seed propagation registration (1996) – Full conditional registration (1997)


51

Coordinated Framework Case Study – EPA • Registration Conditions

– 5-year duration – Annual reports to EPA – Data required for non-targets (1999) – Amendments to address insect resistance

management (IRM) • EPA Reassessment & Reregistration (1999

– 2001)


52


• New Conditional Registrations (2001) – 7-year duration (through 2008, extended

through 2010) • Continued Reauthorization of Conditional

Registrations • Duration set by EPA based on product-specific

basis including assessment of potential risk of insect resistance


53

Coordinated Framework Case Study – Summary • Unprecedented Regulation of Plants and Plant

Products – Health, safety and environmental data reviewed by

three federal agencies over multi-year period • Plus ongoing EPA oversight including annual IRM

reports, on-farm assessments, CAP reports, and data submissions

• Plus USDA ability to regulate existing products that present plant pest or noxious weed risk under PPA

– No comparable oversight for conventional hybrids


54

J.ThomasCarratoCreativeBiotechSolutions,LLCjtcarrato@creativebiotechsolutions.com1.314.420.3573AddendatoSlideDeck:Slide12:EPAStatutoryAuthorityFIFRAhasbeenruledtobethe“functionalequivalentofNEPA”,andtherefore,EPAisnotrequiredtoperformanyenvironmentalassessmentunderNEPA.Slide13:ProductOversightTransgenicAnimals:TheFDAwillhaveoversightovertransgenicanimals,andwillregulatethemodificationofanimalsasnewanimaldrugsonthebasisthatthemodificationsareintendedtochangethestructureorfunctionoftheanimal(thedefinitionofadrug).Asofthiswriting,theFDAwillapplythisauthorityregardlessofhowthechangeoccurs,includingthroughgeneediting.Slide15A:CoordinatedFramework–CurrentDevelopments

• July2,2015–MemofromOSTP,OMB,USTR&CEQtoHeadsofFDA,EPA&USDA

o Begantheprocessofmodernizingtheregulatorysystemforbiotechnologyproducts

• Ultimatelyresultedin:o NationalStrategyforModernizingtheRegulatorySystemforBiotechnologyProducts–September2016;and

o TheFinalVersionofthe2017UpdatetotheCoordinatedFrameworkfortheRegulationofBiotechnology–WhiteHouseblogon4January2017.

©J.ThomasCarrato,CreativeBiotechSolutions,LLC

mailto:[email protected]

• Subsequently,on19January2017:

o USDAissueditsproposedrevisionsto7CFRPart340–APHISBiotechnologyRegulations&RequestforComments–82FR7008

§ USDAextendedthedeadlineforcommentto19June2017–82FR10312

o FDAissuedarequestforcommentontheuseofgenomeeditingtechniquestoproducenewplantvarietiestobeusedforfoodorfeed–82FR6564

§ FDAextendedthedeadlineforcommentto19June2017–82FR17840

• ForinformationontheviewsandcommentsofthebroadbiotechnologysectorandseedindustryontheUSDAandFDAproposalsandrequests,contacttheBiotechnologyInnovationOrganization(BIO)andtheAmericanSeedTradeAssociation(ASTA)

Slide16:USDAImplementation

• Most“traditional”oroldertransgenicplantmodificationsusedelementsofplantpests:e.g.agrobacteriumtransformationorplantpestpromoters(CMVorNPTII)&hencewereartificiallypresumedtobeplantpestsuntil“de-regulated”byUSDA

o “PlantPest”–anylivingstageofvariousentitiesthatcandirectlyorindirectlyinjure,causedamagetoorcausediseaseinanyplantorplantproduct–includingbacterium,fungus,virusorpathogens

• OfnoteintheproposedPart340,USDAintendstomoreexpresslyexerciseitsnoxiousweedauthorityunderthePlantProtectionAct

o “NoxiousWeed”:aninvasive(asapplied=“weedy”)speciesofplantwhichisdesignatedharmfultoagriculturalcrops,ecosystemsorhumansorlivestock.


USDAImplementation

• ThereishopethatUSDAwillbroadlyapplythis“letterofinquiry”approachtogene-editingtechniques.

• USDAisapplyingspecificcriteriaindeterminingthatgeneticallymodifiedplantsarenotsubjecttoregulation,andthecriteriaseemtobeevolving.Examplesofplantsnotsubjecttoregulation:

o Greenfoxtail–DanforthCenter–delayedflowering–Crispr-CAS9–agrotransformation&CMV

§ NoplantpestDNAaftersegregation–notaplantpest§ Notanoxiousweed

o Grasspoaceae–Ceres–salttolerance&wateruseefficiency–biolistics(genegun)–noplantpestelements

§ Notaplantpest§ USDAconsideringlistingmiscanthussinensisasanoxiousweed

• Listedinsomestates• NationalParkService=“planttowatch”

§ USDArequiringfurther“discussion”ofnoxiousweedissue

o Foragebahiagrass–UnivofFL–reducedlignin–Noplantpestsequencesorvectors

§ Notaplantpest§ Notanoxiousweed

o Potato–Simplot–lowPPO5&reducedblackspot–agrotransformation&TALENS

§ NoAgroorTALENSDNAaftersegregation§ OnlyendogenouspotatoDNA

o Sugarcane&sorghum–increasedsugaryield&starch,respectively–biolistic&rDNAinserted,butnoplantpestelements

§ ExogenousDNA§ Noplantpestmaterial


o Wheat–diseaseresistant

§ “mayberegulatedbyEPA&FDA”Slide20:EPAImplementationBecauseRPA’sregulationisbasedontheintenttoconfer,distributeandsellforpesticidaleffect,thereisnoreasontobelievethatEPAwillregulategene-editingdifferentlythanoldertransgenictechniques–ifyoupromoteapesticidaltraityouwillberegulatedbyEPAasaPIP.Slide22:FDAImplementation

• FDA’s1992Policyappliestofoodorfeedfromnewplantvarietiesregardlessofthemethodusedtodevelopthenewplantvariety,includingtraditionalbreeding,ifchange:

o nutritionalcharacteristicso allergens,toxicantsoranti-nutrientso natureoftheplantvariety

• FDA’srequestforcommentsongene-editingtodevelopnewplantvarietiesasksforscientificbasisfordeterminingwhethergene-editing:

o Createsnonewriskso Createspotentialnewriskso ShouldnotorshouldbesubjecttoregulationunderthePolicy

• Todate,FDAexpectsconsultationongene-editednewplantvarieties

Slide23:FDAconsultationdossiersaddressallofthereferencedpotentialissues,aswellasincludingacompletecompositionalanalysis.©J.ThomasCarrato,CreativeBiotechSolutions,LLC

Todate,noGEfoodorfeedproducthasbeencommercializedintheU.S.withoutgoingthroughtheFDAconsultationprocess.Slide27:GeneeditingisexcludedfromthenewFederalGMO“disclosure”law,totheextentthatthemodificationcouldbeaccomplishedthroughtraditionalbreedingandthereisnoexogenousDNA.TheUSDAischargedwithdevelopingimplementingregulations.Slide46:TheUSDAprocessnowtakessignificantlylonger!©J.ThomasCarrato,CreativeBiotechSolutions,LLC

u.s. coordinated framework for regulation of biotechnology · • national academy of sciences ......

Documents